Novigan instructions for use. Use during pregnancy and lactation

It is known that it is dangerous to stop painful sensations without finding out their exact cause. At the same time, there are situations when the pain is difficult to endure, and you have to self-medicate. The main thing in such cases is to find out more information about the medicine. Consider what Novigan analgesic is, indications for the use of this drug.

Novigan - composition

The drug Nogwigan is produced in India pharmaceutical company in tablet form. These are round tablets with a film-coated top. In their composition, they contain three active ingredients at once, acting in different ways and thereby ensuring maximum effectiveness for pain sensations of a different nature. The composition of the Novigan tablet according to the active substances is as follows:

ibuprofen;
pitofenone hydrochloride;
fenpiverinium bromide.

As auxiliary components that are used in the manufacture of the drug shell and are added to active substances to ensure the chemical and mechanical stability of the drug, its better susceptibility by the body, etc., Novigan contains:

starch;
cellulose;
talc;
silica;
titanium dioxide;
glycerol;
magnesium stearate;
polysorbate 80;
macrogol 6000;
hypromellose;
dimethicone.

Novigan - action

Novigan tablets are quickly absorbed and show their therapeutic effect one to two hours after ingestion. After a day, the drug is completely excreted from the body - mainly through the urinary system. Novigan works, the indications for the use of which include different types of pain, due to the properties of each of the active substances separately and due to their interaction, which enhances the overall effect. Consider what these components are and how they affect pain sensations:

Ibuprofen (400 mg)- non-steroidal anti-inflammatory substance, a derivative of phenylpropionic acid. By suppressing the biosynthesis of prostaglandins (hormone-like substances that cause pain at the biochemical level), there is a decrease in pain, as well as a decrease in inflammation, swelling, and elevated body temperature.
Pitophenone hydrochloride (5 mg)- a compound that has a direct effect on spasmodic smooth muscle tissues internal organs eliminating spasm. Muscle tension, which provokes compression of blood vessels and nerve fibers, often causes intense pain sensations that recede when relaxation occurs.
Fenpiverinium bromide (0.1 mg)- this component belongs to the group of m-anticholinergic agents that “turn off” the receptors of internal organs that respond to the mediator of nervous excitation acetylcholine. Due to this, a decrease in the tone of smooth muscles and a weakening of the pain syndrome are achieved.

What helps Novigan?

Novigan, the indications for which are listed in the attached instructions, is recommended for pain of moderate and low intensity, and in relation to debilitating, unbearable pain syndrome, it will not show the desired effect. Let's consider what Novigan's indications are:

pain associated with spasm of smooth muscles of internal organs - kidneys, liver, gallbladder and biliary tract, etc .;
spastic pain syndrome with dysmenorrhea;
pain in the head of various origins, including;
pain in the joints, lower back, nerves, skeletal muscles(as short-term analgesic therapy).

The above symptoms are the main ones for the appointment of this anesthetic and in most cases are successfully eliminated when taking the standard dosage. At the direction of the attending physician, Novigan can also be used in some other pathological situations associated with painful sensations that are not mentioned in the instruction leaflet.

How to take Novigan?

The drug Novigan, the use of which must take place in accordance with certain rules, is an intensively acting remedy. It is recommended to take it one hour before a meal or three hours after it, which will ensure the highest efficiency. At the same time, in order to avoid potential negative effects on the walls of the stomach, it is permissible to drink these tablets immediately after eating. Reducing the risk of irritating action on the mucous membranes of the digestive tract is also achieved when the drug is washed down with milk rather than water.

The standard dosage of Novigan is 1 tablet three times a day with an interval of at least 4-6 hours between doses. The duration of the drug should be as short as possible and not exceed five days with self-treatment. Longer use of these tablets is permissible only under the supervision of specialists and with the performance of certain tests.

Novelty for toothache

Pain caused by damage to dental tissues or gums causes great discomfort, so it should be stopped in time. This is an acceptable solution when it is not possible to immediately contact the dentist. The drug Novigan from helps effectively, but at the same time, the analgesic effect is manifested due to one component - ibuprofen.

The other two active components of the drug, which act on spasmodic muscle tissue, do not help in this case. Therefore, it is more rational to take other one-component tablets with ibuprofen for toothache, but if there is nothing else on hand, it is better to use Novigan. In this case, it is recommended to combine the use of an analgesic with the use of a local antiseptic for oral cavity.

Novigan for headaches

The drug Novigan, the main indications for the use of which include pain in the head of various origins, very effectively and quickly relieves painful sensations. This is achieved through a combination of tablet components that act in different directions on several pain mechanisms. Novigan's medicine is recommended mainly for tension headaches associated with stress, anxiety or overexertion of the muscles of the neck and head, due to a long stay in an uncomfortable position. Copes with migraine syndrome of moderate severity.

Novigan for menstrual pain

Pain in the lower abdomen during menstruation annoys many women, often accompanied by bloating and intestinal upset, headache, and nausea. It should be understood that these symptoms may indicate pathological disorders of the reproductive system that require examination and treatment. Because in this case, the spasmodic uterus acts as a source of pain, Novigan helps with menstruation. To further help yourself with, you should lie down with a warm heating pad on your stomach, which helps relieve spasm.

Novigan side effects

Due to the presence of several active components in the composition of the drug in question, Novigan side effects counts in large numbers. We list the main complaints that may be presented when eliminating pain through these tablets:

lowering blood pressure;
tachycardia;
pain in the stomach;
stool disorder;
dry mouth;
dry skin;
visual disturbances;
dizziness;
drowsiness;
irritability;
weakness;
convulsions;
allergic manifestations.

Novigan - contraindications

Like any other medication, Novigan tablets have limited use. Consider the cases in which it is undesirable and dangerous to use them for pain relief:

ulcers and erosion of the walls gastrointestinal tract;
acute inflammatory bowel disease;
intestinal obstruction;
a history of allergic reactions in response to taking non-steroidal anti-inflammatory drugs;
severe liver or kidney disease;
disorders of blood clotting and hematopoiesis;
granulocytopenia;
tachyarrhythmia;
diseases of the optic nerve;
severe dehydration;
heart failure;
severe somatic diseases;
concomitant use of certain medications (anticoagulants, glucocorticosteroids, antiplatelet agents, etc.);
arterial hypertension;
pregnancy;
under 16 years of age, etc.

