Medicinal reference book geotar. Calcium-D3 Nycomed Forte - instructions for use Calcium D3 Nycomed Forte - photo
A drug: CALCIUM-D 3 NIKOMED FORTE
Active substance: calcium carbonate, colecalciferol
ATX code: A12AX
KFG: A drug that regulates the metabolism of calcium and phosphorus
ICD-10 codes (indications): E55, E58, M81.0, M81.1, M81.2, M81.4, M81.8, M82
KFU code: 16.04.02
Reg. number: P No. 013355/01
Date of registration: 29.12.06
The owner of the reg. acc.: NYCOMED PHARMA A/S (Norway)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
? Tablets chewable (lemon) round, biconvex, without shell, white, with lemon flavor; may have small inclusions and jagged edges.
Excipients: sorbitol, isomalt, povidone, magnesium stearate, aspartame, lemon oil, mono- and diglycerides of fatty acids.
30 pcs. - polyethylene bottles.
60 pcs. - polyethylene bottles.
120 pcs. - polyethylene bottles.
CALCIUM-D3 NIKOMED FORTE INSTRUCTION FOR SPECIALIST.
The description of the drug CALCIUM-D3 NIKOMED FORTE is approved by the manufacturer.
PHARMACHOLOGIC EFFECT
Combined drug that regulates the exchange of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).
Reduces resorption (resorption) and increases density bone tissue, making up for the lack of calcium and vitamin D 3 in the body, is necessary for the mineralization of teeth.
Calcium is involved in the regulation of nerve conduction, muscle contractions and is a component of the blood coagulation system.
Vitamin D 3 (colcalciferol) increases the absorption of calcium in the intestine.
The use of calcium and vitamin D 3 prevents an increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption (washing out of calcium from the bones).
PHARMACOKINETICS
Vitamin D 3 is absorbed in the lower intestines.
Calcium is absorbed in ionized form in the proximal small intestine via an active vitamin D-dependent transport mechanism.
INDICATIONS
For the prevention and complex therapy of osteoporosis and its complications (bone fractures);
To compensate for the deficiency of calcium and vitamin D 3 in the body.
DOSING MODE
Adults for prevention of osteoporosis appoint 1 tab. 2 times / day; v complex therapy of osteoporosis- 1 tab. 2-3 times / day.
At calcium and vitamin D deficiencyadults and children over 12 years old appoint 1 tab. 2 times / day, children aged 3 to 12 years- 1 tab./day or set an individual dosing regimen.
The tablet can be chewed or sucked and taken with meals.
SIDE EFFECT
From the side digestive system: possible constipation, diarrhea, flatulence, nausea, abdominal pain.
From the side of metabolism: hypercalcemia, hypercalciuria.
Others: allergic reactions.
CONTRAINDICATIONS
hypercalcemia;
Hypercalciuria;
Nephrolithiasis;
Hypervitaminosis D;
Severe renal failure;
Active form of tuberculosis;
Sarcoidosis;
Hypersensitivity to the components of the drug.
The dosage form of the tablet is not used in children under the age of 3 years.
PREGNANCY AND LACTATION
Caution should be exercised when prescribing the drug during pregnancy and lactation.
During pregnancy daily dose the drug should not exceed 1500 mg of calcium and 600 IU of vitamin D 3 . Hypercalcemia, which develops against the background of an overdose during pregnancy, can cause defects in the mental and physical development of the child.
Vitamin D and its metabolites can be excreted in breast milk, so the additional intake of calcium and vitamin D from other sources in the mother and child must be taken into account.
SPECIAL INSTRUCTIONS
Tablets Calcium-D 3 Nycomed Forte contain aspartame, which is transformed into phenylalanine in the body, so the drug should not be taken with phenylketonuria.
When using the drug Calcium-D 3 Nycomed Forte in patients who receive cardiac glycosides and / or diuretics, it is necessary to control the concentration of calcium and creatinine in the blood serum.
In the event of an increased concentration of calcium or creatinine in the blood serum, as well as in the case of hypercalciuria exceeding 7.5 mmol / day (300 mg / day), the dose of the drug should be reduced or treatment should be temporarily discontinued.
In order to avoid overdose, it is necessary to take into account the additional intake of vitamin D 3 from other sources.
The intake of foods containing oxalates (sorrel, spinach) and phytin (cereals) reduces the absorption of calcium, so you should not take Calcium-D 3 Nycomed Forte within 2 hours after taking sorrel, spinach, cereals.
Calcium-D 3 Nycomed Forte should be used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia.
