Complivit-Active for children and adolescents, p.p.o. tablets. N60

Composition and release form

Complivit is dispensed from the pharmacy in the form of biconvex white tablets with a specific odor for oral administration. Polymer cans contain 30 or 60 pieces, blisters contain 10 pieces. In a cardboard package there is 1 can or 3 blisters of tablets.

The active components of the medicine are biologically active complexes and macroelements. It also contains 8 minerals.

Excipients: starch, flour, wax, gelatin, sucrose, talc, magnesium carbonate and calcium stearate.

Shelf life is no more than 2 years, observing the optimal conditions indicated on the packaging.

Calcium Complivit D3 for babies: instructions for use

Registration number:
Trade name of the drug : Complivit® Calcium D3 for babies
International non-proprietary or generic name: Calcium carbonate + Colecalciferol &.

Dosage form: powder for the preparation of suspension for oral administration.

Composition per 43.0 g of powder:

Active ingredients: calcium carbonate (in terms of calcium) – 4.0 g; colecalciferol (in terms of 100% colecalciferol) - 0.027 mg (1000 IU), in the form of a granulate containing: cholecalciferol, d,l-alpha-tocopherol, triglycerides with medium-length fatty acid residues, sucrose, acacia gum, corn starch, calcium phosphate, water. Excipients: sorbitol (sorbitol), pregelatinized starch (pregel), colloidal silicon dioxide (aerosil), orange flavor.

Composition per 5 ml suspension:

Active ingredients : calcium carbonate (in terms of calcium) - 200 mg/5 ml; colecalciferol (in terms of 100% colecalciferol) - 0.00135 mg (50 IU)/5 ml, in the form of a granulate containing: cholecalciferol, d,l-alpha-tocopherol, triglycerides with medium-length fatty acid residues, sucrose, acacia gum , corn starch, calcium phosphate, water. Excipients: sorbitol (sorbitol), pregelatinized starch (pregel), colloidal silicon dioxide (aerosil), orange flavor.

Description

white or almost white powder with a characteristic odor of orange.

Description of the prepared suspension : a homogeneous suspension of white or almost white color with a characteristic odor of orange.

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator

ATX code : [A12AX]

Pharmacological properties

A combined drug designed to compensate for the deficiency of calcium and vitamin D3 in the body.

Pharmacodynamics . Calcium is involved in the formation of bone tissue, increases its density, participates in the mineralization of teeth, in the regulation of nerve conduction and muscle contractions, in maintaining the stability of cardiac activity, and in the process of blood clotting.

Vitamin D3 (colecalciferol) regulates the exchange of calcium and phosphorus in the body, increases the absorption of calcium in the intestines, promotes bone mineralization, the formation of the bone skeleton and teeth in children.

The drug reduces the production of parathyroid hormone, which is a stimulator of increased bone resorption.

Indications for use

Prevention of calcium and vitamin D3 deficiency in young children.

Contraindications

Hypersensitivity, hypercalcemia, hypercalciuria, calcium nephrourolithiasis, hypervitaminosis D, decalcifying tumors (myeloma, bone metastases, sarcoidosis), osteoporosis due to immobilization, active form of pulmonary tuberculosis; sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully

Renal failure, benign granulomatosis, taking cardiac glycosides and thiazide diuretics.

Directions for use and doses

The drug is taken orally with meals. The dosage form is specially designed for young children under 3 years of age.

Preparation of a suspension from powder: Add boiled and cooled water to the bottle containing the powder.

2/3 of the bottle volume, mix thoroughly (for 1-2 minutes). Add boiled and cooled water to a volume of 100 ml (up to the neck of the bottle) and mix again. Shake the contents of the bottle before each dose.

5 ml of the resulting suspension contains calcium carbonate in terms of elemental calcium - 200 mg, colecalciferol - 50 IU.

Children over 1 year of age – 5-10 ml once a day; children under 1 year - 5 ml of suspension 1 time per day, as recommended by a doctor. The drug is prescribed to other age groups if necessary in appropriate doses on the recommendation of a doctor.

The duration of the prophylaxis course is 1 month, a longer course is prescribed by a doctor.

Side effect

Allergic reactions. When using the drug in recommended doses, no other side effects were identified. If recommended doses are exceeded or other drugs containing calcium are taken simultaneously, hypercalcemia and hypercalciuria (increased calcium levels in the blood and urine) may develop.