Can I drink Novigan during pregnancy?

The instructions for use indicate that it is forbidden to prescribe Novigan during pregnancy, and this applies to all periods of gestation. Taking this drug can adversely affect not only the condition of a pregnant woman, but also jeopardizes the normal development of the unborn child. In addition, you can not stop the pain of this remedy during breastfeeding.

Novigan and alcohol - compatibility

As with most systemic medications, Novigan and alcohol should not be taken together. Therefore, during the treatment period, it is recommended to refrain from drinking even small doses of low-alcohol drinks. It is worth remembering that some medicines may include alcohol in their composition, so their use at the same time as Novigan is dangerous.

The Indian drug Novigan (ibuprofen + pitofenone hydrochloride + fenpiverinium bromide) is a combined analgesic and antispasmodic agent used for pain syndromes of various etiologies, incl. - with a headache. One of the main tasks of doctors with chronic headaches and pain syndromes of other localization is the choice of the optimal drug in this situation, which, at the same time as being highly effective, would also have a favorable safety profile with single and long-term use. Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used agents for the treatment of pain-related conditions. Recently, the arsenal of NSAIDs has been significantly updated. Combination preparations appeared on the pharmacy shelves, containing, in addition to NSAIDs, two or even three pharmacologically friendly components. One of the most promising NSAID-containing painkillers is Novigan. It consists of the NSAIDs ibuprofen, the peripheral papaverine-like antispasmodic pitofenone hydrochloride and the mixed anticholinergic (central and peripheral) action fenpiverinium bromide. All active substances of Novigan are endowed with different mechanisms of action and enhance the analgesic and antispasmodic effects of each other. Ibuprofen, like other NSAIDs, inhibits the synthesis of prostaglandins, mediators of pain and inflammation. Its anti-inflammatory action is also realized through the stabilization of the cell membrane and specific proteins, suppression of leukocyte adhesion and phagocytosis, inhibition of the production free radicals. The analgesic effect of ibuprofen is stronger than that of propoxyphene and acetylsalicylic acid. In patients with primary dysmenorrhea (menstrual pain in the absence of organic pathology of the genital organs), ibuprofen, reducing the concentration of prostaglandins in the uterus, reduces intrauterine pressure and its excessive tone. In addition, ibuprofen inhibits the formation of thromboxane, which promotes platelet aggregation (gluing).

Pitophenone hydrochloride, being a papaverine-like substance, acts on the smooth muscle "skeleton" of the genital organs, helping to relax the muscles. Fenpiverinium acts together with pitofenone hydrochloride, relaxing smooth muscles due to the blockade of m-cholinergic receptors. Novigan is rapidly absorbed in the digestive tract. Maximum concentrations active ingredients in blood plasma are observed at 2 hours of the drug in the body. Novigan is excreted just as quickly (its half-life does not exceed 2 hours). If Novigan is taken after a meal, then the rate and extent of its absorption is significantly reduced, but this has little effect on the bioavailability of the drug. Novigan is excreted in the urine (more than 90%), and the remainder is excreted in the bile. The drug should be taken 1 hour before or 3 hours after a meal, and the second option should be considered more successful, because. in this case, the irritating effect of ibuprofen on the gastric mucosa is leveled. By general recommendations novigan is taken 1 tablet up to 3 times a day, with 3 tablets being the maximum allowable dose. Novigan should not be taken for more than 5 days. A long-term drug course with the use of Novigan is possible only under medical supervision, including monitoring of the blood picture and the functions of the liver and kidneys. To reduce the risk of adverse reactions from the gastrointestinal tract, Novigan should be taken at a minimum effective dosage. If symptoms of gastropathy appear, the patient should be referred for esophagogastroduodenoscopy and blood and stool tests. During treatment, alcohol consumption should be completely excluded. Simultaneous use of Novigan with other NSAIDs increases the risk of side effects from the gastrointestinal tract. Caffeine potentiates the analgesic effect of the drug. When Novigan is used at the recommended doses, it does not enter into clinically significant interactions with commonly used drugs. medicines.

Pharmacology

The combined drug has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins. The composition of the drug includes the NSAID ibuprofen, the myotropic antispasmodic pitofenone hydrochloride and the m-anticholinergic agent of central and peripheral action fenpiverinium bromide.

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of the synthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, it reduces elevated level prostaglandins in the myometrium and thereby reduces intrauterine pressure and the frequency of uterine contractions.

Pitophenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.

Fenpiverinium bromide, due to anticholinergic action, has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to mutual reinforcement of their pharmacological action.

Pharmacokinetics

Suction and distribution

When taken orally, the components of Novigan ® are well absorbed in the gastrointestinal tract. C max in plasma is reached after about 1-2 hours. The main component of the drug ibuprofen is 99% bound to plasma proteins, accumulates in the synovial fluid.

Metabolism and excretion

Ibuprofen is metabolized in the liver and 90% is excreted in the urine as metabolites and conjugates. A small part of ibuprofen is excreted in the bile. T 1/2 from blood plasma is 2 hours.

Release form

Tablets, film-coated, white, round, biconvex, embossed "NOVIGAN" on one side; cross-sectional view: from white to almost white.

Excipients: microcrystalline cellulose - 55 mg, corn starch - 76 mg, glycerol - 2.9 mg, colloidal silicon dioxide - 5 mg, talc - 12 mg, magnesium stearate - 4 mg.

Shell composition: hypromellose 6 cps - 5.686 mg, macrogol 6000 - 1.124 mg, talc - 1.957 mg, titanium dioxide - 1.059 mg, polysorbate 80 - 0.058 mg, sorbic acid - 0.058 mg, dimethicone - 0.058 mg.

10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.

Dosage

Inside, 1 hour before or 3 hours after a meal. To avoid irritating the stomach, you can take the drug immediately after a meal or drink it with milk.

In the absence of special prescriptions from a doctor, it is recommended to take Novigan ® for spastic pains, 1 tab. up to 3 times / day. Maximum daily dose- 3 tab. Do not exceed the indicated dose!

The course of treatment with Novigan ® , without consulting a doctor, should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood parameters and the functional state of the liver.