OVERDOSE
Symptoms: anorexia, thirst, polyuria, decreased appetite, dizziness, fainting, weakness, nausea, vomiting, hypercalciuria, hypercalcemia, hypercreatininemia; with prolonged use in excess doses - calcification of blood vessels and tissues.
The patient should be warned that if signs of an overdose appear, it is necessary to consult a doctor.
Treatment: the drug should be discontinued immediately. It is recommended to introduce a large amount of fluid into the body, the use of "loop" diuretics (for example, furosemide), corticosteroids, calcitonin, bisphosphonates.
DRUG INTERACTIONS
With simultaneous use with phenytoin or barbiturates, a decrease in the activity of vitamin D 3 is possible.
Calcium preparations can potentiate the therapeutic and toxic effects of cardiac glycosides, therefore, with the simultaneous use of Calcium-D 3 Nycomed Forte and cardiac glycosides, it is necessary to monitor the ECG and the patient's clinical condition.
Calcium and vitamin D 3 preparations can increase the absorption of tetracyclines from the gastrointestinal tract, so the interval between taking Calcium-D 3 Nycomed Forte and antibiotics of the tetracycline group should be at least 3 hours.
With simultaneous use with bisphosphonates or sodium fluoride, their absorption may decrease, therefore it is recommended to take Calcium-D 3 Nycomed Forte no earlier than 2 hours after these drugs.
Corticosteroids reduce calcium absorption, therefore, in patients receiving corticosteroids, an increase in the dose of Calcium-D 3 Nycomed Forte may be required.
With simultaneous use with colestyramine or laxatives based on mineral or vegetable oil, a decrease in the absorption of vitamin D 3 is possible.
With simultaneous use with thiazide diuretics, the risk of developing hypercalcemia increases due to an increase in tubular reabsorption of calcium. Furosemide and other "loop" diuretics, on the contrary, increase the excretion of calcium by the kidneys.
TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place, in a tightly closed vial at a temperature not exceeding 25°C. Shelf life - 3 years.
Calcium-D3 Nycomed Forte: instructions for use and reviews
Latin name: Calcium-D3 Nycomed Forte
ATX code: A12AX
Active substance: Colecalciferol + Calcium carbonate (Colecalciferol + Calcium carbonate)
Manufacturer: Nycomed Pharma AS (Norway)
Description and photo update: 24.10.2018
Calcium-D3 Nycomed Forte is a remedy containing calcium and vitamin D 3 that compensates for their deficiency.
Release form and composition
Lemon chewable tablets: round, biconvex, white, without shell, with lemon flavor; there may be small inclusions and jagged edges.
Packing: bottles with a screw cap - 30, 60 and 120 pieces, each bottle in a carton box.
Composition of 1 tablet:
- active ingredients: calcium carbonate - 1250 mg, equivalent to 500 mg of elemental calcium, cholecalciferol (vitamin D 3) - 400 IU (0.01 mg), in the form of cholecalciferol concentrate (4 mg);
- additional components: aspartame, sorbitol, mono- and diglycerides of fatty acids, povidone, isomalt, lemon oil, magnesium stearate.
Pharmacological properties
Pharmacodynamics
Calcium-D3 Nycomed Forte, thanks to its constituent components, regulates the exchange of calcium and phosphorus in the body (in bones, nails, teeth, muscles, hair). Replenishing the deficiency of vitamin D 3 and calcium, reduces bone resorption and increases its density, participates in the mineralization of teeth.
In addition, calcium is a component of the blood coagulation system, is involved in the regulation of muscle contractions and nerve conduction. Vitamin D 3 promotes better absorption of calcium in the intestines.
The use of calcium in combination with vitamin D 3 prevents the increase in the production of parathyroid hormone, which is a stimulator of calcium leaching from bones (increased bone resorption).
Pharmacokinetics
Calcium is absorbed in the gastrointestinal tract in an amount of about 30% of the dose taken. 99% of the substance present in the human body is concentrated in the rigid structure of bones and teeth, another 1% in extra- and intracellular fluids. About 50% of the calcium in the blood is present in a physiologically active ionized form, of which about 40% are associated with proteins (mainly albumin), the remaining 10% are present in a complex with phosphate, citrate or other anions. Calcium is excreted by the intestines, kidneys, sweat glands. In the latter case, excretion depends on tubular calcium reabsorption and glomerular filtration.
