In this article, you can read the instructions for using the drug Flemoclav Solutab. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of the antibiotic Flemoklav solutab in their practice are presented. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Flemoclav Solutab in the presence of existing structural analogues. Use for the treatment of sore throats, herpes and others infectious diseases adults, children, as well as during pregnancy and lactation. The composition and interaction of the drug with alcohol.

Flemoclav Solutab- a broad-spectrum antibiotic; combination drug amoxicillin and clavulanic acid, a beta-lactamase inhibitor. Active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamase).

Amoxicillin acts bactericidal, inhibits the synthesis of peptidoglycan of the bacterial cell wall. Clavulanic acid inhibits beta-lactamase types 2, 3, 4 and 5. Not active against type 1 beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases and expands its spectrum of action.

Flemoklav Solutab is active against aerobic and anaerobic gram-positive bacteria, aerobic and anaerobic gram-negative bacteria.

Composition

Amoxicillin trihydrate (Amoxicillin) + Potassium clavulanate (Clavulanic acid) + excipients.

Pharmacokinetics

Amoxicillin

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The absorption of amoxicillin when administered orally is 90-94%. Simultaneous food intake does not affect absorption. Amoxicillin crosses the placental barrier and is excreted in small amounts in breast milk. Approximately 60-80% of amoxicillin is excreted through the kidneys during the first 6 hours after taking the drug.

clavulanic acid

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 60%. Simultaneous food intake does not affect absorption. Serum protein binding is 22%. Clavulanic acid crosses the placental barrier. There are no reliable data on excretion with breast milk. Clavulanic acid is extensively metabolized by hydrolysis and subsequent decarboxylation. Approximately 30-50% of clavulanic acid is excreted through the kidneys during the first 6 hours after taking the drug.

Indications

• bacterial infections caused by susceptible pathogens: infections of the lower respiratory tract(bronchitis (acute and exacerbation of chronic), pneumonia, pleural empyema, lung abscess);
• ENT infections (sinusitis, tonsillitis, tonsillitis, otitis media);
• infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvic peritonitis, soft chancre, gonorrhea);
• infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);
• osteomyelitis;
• postoperative infections;
• infection prevention in surgery.

Release form

Dispersible tablets 125 mg, 250 mg, 500 mg, 625 mg, 875 mg and 1000 mg.

There are no other forms of release, whether it be syrup, injections in ampoules or capsules.

Instructions for use and dosage

Adults and children over 12 years old and children under 12 years old weighing more than 40 kg Flemoclav Solutab at a dose of 875 mg / 125 mg is prescribed 2 times a day (every 12 hours).

Children under 12 years of age weighing less than 40 kg are prescribed Flemoklav Solutab in smaller dosages.

For adults and children weighing more than 40 kg, the drug is prescribed 500 mg / 125 mg 3 times a day. In severe, chronic, recurrent infections, this dose can be doubled.

The daily dose for children is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. Possible dosing regimen for children, depending on the age and body weight of the child:

• age from 3 months to 2 years - body weight from 5 to 12 kg - daily dose tablets 125 mg / 31.25 mg 2 times a day;
• age from 2 to 7 years - body weight from 13 to 25 kg - daily dose of a tablet 125 mg / 31.25 mg 3 times a day;
• age from 7 to 12 years - body weight from 25 to 37 kg - daily dose of a tablet 250 mg / 62.5 mg 3 times a day.

In severe infections, these doses can be doubled (the maximum daily dose is 60 mg of amoxicillin and 15 mg of clavulanic acid per kg of body weight).

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless necessary.

To prevent the occurrence side effects from the side digestive system the drug is recommended to be taken at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use (a suspension suitable for children is obtained).

Side effect

• thrombocytosis, hemolytic anemia, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia;
• increase in prothrombin time and bleeding time;
• dizziness;
• headache;
• convulsions;
• anxiety;
• anxiety;
• insomnia;
• disturbance of consciousness;
• aggressive behavior;
• vasculitis;
• abdominal pain;
• nausea, vomiting;
• flatulence;
• diarrhea;
• pseudomembranous colitis (in case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy);
• intestinal candidiasis;
• hemorrhagic colitis;
• cholestatic jaundice;
• itching, burning and vaginal discharge;
• interstitial nephritis;
• skin rash and itching;
• morbilliform exanthema;
• hives;
• bullous or exfoliative dermatitis (erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• anaphylactic shock;
• medicinal fever;
• eosinophilia;
• angioedema (Quincke's edema);
• swelling of the larynx;
• serum sickness;
• hemolytic anemia;
• allergic vasculitis;
• bacterial or fungal superinfections (with prolonged therapy or repeated courses of therapy).

Contraindications

• abnormal liver function (including jaundice) when taking amoxicillin / clavulanic acid in history;
• Infectious mononucleosis;
• lymphocytic leukemia;
• renal failure (glomerular filtration ≤ 30 ml / min) - for dispersible tablets 875 mg / 125 mg;
• children under the age of 12 weighing less than 40 kg (for dispersible tablets 875 mg / 125 mg);
• hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;
• hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins).

Use during pregnancy and lactation

When using Flemoclav Solutab during pregnancy, its negative effect on the fetus or newborn was not noted. The use of the drug in the 2nd and 3rd trimester of pregnancy is possible after a medical risk / benefit assessment. In the 1st trimester of pregnancy, the use of Flemoclav Solutab should be avoided (only for dispersible tablets 875 mg / 125 mg). Dispersible tablets 125 mg / 31.25 mg, 250 mg / 62.5 mg, 500 mg / 125 mg in the 1st trimester of pregnancy should be administered with caution.

Amoxicillin and clavulanic acid cross the hematoplacental barrier and are excreted in breast milk. It is possible to use the drug during breastfeeding.

If a child develops sensitization, diarrhea or mucosal candidiasis, breastfeeding should be discontinued.

special instructions

When taking Flemoclav Solutab, there is the possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

In the event of the development of anaphylactic reactions, the drug should be stopped immediately and appropriate therapy should be carried out: for the treatment of anaphylactic shock, urgent administration of epinephrine (adrenaline), glucocorticosteroids (GCS) and elimination of respiratory failure may be required.

Superinfection (eg, candidiasis) may develop, especially in patients with chronic diseases and/or dysfunction immune system. In the event of superinfection, the drug is canceled and / or antibiotic therapy is changed accordingly.

For patients with severe gastrointestinal disorders accompanied by vomiting and / or diarrhea, the appointment of Flemoklav Solutab is not advisable until the above symptoms are eliminated, because. possible violation of the absorption of the drug from the gastrointestinal tract.

The appearance of severe and persistent diarrhea may be associated with the development of pseudomembranous colitis, in which case the drug is canceled and prescribed necessary treatment. In the case of the development of hemorrhagic colitis, immediate withdrawal of the drug and corrective therapy are also necessary. The use of drugs that weaken intestinal motility in these cases is contraindicated.

In case of impaired liver function, the drug should be administered with caution and under constant medical supervision. Do not use the drug for more than 14 days without assessing liver function.

In a single study, prophylactic amoxicillin/clavulanate in women with preterm rupture of membranes increased the risk of neonatal necrotizing enterocolitis.

While taking the drug, there may be an increase in prothrombin time. Therefore, Flemoklav Solutab should be administered with caution to patients receiving anticoagulant therapy (it is necessary to monitor blood clotting indicators).

Due to the high concentration of amoxicillin in the urine, it can be deposited on the walls of the urinary catheter, so such patients require periodic change of catheters. Forced diuresis accelerates the excretion of amoxicillin and reduces its plasma concentration.

During the period of use of Flemoclav Solutab, non-enzymatic methods for determining glucose in the urine, as well as a test for urobilinogen, may give false positive results.

During the course of treatment, it is necessary to control the functions of the hematopoietic organs, liver and kidneys.

In the event of seizures during therapy, the drug is canceled.

It should be noted that 1 dispersible tablet 875 mg/125 mg contains 25 mg of potassium.

drug interaction

With simultaneous use with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin / clavulanic acid was noted.

Flemoklav solutab should not be administered concomitantly with disulfiram.