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute kidney failure, decrease in blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only within an hour after ingestion), activated charcoal, alkaline drink, forced diuresis, symptomatic therapy(correction of the acid-base state, blood pressure). There is no specific antidote.

Interaction

In therapeutic doses, Novigan ® does not enter into significant interactions with commonly used drugs.

Inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe intoxications.

Microsomal oxidation inhibitors reduce the risk of hepatotoxicity.

The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

Enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

Enhances the side effects of mineralocorticoids, glucocorticoids (increased risk of gastrointestinal bleeding), estrogen, ethanol.

Enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of ibuprofen.

The drug increases the concentration of digoxin, lithium preparations, methotrexate in the blood.

Enhances the action of m-anticholinergics, blockers of histamine H 1 receptors, butyrophenones, phenothiazines, amantadine and quinidine.

The simultaneous appointment of other NSAIDs increases the incidence of side effects.

Caffeine enhances the analgesic effect.

With simultaneous administration, it reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting Novigan ®).

Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia with simultaneous administration.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase the plasma concentration of ibuprofen.

Side effects

From the side digestive system: NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulceration of the gastrointestinal mucosa, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth , ulceration of the mucous membrane of the gums, aphthous stomatitis), pancreatitis, hepatitis.

On the part of the respiratory system: shortness of breath, bronchospasm.

From the CNS and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

On the part of the organ of hearing: hearing loss, hearing loss, ringing in the ears.

On the part of the organ of vision: visual impairment ( toxic injury optic nerve, blurred vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), paresis of accommodation).

From the side of cardio-vascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining red.

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell), eosinophilia, allergic rhinitis.

On the part of the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Other: increased or decreased sweating.

On the part of laboratory parameters: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), liver transaminase activity (may increase ).

Indications

mild or moderate pain syndrome with spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic;
dysmenorrhea;
headache, incl. migraine character;
short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia.

Contraindications

erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding;
inflammatory bowel disease in the acute phase, incl. ulcerative colitis;
anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or another NSAID (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
liver failure or active liver disease;
renal failure (CC less than 30 ml / min), progressive kidney disease;
confirmed hyperkalemia;
hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;
the period after coronary artery bypass grafting;
acute intermittent porphyria;
granulocytopenia;
hematopoietic disorders;
deficiency of glucose-6-phosphate dehydrogenase;
tachyarrhythmias;
angle-closure glaucoma;
diseases of the optic nerve;
prostatic hyperplasia;
intestinal obstruction;
pregnancy;
lactation period (breastfeeding);
age up to 16 years;
hypersensitivity to any component of the drug.

Carefully:

elderly age;
congestive heart failure;
cerebrovascular diseases;
arterial hypertension;
dyslipidemia/hyperlipidemia;
diabetes;
peripheral arterial disease;
nephrotic syndrome;
CC less than 30-60 ml / min;
hyperbilirubinemia;
peptic ulcer of the stomach and duodenum (in history);
presence of Helicobacter pylori infection;
gastritis, enteritis, colitis;
prolonged use of NSAIDs;
blood diseases of unknown etiology (leukopenia, anemia);
smoking;
frequent use of alcohol (alcoholism);
severe somatic diseases;
concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral corticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

Application features

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Contraindicated in liver failure or active liver disease

Application for violations of kidney function

Contraindicated in renal failure (CC less than 30 ml / min), progressive kidney disease. With caution - with nephrotic syndrome, CC less than 30-60 ml / min.

Use in children

Contraindicated in children under 16 years of age

special instructions

With prolonged use, it is necessary to control the pattern of peripheral blood and the functional state of the liver and kidneys.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a fecal occult blood test.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the period of treatment should refrain from drinking alcohol.

Influence on the ability to drive vehicles and control mechanisms

During the period of treatment, the patient should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Compound

Active ingredients: ibuprofen, p-piperidinoetoxy o carbomethoxybenzophenone hydrochloride, alpha-methobromide;

1 coated tablet contains ibuprofen 400 mg p-piperidinoetoxa o carbomethoxybenzophenone hydrochloride 5 mg, alpha-methobromide 0.1 mg

Excipients: microcrystalline cellulose, corn starch, glycerin, colloidal silicon dioxide, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E 171), polysorbate 80, sorbic acid, dimethicone.

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Dosage form

Film-coated tablets.

Basic physical and chemical properties: white round biconvex coated tablets with a smooth one side and embossed "NOVIGAN" on the other side.

Pharmacological group

Non-steroidal anti-inflammatory drugs. Ibuprofen, combinations. ATX code M01A E51.

Pharmacological properties

Pharmacological.

Novigan ® - combination drug, which belongs to the group of analgesic and antispasmodic drugs. The composition of the drug includes: ibuprofen - NSAIDs (NSAIDs), p-piperidinoetoxes about carbomethoxybenzophenone hydrochloride - a myotropic antispasmodic and alpha-methobromide - an anticholinergic agent of central and peripheral action.

The main mechanism of pharmacological action of ibuprofen is the inhibition of prostaglandin synthesis. Non-selective non-steroidal anti-inflammatory drugs, which include ibuprofen, act as systemic inhibitors (peripheral and central) of the synthesis of prostaglandin G / H enzymes, also known as cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). These enzymes are responsible for the conversion of arachidonic acid to various tissue-specific prostaglandins and thromboxanes. COX-1 is constitutively expressed in all tissues and is responsible for the production of prostaglandins that maintain organ function, protect the integrity of the gastric mucosa, and generate thromboxin, which is responsible for platelet aggregation and vasoconstriction. Inflammation induces COX-2, which produces prostaglandins that mediate pain and inflammation.

P-piperidine toxins about carbomethoxybenzophenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs. It inhibits phosphodiesterase, causes the accumulation of cAMP and a decrease in calcium in the cell, weakens the smooth muscles of blood vessels and internal organs.

Alpha-methobromide, due to ganglioblocking and parasympathetic action, reduces the tone and motility of the smooth muscles of the stomach, intestines, biliary and urinary tract.

Pharmacokinetics.

Ibuprofen is well absorbed from the gastrointestinal tract oral intake. The maximum plasma concentration is reached within 1-2 hours after application. About 99% of ibuprofen binds to plasma proteins. It is excreted mainly in the urine unchanged or in the form of oxidized inactive metabolites. Completely excreted from the body within 24 hours.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action, which leads to pain relief, relaxation of smooth muscles, and a decrease in elevated body temperature.