Colecalciferol is absorbed in the small intestine in an amount of about 80% of the dose taken. Vitamin D 3 and its metabolites circulate in the blood by binding to a specific globulin. Colecalciferol is metabolized in the liver by hydroxylation to 25-hydroxycholecalciferol, after which it is converted in the kidneys to the active metabolite 1,25-hydroxycolecalciferol, which is responsible for enhancing calcium absorption. Unmetabolized colecalciferol is deposited in muscle and adipose tissues. Excreted by the intestines and kidneys.
Indications for use
Prevention and treatment:
- deficiency of calcium and/or vitamin D 3 ;
- osteoporosis and its complications (bone fractures).
Contraindications
- children's age up to 3 years;
- hypersensitivity to peanuts or soy;
- hypercalciuria;
- hypercalcemia;
- hypervitaminosis D;
- sarcoidosis;
- active tuberculosis;
- hereditary fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency;
- phenylketonuria;
- nephrolithiasis;
- heavy kidney failure;
- individual sensitivity to any component of the drug.
Instructions for use Calcium-D3 Nycomed Forte: method and dosage
Tablets Calcium-D3 Nycomed Forte should be taken with meals: dissolve in the mouth or chew.
To compensate for the lack of vitamin D 3 and calcium, it is prescribed: for adults and adolescents from 12 years old - 2 tablets per day, for children from 3 to 12 years old - 1 tablet per day, unless otherwise prescribed by a doctor.
The duration of admission is on average 4-6 weeks. The doctor determines the need for repeated courses and their number during the year individually.
For the prevention of osteoporosis, it is recommended to take 2 tablets 1 time per day or 1 tablet 2 times a day. As part of the complex therapy of osteoporosis, Calcium-D3 Nycomed Forte is prescribed 1 tablet 2 or 3 times a day. The duration of the drug is determined individually.
Side effects
During therapy, adverse reactions may occur:
- from the digestive system: rarely - dysfunction gastrointestinal tract(increased formation of gases in the intestines, abdominal pain, nausea, dyspepsia, diarrhea or constipation);
- allergic reactions: very rarely - skin rashes, itching, urticaria;
- laboratory indicators: infrequently - hypercalciuria and hypercalcemia (increased calcium in the urine or blood).
Overdose
An overdose of calcium is manifested by hypercalcemia, its possible symptoms are: thirst, abdominal pain, constipation, nausea, anorexia, vomiting, muscle weakness, fatigue, mental disorders, bone pain, increased urine production, urolithiasis disease, nephrocalcinosis. In severe cases, cardiac arrhythmias may develop. With prolonged use of high doses of calcium (more than 2500 mg), soft tissue calcification is noted, kidney damage is possible.
In case of an overdose, it is necessary to cancel Calcium-D3 Nycomed Forte, as well as, if used simultaneously, cardiac glycosides and thiazide diuretics.
First measures: gastric lavage and replenishment of fluid loss.
Treatment of overdose: the use of calcitonin, glucocorticosteroids, bisphosphonates, loop diuretics (eg, furosemide). Patients should be monitored for plasma electrolytes, diuresis and kidney function, with severe symptoms of overdose, it is recommended to measure central venous pressure and monitor the electrocardiogram.
special instructions
In order to avoid overdose, it is important to take into account the additional intake of vitamin D from any other sources, including food.
With long-term use of the drug, it is necessary to control the level of calcium and creatinine in the blood serum, especially in elderly people receiving diuretics and / or cardiac glycosides at the same time, as well as in patients with an increased tendency to form kidney stones. If symptoms of impaired renal function appear or hypercalcemia develops, the dose of Calcium-D3 Nycomed Forte should be reduced or it should be canceled altogether.
The drug should be used with caution in the treatment of patients with osteoporosis, if they are immobilized, since this category is at increased risk of developing hypercalcemia.
Influence on the ability to drive vehicles and complex mechanisms
Active substances Calcium-D3 Nycomed Forte do not affect a person's ability to drive vehicles and work with technically complex mechanisms.
Use during pregnancy and lactation
According to the instructions, Calcium-D3 Nycomed Forte during pregnancy and lactation is prescribed to compensate for the lack of calcium and vitamin D 3.
For pregnant women, daily doses of vitamins should not exceed: calcium - 1500 mg, colecalciferol - 600 IU. This should be taken into account, since hypercalcemia may develop due to an overdose, and it has a negative effect on the development of the fetus.
Vitamin D 3 and its metabolites penetrate into breast milk Therefore, nursing mothers need to take into account the intake of cholecalciferol and calcium from other sources, both in themselves and in the child.
Application in childhood
Calcium-D3 Nycomed Forte is contraindicated in children under 3 years of age (due to dosage form in the form of tablets).
For impaired renal function
Severe renal insufficiency and nephrolithiasis are contraindications to prescribing the drug.