Possible side effects of vitamin D3 also include: decreased appetite, polyuria, constipation, headache, myalgia, arthralgia, increased blood pressure, arrhythmias, impaired renal function, exacerbation of the tuberculosis process in the lungs.

Possible side effects of calcium carbonate also include: gastralgia, constipation or diarrhea, flatulence, nausea, secondary increased gastric secretion.

Overdose

Symptoms: thirst, polyuria, loss of appetite, nausea, vomiting, constipation, dizziness, weakness, headache, fainting, coma; with long-term use, calcification of blood vessels and tissues. Laboratory indicators in case of overdose: hypercalciuria, hypercalcemia. Treatment: stop taking the drug, consult a doctor, restricted diet

calcium, rehydration, diuretics, glucocorticosteroids, in severe cases - hemodialysis.

Interaction with other drugs

Calcium and vitamin D3 preparations reduce the absorption of bisphosphonates, digoxin, iron supplements and tetracycline antibiotics (an interval between doses of at least 2-3 hours is required).

It is possible to enhance the effect of cardiac glycosides (with simultaneous use, monitoring of the ECG and the patient’s condition is necessary).

Phenytoin, barbiturates, and primidone reduce the effect of vitamin D3 by enhancing its metabolism.

Vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin weaken the toxic effect of vitamin D3.

Glucocorticosteroids reduce the absorption of calcium ions in the intestine.

Cholestyramine, colestipol and mineral oils reduce the absorption of vitamin D3 and require an increase in its dosage.

Thiazide diuretics increase the risk of hypercalcemia.

Vitamin D increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia. When used simultaneously with sodium fluoride, the interval between doses should be at least 2 hours; with oral forms of tetracyclines - at least 3 hours.

Long-term therapy with vitamin D3 against the background of simultaneous use of Al3+ and Mg2+-containing antacids increases their concentration in the blood and the risk of intoxication (especially in the presence of chronic renal failure).

Concomitant use with other vitamin D analogues and calcium preparations increases the risk of developing hypervitaminosis D.

special instructions

To avoid overdose, do not use simultaneously with vitamin complexes containing calcium and vitamin D3.

When using vitamin D3 prophylactically, it is necessary to keep in mind the possibility of overdose, especially in children (you should not prescribe more than 10-15 mg per year). Long-term use in high doses leads to chronic hypervitaminosis D3. With long-term treatment, it is necessary to monitor the concentration of Ca2+ in the blood and urine (especially when combined with thiazide diuretics).

It should be borne in mind that sensitivity to vitamin D varies from patient to patient, and in some patients taking even therapeutic doses can cause symptoms of hypervitaminosis.

The sensitivity of newborns to vitamin D varies, some may be sensitive even to very low doses, so prophylaxis should be carried out under the supervision of a physician.

Breastfed newborns, especially those born to mothers with dark skin and/or insufficient sun exposure, are at high risk of developing vitamin D deficiency.

Release form

Powder for the preparation of suspension for oral administration 200 mg + 50 IU/5 ml.

43.0 g in 100 ml bottles of dark (amber) glass. One bottle, along with instructions for use and a measuring spoon, is placed in a cardboard pack.

Storage conditions

Store in a place protected from light, at a temperature not exceeding 25 °C.

Store the prepared suspension in a place protected from light, at a temperature not exceeding 15 ºС (in the refrigerator). Do not freeze.

Keep out of the reach of children.

Best before date

Powder for preparation of suspension for oral administration should be stored for 2 years. Store the prepared suspension for no more than 20 days. Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

Over the counter

Name and address of the manufacturer/organization receiving claims:

OJSC "Pharmstandard - Leksredstva", 305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a/18 Tel./fax, www.pharmstd.ru

Representative

OJSC Pharmstandard-Leksredstva

pharmachologic effect

Complivit has a unique composition, thanks to which it has a comprehensive effect on the body. 1 tablet contains the required amount of vitamins and minerals, which corresponds to the daily requirement.

The drug is developed as a dietary supplement and is used as an addition to the general diet.