Indications

Mild or moderate pain syndrome with spasms of smooth muscles of internal organs - renal or hepatic colic, biliary dyskinesia, intestinal spasms, spastic dysmenorrhea and other spastic conditions of smooth muscles of internal organs. Headache, including migraine. Short-term symptomatic treatment of joint pain, neuralgia, sciatica, myalgia. To reduce elevated body temperature in colds and infectious and inflammatory diseases.

Contraindications

Hypersensitivity to the components of the drug and other NSAIDs.
Hypersensitivity reactions (for example, bronchial asthma, rhinitis, angioedema or urticaria) that have been observed previously after the use of ibuprofen, acetylsalicylic acid (aspirin) or other NSAIDs.
Novigan ® is contraindicated in patients who have a history of erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding or perforation after the use of NSAIDs.
Severe violations of the liver and kidneys, heart failure.
The use of ibuprofen, especially at high doses, together with other nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors, should be avoided due to the possibility of additive effects and the development of adverse reactions from the heart, stroke.
The drug is also contraindicated in hepatic porphyria, hereditary deficiency of glucose-6-phosphate dehydrogenase, tachyarrhythmia, damage to the optic nerve, impaired hematopoiesis or blood clotting, blood diseases, angle-closure glaucoma, heart failure, prostatic hypertrophy, mechanical obstruction of the gastrointestinal tract or megacolon.
Cerebrovascular or other bleeding.
Severe dehydration.
Last trimester of pregnancy and lactation.
Age up to 16 years.

Interaction with other medicinal products and other forms of interaction

Simultaneous use of the drug Novigan ® with other non-steroidal anti-inflammatory drugs (NSAIDs) or non-narcotic analgesics can lead to a double increase in toxic effects.

Novigan ® should be used with caution in combination with the following medicinal products:

Anticoagulants NSAIDs may increase the effect of anticoagulants such as warfarin.

Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the therapeutic effect of these drugs. In some patients with impaired renal function (for example, in dehydrated patients or in elderly patients with impaired renal function), the simultaneous use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit COX may lead to further deterioration of renal function, including possible acute renal failure, is usually reversible. Therefore, such combinations should be used with caution, especially in elderly patients. If long-term treatment is required, the patient should be adequately hydrated and consideration should be given to monitoring renal function at the start of combination treatment and at regular intervals thereafter.

Diuretics may increase the risk of nephrotoxic effects of NSAIDs.

Corticosteroids: increased risk of ulceration and bleeding in the gastrointestinal tract.

Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Cardiac glycosides - with simultaneous use with NSAIDs, an exacerbation of heart failure, a decrease in the glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma are possible.

Lithium preparations - with simultaneous use, the elimination of lithium preparations decreases and their toxicity and concentration in the blood plasma increase.

Methotrexate - with simultaneous use, the elimination of methotrexate decreases and its toxicity and concentration in blood plasma increase.

Cyclosporine - with simultaneous use with NSAIDs, nephrotoxicity increases.

Mifepristone - the use of NSAIDs is allowed only 8-12 days after mifepristone is discontinued, since NSAIDs reduce the effect of mifepristone.

Quinolone antibiotics - NSAIDs may increase the risk of seizures associated with the use of quinolones.

Zidovudine - there is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients receiving concomitant treatment with zidovudine and ibuprofen.

Tacrolimus - the risk of nephrotoxicity increases with the simultaneous use of NSAIDs with tacrolimus.

The herbal preparation ginkgo biloba may increase the risk of bleeding with non-steroidal anti-inflammatory drugs.

Application features

With caution under the supervision of a physician, the drug should be used to treat patients with moderate impairment of liver or kidney function, with a tendency to arterial hypertension, bronchospasm, with systemic lupus erythematosus and other systemic connective tissue diseases - an increased risk of aseptic meningitis; history of heart failure, which was accompanied by fluid retention and edema when using non-steroidal anti-inflammatory drugs.

Influence on the cardiovascular and cerebrovascular system.

Data clinical trial and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day), as well as long-term use, may lead to a slight increase in the risk of developing arterial thrombotic complications (for example, myocardial infarction or stroke). In general, data from epidemiological studies do not suggest that low dose ibuprofen (eg, ≤ 1200 mg daily) may lead to an increased risk of myocardial infarction. Patients with uncontrolled arterial hypertension, congestive heart failure, diagnosed ischemic disease heart disease, peripheral arterial disease, and/or cerebrovascular disease, long-term treatment can only be prescribed by a physician after careful consideration. Patients with significant risk factors for cardiovascular complications (such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking) should be given long-term treatment NSAIDs should only be given after careful consideration.

Impact on the respiratory system.

Bronchospasm may occur in patients suffering from bronchial asthma or allergic diseases, or have a history of these diseases.

Other NSAIDs.

The simultaneous use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors, should be avoided, as this increases the risk of adverse reactions.

Effect on the kidneys.

Risk of renal failure due to deterioration of renal function Long-term use of NSAIDs can lead to a dose-dependent decrease in prostaglandin synthesis and provoke the development of renal failure. Patients with impaired renal function, cardiac disorders, impaired liver function, patients taking diuretics, and elderly patients are at high risk of this reaction. In such patients, renal function should be monitored.

Effects on fertility in women.

There is limited evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may interfere with ovulation. This process is reversible upon discontinuation of treatment. Long-term use (applies to a dose of 2400 mg during the day, as well as the duration of treatment for more than 10 days) of ibuprofen can impair female fertility and is not recommended for women who are trying to become pregnant. Women who have problems getting pregnant or who are being tested for infertility should discontinue this drug.

Influence on the gastrointestinal tract.

NSAIDs should be used with caution in patients with chronic inflammatory diseases intestines (ulcerative colitis, Crohn's disease), as these conditions can worsen. There are reports of cases of gastrointestinal bleeding, perforation, ulcers, which can be fatal, which occurred at any stage of NSAID treatment, regardless of the presence of warning symptoms or the presence of severe disorders of the gastrointestinal tract in history.

Increasing the dose of NSAIDs, old age and a history of peptic ulcer risk of adverse reactions from the digestive tract. During treatment in such cases, it is recommended to use the minimum effective dose of the drug.