In case of renal insufficiency, care should be taken to control the content of calcium and phosphate in the blood serum, to take into account the risk of developing soft tissue calcification.
For impaired liver function
Patients with impaired hepatic function do not need dose adjustment.
Use in the elderly
Elderly people do not need to adjust the dose, but the possibility of an age-related decrease in creatinine clearance cannot be ruled out.
drug interaction
Calcium can reduce the absorption of tetracyclines and quinolone from the gastrointestinal tract, so they should be taken at least 2 hours before taking Calcium-D3 Nycomed Forte or 4-6 hours after.
Calcium absorption decreases with the simultaneous use of glucocorticosteroids, so an increase in its dose may be required.
The absorption of bisphosphonates decreases with the combined intake of calcium preparations, so they should be taken at least 1 hour before Calcium-D3 Nycomed Forte. The situation is similar when using levothyroxine, but in this case it is recommended to make an interval of at least 4 hours between doses.
Thiazide diuretics increase tubular reabsorption of calcium and, as a result, the risk of increasing its level in the blood serum, so monitoring is required.
Hypercalcemia can enhance the toxic effects of cardiac glycosides, so it is necessary to control the electrocardiogram and the level of calcium in the blood serum.
Calcium absorption is reduced by foods containing oxalates (spinach, rhubarb, sorrel) and phytin (cereals), so it is recommended to refrain from eating them for 2 hours before taking Calcium-D3 Nycomed Forte.
Analogues
Analogues of Calcium-D3 Nycomed Forte: Natemille, Revital Calcium D 3, Calcium-D 3 -MIG, Calcium D 3 Classic, Ideos, Complivit calcium D 3, Complivit calcium D 3 forte, Natekal D 3, Calcium-D 3 Nycomed, Calcium + Vitamin D 3 Vitrum.
Terms and conditions of storage
Storage conditions: tightly closed vial, temperature up to 25 °C, dry, out of reach of children.
Shelf life - 3 years from the date of production.
Calcium-D3 Nycomed Forte is a mineral supplement that regulates the exchange of calcium and phosphorus.
Release form and composition
Calcium-D3 Nycomed Forte is available in the form of chewable tablets with lemon flavor (in high-density polyethylene bottles of 30, 60 or 120 pieces, 1 bottle in a cardboard box).
Active ingredients:
- Calcium carbonate - 1250 mg (equivalent to 500 mg of elemental calcium);
- Colecalciferol (Vitamin D3) 10 mcg (400 IU)
Excipients: povidone, sorbitol, isomalt, aspartame, magnesium stearate, mono- and diglycerides of fatty acids, lemon oil.
Indications for use
- Prevention of deficiency and treatment of calcium and / or vitamin D3 deficiency;
- Treatment (as part of complex therapy) and prevention of osteoporosis and its complications.
Contraindications
- Hypervitaminosis D;
- Hypercalciuria;
- hypercalcemia;
- Sarcoidosis;
- Active form of tuberculosis;
- Nephrolithiasis;
- severe renal failure;
- Children's age up to 3 years;
- Hypersensitivity to any component, as well as to soy and / or peanuts.
The tablets also contain sucrose, isomalt and sorbitol, so they are not recommended for sucrase-isomaltase deficiency, glucose-galactose malabsorption and hereditary fructose intolerance.
Special observation during the period of treatment is required for pregnant and lactating women, patients diagnosed with renal failure.
Method of application and dosage
The drug must be taken with meals, sucking or chewing the tablets until completely dissolved.
- To compensate for the lack of calcium and vitamin D: for children over 12 years old and adults - 2 tablets per day, for children 3-12 years old - 1 tablet per day or as directed by a doctor;
- For the prevention of osteoporosis: adults - 1 tablet 2 times a day or 2 tablets 1 time a day;
- As part of the complex therapy of osteoporosis: adults - 1 tablet 2-3 times a day.
When prescribing Calcium-D3 Nycomed Forte for prevention or as part of the complex therapy of osteoporosis, the duration of therapy is determined individually.
To compensate for the lack of calcium and / or vitamin D3, the drug is taken for at least 4-6 weeks. The doctor determines the need for and the number of repeated courses individually.
Side effects
Side effects of Calcium-D3 Nycomed Forte are rare. In some cases, there are:
- From the digestive system: flatulence, abdominal pain, nausea, diarrhea or constipation, dyspepsia;
- From the skin and subcutaneous tissue: rash, urticaria, itching;
- From the side of metabolism: hypercalciuria and hypercalcemia.
