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Pharmacological properties

Elevit® pronatal is a multivitamin-mineral preparation containing 12 vitamins in combination with 3 minerals and 4 trace elements, specially designed to provide optimal micronutrient support for both the fetus and the expectant mother.

Vitamins are vital for the normal development and growth of the fetus and newborn, for metabolism and the formation of carbohydrates, energy, lipids, nucleic acids and proteins, as well as for the synthesis of amino acids, collagen and neurotransmitters.

Multivitamin-multimineral preparations are indicated for the prevention and correction of nutritional deficiency of micronutrients. Pregnancy and lactation periods are periods of increased need for micronutrients, as a result of which there is an increased risk of micronutrient deficiency for both the mother and the baby. Micronutrient deficiency causes a more serious threat to health, especially during pregnancy, since it can also disrupt normal fetal development.

When evaluating the effectiveness and safety of Elevit® Pronatal during the pregnancy planning period (1 month before conception and up to the 3rd month of gestation) showed no neural tube defects compared with 6 cases in the placebo group. The difference was statistically significant and was confirmed in the following pharmacoepidemiological two-cohort study, in which in the group using Elevit® Pronatal recorded 1 case of a neural tube defect compared to 9 cases in the control group without vitamin support. In addition, both studies found that the overall coefficient of gross malformations (for example, defects in the urinary system, cardiovascular system, limbs, and hypertrophic pyloric stenosis) was reduced in the group that used Elevit® Pronatal compared with the placebo group or the control group without the addition of vitamins, respectively. It was also revealed that in the group using Elevit® Cases of nausea, vomiting, and dizziness were observed 2 times less often than Pronatal compared with the placebo group.

The level of folate in pregnant red blood cells is an indicator of the possible development of a neural tube defect in the fetus. Threshold folate levels associated with a low risk of neural tube defects were 906 nmol / L.

Elevit Application® Pronatal is recommended for women when planning pregnancy, since neural tube malformations occur in the first weeks after conception, even before pregnancy can be diagnosed.

Pharmacokinetics Pharmacokinetic studies of the drug Elevit® Pronatal was not performed.

Indications

To prevent and correct vitamin and mineral deficiency during pregnancy planning, during pregnancy and lactation.

To use the drug at least 1 month before conception to reduce the risk of neural tube defects and other congenital malformations.

To prevent the development of anemia associated with iron and folic acid deficiency.

To reduce the frequency of nausea and vomiting in early pregnancy.

Application

1 tablet of elevit® pronatal per day, in the morning during meals, with a glass of water. do not chew.

In case of nausea in the morning, the tablet is recommended to be used in the afternoon or in the evening.

Recommended duration of use: 1 month before the planned pregnancy, during pregnancy and lactation. This medicine is intended for use in women of reproductive age.

Contraindications

Elevit® pronatal should not be used in patients with hypersensitivity reactions to any component of the drug, hypervitaminosis a and / or d, in the treatment of vitamin A or synthetic isomers of isotretinoin and etretinate or beta-carotene, beta-carotene is considered as a source of vitamin A, while taking retinoids ; with severe renal impairment, impaired iron and / or copper metabolism, hypercalcemia, severe hypercalciuria, a history of sarcoidosis, active forms of pulmonary tuberculosis, gastric and duodenal ulcer in the acute stage, hypervitaminosis e.

Side effects

The drug is usually well tolerated.In the post-registration period, the following adverse reactions were noted. since they were reported randomly in an undetermined number of populations, it is not always possible to determine their frequency.

From the digestive tract: dyspeptic disorders, including stomach discomfort, gastrointestinal pain and abdominal pain, constipation, diarrhea, bloating, vomiting, and nausea.

On the part of the immune system: allergic reactions (including anaphylactic reactions), including urticaria, facial swelling, shortness of breath, asthmatic syndrome, redness of the skin, rash, itching, blisters and shock. If allergic reactions occur, the patient must stop treatment and consult a doctor.

Metabolic disorders. Hypercalciuria, hypercalcemia.

From the nervous system. Headache, dizziness, irritability, insomnia, drowsiness, and hyperthermia may occur.

