Universal reference book for medicines
Product name: ELEVIT ® PRONATAL (ELEVIT ® PRONATAL)

Active substance: comb.
drug
Type: Multivitamins with macro and microelements

Manufacturer: BAYER (Russia) manufactured by ROTTENDORF PHARMA (Germany)
Composition, form of production and packaging

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Tablets covered with a film coat of grayish-yellow color, oblong, biconvex, with a risk for breaking on one side; odor is absent or slightly detectable.
1 tab.

retinol palmitate (Vitamin A) 1 3600 IU

-tocopherol acetate (VitE) 2 15 mg

Colcalciferol (Vit. D 3 ) 3,500 IU

ascorbic acid (vit C.) 4 100 mg

thiamine mononitrate (vit B 1 ) 1.6 mg

riboflavin (Vit B 2 ) 1.8 mg

calcium pantothenate (Vit B 5 ) 10 mg

pyridoxine hydrochloride (Vit B 6 ) 5 2.6 mg

Folic acid (Vit B 9 ) 800 μg

cyanocobalamin (Vit B 12 ) 6 4 μg

nicotinamide (Vit PP) 19 mg

Biotin (Vit. H) 200 μg

calcium (in the form of calcium hydrophosphate, calcium pantothenate, calcium ascorbate) 125 mg

magnesium (in the form of magnesium oxide, magnesium hydrogen phosphate trihydrate, magnesium stearate) 100 mg

phosphorus (in the form of calcium hydrophosphate, magnesium hydrogen phosphate trihydrate) 125 mg

iron (in the form of iron fumarate) 60 mg

copper (in the form of copper sulfate) 1 mg

zinc (in the form of zinc sulfate monohydrate) 7.5 mg

manganese (in the form of manganese sulfate monohydrate) 1 mg

Excipients: glyceryl distearate 8.25 mg, gelatin 1.71 mg, microcrystalline cellulose 66.12 mg, sodium carboxymethyl starch 55 mg, povidone K90 32.2 mg, povidone K30 1.67 mg, lactose monohydrate 45.78 mg, mannitol 58.9 mg, magnesium stearate - 15 mg, macrogol 400 - 10 mg, ethylcellulose - 10 mg.

The composition of the membrane: hypromellose - 9 mg, ethylcellulose, aqueous dispersion - 3 mg, macrogol 6000 - 2.5 mg, talc - 6 mg, titanium dioxide (E171) - 3 mg, iron oxide yellow oxide (E172) - 1.5 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
20 pcs.
- blisters (5) - packs of cardboard.
1 in the form of dry retinol palmitate 250 CWS (1 g contains: Vitamin A palmitate 148 mg, butylhydroxyanisole 2 mg, butyl hydroxytoluene 9 mg, β-tocopherol 3 mg, gelatin 330 mg, sucrose 330 mg, corn starch - 178 mg)

2 in the form of dry vit.
E 50% CWS / S (1 g contains:? -tocopherol acetate - 500 mg, modified food starch - 245 mg, maltodextrin - 245 mg, silicon dioxide - 10 mg).
3 in the form of colcalciferol 100 CWS (1 g contains: colcalciferol 2.5 mg, α-tocopherol 2 mg, soybean oil 75 mg, gelatin 380 mg, sucrose 380 mg, corn starch 160.5 mg).

4 in the form of calcium ascorbate.

5 in the form of pyridoxine hydrochloride 33 1/3% (pyridoxine hydrochloride - 333 mg, mono- and diglycerides of dietary fatty acids - 667 mg).

6 in the form of an aqueous solution of cyanocobalamin 0.1% WS (1 g contains: cyanocobalamin - 1 mg, sodium citrate - 30 mg, citric acid anhydrous - 10 mg, maltodextrin - 959 mg).

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Multivitamins with macro- and microelements.
Elevit ® Pronatal is a medicinal product. Contains 12 essential vitamins, 4 minerals and 3 microelements. The quantitative content of vitamins and minerals corresponds to the doses recommended for use during pregnancy and breastfeeding.
Vitamin A (retinol) is involved in the synthesis of various substances (proteins, lipids, mucopolysaccharides) and provides a normal function of the skin, mucous membranes, as well as the organ of vision.

Vitamin B 1 (thiamin) normalizes the activity of the heart and promotes the normal functioning of the nervous system.

Vitamin B 2 (riboflavin) promotes the processes of tissue regeneration, incl.
skin cells.
Vitamin B 5 (calcium pantothenate) is involved in the metabolism of fats, proteins and carbohydrates.

Vitamin B 6 (pyridoxine) helps maintain the structure and function of bones, teeth, gums, affects erythropoiesis.

Vitamin B 9 (folic acid) stimulates erythropoiesis, prevents the development of congenital malformations in the fetus (neural tube defect).

Vitamin B 12 (cyanocobalamin) is involved in erythropoiesis, contributes to the normal functioning of the nervous system.

B vitamins participate in the formation of various enzymes that regulate different types of metabolism in the body.

Vitamin C (ascorbic acid) is involved in the oxidation of a number of biologically active substances, regulation of metabolism in connective tissue, carbohydrate metabolism, blood clotting and tissue regeneration, stimulates the formation of steroid hormones, normalizes the permeability of capillaries.