Concomitant use of drugs that inhibit the renal excretion of amoxicillin (probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazone), promotes an increase in the concentration and a longer stay of amoxicillin in the blood plasma and bile. The excretion of clavulanic acid is not disturbed.

With simultaneous use with Flemoclav Solutab, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of amoxicillin, ascorbic acid increases the absorption of amoxicillin.

The simultaneous use of Flemoclav Solutab with allopurinol may increase the risk of developing a skin rash.

Ethanol (alcohol) reduces the rate of absorption of Amoxicillin in the gastrointestinal tract.

Aminopenicillins can reduce the concentration of sulfasalazine in the blood serum.

Amoxicillin reduces the renal clearance of methotrexate, which may lead to an increased risk of its toxic effects. When taken simultaneously with amoxicillin, monitoring of the concentration of methotrexate in the blood serum is necessary.

The simultaneous use of amoxicillin / clavulanic acid and digoxin may lead to increased absorption of digoxin.

With the simultaneous use of Flemoclav Solutab and indirect anticoagulants, an increase in the risk of bleeding is possible.

IN rare cases while taking amoxicillin, there was a decrease in the effectiveness of oral contraceptives, so the patient should be advised to use non-hormonal methods of contraception.

Analogues of the drug Flemoklav solutab

Structural analogues for the active substance:

• Amovicomb;
• Amoxiclav;
• Amoxiclav Quiktab;
• Amoxicillin + Clavulanic acid Pfizer;
• Arlet;
• Augmentin;
• Bactoclav;
• Verclave;
• Klamosar;
• Liklav;
• Medoklav;
• Panklav;
• ranclave;
• Rapiclav;
• Taromentin;
• Fibell;
• Ecoclave.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Catad_pgroup Antibiotics penicillins

Flemoklav Solutab - instructions for use

Registration number:

LSR-000392/09 - 060516

Tradename:

Flemoklav Solutab ®

INN or grouping name:

amoxicillin + clavulanic acid

Dosage form:

dispersible tablets

Composition:

One tablet contains:

Active substance: amrxicillin trihydrate (which corresponds to amoxicillin base) - 1019.8 mg (875.0 mg); potassium clavulanate (corresponding to clavulanic acid) -148.9 mg (125 mg).

Excipients: dispersed cellulose - 30.4 mg, microcrystalline cellulose - 125.9 mg, crospovidone - 64.0 mg, vanillin - 1.0 mg, tangerine flavor - 9.0 mg, lemon flavor - 11.0 mg, saccharin - 13, 0 mg, magnesium stearate - 6.0 mg.

Description

Dispersible tablets, oblong, white to yellow in color, without a risk, marked "425" and the graphic part of the company's logo. Brown spots are allowed.

Pharmacotherapeutic group:

Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.

CodeATH:

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Mechanism of action

Amoxicillin is a semi-synthetic broad-spectrum antibiotic with activity against many fam-positive and fam-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not apply to microorganisms that produce this enzyme. Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins.

Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the drug Flemoklav Solutab protects amoxicillin from destruction by enzymes - beta-lactamases, which allows expanding the antibacterial spectrum of amoxicillin. The following is the activity of the combination of amoxicillin with clavulanic acid in vitro.

Bacteria normally sensitive to the combination of amoxicillin with clavulanic acid

Gram-positive aerobes:

Bacillus anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroides
Streptococcus pyogenes 1.2
Streptococcus agalactiae 1.2
Streptococcus spp.(other beta-hemolytic streptococci) 1.2
Staphylococcus aureus(sensitive to methicillin) 1
Staphylococcus saprophyticus(sensitive to methicillin)

Coagulase-negative staphylococci, (sensitive to methicillin).

Gram-positive anaerobes:

Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.

Gram-negative aerobes:

Bordetella pertussis
Haemophilus influenzae 1
Helicobacter pylori
Moraxella catarrhalis 1
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae.

Gram-negative anaerobes:

Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.

Others:

Borrelia burgdorferi
Leptospira icterohaemorrhagiae
Treponema pallidum.

Bacteria for which acquired resistance is likely to the combination of amoxicillin with clavulanic acid

Gram-negative aerobes:

Escherichia coli 1
Klebsiella oxytoca
Klebsiella pneumoniae 1
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris,
Proteus spp.
Salmonella spp.
Shigella spp.

Gram-positive aerobes:

Corynebacterium spp.
Enterococcus faecium
Streptococcus pneumoniae 1.2

group streptococci Viridans 2

Bacteria that are naturally resistant to the combination of amoxicillin withclavulanic acid

Gram-negative aerobes:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomonas maltophilia
Yersinia enterocolitica.

Other:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetii
Mycoplasma spp.

1 - for these types of microorganisms, the clinical efficacy of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 - strains of these bacterial species do not produce p-lactamase. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Pharmacokinetics

Suction

Both active substances and the drug Flemoklav Solutab®, amoxicillin and clavulanic acid, are rapidly and completely absorbed from gastrointestinal tract(GIT) after oral intake. Absorption of active ingredients is optimal if the drug is taken at the beginning of a meal.

After a single dose of Flemoclav Solutab® at a dose of 875/125 mg (amoxicillin / clavulanic acid), the maximum concentration of amoxicillin in the blood plasma is created after 1.5 hours (t max), and is 12 μg / ml (Cmax), clavulanic acid - after 1 hour, amounting to 3 μg / ml. AFC (area under the pharmacokinetic curve) of amoxicillin and clavulanic acid is 33 mcg/l and 6 mcg/l, respectively. The absorption of amoxicillin when administered orally reaches 90%, the absolute bioavailability of clavulanic acid averages 60%.

Distribution

As with intravenous administration combinations of amoxicillin with clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (in gallbladder, abdominal tissues, skin, fat and muscle tissues, synovial and peritoneal fluids, bile, purulent discharge). Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Approximately 17-20% of amoxicillin and 22% of clavulanic acid binds to plasma proteins.

In animal studies, no accumulation of the components of the drug Flemoklav Solutab in any organ was found.

Amoxicillin, like most penicillins, penetrates into breast milk. Trace amounts of clavulanic acid have also been found in breast milk. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the mucous membranes of the oral cavity, no other negative effects of amoxicillin and clavulanic acid on the health of breastfed infants are known. Reproductive studies in animals have shown that amoxicillin and clavulanic acid cross the placental barrier. However, there was no negative effect on the fetus.

Metabolism

10-25% of the initial dose of amoxicillin is excreted in the urine as an inactive metabolite (penicillic acid). Clavulanic acid is extensively metabolized to 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxybutan-2-one and excreted by the kidneys , through the gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide.

breeding

The total clearance for two active substances is 25 l / h, the half-life (t1 / 2) of amoxicillin is 1.1 hours, clavulanic acid is 0.9 hours.

Approximately 60-80% of amoxicillin and 30-50% of clavulanic acid is excreted through the kidneys during the first 6 hours after taking the drug.

The simultaneous administration of probenecid slows down the excretion of amoxicillin, but not clavulanic acid (see section "Interaction with other medicinal products").

INDICATIONS FOR USE

The combination of amoxicillin with clavulanic acid is indicated for the treatment bacterial infections the following localizations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:

Upper respiratory tract infections (including ENT infections), eg, recurrent tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae, Haemophilus influenzae#, Moraxella catarrhalis# And Streptococcus pyogenes.

Lower respiratory tract infections, such as exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae# And Moraxella catarrhalis # .

Urinary tract infections, eg, cystitis, urethritis, pyelonephritis, female genital infections, usually caused by species of the family Enterobacteriaceae 1 (mainly Escherichiacoli # ), Staphylococcussaprophyticus and species of the genus Enterococcus, but also gonorrhea, caused Neisseria gonorrhoeae#

Skin and soft tissue infections, usually caused by Staphylococcus aureus # , Streptococcus pyogenes and species of the genus Vasteroides # .

Bone and joint infections, such as osteomyelitis, usually caused by Staphylococcus aureus # , if necessary, long-term therapy is possible.

Odontogenic infections, eg, periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulitis.