Caution should be used in patients receiving therapy with medicinal products that may increase the risk of gastric and duodenal ulcers or bleeding, in particular oral corticosteroids, anticoagulants, warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. Patients who have observed gastrointestinal disorders, especially in the elderly, should stop treatment and consult a doctor if any undesirable symptoms (especially bleeding from the digestive tract) appear.

From the skin and subcutaneous tissue.

Very rarely, severe forms of skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur while taking NSAIDs. The highest risk of such reactions is observed in the early stages of therapy, in most cases the onset of such reactions occurs during the first month of treatment. Ibuprofen should be discontinued at the first sign skin rash, pathological changes mucous membranes or any other sign of hypersensitivity.

With prolonged (more than a week) use of the drug, it is necessary to monitor peripheral blood parameters and the functional state of the liver.

The drug can affect the psychophysiological state of patients when taken simultaneously with alcohol and drugs that depress the central nervous system.

Prolonged and uncontrolled use of painkillers, especially the combination of different analgesic active substances, can lead to chronic kidney damage with a risk of kidney failure (analgesic nephropathy).

The drug should not be used in the presence of hereditary intolerance to galactose and dairy products, lactase deficiency.

As with other non-steroidal anti-inflammatory drugs, ibuprofen may mask signs of infection.

Use during pregnancy or lactation

Suppression of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of miscarriage, congenital malformations after the use of prostaglandin synthesis inhibitors on early stage pregnancy. It is believed that the risk increases with increasing dose and duration of therapy. During the I and II trimesters of pregnancy, the use of the drug should be avoided.

During the third trimester of pregnancy, with the use of any prostaglandin synthesis inhibitors, such effects on the fetus as cardiopulmonary toxicity (premature closure of the arterial duct of the fetus with pulmonary hypertension) and impaired renal function, which can progress to renal failure with the manifestation of oligohydroamnios.

Ibuprofen is contraindicated in the third trimester of pregnancy due to the possibility of inhibition contractile function uterus, which can lead to an increase in the duration of labor with a tendency to increase bleeding in mother and child, even at low doses.

Breastfeeding for the period of treatment should be discontinued.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Dosage and administration

The lowest effective dose needed to treat symptoms should be used for the shortest period of time. If symptoms persist for more than 5 days from the start of treatment or worsen, you should consult a doctor.

Novigan ® is advisable to use either 1:00 before a meal or 3:00 after a meal. Take the tablets with water, do not chew. To prevent irritating effects on the stomach, it should be used immediately after meals or washed down with milk.

Repeat the dose if necessary after 4-6 hours. Do not exceed 1200 mg ibuprofen per day.

The elderly do not need special dosing.

Children

Do not prescribe the drug to children under the age of 16 years.

Overdose

Symptoms. Manifested in the form of gastrointestinal disorders (diarrhea, nausea, vomiting, anorexia, pain in the epigastric region), manifestations of hepatotoxicity, impaired consciousness.

Tinnitus, headache, and gastrointestinal bleeding may also occur. In severe poisoning, toxic damage to the central nervous system is observed, manifested by drowsiness, sometimes by an excited state and disorientation or a comma. Occasionally, patients develop seizures. In more severe poisoning, metabolic acidosis and an increase in PT/INR may occur (probably through interaction with blood coagulation factors circulating in the bloodstream). Acute kidney failure and liver damage may occur. Patients with bronchial asthma may experience an exacerbation of the course of asthma.

Treatment. Symptomatic and supportive therapy is indicated, including patency respiratory tract and monitoring cardiac function and vital signs until the patient's condition returns to normal. Within an hour after taking a large dose, gastric lavage, taking activated charcoal. It is necessary to ensure proper urination and monitor the state of kidney and liver function. After taking potentially toxic doses, patients should be observed for at least 4:00. In the event of seizures, diazepam or lorazepam can be used intravenously. When bronchial asthma bronchodilators should be used.

Adverse reactions

The following adverse reactions have been observed with short-term use of ibuprofen at doses not exceeding 1200 mg/day. During treatment chronic diseases and with prolonged use, other adverse reactions may occur.

Adverse reactions associated with the use of ibuprofen, classified by organ system and frequency. The frequency is defined as follows: very often ≥1 / 10; often: ≥1/100 and<1/10; нечасто ≥1 / 1000 и <1/100; редко ≥1 / 10000 и <1/1000; очень редко <1/10000, частота неизвестна (невозможно оценить частоту по имеющимся данным).

From the gastrointestinal tract.

Possible - abdominal pain, dyspepsia, nausea.

Rarely - diarrhea, flatulence, constipation, vomiting.

Very rarely - peptic ulcers, perforation or gastrointestinal bleeding, heartburn, ground, hematemesis (sometimes fatal), ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, gastritis, esophagitis.

From the blood and lymphatic systems.

Very rare: impaired hematopoiesis 1.

1 Includes anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis. The first signs of such disorders are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe malnutrition, bleeding, and bruising of unknown etiology.

From the side of the cardiovascular system. Rarely tachycardia, shortness of breath, cerebrovascular complications, arterial hypotension, palpitations.

Very rarely, edema, arterial hypertension, heart failure.

With long-term use and at high doses (2400 mg / day), an increase in the risk of arterial thrombotic complications (for example, stroke or myocardial infarction), a decrease in the effectiveness of antihypertensive drugs, may be possible.

General disorders. Very rare: non-specific allergic reactions and anaphylactic shock, asthma or worsening of asthma, bronchospasm, rash, itching, urticaria, purpura, angioedema.

From the side of the nervous system. Uncommon: headache.

Very rarely, optic neuritis, paresthesia, nervousness, dizziness, drowsiness, irritability, tinnitus, depression, insomnia, anxiety, psychomotor agitation, emotional instability, convulsions. Frequency unknown: hallucinations, confusion.

From the immune system.

Infrequently, hypersensitivity reactions accompanied by urticaria and itching 2. Very rare: severe hypersensitivity reactions, the symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, angioedema or severe shock).

2 Hypersensitivity reactions may include: (a) non-specific allergic reactions and anaphylaxis, (b) airway reactivity including asthma, asthma exacerbation, bronchospasm and dyspnoea, or (c) various forms of skin reactions including pruritus, urticaria, purpura, angioedema , and less commonly, exfoliative and bullous dermatosis, including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme.