An overdose of calcium is manifested by hypercalcemia: abdominal pain, nausea, vomiting, thirst, constipation, anorexia, fatigue, muscle weakness, polyuria, urolithiasis, nephrocalcinosis, bone pain, mental disorders, and in severe cases, also cardiac arrhythmias. With prolonged use in excess doses (over 2500 mg of calcium), there is a possibility of developing soft tissue calcification and kidney damage.
If any symptoms of an overdose appear, you should stop taking Calcium-D3 Nycomed Forte, as well as cardiac glycosides and thiazide diuretics (if used) and consult a doctor. Treatment involves gastric lavage in the first place, then replenishing fluid loss, taking loop diuretics, bisphosphonates, calcitonin and glucocorticosteroids. It is necessary to control diuresis, kidney function and the content of electrolytes in the blood plasma. In severe cases, ECG monitoring and measurement of central venous pressure is required.
Hypercalcemia as a result of an overdose that develops during pregnancy can have an adverse effect on the fetus.
special instructions
When selecting a dose, it is necessary to take into account the intake of calcium and vitamin D3 from other sources.
With prolonged use of Calcium-D3 Nycomed Forte, it is necessary to control the concentration of creatinine and calcium in the blood, especially in patients at risk of kidney stones, and in elderly people receiving cardiac glycosides and diuretics. In case of impaired renal function or the appearance of signs of hypercalcemia, a dose reduction is required, and sometimes the drug is completely discontinued.
In patients with renal insufficiency, the risk of soft tissue calcification increases, therefore, during treatment, it is necessary to control the content of calcium and phosphate in the blood serum.
The maximum daily doses for pregnant women: calcium - 1500 mg, vitamin D3 - 600 IU.
The drug can be used during lactation, but in this case, the intake of calcium and vitamin D3 from other sources should be taken into account not only in the mother, but also in the child.
The risk of developing hypercalcemia increases in immobilized patients with osteoporosis, so they are prescribed Calcium-D3 Nycomed Forte with caution.
The mineral supplement does not adversely affect the speed of psychophysical reactions and the ability to concentrate.
drug interaction
Hypercalcemia can cause potentiation of the toxic effects of cardiac glycosides taken simultaneously with Calcium-D3 Nycomed Forte. It is necessary to control the concentration of calcium in the blood serum and ECG parameters.
Calcium absorption is reduced by glucocorticosteroids, which may require an increase in the dose of Calcium-D3 Nycomed Forte.
Calcium intake reduces the absorption of tetracyclines and bisphosphonates from the gastrointestinal tract. For this reason, it is recommended to take the former at least 2 hours before or 4-6 hours after taking the mineral supplement, the latter at least 1 hour before taking Nycomed Calcium-D3. Due to the decrease in absorption and the decrease in the effectiveness of levothyroxine, at least 4-hour intervals should be maintained between taking the drugs. For the same reason, quinolone antibiotics must be taken 2 hours before or 6 hours after calcium supplementation.
The risk of hypercalcemia increases with the simultaneous use of thiazide diuretics, so it is necessary to control calcium in the blood serum.
Terms and conditions of storage
Store in a tightly closed vial in a dry place out of the reach of children at temperatures up to 25 ºC.
Shelf life - 3 years.
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A drug that regulates the metabolism of calcium and phosphorus
Active ingredients
Calcium carbonate (calcium carbonate)
- colecalciferol (vit. D 3) (colecalciferol)
Release form, composition and packaging
◊ Chewable tablets (lemon) white, round, biconvex, with lemon flavor; may have small blotches of a grayish color and jagged edges.
Excipients: sorbitol - 390 mg, lemon granulate flavor *** - 50.7 mg, - 36.4 mg, magnesium stearate - 6 mg, aspartame - 1 mg.
30 pcs. - high-density polyethylene bottles with first opening control (1) - cardboard packs.
60 pcs. - high-density polyethylene bottles with first opening control (1) - cardboard packs.
120 pcs. - high-density polyethylene bottles with first opening control (1) - cardboard packs.
* the amount of cholecalciferol (vit. D 3), including a 10% excess, is 11 mcg, in the form of a concentrate of cholecalciferol - 4.4 mg.
** colcalciferol concentrate contains, including 10% excess: colcalciferol - 0.011 mg, alpha-tocopherol - 0.044 mg, modified corn starch - 3.214 mg, sucrose - 0.77 mg, sodium ascorbate - 0.176 mg, medium chain triglycerides - 0.134 mg, silicon dioxide - 0.053 mg.