Other mixed infections (eg, septic abortion, puerperal sepsis, intra-abdominal sepsis) within step therapy.

Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see also the section " Pharmacological properties"). Infections caused by microorganisms sensitive to amoxicillin can be treated with Flemoklav Solutab, since amoxicillin is one of its active ingredients. Flemoklav Solutab is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing beta-lactamase sensitive to the combination of amoxicillin with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies by region and over time. Where possible, local sensitivity data should be taken into account. Where necessary, microbiological samples should be collected and tested for bacteriological susceptibility.

CONTRAINDICATIONS

• Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins) in history;
• previous episodes of jaundice or abnormal liver function when using a combination of amoxicillin with clavulanic acid in history;
• children under 12 years of age or body weight less than 40 kg;
• impaired renal function (creatinine clearance< 30 мл/мин).

Carefully: severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure.

USE IN PREGNANCY AND DURING BREASTFEEDING

Pregnancy

In studies of reproductive function in animals, oral and parenteral administration of the drug amoxicillin + clavulanic acid did not cause teratogenic effects. In a single study in women with premature rupture of the membranes, it was found that prophylactic drug therapy may be associated with an increased risk of necrotizing enterocolitis in newborns. Like everyone else medications, Flemoklav Solutab is not recommended during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

breastfeeding period

Flemoklav Solutab can be used during breastfeeding. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the mucous membranes of the oral cavity associated with the penetration into breast milk of trace amounts of the active substances of this drug, no other adverse effects in children who are on breastfeeding, was not observed. In the event of adverse effects in children who are breastfed, breastfeeding should be discontinued.

METHOD OF APPLICATION AND DOSES

To prevent dyspeptic symptoms, Flemoklav Solutab® is prescribed at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use.

For oral administration.

The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.

Treatment should not be continued for more than 14 days without a review of the clinical situation.

If necessary, it is possible to carry out stepwise therapy (first, parenteral administration of the drug, followed by the transition to oral administration).

Adults and children 12 years of age or older or weighing 40 kg or more

1 tablet 875 mg / 125 mg 2 times a day.

Special patient groups

Children under 12 years of age weighing less than 40 kg

Elderly patients

Dosing regimen correction is not required. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function.

Patients with impaired renal function

Tablets 875 mg / 125 mg should only be used in patients with creatinine clearance greater than 30 ml / min, and dosing adjustments are not required.

In most cases, if possible, parenteral therapy should be preferred. Seizures may occur in patients with impaired renal function (see section " Side effects”, “Overdose”).

Patients with impaired liver function

Treatment is carried out with caution; regularly monitor liver function. There is not enough data to change the recommendation of the dosing regimen in these patients.

SIDE EFFECTS

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: Often(>1/10), often(>1/100, <1/10), infrequently(>1/1000, <1/100), seldom(>1/10 000, <1/1000), very rarely(<1/10 000). Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

Frequency of occurrence of undesirable reactions

Rare: reversible leukopenia (including neutropenia), reversible thrombocytopenia.

Very rare: reversible agranulocytosis and reversible hemolytic anemia, prolongation of bleeding time and prothrombin time, anemia, eosinophilia, thrombocytosis.

Immune System Disorders

Very rarely: angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis.

Nervous System Disorders

Uncommon: dizziness, headache.

Very rare: reversible hyperactivity, convulsions. Convulsions may occur in patients with impaired renal function, as well as in those who receive high doses of the drug (see section "Method of application and doses" - Patients with impaired renal function,"Overdose"). Insomnia, agitation, anxiety, behavior change.

Gastrointestinal disorders

Adults:

Very common: diarrhea. Often: nausea, vomiting.

Children:

Often: diarrhea, nausea, vomiting.

Whole population:

Nausea was most commonly associated with the use of high doses of the drug. If, after the start of taking the drug, undesirable reactions from the gastrointestinal tract are observed, they can be eliminated if Flemoklav Solutab is taken at the beginning of a meal.

Uncommon: indigestion.

Very rarely: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) (see section "Special Instructions"), black "hairy" tongue, gastritis, stomatitis.

Liver and biliary tract disorders

Infrequently: a moderate increase in the activity of aspartate aminotransferase and / or alanine aminotransferase (ACT and / or ALT). This reaction has been observed in patients treated with beta-lactam antibiotics, but its clinical significance is unknown.

Very rare: hepatitis and cholestatic jaundice. These reactions are observed in patients receiving therapy with penicillin antibiotics and cephalosporins. An increase in the concentration of bilirubin and alkaline phosphatase.

Adverse reactions from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rare in children.

The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, in extremely rare cases there have been reports of death. In almost all cases, these were individuals with serious comorbidities or patients receiving concomitantly potentially hepatotoxic drugs.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, urticaria.

Rare: erythema multiforme.

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

Renal disorders and urinary tract

Very rarely: interstitial nephritis, crystalluria (see section "Overdose"), hematuria.

OVERDOSE

Symptoms

Gastrointestinal symptoms and fluid and electrolyte imbalance may occur. Amoxicillin crystalluria has been described, in some cases leading to the development kidney failure(See section "Special instructions and precautions"). Convulsions may occur in patients with impaired renal function, as well as in those who receive high doses of the drug (see section "Method of application and doses" - Patients withimpaired renal function,"Side effects").

Treatment

Gastrointestinal symptoms - symptomatic therapy, paying special attention to the normalization of water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study, which was conducted in 51 children in a poison control center, showed that the administration of amoxicillin at a dose of less than 250 mg/kg did not lead to significant clinical symptoms and did not require gastric lavage.

INTERACTIONS WITH OTHER DRUGS

Simultaneous use of the drug Flemoklav Solutab® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Flemoklav Solutab® and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid.

Concomitant use of allopurinol and amoxicillin may increase the risk of allergic skin reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. Penicillins are able to slow down the excretion of methotrexate from the body by inhibiting its tubular secretion, therefore, the simultaneous use of the drug Flemoklav Solutab and methotrexate may increase the toxicity of methotrexate. Like other antibacterial drugs, Flemoclav Solutab® can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of an increase in the international normalized ratio (MNR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If it is necessary to simultaneously prescribe the drug Flemoclav Solutab® with anticoagulants, the prothrombin time or MHO should be carefully monitored when prescribing or canceling the drug Flemoclav Solutab, dose adjustment of anticoagulants for oral administration may be required.

In patients treated with mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure.

SPECIAL INSTRUCTIONS

Before starting treatment with Flemoklav Solutab, a detailed history should be taken regarding previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient. Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In the event of an allergic reaction, treatment with Flemoklav Solutab should be discontinued and appropriate alternative therapy initiated. Serious hypersensitivity reactions should promptly administer epinephrine to the patient. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.

In the event of skin allergic reactions, treatment with Flemoklav Solutab should be discontinued.

If infectious mononucleosis is suspected, Flemoclav Solutab should not be used, since in patients with this disease, amoxicillin can cause a measles-like skin rash, which makes it difficult to diagnose the disease.

Long-term treatment with Flemoklav Solutab may lead to overgrowth of non-susceptible microorganisms.

Cases of pseudomembranous colitis have been described with antibiotics, the severity of which can vary from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If diarrhea is prolonged or severe and the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined.

In general, Flemoklav Solutab® is well tolerated and has a low toxicity characteristic of all penicillins. During long-term therapy with Flemoklav Solutab®, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis. In patients receiving a combination of amoxicillin with clavulanic acid together with indirect (oral) anticoagulants, in rare cases, an increase in prothrombin time (increased MHO) was reported. With the joint appointment of indirect (oral) anticoagulants with a combination of amoxicillin with clavulanic acid, it is necessary to control the relevant indicators.

To maintain the desired effect of oral anticoagulants, dose adjustment may be required. In patients with reduced diuresis, crystalluria very rarely occurs, mainly with parenteral therapy. During the introduction of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation (see section "Overdose").

Taking Flemoklav Solutab® orally leads to a high content of amoxicillin in the urine, which can lead to false positive results in determining glucose in the urine (for example, Benedict's test, Fehling's test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine. Clavulanic acid can cause non-specific binding of immunoglobulin G and albumin to erythrocyte membranes, leading to false positive Coombs test results.