In patients with systemic lupus erythematosus and mixed connective tissue diseases, taking ibuprofen, in rare cases, can lead to symptoms of aseptic meningitis, namely, neck stiffness, headache, vomiting, high fever, or confusion.

From the side of the blood-forming organs and the lymphatic system. Very rarely: hematopoietic disorders (hemolytic anemia, aplastic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased hematocrit and hemoglobin levels, pancytopenia, agranulocytosis). The first signs are high fever, sore throat, mouth ulcers, flu-like symptoms, severe malnutrition, unexplained bleeding and bruising. Reverse platelet aggregation, alveolitis, pulmonary eosinophilia.

From the organs of vision. Very rarely blurred vision, altered color perception, toxic amblyopia. Frequency unknown: blurred vision.

From the digestive system. Very rare: liver dysfunction, hepatitis, jaundice, duodenitis, pancreatitis, hepatorenal syndrome, liver failure, hepatonecrosis.

From the skin and subcutaneous tissue. Rarely skin peeling, alopecia, photosensitivity, various skin rashes. Very rarely bullous lesions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.

From the side of the kidneys and urinary system. Very rarely, papilonecrosis, cystitis, hematuria, nephrotic syndrome, oliguria, polyuria, tubular necrosis, glomerulonephritis, impaired renal function, toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure, acute renal dysfunction. 3

3 Especially with long-term use of NSAIDs, in combination with an increase in the level of urea in the blood serum and the appearance of edema. Also includes papilonecrosis.

Other effects. Rarely: dryness of the mucous membranes of the eyes and mouth, stomatitis, high fever, feeling unwell, weakness, fatigue, hearing impairment, ulcerative stomatitis.

Very rarely: changes in the endocrine system and metabolism, decreased appetite.

Laboratory research.

Very rare: Decreased hemoglobin levels.

Best before date

Storage conditions

Keep out of the reach of children, dry, dark place at a temperature not exceeding 25 ° C.

Package

10 tablets in a blister, 1 blister in a cardboard box.

1 tablet contains active ingredients: 5mg pitofenone hydrochloride , 400mg , 0.1mg fenpiverinium bromide.

Excipients: 76mg cornstarch, 5mg colloidal silicon dioxide, 4mg magnesium stearate , 55mg MCC, 12mg talc, 2.9mg .

The composition of the film shell of the shell: 1.124 mg of macrogol 6000, 1.059 mg of titanium dioxide, 0.058 mg sorbic acid , 5.686mg hypromellose 6 cps, 1.957mg talc, 0.058mg polysorbate 80, 0.058mg .

Release form

The drug is available in the form of coated tablets of 10 pieces in a blister. The carton box contains 2, 10 or 20 blisters with tablets, as well as instructions for use.

There is a release form in film-coated tablets. One blister contains 10 tablets. The cardboard box contains instructions for the use of the drug, as well as one or two blisters.

pharmachologic effect

Pills render anti-inflammatory, analgesic and antispasmodic action.

Indications for Novigan's use

Novigan tablets are indicated for:

moderate or mild pain syndrome, observed when the smooth muscles of the internal organs are exposed to - intestinal, bile and, as well as in the case of ;
headaches, including those that have a migraine character;
symptomatic short-term treatment for , myalgia , sciatica and pain in the joints.

Pharmacodynamics and pharmacokinetics

Novigan is a combination drug that has antispasmodic, anti-inflammatory and analgesic effects. The medicine suppresses synthesis. The preparation contains ibuprofen, which is a non-steroidal anti-inflammatory drug, fenpiverinium bromide- m-anticholinergic agent with peripheral and central action, as well as myotropic antispasmodic pitofenone hydrochloride.

Pitophenone hydrochloride causes relaxation of the muscles of the internal organs, exerting a direct myotropic effect on it.

Ibuprofen(derived from phenylpropionic acid) has analgesic, anti-inflammatory and antipyretic effects. The main effect of the substance is reduced to the inhibition of synthesis prostaglandins, which are modulators of thermoregulation, pain sensitivity and inflammation in peripheral tissues and CNS. In women suffering from primary dysmenorrhea , the level decreases prostaglandins v myometrium thereby reducing heart rate and intrauterine pressure.

Fenpiverinium bromide It has an additional relaxing effect on smooth muscles due to its anticholinergic action.

Combined, these three main components mutually reinforce each other's pharmacological action.

The components that make up Novigan are perfectly absorbed into gastrointestinal tract. After taking, after about 1-2 hours, the peak concentration of the drug is reached. Ibuprofen, the main component of this drug, is almost completely (99%) associated with blood plasma proteins, it can also be accumulated in synovial fluid. This component metabolized in the liver and 90% excreted in the urine as conjugates and . A small part of Novigan is excreted with bile. The half-life from blood plasma is 2 hours.

Contraindications

The drug is contraindicated in:

anamnestic data about the attack, bronchial obstruction after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (with incomplete or complete acetylsolicylic acid intolerance syndrome - hives , polyps nasal mucosa);
inflammatory bowel disease in the acute phase, including ulcerative ;
erosive and ulcerative changes in the mucous membrane of the duodenum or stomach, as well as with active bleeding in the gastrointestinal tract;
active liver disease or liver failure;
advanced kidney disease or Cl is less than 30 ml/min);
hemophilia or any other bleeding disorder (including hypocoagulation ), hemorrhagic diathesis ;
confirmed hyperkalemia ;
acute intermittent porphyria ;
hematopoietic disorders;
tachyarrhythmias ;
deficit glucose-b-phosphate dehydrogenase;
granulocytopenia ;
closed-angle ;
intestinal obstruction;
diseases optic nerve;
the period of breastfeeding or pregnancy;
in the period after the coronary artery bypass grafting;
individual intolerance to the components contained in the preparation;
patient under 16 years of age.