*** lemon flavor granulate contains: isomalt - 49.9 mg, lemon flavor - 0.76 mg, mono- and diglycerides of fatty acids - 0.0006 mg.
pharmachologic effect
Combined drug that regulates the exchange of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).
Reduces resorption (resorption) and increases bone density, making up for the lack of calcium and D 3 in the body, necessary for the mineralization of teeth.
Calcium is involved in the regulation of nerve conduction, muscle contractions and is a component of the blood coagulation system. Adequate calcium intake is especially important during growth, pregnancy and lactation.
Vitamin D 3 increases the absorption of calcium in the intestine.
The use of calcium and vitamin D 3 prevents an increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption (washing out of calcium from the bones).
Pharmacokinetics
Calcium
Suction
Usually the amount of calcium that is absorbed from the gastrointestinal tract is approximately 30% of the dose taken.
Distribution and metabolism
99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is found in intra- and extracellular fluids. About 50% of the total calcium in the blood is in a physiologically active ionized form, of which about 10% is in combination with citrate, phosphate or other anions, the remaining 40% is associated with proteins, primarily with.
breeding
Calcium is excreted through the intestines, kidneys and sweat glands. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.
Colecalciferol
Suction
Colecalciferol is readily absorbed from the small intestine (about 80% of the dose taken).
Distribution and metabolism
Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is metabolized in the liver by hydroxylation to 25-hydroxycolecalciferol. Then it is converted in the kidneys to the active form 1.25-hydroxycolcalciferol. 1.25-hydroxycholecalciferol is the metabolite responsible for increasing calcium absorption. Unchanged colecalciferol is deposited in adipose and muscle tissue.
breeding
Colecalciferol is excreted by the kidneys and through the intestines.
Indications
- prevention and treatment of calcium and / or vitamin D 3 deficiency;
- addition to specific therapy and prevention of osteoporosis and its complications (bone fractures).
Contraindications
- hypercalcemia;
- hypercalciuria;
- nephrolithiasis;
- hypervitaminosis D;
- severe renal failure;
- active form of tuberculosis;
- sarcoidosis;
- hypersensitivity to the components of the drug, soy or peanuts.
The drug contains sorbitol, isomalt and sucrose, so its use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
WITH caution: pregnancy, lactation, renal failure.
Dosage
The drug is taken orally. Tablets can be chewed or sucked and taken with meals.
For prevention and treatment of calcium and/or vitamin D deficiency 3 adults and children over 12 years old appoint 1 tab. 2 times / day or 2 tab. 1 time / day; children from 3 to 12 years old- 1 tab./day or as directed by a doctor. The average duration of the course of treatment is at least 4-6 weeks. The number of repeated courses during the year is determined individually.
As additions to specific therapy and prevention of osteoporosis and its complications (bone fractures) adults- 1 tab. 2 times / day or 2 tab. 1 time / day The duration of treatment is determined by the doctor individually.
Patients with impaired liver function dose adjustment is not required.
Should not be used when severe renal failure.
Elderly patients the same dose as for adults is prescribed. A possible decrease in QC should be taken into account.
Side effects
Frequency side effects the drug is regarded as follows: very often (> 1/10); often (>1/100,<1/10); нечасто (>1/1000, <1/100); редко (>1/10 000, <1/1000); очень редко (<1/10 000); частота неизвестна (не может быть подсчитана по имеющимся данным).
From the side of metabolism and nutrition: infrequently - hypercalcemia, hypercalciuria; very rarely - milk-alkaline syndrome (Burnett's syndrome), usually noted only with an overdose.
From the digestive system: rarely - constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia.
From the skin and subcutaneous tissue: very rarely - itching, rash, urticaria.
From the immune system: frequency unknown - hypersensitivity reactions such as angioedema or laryngeal edema.
Overdose
Overdose can lead to hypercalcemia and hypervitaminosis D.
Symptoms: manifestations of hypercalcemia - anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, fatigue, bone pain, mental disorders, polydipsia, nephrocalcinosis, urolithiasis and, in severe cases, arrhythmias. With prolonged use of excess doses (over 2500 mg of calcium) - kidney damage, soft tissue calcification. Milk-alkaline syndrome (Burnett's syndrome) can occur in patients with ingestion of large amounts of calcium and well-absorbed alkaline solutions.
If symptoms of an overdose are detected, the patient should stop taking calcium and vitamin D 3, as well as thiazide diuretics and cardiac glycosides, and consult a doctor.