One dispersible tablet of Flemoklav Solutab® 875/125 mg contains 0.64 mmol (25 mg) of potassium. Potassium intake of more than 1 mmol per day requires special attention in patients with reduced kidney function and those on a controlled potassium diet.

Abuse and drug dependence

There were no drug dependence, addiction and euphoria reactions associated with the use of the drug Flemoklav Solutab.

EFFECT ON ABILITY TO DRIVE VEHICLES,MECHANISMS

Studies on the effect on the ability to drive vehicles and work with mechanisms have not been conducted. Since the drug can cause side effects (for example, allergic reactions, dizziness, convulsions) (see section "Side Effects"), it is necessary to warn patients about precautions when driving a vehicle or working with moving mechanisms.

RELEASE FORM

Dispersible tablets 875 mg + 125 mg. 7 tablets in a blister, 2 blisters, together with instructions for use, are placed in a cardboard box.

STORAGE CONDITIONS

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Best before date

2 years. Do not use after the expiry date stated on the packaging.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES

On prescription.

REGISTRATION AUTHORIZATION OWNER

Astellas Pharma Europe B.V.
Silviusweg 62, 2333 BE Leiden, The Netherlands

MANUFACTURER

Astellas Pharma Europe B.V.,
Hogemaat 2, 7942 JG Meppel, The Netherlands

BAGGED AND/OR PACKED

Astellas Pharma Europ B.V., Netherlands or CJSC ORTAT, Russia

Claims for quality are accepted by the Representative Office of the Private Limited Liability Company "Astellas Pharma Europe B.V." (Netherlands) in Moscow at the address:

109147 Moscow, Marksistskaya st., 16, "Mosalarko Plaza-1" business center, floor 3.

Flemoclav Solutab (Flemoclav Solutab)

Composition

1 tablet of Flemoclav 125+31.25 contains:
Amoxicillin - 125 mg;
Clavulanic acid - 31.25 mg;

1 tablet of Flemoclav 250+62.5 contains:
Amoxicillin - 250 mg;
Clavulanic acid - 62.5 mg;
Additional substances, including vanillin and saccharin.

1 tablet of Flemoclav 500+125 contains:
Amoxicillin - 500 mg;

Additional substances, including vanillin and saccharin.

1 tablet of Flemoclav 875+125 contains:
Amoxicillin - 875 mg;
Clavulanic acid - 125 mg;
Additional substances, including vanillin and saccharin.

pharmachologic effect

Flemoklav Solutab is a broad-spectrum antibiotic that is active against gram-positive and gram-negative microorganisms, including bacteria that produce beta-lactamase. Amoxicillin in combination with clavulanic acid has a significantly greater spectrum of action than with monotherapy.
Amoxicillin is a beta-lactam antibiotic of the penicillin group. Amoxicillin breaks the integrity of the cell membrane of bacteria, resulting in the death of the microorganism. Amoxicillin is inactivated by beta-lactamases, therefore, when monotherapy is inactive against strains that produce beta-lactamases.

Clavulanic acid - has a slight antimicrobial effect. Clavulanic acid inactivates beta-lactamase of staphylococci and gram-negative bacteria.
Flemoklav Solutab is effective against Streptococcus faecalis, Streptococcus pyogenes, Staphylococcus aureus, Staphylococcus epidermidis, Moraxella catarrhalis, Haemophilus influenzae, Proteus mirabilis, as well as Bacteroides fragilis, Neisseria gonorrhoeae, Neisseria meningitidis, Klebsiella spp., Escherichella spps, Salmongella coli. .
The absolute bioavailability of amoxicillin when administered orally depends on the dose and is about 72-94%, clavulanic acid - about 60%. The peak plasma concentration of amoxicillin and clavulanic acid is reached within 1-2 hours. Eating does not affect the rate of absorption and bioavailability of the drug Flemoklav Solutab.

Amoxicillin is excreted mainly by the kidneys, the half-life is about 1-1.5 hours, in patients with impaired renal function, the half-life of amoxicillin increases. Amoxicillin crosses the hematoplacental barrier and is found in breast milk.

Indications for use

Flemoklav Solutab is intended for the treatment of patients with infectious diseases of various localization and severity, which are caused by microflora sensitive to the combination of amoxicillin and clavulanic acid.
In particular, Flemoklav Solutab is prescribed in otolaryngological practice and for infectious diseases of the skin, soft tissues, respiratory tract and organs of the genitourinary tract.
Flemoklav Solutab can also be prescribed for sepsis, osteomyelitis, peritonitis and postoperative infections.

Mode of application

Flemoklav Solutab is intended for oral use. Dispersed tablets should be swallowed whole or chewed with a small amount of drinking water. In addition, tablets can be taken by first dissolving in half a glass of drinking water. To reduce the risk of developing undesirable effects from the digestive tract, the drug should be taken immediately before meals. To achieve the maximum therapeutic effect, the tablets are recommended to be taken at regular intervals. Therapy with the drug should be continued for at least 3 days after the disappearance of the symptoms of the disease. For infections caused by hemolytic streptococcus, the duration of therapy should be at least 10 days.
The maximum recommended duration of the drug is 14 days, in case a longer intake is required, it is advisable to regularly monitor the function of the liver and kidneys, as well as the blood picture.

The duration of administration and dose of the drug Flemoclav is determined by the attending physician.
The recommended doses of the drug are given in terms of amoxicillin.
Adults and adolescents weighing more than 40 kg are usually prescribed 500 mg of the drug three times a day. In chronic, recurrent infections, as well as severe forms of disease, the dose can be increased to 875-1000 mg of amoxicillin three times a day.
Children weighing 13 to 37 kg are usually prescribed 20-30 mg/kg of body weight per day. The daily dose should be divided into three doses. In chronic, recurrent infections, as well as severe forms of disease, the dose can be increased to 60 mg / kg of body weight per day.
Elderly patients with normal renal function dose adjustment of Flemoclav is not required.
For patients with impaired renal function, the dose of amoxicillin and clavulanic acid is calculated depending on creatinine clearance.

Adults with creatinine clearance from 10 to 30 ml / min, as a rule, are prescribed 500 mg of amoxicillin twice a day.
Adults with creatinine clearance less than 10 ml / min, as a rule, are prescribed 500 mg of amoxicillin per day.
Adults on hemodialysis are advised to prescribe 500 mg of amoxicillin per day, as well as taking an additional dose (500 mg of amoxicillin) after a hemodialysis session.
Children with creatinine clearance from 10 to 30 ml / min, as a rule, are prescribed amoxicillin at a dose of 15 mg / kg of body weight twice a day.
Children with creatinine clearance less than 10 ml / min, as a rule, are prescribed amoxicillin at a dose of 15 mg / kg of body weight per day.
For children on hemodialysis, it is recommended to prescribe amoxicillin at a dose of 15 mg/kg body weight per day, as well as taking an additional dose (15 mg/kg body weight) after a hemodialysis session.

Side effects

During therapy with amoxicillin and clavulanic acid, the following adverse events may develop:
From the hepatobiliary system and gastrointestinal tract: pain and discomfort in the stomach, nausea, flatulence, vomiting, diarrhea, dyspepsia, discoloration of tooth enamel, dryness of the oral mucosa, changes in taste sensations and increased levels of liver enzymes. In some cases, the development of pseudomembranous colitis, hemorrhagic colitis, intestinal candidiasis, hepatitis (including cholestasis) and severe liver dysfunction have been noted.
From the side of blood vessels, heart and hematopoietic system: hemolytic anemia, thrombocytosis, granulocytopenia, leukopenia, thrombocytopenia, pancytopenia, anemia and myelosuppression. In addition, there was an increase in bleeding time and the development of vasculitis.

From the side of the central nervous system: convulsions, headache, dizziness, causeless anxiety, increased fatigue, aggression.
Allergic reactions: urticaria, exanthema, pruritus, Stevens-Johnson syndrome, exudative erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis and angioedema. In isolated cases, the development of anaphylactic shock (including fatal) was noted; in this case, epinephrine, parenteral glucocorticosteroids are prescribed, and respiratory failure is treated.
Others: superinfection, vaginal candidiasis, vaginitis, interstitial nephritis, crystalluria.