The therapeutic effect of the drug is determined by the combined composition:

1. Vitamin A – essential for skin, bone growth and vision. Also ensures healthy function of the immune and reproductive systems, and is responsible for gene activity.
2. B vitamins - normalize the emotional background, intestinal function, regulate the activity of the nervous and cardiovascular systems.
3. Nicotinamide is a participant in tissue respiration.
4. Vitamin C - increases the body's resistance to colds.
5. Rutin is an important participant in redox reactions.
6. Calcium pantothenate – improves the condition of the epithelium.
7. Lipoic acid – regulates the metabolism of fats and carbohydrates.
8. Folic acid – participates in the formation of amino acids.
9. Vitamin E is a natural antioxidant.
10. Iron – ensures the transport of oxygen by blood cells.
11. Copper – prevents the formation of osteoporosis and anemia, strengthens the vascular wall.
12. Magnesium – has a positive effect on the cardiovascular system, stimulates the production of necessary hormones.
13. Calcium is an important element in ensuring proper function of the musculoskeletal system and improves myocardial function.
14. Zinc – strengthens immune activity, helps the absorption of retinol.
15. Phosphorus – increases the strength of bone tissue and teeth.
16. Manganese is responsible for the normal course of metabolic reactions.

How to take Complivit

Complivit tablets are intended for oral use. It is recommended to drink the product once a day after meals.

The course of therapy is compiled individually by a specialist. The duration of treatment depends on age, gender, work activity, and physical activity. As a rule, 3-4 weeks, after a break. Then, according to indications, a second appointment is possible.

In case of deficiency of biologically active substances, 1 tablet is prescribed 2 times a day.

Use the product with caution in case of disruption of the digestive system, kidneys, thyroid gland and the development of neoplasms.

Complivit-Active tab for children from 7 to 12 years old N 30

Active substance

thiamine

ATX code

A11AA04 (Multivitamins with microelements)

Release form, packaging and composition of the drug

◊ Film-coated tablets

from light green to green, biconvex, oblong; on the fracture - yellow-gray with inclusions of different colors.

[PRING] talc, potato starch, citric acid, low molecular weight povidone (low molecular weight polyvinylpyrrolidone), calcium stearate, stearic acid, sucrose (sugar).

Shell composition:

hyprolose, macrogol 4000, low molecular weight povidone (low molecular weight polyvinylpyrrolidone), titanium dioxide, talc, indigo carmine, quinoline yellow dye (E104).

30 pcs. — polymer jars (1) — cardboard packs. 60 pcs. — polymer jars (1) — cardboard packs.

Clinical and pharmacological group

Multivitamins with macro- and microelements

Pharmacotherapeutic group

Multivitamin+multimineral

pharmachologic effect

The effect of the drug Complivit-Active is the combined effect of its components, so kinetic observations are not possible; Collectively, the components cannot be traced using markers or bioassays.

Indications for use

Children and adolescents aged 7 to 12 years:

• for the prevention and treatment of hypovitaminosis, avitaminosis, lack of minerals and trace elements in the body during the period of growth and development;
• to increase the body's resistance to increased physical and mental stress, with regular exercise;
• with insufficient and unbalanced nutrition;
• for regions with unfavorable environmental conditions.

Dosage

Prescribe 1 tablet orally. 1 time/day after meals, with a sufficient amount of liquid. The course of treatment is 1 month.

Contraindications

• children under 7 years of age;
• hypervitaminosis A;
• increased levels of calcium and iron in the body;
• hypersensitivity to the components of the drug.

Use is not recommended for pernicious B12 deficiency anemia.

Overdose

The patient should be informed that in case of accidental overdose, consult a doctor.

Treatment:

temporarily stopping the drug, gastric lavage, taking activated charcoal, carrying out symptomatic therapy.

Side effects

Possible:
allergic reactions to the components of the drug.

Overdose

The drug contains iron and calcium, and therefore delays the absorption of antibiotics from the tetracycline group and fluoroquinolone derivatives from the gastrointestinal tract.

With the simultaneous use of vitamin C and short-acting sulfa drugs, the risk of developing crystalluria increases.

Antacids containing aluminum, magnesium, calcium, and cholestyramine reduce iron absorption.

With simultaneous administration of thiazide diuretics, the risk of developing hypercalcemia increases.

Storage conditions

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25°C. Shelf life – 2 years.

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Special Instructions

If allergic reactions to the components of the drug Complivit-Active occur, it should be discontinued.

It is not recommended to take other multivitamin medications at the same time to avoid overdose.

During the period of use of Complivita-Active, urine may turn bright yellow, which has no clinical significance and is explained by the presence of riboflavin in the drug.