Treatment: gastric lavage, replenishment of fluid loss, the use of "loop" diuretics (for example,), GCS, calcitonin, bisphosphonates. It is necessary to control the content of electrolytes in the blood plasma, kidney function and diuresis. In severe cases, it is necessary to measure the central venous pressure and control the ECG.
drug interaction
Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used simultaneously with calcium and vitamin D preparations. ECG and serum calcium monitoring is necessary.
Calcium preparations can reduce absorption from the gastrointestinal tract. Therefore, tetracycline preparations should be taken at least 2 hours before or 4-6 hours after taking Calcium-D 3 Nycomed Forte.
To prevent a decrease in the absorption of bisphosphonate preparations, it is recommended to take them at least 1 hour before taking Calcium-D 3 Nycomed Forte.
GCS reduce the absorption of calcium, so the treatment of GCS may require an increase in the dose of Calcium-D 3 Nycomed.
With the simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because. they increase tubular reabsorption of calcium. With the simultaneous use of thiazide diuretics, the calcium content in the blood serum should be regularly monitored.
Calcium reduces effectiveness by reducing its absorption. The period of time between taking levothyroxine and Calcium-D 3 Nycomed Forte should be at least 4 hours.
The absorption of antibiotics of the quinolone group is reduced with simultaneous use with calcium preparations. Therefore, antibiotics of the quinolone group should be taken 2 hours before or 6 hours after taking Calcium-D 3 Nycomed Forte.
Calcium salts can reduce the absorption of iron, zinc and strontium ranelate. Therefore, preparations of iron, zinc or strontium ranelate should be taken at least 2 hours before or 2 hours after taking Calcium-D 3 Nycomed.
Treatment with orlistat may potentially interfere with the absorption of fat-soluble vitamins (eg, vitamin D3).
special instructions
With long-term therapy, the content of calcium and creatinine in the blood serum should be monitored. Observation is especially important in elderly patients with simultaneous treatment with cardiac glycosides and diuretics and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of impaired renal function, reduce the dose or stop treatment.
Vitamin D 3 should be taken with caution in patients with renal insufficiency. In this case, it is necessary to control the content of calcium and phosphates in the blood serum. It is also necessary to take into account the risk of soft tissue calcification.
In order to avoid overdose, it is necessary to take into account the additional intake of vitamin D and calcium from other sources.
Calcium and vitamin D 3 should be used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia.
Simultaneous use with antibiotics of the tetracycline or quinolone group is usually not recommended or should be carried out with caution.
Influence on the ability to drive vehicles and mechanisms
There is no data on the effect of the drug Calcium D 3 Nycomed Forte on the ability to drive vehicles and mechanisms.
Pregnancy and lactation
Calcium-D 3 Nycomed Forte is used during pregnancy to compensate for the deficiency of calcium and vitamin D 3 in the body. The total daily intake during pregnancy should not exceed 2500 mg of calcium and 4000 IU of vitamin D. Hypercalcemia due to overdose during pregnancy may have an adverse effect on the developing fetus.
The drug is used during lactation. Calcium and vitamin D 3 can pass into breast milk, so the intake of calcium and vitamin D from other sources in the mother and child must be taken into account.
Application in childhood
The drug in the form of tablets is not used in children under the age of 3 years.
The drug should be stored in a tightly closed vial, in a dry place, out of the reach of children, at a temperature not exceeding 25°C. Shelf life - 2.5 years. Do not use after the expiration date.
Combined drug, regulates the exchange of calcium and phosphorus, compensates for the deficiency of calcium and vitamin D3 in the body. Calcium takes part in the formation of bone tissue, mineralization of teeth, blood clotting, regulation of nerve conduction and muscle contractions, maintaining a stable activity of the nervous system.
Colecalciferol (vitamin D3) regulates the exchange of calcium and phosphorus in the body, enhances calcium absorption in the intestine.
Calcium. About 30% of the accepted dose of calcium is absorbed in the gastrointestinal tract. 99% of calcium is concentrated in the solid structures of the body (bones, teeth); 1% - in extra- and intracellular space.
About 50% of calcium in the blood is in a physiologically active ionized form. Almost 10% - in a complex with citrates, phosphates and other anions. The remaining 40% are in the composition of proteins, mainly albumins. Calcium is excreted in faeces, urine and sweat.
Vitamin D 3 l is easily absorbed in the small intestine. Colecalciferol and its metabolites circulate in the blood as specific globulins. In the liver, cholecalciferol is converted to the hydroxyl-active form 25-hydroxycholecalciferol, then in the kidneys it is converted to 1,25-hydroxycholecalciferol, which is responsible for enhanced calcium absorption. Unmetabolized vitamin D3 c is stored in muscle and adipose tissue. Vitamin D3 is excreted in faeces and urine.