Contraindications

Flemoclav is not prescribed to patients with individual intolerance to amoxicillin, clavulanic acid and beta-lactam antibiotics (including penicillins and cephalosporins).
Flemoklav should not be used in patients who have developed liver dysfunction with a previous intake of clavulanic acid or amoxicillin, as well as in patients with diseases of the digestive tract, which are accompanied by chronic diarrhea and vomiting.
The drug is not recommended for the treatment of children weighing less than 13 kg.
Flemoclav is contraindicated in infectious mononucleosis and lymphocytic leukemia.

Special care should be taken when prescribing Flemoclav to patients with a tendency to develop anaphylactoid reactions, bronchial asthma, and impaired liver and kidney function.
During therapy with Flemoclav, it is recommended to carefully monitor the condition of patients receiving anticoagulants, as well as patients who use urinary catheters.
Patients who drive a car or operate potentially unsafe machinery should be especially careful during the period of therapy with Flemoklav.

Pregnancy

Amoxicillin and clavulanic acid do not adversely affect the development of the fetus. The combination of amoxicillin and clavulanic acid may be given during pregnancy after a careful assessment of the risks and benefits. In the first trimester of pregnancy, safer alternatives are recommended.
If it is impossible to avoid taking Flemoklav during lactation, it is recommended to resolve the issue of temporary interruption of breastfeeding.

drug interaction

During therapy with Flemoklav, chemotherapeutic drugs and antibiotics with a bacteriostatic effect should not be prescribed (with combined use, the effectiveness of amoxicillin decreases).
The effectiveness of amoxicillin may increase when used in combination with cephalosporins, rifampicin, vancomycin and cycloserine.
The combined use of amoxicillin with disulfiram is prohibited.
There is an increase in the level of plasma concentrations of amoxicillin when combined with probenecid, oxyphenbutazone, butadione, indomethacin, sulfinpyrazone and acetylsalicylic acid.
The risk of skin allergic reactions increases with the combined use of Flemoclav with allopurinol.

Amoxicillin reduces plasma concentrations of sulfasalazine and increases plasma concentrations and toxicity of methotrexate when used concomitantly.
Flemoklav with simultaneous use can increase the absorption of digoxin.
The risk of bleeding increases with the combined use of coumarin anticoagulants and Flemoclav.
The combination of amoxicillin and clavulanic acid may reduce the effectiveness of estrogen-containing oral contraceptives and change some laboratory results.
Ascorbic acid increases the absorption of amoxicillin, and laxatives, glucosamine, antacids and aminoglycosides reduce the absorption of amoxicillin in the intestine.

Overdose

When using excessive doses of amoxicillin and clavulanic acid in patients, the risk of developing and the severity of undesirable effects increases.
In case of an overdose of the drug Flemoclav, the development of disorders of the digestive tract, disorders of the water and electrolyte balance and convulsions is possible.
In severe intoxication with amoxicillin, patients have impaired consciousness, muscle cramps, hemolytic reactions, acidosis and renal failure, as well as shock and crystalluria.

There is no specific antidote. When taking high doses of Flemoclav, gastric lavage, enterosorbent preparations and osmotic laxatives are indicated. In case of an overdose, the water-electrolyte balance and blood pH should be monitored.
With the development of seizures, diazepam is prescribed. In severe renal failure, hemodialysis should be performed.
The development of a state of shock requires immediate resuscitation.
In order to reduce the plasma concentration of amoxicillin, forced diuresis is also shown.

Release form

Dispersed tablets containing 125, 250 or 50 mg of amoxicillin, packaged in 5 pieces in blister packs, in a cardboard box 4 blister packs.
Dispersed tablets containing 875 mg of amoxicillin, packaged in 5 or 7 pieces in blister packs, in a cardboard box 2 blister packs.

Storage conditions

Flemoklav should be stored for no more than 3 years after manufacture in rooms with a temperature not exceeding 25 degrees Celsius.
Marbling and small dots of brown color may appear on the surface of the tablets during storage. Information about the drug is provided for informational purposes only and should not be used as a guide to self-treatment. Only a doctor can decide on the appointment of the drug, as well as determine the dose and methods of its use.

This drug belongs to broad-spectrum antibiotics. It has become widespread in medical practice. Loved by doctors and parents for the quick and effective treatment of various diseases. The composition of Flemoklav Solutab includes amoxicillin and clavulanic acid. This medicine is available in the form of dispersible tablets with a dosage of 125 mg, 250 mg, 500 mg and 875 mg. The dosage (given in terms of amoxicillin) when administered depends on the age and body weight of each patient (and the severity of the disease).

Flemoklav Solutab (has analogues in composition) is used orally for infections:

• respiratory tract (bronchitis, pneumonia, pleural empyema, lung abscess);
• ENT organs (sinusitis, tonsillitis, otitis media);
• genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis and others);
• soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscesses);
• joints and bones (including osteomyelitis);
• postoperative.

How to take the drug in each individual case is decided by the doctor.

It is especially important to remember this when the appointment is made to a child.

Application

Tablets of medicine Flemoklav Solutab are taken immediately before meals, without chewing (whole) and washed down with a whole glass of water. For children, it is better and easier to give the drug in the form of a suspension. For this, the instructions for use recommend dispersible tablets to be thoroughly dissolved in water (0.5 cups).

The dosage of Flemoklav Solutab for children who have not yet reached 3 months of age is 20 mg per unit of weight of the child per day (should be divided into 2 doses). A child from 3 months to 2 years - 25 mg per weight unit per day (also for 2 doses).

Children aged 2 to 7 years, having a weight of 13-25 kg, should take a single dose of 125 mg (two or three times a day). From 7 to 12 years (weight 25-37 kg) - 1 tablet of 250 mg (or 2 to 125) 2 to 3 times a day. The exact dose is determined by the doctor.

For children over 12 years of age, whose weight exceeds 40 kg (and for adults), the dosage of Flemoklav Solutab is 1 tablet 250 mg (or 2 tablets 125) three times a day. In severe form of the disease, it is possible to increase the dose - 1 tablet of 500 mg (2 tablets 250 or 4 tablets 125) three times a day.

How to prepare a suspension

We calculate the dosage of the suspension for a child of 2 months, weighing about 5 kg. This will require Flemoklav Solutab dispersible tablet with a dosage of 125 mg and 125 ml of boiled water (strictly at room temperature). Dissolve the tablet in a glass of water, mixing thoroughly.

Since the daily dose for a 2-month-old baby is 20 mg per unit of weight, then 20 5 \u003d 100.

Therefore, 100 ml of the resulting solution of Flemoklav Solutab must be divided into 2 doses (50 ml each) and given to the baby at regular intervals. Use a bottle and a nipple with a large hole for this.

The suspension is stored in a cold dark place for no more than one day.

Special cases

For patients with impaired renal function, the daily dose of Flemoklav Solutab should be less than the values ​​\u200b\u200bspecified in the table.

In this case, the dosage of Flemoklav Solutab requires adjustment by the attending physician. He also gives recommendations for use and decides how long to use the drug.

Patients with problems with the liver, it is strictly necessary to control its functions. Therefore, strict medical supervision is also exercised.

Contraindications

Instructions for use include Flemoklav Solutab among the contraindications:

• increased sensitivity of the patient to the components of the drug;
• hypersensitivity to penicillin and cephalosporin antibiotics;
• mononucleosis (infectious);
• jaundice or abnormal liver function after the use of amoxicillin or clavulanic acid.

With special care, Flemoklav Solutab is prescribed to children with diseases of the gastrointestinal tract.

Parents need to remember that a developing child's body requires an attentive attitude towards itself.

Side effect

When using a medication with a dosage of 125 or 250 mg in a child's body, such negative manifestations may occur as:

• skin allergy- urticaria, erythematous rashes, exanthema;
• gastrointestinal organs- vomiting, nausea, abdominal pain, diarrhea;
• blood and lymph- leukopenia, hemolytic anemia, thrombocytopenia;
• hepatobiliary system- jaundice (cholestatic), hepatitis;
• the immune system- vasculitis, angioedema;
• urinary system- interstitial nephritis.