In addition, the drug should be taken with caution when:

advanced age of the patient;
cerebrovascular diseases;
heart failure;
hyperlipymedia /dyslipidemia ;
arterial hypertension ;
Cl creatinine 30–60 ml/min;
ischemic heart disease;
nephrotic syndrome ;
hyperbilirubinemia ;
congestive heart failure;
diseases of peripheral arteries;
peptic ulcer of the duodenum and stomach (history);
infection Helicobacter pylori ;
esterite ;
long-term use of non-steroidal anti-inflammatory drugs;
heavy somatic diseases;
alcoholism or smoking;
blood diseases of unknown etiology ( anemia , leukopenia );
concomitant therapy with anticoagulants(For example, ), oral GKS(For example, ),antiplatelet agents ( , acetylsolicylic acid etc.), as well as using SSRIs(For example, , , citalopram, ).

Side effects

For the gastrointestinal tract: mouth pain, aphthous stomatitis , ulceration of the mucous membrane of the gastrointestinal tract, sometimes complicated by bleeding and perforation, ulceration of the mucous membrane of the gums, NSAID gastropathy(nausea, heartburn, vomiting, loss of appetite, abdominal pain, ), dryness and irritation of the mucous membrane may appear in the oral cavity, .

For the respiratory system: bronchospasm, shortness of breath.

For the hepabolic system: hepatitis .

For peripheral and central nervous system: anxiety, dizziness, confusion, insomnia, irritability and nervousness, hallucinations, psychomotor agitation , headache, drowsiness, and aseptic most commonly seen in patients with autoimmune diseases.

For the cardiovascular system:, increased blood pressure, heart failure.
For the senses: visual disturbances - blurred visual perception, irritation and dryness of the eyes, scotoma, swelling of the eyelids and conjunctiva, paresis of accommodation, as well as hearing impairment - its deterioration, as well as ringing or noise in the ears.

For hematopoietic organs: leukopenia , anemia (including also hemolytic aplastic), thrombocytopenic purpura and thrombocytopenia .

For the urinary system: acute renal failure, allergic nephritis , oliguria , nephrotic syndrome (edema), anuria , polyuria and urine turns red.

Allergic reactions: fever, anaphylactoid reactions, dyspnea or bronchospasm, skin itching, erythema multiforme exudative(including Stevens-Johnson syndrome ), eosinophilia skin rash (usually hives or erythematous), toxic epidermal necrolysis , allergic rhinitis .

Laboratory indicators: serum concentration may decrease glucose, may increase bleeding time, may decrease clearance creatinine, a decrease in level may occur or hematocrit may increase liver activity transaminases and may also increase serum concentrations creatinine.

Other side effects: decreased or increased sweating.

In the event that changes have occurred in the normal state when taking the drug, you should immediately stop taking the drug and seek medical help without delay.

Instructions for use Novigan (Method and dosage)

The drug is taken orally one hour before a meal or after a meal three hours later. To avoid the negative irritating effect of the drug on the stomach, you can take Novigan immediately after a meal or you can drink the tablets with milk.

In the absence of any doctor's prescriptions for admission, if spastic pains Novigan is recommended to take one tablet three times a day. The maximum dose of the drug per day is three Novigan tablets.

The instructions for use also warns that without consulting a doctor, the course of taking the tablets should not last more than five days. If you need to use the drug for a longer time, then this is done only under the supervision of a doctor and strict control of indicators of the functional state of the liver and peripheral blood.

Overdose

Overdose symptoms are: lethargy, nausea, abdominal pain, drowsiness, vomiting, depression, metabolic acidosis, tinnitus, lowering blood pressure, atrial fibrillation, headache, acute renal failure, respiratory arrest and .

As a treatment, it is used: alkaline drink, gastric lavage (maximum - after 3 hours), forced diuresis, and activated charcoal is prescribed or symptomatic therapy is used (blood pressure, acid-base state is corrected). However, there is no specific drug that could be used in case of an overdose.

Interaction

When taking Novigan in therapeutic doses with other commonly used drugs, significant interactions do not occur.

Microsomal oxidation inhibitors reduce the risk of developing hepatotoxic effect.

In the liver, inducers of microsomal oxidation enzymes ( ethanol, flumecinol, phenylbutazone, phenytonin, tricyclic antidepressants, barbiturates) increases the production of hydroxylated active metabolites, thereby increasing the risk that severe intoxication will develop.

Decreases natriuretic effect and furosemide, as well as hypotensive activity of vasodilators.

Efficiency uricosuric drugs is reduced.

There is an increased risk that bleeding will develop due to increased drug action fibrinolytics, indirect anticoagulants and antiplatelet agents.

Absorption ibuprofen is reduced cholestyramine and antacids.

The drug enhances the likely side effects, ethanol, GKS(increased risk of gastrointestinal bleeding) mineralocorticosteroids; derivatives sulfonylurea when interacting with the drug, they increase their hypoglycemic effect.

Concentration in the blood, as well as drugs methotrexate and lithium increases.
Simultaneous administration of the drug with other non-steroidal anti-inflammatory drugs increases the frequency of possible side effects.

The action is getting stronger butyrophenones, quinidine, phenothiazines, blockers H1-histamine receptors, , m-anticholinergics.

When the drug interacts with caffeine increases analgesic effect.

In case of simultaneous administration with acetylsalicylic acid her antiplatelet and anti-inflammatory action(in patients who receive small doses of acetylsalicylic acid as an antiplatelet agent, acute coronary insufficiency may develop at an increased frequency).

Manifestations of hematotoxicity of the drug is enhanced myelotoxic drugs.

In the case of simultaneous use of Novigan with, valproic acid, cefamandol, cefotetan or plicamycin the frequency of development increases hypoprothrombinemia .

Gold preparations and enhance the effect of ibuprofen on the synthesis of PG in the kidneys, the effect of which is manifested in an increase nephrotoxicity. Plasma concentration, as well as the likelihood that its hepatotoxic effects will develop, are increased by ibuprofen.

drugs that block tubular secretion, increase the plasma concentration of the substance ibuprofen, and also lower its excretion.

Terms of sale

The drug is dispensed in pharmacies without a prescription.

Storage conditions

Novigan should be stored out of the reach of children in a dry place protected from light. The storage temperature must not exceed 25°C.

Best before date

special instructions

In the case of prolonged use of the drug, careful monitoring of the picture of the functional state of the kidneys and liver and peripheral blood is required.