Indications for the use of the drug Calcium-D3 nycomed forte
For the prevention and complex therapy of osteoporosis (menopausal, senile, steroid, idiopathic, etc.) and its complications (pathological bone fractures); for the prevention and treatment of calcium and/or vitamin D3 deficiency.
The use of the drug Calcium-D3 nycomed forte
For the prevention and treatment of osteoporosis - 1 tablet 2-3 times a day.
To compensate for the deficiency of calcium and vitamin D3:
- adults and children aged 12 years and the elderly - 1 tablet 2 times a day;
- children from 5 to 12 years old - 1-2 tablets per day;
- children under 5 years - no more than 1 tablet per day.
The average course of treatment is 4-6 weeks. The number of courses conducted during the year is determined by the doctor based on individual indications. The tablet can be chewed, swallowed whole or sucked.
Contraindications to the use of the drug Calcium-D3 nycomed forte
- hypercalcemia (high calcium in the blood);
- hypercalciuria (high calcium in the urine);
- urolithiasis (formation of calcium stones);
- hypersensitivity to the components of the drug;
- hypervitaminosis D3;
- severe degree of renal failure.
Side effects of the drug Calcium-D3 nycomed forte
from the gastrointestinal tract: constipation, increased gas formation. Rarely hypercalcemia and hypercalciuria. Rarely- an allergic reaction in the form of itching, skin rashes, urticaria.
Special instructions for the use of the drug Calcium-D3 nycomed forte
Tablets of Calcium-D3 N icomed Forte contain aspartame, so it should not be prescribed for phenylketonuria.
In patients with mild or moderate renal insufficiency (including the elderly) or mild hypercalciuria, urinary and plasma calcium levels should be monitored periodically. In addition, urine calcium levels should be monitored in patients with a history of renal calculi in order to rule out hypercalciuria.
In order to avoid overdose, the intake of calcium and vitamin D3 and other sources should be taken into account within the recommended daily intake of calcium and vitamin D3.
Calcium-D3 Nycomed Forte should be used with caution in patients with prolonged immobilization due to the risk of hypercalcemia.
Do not use simultaneously with vitamin complexes containing calcium and vitamin D3.
Use during pregnancy and lactation. In order to prevent overdose, the daily dose during this period should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Vitamin D3 and its metabolites can be excreted in breast milk, so the intake of calcium and vitamin D3 from other sources in the mother and child must also be taken into account.
Interactions of the drug Calcium-D3 nycomed forte
Calcium can enhance the absorption of tetracycline drugs in the gastrointestinal tract, so the interval between taking tetracycline drugs and Calcium-D3 N icomed Forte should be at least 3 hours.
To prevent a decrease in the absorption of bisphosphonates or sodium fluoride, it is recommended to take Calcium-D3 N Icomed Forte no earlier than 2 hours after taking them.
The activity of vitamin D3 may decrease with the simultaneous use of phenytoin or barbiturates.
With simultaneous treatment with cardiac glycosides, it is necessary to monitor the ECG and the clinical condition of the patient, since calcium preparations can potentiate the therapeutic and toxic effects of cardiac glycosides.
GCS reduce the absorption of calcium, therefore, during systemic therapy with GCS, it may be necessary to increase the dose of Calcium-D3 Nycomed Forte. Simultaneous treatment with cholestyramine preparations or the use of laxatives based on mineral or vegetable oil may reduce the absorption of vitamin D.
With the simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, since thiazide diuretics increase tubular calcium reabsorption. Furosemide and other loop diuretics, on the contrary, increase the excretion of calcium by the kidneys.
Overdose of the drug Calcium-D3 nycomed forte, symptoms and treatment
The most serious consequence of acute or chronic overdose of the drug is hypercalcemia due to hypersensitivity to vitamin D.
The toxic effect is possible in case of taking 200 chewable tablets during the day.
Symptoms hypercalcemia include anorexia, nausea, vomiting, dizziness, weakness, headache, hypercalciuria, hypercreatinemia. Coma may develop. The presence of polydipsia and polyuria indicates the possibility of kidney damage.
Treatment. It is necessary to stop taking the tablets, introduce a large amount of fluid into the body and prescribe a diet with a limited calcium content. In especially severe cases, it may be necessary to use corticosteroids and other symptomatic therapy.
Storage conditions of the drug Calcium-D3 nycomed forte
In a tightly closed package at a temperature of 15-25 ° C.
List of pharmacies where you can buy Calcium-D3 nycomed forte:
- Saint Petersburg