In very rare cases, anaphylactic shock is possible.

It should be noted that all of the above reactions to the drug Flemoklav Solutab, as a rule, occur immediately during treatment.

However, there is a possibility of their manifestations after some time (about a week).

In any case, parents should immediately notify the attending physician about this and consult on the advisability of further use of the medication.

Overdose

Toxication is possible if the instructions for use of the drug Flemoclav Solutab are not followed and entails nausea, vomiting, diarrhea.

To eliminate such symptoms, children are shown urgent gastric lavage and subsequent intake of sorbent preparations (activated charcoal).

We emphasize once again that the dosage for the child is set by the doctor depending on the weight and age. Parents must strictly adhere to the appointments.

Drug substitutes

Analogues of the drug Flemoklav Solutab are known on the domestic market of medical preparations : Amoxiclav 2X, Amoxil - K 625, Amoxiclav Quiktab, Augmentin (BD), Augmentin (SR), Baktolkav, Clavam, Clavamitin, Medoklav, Panklav, Rapiclav, Rekut, Trifamox IBL.

All of them have a similar ATC code, active substances.

Which of the listed drugs is suitable for a child of different ages, and what dosage will be required, is determined only by the attending physician.

Parents should never make this decision on their own. Since each medication requires an individual approach.

Assistant in the fight for health

Long gone are the days when the use of antibiotics was treated as an out-of-the-ordinary case. Modern pharmacology boasts the latest developments in the field of such medicines.

Flemoklav Solutab and its analogues allow you to quickly cope with various diseases and their consequences.

The only rule that all patients need to remember is that antibiotics require a strict dosage.

And then they will bring only benefits, without any side effects.

Dosage form:  dispersible tablets Composition:

The 125 mg/31.25 mg tablet contains:

Currentsubstance: amoxicillin trihydrate (corresponding to amoxicillinbase) - 145.7 mg (125 mg); potassium clavulanate (which corresponds to clavulanic acid) - 37.2 mg (31.25 mg).

Excipients: microcrystalline cellulose - 81.8 mg; crospovidone - 25.0 mg; vanillin - 0.25 mg; apricot flavor - 2.25 mg; saccharin - 2.25 mg; magnesium stearate - 1.25 mg.

250 mg/62.5 mg tablet contains:

base) -291.4 mg (250 mg); potassium clavulanate (which corresponds to clavulanic acid) - 74.5 mg (62.5 mg).

Excipients: microcrystalline cellulose - 163.6 mg; crospovidone - 50.0 mg; vanillin - 0.5 mg; apricot fragrance - 4.5 mg; saccharin - 4.5 mg; magnesium stearate - 2.5 mg.

The 500 mg/125 mg tablet contains:

Active ingredient: amoxicillin trihydrate (corresponding to amoxicillinbase) - 582.8 mg (500 mg); potassium clavulanate (which corresponds to clavulanic acid) - 148.9 mg (125 mg).

Excipients: microcrystalline cellulose - 327.3 mg; crospovidone - 100.0 mg; vanillin - 1.0 mg; apricot flavor - 9.0 mg; saccharin - 9.0 mg; magnesium stearate - 5.0 mg.

Description: Oblong-shaped white to yellow tablets with brown dotted spots without a risk and labeled "421" - for a dosage of 125 mg + 31.25 mg; "422" - for a dosage of 250 mg + 62.5 mg; "424" - for a dosage of 500 mg + 125 mg and the company logo. Pharmacotherapeutic group:Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor ATX:  

J.01.C.R.02 Amoxicillin in combination with enzyme inhibitors

Pharmacodynamics:

Mechanism of action

Amoxicillin is a semi-synthetic broad-spectrum antibiotic with activity against many gram-positive and gram-negative microorganisms. At the same time, it is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not apply to microorganisms, that produce this enzyme. Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamase found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient efficacy against plasmid beta-lactamases, which most often cause bacterial resistance, and not effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid.

The presence of clavulanic acid in the drug Flemoklav Solutab® protects against destruction by enzymes - beta-lactamases, which allows expanding the antibacterial spectrum of amoxicillin. The following is the activity of the combination of amoxicillin with clavulanic acidin vitro.

Bacteria normally sensitive to the combination of amoxicillin with clavulanic acid

Gram positive aerobes:

Bacillus anthracis

Enterococcus faecalis

Listeria monocytogenes

Nocardia asteroides

Streptococcus pyogenes 1,2

Streptococcus agalactiae 1,2

Streptococcus spp . (other beta-hemolytic streptococci) 1.2

Staphylococcus aureus(sensitive to methicillin) 1

Staphylococcus saprophyticus(sensitive to methicillin)

coagulase-negative staphylococci,(sensitive to methicillin)

Gram-positive anaerobes:

Clostridium spp.

Peptococcus Niger

Peptostreptococcus magnus

Peptostreptococcus micros

Peptostreptococcus spp.

Gram negative aerobes:

Bordetella pertussis

haemophilus influenzae 1

Helicobacter pylori

Moraxella catarrhalis 1

Neisseria gonorrhoeae

Pasteurella multocida

Vibrio cholerae

Gram negative anaerobes:

Bacteroides fragilis

Bacteroides spp.

Capnocytophaga spp.

Eikenella corrodens

Fusobacterium nucleatum

Fusobacterium spp.

Porphyromonas spp.

Prevotella spp.

Other:

Borrelia burgdorferi

Leptospira icterohaemorrhagiae

Treponema pallidum

Bacteria that are likely acquired resistance to combinations of amoxicillin with clavulanic acid

Gram-negative aerobes:

Escherichia coli 1

Klebsiella oxytoca

Klebsiella pneumoniae 1

Klebsiella spp.

Proteus mirabilis

Proteus vulgaris

Proteus spp.

Salmonella spp.

Shigella spp.

Gram positive aerobes:

Corynebacterium spp.

Enterococcus faecium

Streptococcus pneumoniae 1,2

group streptococci Viridans 2

Bacteria that are naturally resistant to the combination of amoxicillin with clavulanic acid

Gram-negative aerobes:

Acinetobacter spp.

Citrobacter freundii

Enterobacter spp.

Hafnia alvei

Legionella pneumophila

Morganella morganii

Providencia spp.

Pseudomonas spp.

Serratia spp.

Stenotrophomonas maltophilia

Yersinia enterocolitica

Other:

Chlamydia pneumoniae

Chlamydia psittaci

Chlamydia spp.

Coxiella burnetii

Mycoplasma spp.

1 for these types of microorganisms, the clinical efficacy of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 strains of these bacterial species do not produce β-lactamase.

Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Pharmacokinetics:

Suction

Amoxicillin and clavulanic acid completely dissociate in aqueous solution at physiological pH values. Both active components of the drug, and clavulanic acid, are rapidly and well absorbed from the gastrointestinal tract (gastrointestinal tract) after oral administration. Absorption of active ingredients is optimal at the beginning of a meal. Bioavailabilityamoxicillin and clavulanic acid when taken orally high. After a single dose of Flemoclav Solutab at a dose of 500 mg amoxicillin / 125 mg clavulanic acid, the maximum concentration of amoxicillin in the blood plasma is created after 1.5 hours (1.0-2.5 hours), and is 7.19 ± 2.26 mcg / ml (C m ah), clavulanic acid - after 1.5 hours (1.0-2.0 hours), amounting to 2.4 ± 0.83 μg / ml. PFC (indicator "area underpharmacokinetic curve") amoxicillin and clavulanic acid is 53.5±8.87 µg*h/l and 15.72±3.86 µg*h/l, respectively.

Plasma concentrations of amoxicillin and clavulanic acid achieved with amoxicillin/clavulanate are similar to those obtained with oral administration of equivalent doses of amoxicillin andclavulanic acid alone.

Distribution

Approximately about 18% of amoxicillin and 25% of clavulanic acid binds to plasma proteins. The apparent volume of distribution is 0.3-0.4 l/kg for amoxicillin and about 0.2 l/kg for clavulanic acid. poorly distributed into the cerebrospinal fluid.