Vitamin D 3 (colcalciferol) plays an important role in maintaining the balance of calcium and phosphorus in the body of a pregnant woman.
With vitamin D deficiency, children develop rickets.
Vitamin E (tocopherol) is a natural antioxidant.

Biotin (vitamin H) takes part in metabolic processes, promotes the assimilation of protein.

Nicotinamide (vitamin PP) takes part in oxidation-reduction processes, provides the transfer of hydrogen and phosphate.

Calcium is involved in the formation of bone tissue, blood coagulability, the transmission of nerve impulses, the reduction of skeletal and smooth muscles.

Magnesium is involved in the formation of muscle and bone tissue, and also takes part in the synthesis of protein.

Iron is part of the hemoglobin molecule, participates in the transfer of oxygen in the body and prevents the development of anemia, including.
during pregnancy.
Phosphorus , along with calcium, participates in the formation of bones and teeth, and also participates in the processes of energy metabolism.

Manganese promotes mineralization of bone tissue.

Copper is necessary for the normal function of erythrocytes and iron metabolism.

Zinc is necessary for the normal formation of the fetal skeleton and tissue regeneration, is part of some hormones, including insulin.

PHARMACOKINETICS

Data on the pharmacokinetics of the drug are not available.

INDICATIONS

- prevention and treatment of hypovitaminosis, lack of minerals and trace elements during the planning of pregnancy, during pregnancy, after childbirth and during breastfeeding.

DOSING MODE

Women at the planning stage of pregnancy, during pregnancy, after childbirth and during breastfeeding are advised to take inside 1 tablet / day during meals, washing down with a small amount of water.

The recommended duration of the drug is 1 month before pregnancy (in the case of pregnancy planning), throughout the period of pregnancy and breastfeeding.

SIDE EFFECT

Allergic reactions: urticaria, face swelling, skin hyperemia, rash, anaphylactic shock.
If allergic reactions occur, stop taking the medication and consult a doctor.
On the part of the digestive system: abdominal pain, constipation, diarrhea, nausea, vomiting.

From the nervous system: headache, dizziness, insomnia, increased excitability.

Other: hypercalciuria;
staining of urine in a bright yellow color (due to the content in the preparation of riboflavin), staining of stool black (due to the content in the preparation of iron) - these effects are harmless and have no clinical significance.
CONTRAINDICATIONS

- Vitamin A hypervitaminosis;

- Vitamin D hypervitaminosis;

- hypercalcemia;

- hypercalciuria;

- severe renal failure;

- Iron metabolism disorders;

- Copper exchange disorders (Wilson's disease);

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (the drug contains lactose);

- increased individual sensitivity to the components of the drug.

With caution should prescribe the drug for diseases of the liver and kidneys, urolithiasis.

PREGNANCY AND LACTATION

The drug is recommended for use during pregnancy and lactation in a dose of 1 tab. / Day.

It is necessary to take into account the additional intake of vitamins A and D in order to avoid an overdose.

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in patients with severe renal failure.

With caution should prescribe the drug for kidney disease, urolithiasis.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver disease.

SPECIAL INSTRUCTIONS

The drug should be taken in accordance with recommended doses.

When using other vitamins or multivitamin-mineral complexes, including food additives and / or fortified foods / drinks containing vitamin D, vitamin A, synthetic isomers, isotretinoin and etretinate or beta carotene, a doctor's consultation is necessary, since high doses of the latter can cause hypervitaminosis vitamins D and A.

Impact on the ability to drive vehicles and manage mechanisms

There are no data on the effect of the drug on the speed of psychomotor reactions when driving a car and working with mechanisms.

OVERDOSE

Overdose of the drug can cause hypervitaminosis of vitamins A and D, hypercalcemia, as well as an overdose of iron and copper.
An overdose of vitamin C (more than 15 g) can cause hemolytic anemia in some patients with a deficiency of glucose-6-phosphate dehydrogenase.
Acute overdose is accompanied by the following symptoms: sudden headache, confusion, violations from the digestive tract (constipation, diarrhea, nausea, vomiting).

Treatment: if symptoms of an overdose occur, the patient should stop taking the drug and consult a doctor.
Recommended gastric lavage, symptomatic therapy.
DRUG INTERACTION

Ascorbic acid enhances the effect and side effects of antimicrobial agents from the group of sulfonamides (including crystalluria).

Iron absorption may worsen due to the simultaneous administration of antacids, fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, trentin or antibiotics of the tetracycline group.
If simultaneous application with one of these preparations is required, the interval should be 2-3 hours between doses.
Preparations containing calcium, magnesium, iron, copper or zinc can interact with antacids, antibiotics (tetracycline groups, fluoroquinolones), levodopa, bisphosphonates, penicillamine, thyroxine, trentine, digitalis preparations, antiviral drugs, thiazide diuretics, as well as medications diseases associated with the violation of acidity.
If simultaneous application with such preparations is required, the interval should be 2 hours between meals.
TERMS OF RELEASE FROM PHARMACY

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

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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