To reduce the risk of developing negative effects on the gastrointestinal tract, you need to take the minimum effective dose of the drug. If symptoms appear gastropathy careful monitoring is required, which includes a stool test for the presence of occult blood, a blood test, which includes the definition hematocrit and , as well as carrying out esophagogastroduodenoscopy.

In case a definition is required 17-ketosteroids, you need to stop taking the drug 48 hours before the start of the study.

During treatment with Novigan, you should refrain from drinking alcohol.

Patients taking the drug should refrain from potentially hazardous activities that require the speed of psychomotor reactions and increased concentration of attention (driving vehicles, etc.).

newborn

The drug is contraindicated for use in infants under the age of 4 months.

With alcohol

During the course of treatment with Novigan, you should refrain from drinking alcoholic beverages.

During pregnancy and lactation

During pregnancy, the drug is contraindicated (especially you should refrain from using it in the first trimester and in the last six weeks of pregnancy), and it is also not recommended to take Novigan during breastfeeding.

Spasmoanalgesic

Active ingredients

Release form, composition and packaging

◊ Film-coated tablets white, round, biconvex, embossed "NOVIGAN" on one side; cross-sectional view: from white to almost white.

Excipients: microcrystalline cellulose - 55 mg, corn starch - 76 mg, glycerol - 2.9 mg, colloidal silicon dioxide - 5 mg, talc - 12 mg, magnesium stearate - 4 mg.

Shell composition: hypromellose 6 cps - 5.686 mg, macrogol 6000 - 1.124 mg, talc - 1.957 mg, titanium dioxide - 1.059 mg, polysorbate 80 - 0.058 mg, sorbic acid - 0.058 mg, dimethicone - 0.058 mg.

10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.

pharmachologic effect

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of the synthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, it reduces the elevated level of prostaglandins in the myometrium and thereby reduces intrauterine pressure and the frequency of uterine contractions.

Pitophenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.

Fenpiverinium bromide due to anticholinergic action, it has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Pharmacokinetics

Suction and distribution

When taken orally, the components of Novigan are well absorbed from the gastrointestinal tract. C max in blood plasma is reached after about 1-2 hours. The main component of the drug ibuprofen is 99% bound to blood proteins, accumulates in the synovial fluid.

Metabolism and excretion

Ibuprofen is metabolized in the liver and 90% is excreted in the urine as metabolites and conjugates. A small part of ibuprofen is excreted in the bile. T 1/2 from blood plasma is 2 hours.

Indications

- mild or moderate pain syndrome with spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic;

- dysmenorrhea;

- headache, incl. migraine character;

- short-term symptomatic treatment for pain in the joints, neuralgia, sciatica, myalgia.

Contraindications

- erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;

- inflammatory bowel disease in the acute phase, incl. ulcerative colitis;

- anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

- liver failure or active liver disease;

- renal failure (CC less than 30 ml / min), progressive kidney disease;

- confirmed hyperkalemia;

- hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

- the period after coronary artery bypass grafting;

- acute intermittent porphyria;

- granulocytopenia;

- violations of hematopoiesis;

- deficiency of glucose-6-phosphate dehydrogenase;

- tachyarrhythmias;

- angle-closure glaucoma;

- diseases of the optic nerve;

- prostatic hyperplasia;

- intestinal obstruction;

- pregnancy;

- lactation period (breastfeeding);

- age up to 16 years;

- hypersensitivity to any component of the drug.

WITH caution:

- elderly age;

- congestive insufficiency;

- cerebrovascular diseases;

- arterial hypertension;

- dyslipidemia / hyperlipidemia;

- diabetes;

- diseases of peripheral arteries;

- nephrotic syndrome;

- CC less than 30-60 ml / min;

- hyperbilirubinemia;

- peptic ulcer of the stomach and duodenum (in history);

- the presence of Helicobacter pylori infection;

— gastritis, enteritis, colitis;

- long-term use of NSAIDs;

- blood diseases of unknown etiology (leukopenia, anemia);

- smoking;

- frequent use of alcohol (alcoholism);

- severe somatic diseases;

- concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral corticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

Dosage

Inside, 1 hour before or 3 hours after a meal. To avoid irritating the stomach, you can take the drug immediately after a meal or drink it with milk.

In the absence of special prescriptions from a doctor, Novigan is recommended to be taken with spastic pains 1 tab. up to 3 times / day. The maximum daily dose is 3 tab. Do not exceed the indicated dose!

The course of treatment with Novigan, without consulting a doctor, should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood parameters and the functional state of the liver.

Side effects

From the digestive system: NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulceration of the gastrointestinal mucosa, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis), pancreatitis, hepatitis.

From the side of the respiratory system: shortness of breath, bronchospasm.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

From the organ of hearing: hearing loss, hearing loss, ringing in the ears.

From the side of the organ of vision: visual impairment (toxic damage to the optic nerve, blurred vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis), paresis of accommodation).

From the side of the cardiovascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining red.

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

From the side of the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Others: increased or decreased sweating.

From the side of laboratory indicators: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), liver transaminase activity (may increase).

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only within an hour after ingestion), alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). There is no specific antidote.

drug interaction

At therapeutic doses, Novigan does not interact significantly with commonly used drugs.

Microsomal oxidation inhibitors reduce the risk of hepatotoxicity.

The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

Enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

Enhances the side effects of mineralocorticoids, glucocorticoids (increased risk of gastrointestinal bleeding), estrogen, ethanol.

Enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of ibuprofen.

The drug increases the concentration of digoxin, lithium preparations, methotrexate in the blood.

Enhances the action of m-anticholinergics, blockers of histamine H 1 receptors, butyrophenones, phenothiazines, amantadine and quinidine.

The simultaneous appointment of other NSAIDs increases the incidence of side effects.

Caffeine enhances the analgesic effect.

Cefamandol, cefoperazone, cefotetan, plicamycin increase the incidence of hypoprothrombinemia with simultaneous administration.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase the plasma concentration of ibuprofen.

special instructions

With prolonged use, it is necessary to control the pattern of peripheral blood and the functional state of the liver and kidneys.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the period of treatment should refrain from drinking alcohol.

Influence on the ability to drive vehicles and control mechanisms

During the period of treatment, the patient should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application in childhood

Contraindicated in children under 16 years of age

For impaired renal function

Terms and conditions of storage

The drug should be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25°C. Shelf life - 5 years.