In animal studies, no accumulation of drug components in body tissues was detected.

Like most penicillins, it passes into breast milk. Clavulanic acid is alsofound in breast milk in trace concentrations. and clavulanic acid penetrate the placental barrier.

Metabolism

10-25% of the initial dose of amoxicillin is excreted by the kidneys as inactivemetabolite (penicillic acid). Clavulanic acid undergoes intensive metabolism and is excreted by the kidneys, intestines, and also with exhaled air in the form of carbon dioxide.

breeding

After a single dose of Flemoclav Solutab® at a dose of 500 mg / 125 mg, the half-life of amoxicillin is 1.15 ± 0.20 hours, clavulanic acid is 0.98 ± 0.12 hours, and the total clearance is about 25 l / h. Approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted unchanged by the kidneys during the first 6 hours after taking 1 tablet of the drug 250/125 mg or 500/125 mg. The greatest amount of clavulanic acid is excreted during the first 2 hours after ingestion. Various studies have shown that up to 50-85% of amoxicillin and up to 27-60% of clavulanic acid are excreted through the kidneys within 24 hours. Simultaneous reception of probenecid delays the excretion of amoxicillin, but does not affect the excretion of clavulanic acid by the kidneys (see section "Interaction with othermedicines").

Pharmacokinetics in special cases

Age features

The half-life of amoxicillin in children 3 months - 2 years does not differ from that in older children and adults. Children of the first week of life (including premature infants) should not be prescribed the drug more than 2 times a day due to the immaturity of the renal elimination pathway. Due to the possible decrease in renal function, the selection of the dose of the drug for elderly patients should be done with caution. Monitoring of kidney function may be required.

Sexual characteristics

When taken orallyhealthy men and women did not establish a significant effect of the patient's sex on the pharmacokinetics of the active components of the drug.

Impaired kidney function

Total ground clearanceamoxicillin/clavulanic acid decreases in proportion to the decrease in renal function. The clearance of amoxicillin is especially noticeably disturbed, since most of it is excreted by the kidneys. Thus, in case of impaired renal function, the dose of the drug should be adjusted to avoid excessive concentrations of amoxicillin and to maintain the required level of clavulanic acid.

Impaired liver function

In patients with impaired liver function, the drug should be administered with caution. It is necessary to regularly monitor liver function.

Indications:

The combination of amoxicillin with clavulanic acid is indicated for the treatment of bacterial infections of the following localizations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:

Upper respiratory tract infections (including ENT infections), eg, recurrent tonsillitis, sinusitis, otitis media, usually caused byStreptococcus pneumoniae, Haemophilus influenzae # , Moraxella catarrhalis # And Streptococcus pyogenes.

Lower respiratory tract infections, such as exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia, usually caused byStreptococcus pneumoniae, Haemophilus influenzae # And Moraxella catarrhalis # .

Urinary tract infections, eg, cystitis, urethritis, pyelonephritis, female genital infections, usually caused by species of the familyEnterobacteriaceae 1 (mainlyEscherichia coli # ), Staphylococcus saprophyticus and species of the genus Enterococcusas well as gonorrhea caused byNeisseria gonorrhoeae # .

Skin and soft tissue infections, usually caused byStaphylococcus aureus # , Streptococcus pyogenes and species of the genus Bacteroides # .

Bone and joint infections, such as osteomyelitis, usually caused byStaphylococcus aureus # , if necessary, long-term therapy is possible.

Odontogenic infections, eg, periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulitis.

Other mixed infections (eg, septic abortion, puerperal sepsis, intra-abdominal sepsis) as part of stepwise therapy.

# Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see also the section "Pharmacological properties"). Infections caused by microorganisms sensitive to amoxicillin can be treated with Flemoklav Solutab®, as it is one of its active ingredients. Flemoklav Solutab® is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing beta-lactamase sensitive to the combination of amoxicillin with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies by region and over time. Where possible, local sensitivity data should be taken into account. Where necessary, microbiological samples should be collected and tested for bacteriological susceptibility.

Contraindications:

- Hypersensitivity to amoxicillin, clavulanic acid and other components of the drug, as well as to other beta-lactam antibiotics (penicillins and cephalosporins) in history;

- A history of jaundice or liver failure due to the use of amoxicillin / clavulanic acid;

- Children's age up to 1 year or body weight up to 10 kg (due to the impossibility of dosing the dosage form in this category of patients).

Carefully:Severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure. Pregnancy and lactation:

Pregnancy

In studies of reproductive function in animals, oral and parenteral administration of the drug did not cause teratogenic effects.

In a single study in women with premature rupture of the membranes, it was found that prophylactic drug therapy may be associated with an increased risk of necrotizing enterocolitis in newborns. Like all medicines, Flemoclav Solutab is not recommended for use during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus.

breastfeeding period

The drug Flemoklav Solutab® can be used during breastfeeding. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the mucous membranes of the oral cavity associated with the penetration of trace amounts of the active substances of this drug into breast milk, no other adverse effects were observed in breast-fed children. In the event of adverse effects in children who are breastfed, breastfeeding should be discontinued.

Dosage and administration:

For oral administration.

Dosing regimen is setindividually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection. To reduce potential gastrointestinal disturbances and to optimize absorption, the drug should be taken at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use. The minimum course of antibiotic therapy is 5 days.

Treatment should not be continued for more than 14 days without a review of the clinical situation. If necessary, it is possible to carry out stepwise therapy (at firstparenteral administration amoxicillin + clavulanic acid followed by the transition to oral administration).

Adults and children over 12 years of age weighing ≥ 40 kg the drug is prescribed 500 mg / 125 mg 3 times / day.

The maximum daily dose should not exceed 2400 mg / 600 mg per day.

Children aged 1 to 12 years weighing 10 to 40 kg dosing regimen is setindividually based on the clinical situation and the severity of the infection.

There are no clinical data on the use of amoxicillin/clavulanic acid in a 4:1 ratio at doses > 40 mg/10 mg/kg per day in children under two years of age. The maximum daily dose for children is 60 mg/15 mg/kg per day.

Low doses of the drug are recommended for the treatment of infections of the skin and soft tissues, as well as recurrent tonsillitis; high doses of the drug are recommended for the treatment of diseases such as otitis media, sinusitis, infections of the lower respiratory tract and urinary tract, bone and joint infections. There are insufficient clinical data to recommend the use of the drug at a dose of more than 40 mg / 10 mg / kg / day in 3 divided doses (4: 1 ratio) in children under 2 years of age. Approximate dosing regimen of the drug in patients childhood presented in the table below:

Child weight, kg	Age (approx.)	The use of low doses of the drug	The use of high doses of the drug
10-12	1-2 years		1 tablet 125 mg/31.25 mg 3 times a day*
12-15	2-4 years	2 times a day, 1 tablet 125 mg / 31.25 mg
15-20	4-6 years old	3 times a day, 1 tablet 250 mg / 62.5 mg	1 tablet 250 mg/62.5 mg 3 times a day or 500 mg/152 mg twice a day
20-30	6-10 years old	3 times a day, 1 tablet 250 mg / 62.5 mg
30-40	10-12 years old	2 times a day, 1 tablet of 500 mg / 125 mg
≥40	≥12 years	3 times a day, 1 tablet of 500 mg / 125 mg	3 times a day, 1 tablet of 500 mg / 125 mg

* there are not enough clinical data to recommend the use of the drug at a dose of more than 40 mg / 10 mg / kg / day in 3 divided doses (4: 1 ratio) in children under 2 years of age.

In children aged ≤ 6 years, it is preferable to use the drug in dissolved form.

Special patient groups

Elderly patients

Dosing regimen correction is not required. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function.

Patients with impaired renal function

In patients with renal insufficiency, the excretion of clavulanic acid and amoxicillin through the kidneys is slow. Depending on the severity of renal failure, the total dose of FlemoclavSolutab® (expressed as a dose of amoxicillin) should not exceed quantities shown in the table.

Clearance creatinine	Adults and children over 12 years old with a body weight ≥ 40 kg	Children aged 1 to 12 years weighing 10 kg to 40 kg
>30 ml/min	Correction of the dosing regimen is not required	Correction regime dosing is not required
10-30 ml/min	500 mg/125 mg 2 times a day	15 mg / 3.75 mg / kg 2 times a day (maximum 500 mg/125 mg twice daily)
< 10 мл/мин	500 mg/125 mg once a day	15 mg/3.75 mg/kg once a day (maximum 500 mg/125 mg once daily)
Hemodialysis	500 mg/125 mg daily plus additional 500 mg/125 mg during and after dialysis	15 mg/3.75 mg/kg once daily plus additional 15 mg/3.75 mg/kg before and after dialysis

In most cases, if possible, preference should be given toparenteral therapy.

Patients on hemodialysis

Dosing adjustments are based on the maximum recommended dose of amoxicillin shown in the table. Patients with impaired liver function Treatment is carried out with caution; regularly monitor liver function.

There is not enough data to change the recommendation of the dosing regimen in these patients.

Side effects:

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: Often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), seldom (≥1/10 000, <1/1000), very rarely (<1/10 000). Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

Frequency of occurrence of undesirable reactions

Often: candidiasis of the skin and mucous membranes.

Blood and lymphatic system disorders

Rare: reversible leukopenia (including neutropenia), reversible thrombocytopenia.

Very rare: reversible agranulocytosis and reversible hemolytic anemia, prolongation of bleeding time and prothrombin time, anemia, eosinophilia, thrombocytosis.

Immune System Disorders

Very rarely: angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis.

Nervous System Disorders

Uncommon: dizziness, headache.

Very rarely: reversible hyperactivity, convulsions (in case of impaired renal function or drug overdose). Convulsions can be observed in patients with impaired renal function, as well as in those who receive high doses of the drug (see sections "Method of application and doses", "Overdose", "Special instructions"). Insomnia, agitation, anxiety, behavior change.

Gastrointestinal disorders

Adults:

Very common: diarrhea.

Often: nausea, vomiting.

Children:

Often: diarrhea, nausea, vomiting.

Whole population:

Nausea was most commonly associated with the use of high doses of the drug. If, after the start of taking the drug, adverse reactions from the gastrointestinal tract are observed, they can be eliminated if Flemoklav Solutab® is taken at the beginning of a meal.

Uncommon: indigestion

Very rarely: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) (see section "Special Instructions"), black "hairy" tongue, gastritis, stomatitis.

Liver and biliary tract disorders

Uncommon: Moderate increase in aspartate aminotransferase and/oralanine aminotransferase ( ACT and/or ALT). This reaction has been observed in patients treated with beta-lactam antibiotics, but its clinical significance is unknown.

Very rare: hepatitis and cholestatic jaundice. These reactions are observed in patients receiving therapy with penicillin antibiotics and cephalosporins. An increase in the concentration of bilirubin and alkaline phosphatase.

Adverse reactions from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rare in children.

The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, in extremely rare cases there have been reports of death. In almost all cases, these were individuals with serious comorbidities or patients receiving concomitantly potentially hepatotoxic drugs.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, urticaria.

Rare: erythema multiforme.

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

Renal and urinary tract disorders

Very rarely: interstitial nephritis, crystalluria (see section "Overdose"), hematuria.

Overdose:

Symptoms

Gastrointestinal symptoms and fluid and electrolyte imbalance may occur. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure (see section "Special Instructions and Precautions").

Convulsions may occur in patients with impaired renal function, as well as in those who receive high doses of the drug (see sections "Method of application and doses", "Side effects", "Special instructions").

Treatment

Gastrointestinal symptoms - symptomatic therapy, paying special attention to the normalization of water and electrolyte balance. and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study, which was conducted in 51 children in a poison control center, showed that the administration of amoxicillin at a dose of less than 250 mg/kg did not lead to significant clinical symptoms and did not require gastric lavage.

Interaction: Simultaneous use of the drug Flemoklav Solutab® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Flemoklav Solutab® and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid. Concomitant use of allopurinol and amoxicillin may increase the risk of allergic skin reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.

Penicillins are able to slow down the excretion of methotrexate from the body by inhibiting its tubular secretion, therefore, the simultaneous use of the drug Flemoklav Solutab® and methotrexate may increase the toxicity of methotrexate.

Like other antibacterial drugs, Flemoclav Solutab® can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If it is necessary to simultaneously prescribe the drug Flemoclav Solutab® with anticoagulants, the prothrombin time or INR should be carefully monitored when prescribing or canceling the drug Flemoclav Solutab®, dose adjustment of anticoagulants for oral administration may be required.

In patients treated, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure.

Special instructions:Before starting treatment with Flemoclav Solutab®, a detailed history of previous reactions should be collected.hypersensitivity to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient.

Serious and sometimes fatal hypersensitivity reactions have been described(anaphylactic reactions) to penicillins. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In the event of an allergic reaction, it is necessary to stop treatment with Flemoklav Solutab® and start an appropriate alternative therapy. For severe hypersensitivity reactions,administer to the patient immediately. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.

In the event of allergic skin reactions, treatment with Flemoklav Solutab® should be discontinued.

In case of suspected infectious mononucleosis, FlemoclavSolutab® should not be used because in patients with this disease it may cause morbilliform skin rash, which makes it difficult to diagnose the disease. Long-term treatment with Flemoklav Solutab may lead to overgrowth of non-susceptible microorganisms.

In general, Flemoclav Solutab® is well tolerated and haslow toxicity characteristic of all penicillins. During long-term therapy with Flemoklav Solutab®, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis. Cases have been describedpseudomembranous colitis while taking antibiotics, which can range in severity from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If diarrhea is prolonged or severe and the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined.

Rarely, an increase inprothrombin time (increased INR). With the joint appointment of indirect (oral) anticoagulants with a combination of amoxicillin with clavulanic acid control of the relevant indicators is necessary. To maintain the desired effect of oral anticoagulants may dose adjustment is required.

In patients with impaired renal function, the dose of Flemoclav Solutab® should be reduced according to the degree of impairment (see section "Method of administration and doses" - Patients with impaired renal function).

In patients with impaired renal function, as well as when taking high doses of the drug, convulsions may occur (see sections "Method of application and doses", "Side effects", "Overdose").

In patients with reduced diuresis, crystalluria very rarely occurs,predominantly in parenteral therapy. During the introduction of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid andmaintain adequate diuresis to reduce the likelihood of formationcrystals of amoxicillin (see section "Overdose").

Taking the drug Flemoclav Solutab® orally leads to a high content of amoxicillin in the urine, which can lead to false positiveresults in the determination of glucose in the urine (for example, Benedict's test, Fehling's test). In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.

Clavulanic acid can cause non-specific binding of immunoglobulin G and albumin to erythrocyte membranes, leading to false positive Coombs test results.

One dispersible tablet Flemoklav Solutab® 125 mg / 31.25 mg contains 0.16 mmol (6.13 mg) of potassium, 250 mg / 62.5 mg - 0.32 mmol (12.3 mg), 500 mg /125 mg - 0.64 mmol (24.53 mg). Potassium intake of more than 1 mmol per day requires special attention in patients with reduced kidney function and those on a controlled potassium diet. Influence on the ability to drive transport. cf. and fur.:Studies on the effect on the ability to drive vehicles and work with mechanisms have not been conducted. Since the drug can cause side effects (for example, allergic reactions, dizziness, convulsions) (see section "Side Effects"), it is necessary to warn patients about precautions when driving a vehicle or working with moving mechanisms. Release form / dosage:Dispersible tablets 125 mg + 31.25 mg, or 250 mg + 62.5 mg, or 500 mg + 125 mg. Package: 4 tablets (one dosage) in a blister. 5 blisters, together with instructions for use, are placed in a cardboard box. Storage conditions:

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Best before date:

3 years. Do not use after the expiry date stated on the packaging.

Conditions for dispensing from pharmacies: On prescription Registration number: P N016067/01 Date of registration: 17.11.2009 / 13.01.2014 Expiration date: Perpetual Registration certificate holder:Astellas Pharma Europe B.V.