Perhaps a slight staining of urine in yellow. This effect is safe for health and is a consequence of the content of vitamin B in the preparation.2.

The drug contains iron, which can lead to staining of feces in black. This effect is safe and has no clinical significance.

In a placebo-controlled clinical study, pregnant women used elevit® Pronatal 1 tablet per day for 6 months. The following adverse reactions occurred: constipation - in 1.8%; diarrhea - in 1.4%; exanthema (skin rash) - in 0.08% of patients. The proportion of individuals who developed these symptoms in the placebo group did not statistically differ.

special instructions

Do not exceed recommended doses.

Very high doses of certain constituents, especially vitamin A, vitamin D, iron, copper, can be harmful to health. If other vitamins are used alone or as part of multivitamin preparations or any other medicines, you should consult your doctor before using this drug to avoid a possible overdose.

It should be used with caution together with other products containing vitamin A, synthetic isomers of isotretinoin and etretinate or beta-carotene, since high doses of these components are considered harmful to the fetus and can cause hypervitaminosis A; it should be used with caution together with other products containing vitamin D, since high daily doses can cause hypervitaminosis D. Calcium, ascorbic acid and vitamin D can cause calculus formation, patients with nephrolithiasis and urolithiasis should be used with caution.

This medicine should be used with caution under the supervision of a physician for liver damage, chronic glomerulonephritis, thromboembolism, thyrotoxicosis, cardiac decompensation, thrombophlebitis, gout, hyperuricemia, erythremia, erythrocytosis.

This medicine contains lactose and mannitol. Lactose-containing drugs should not be used in patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome. Mannitol may have a mild laxative effect. If the patient is intolerant of certain sugars, you should consult your doctor before using this drug.

This medicine does not contain iodine. During pregnancy and lactation, a sufficient amount of iodine should be used.

Caution is prescribed for peptic ulcer of the stomach and duodenum, gallstone disease, chronic pancreatitis, diabetes mellitus, neoplasms.

Use during pregnancy and lactation. Elevit® Pronatal is intended for use during pregnancy and lactation, but the recommended daily dose should not be exceeded. Before use, consult your doctor.

Adequate micronutrients in the mother are especially critical during pregnancy and lactation. The need for most micronutrients is higher during these periods. This multivitamin preparation contains the full composition of micronutrients, in particular folic acid and vitamins A, D, as well as other components in safe quantities. So Elevit® Pronatal can be used during pregnancy and lactation, which guarantees the supply of micronutrients in sufficient quantities. But care should be taken to use other medicines that contain vitamins A and D and foods enriched with these vitamins.

Pregnancy. Vitamin A in doses above 10,000 IU / day, which was prescribed in the first trimester of pregnancy, can have a teratogenic effect. Thus, this drug should be taken with extreme caution along with other medicines containing vitamin A, synthetic isomers of isotretinoin and etretinate, or beta-carotene, since the above components are considered harmful to the fetus.

Chronic overdose of vitamin D can be harmful to the fetus.

It is necessary to prevent an overdose of vitamin D, since constant hypercalcemia can lead to a delay in physical and mental development, supravalvular and aortic stenosis, as well as retinopathy in children.

It was shown that in animals an overdose of vitamin D during pregnancy leads to a teratogenic effect. There is no evidence that vitamin D at recommended doses can cause a teratogenic effect in humans.

Lactation. Chronic overdose of vitamin D can be harmful to the newborn. Vitamins and minerals pass into breast milk. This should be considered if the newborn receives appropriate medications.

For women during pregnancy and lactation, the upper allowable limit for the use of vitamin D is 2000 IU / day, which is considered safe. Elevit® Pronatal contains 500 IU of vitamin D in one tablet.

Fertility. There is no evidence of the effect of this product on fertility.

Children. Data on the use of Elevit® Pronatal in children is not.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. No effect on the ability to drive vehicles or work with mechanisms has been identified.

Interactions

If the drug is used according to the recommendations, nonspecific interactions are not expected.

However, with the simultaneous use of elevit® Pronatal with other drugs is recommended to consult a doctor.

Cases of the interaction of the individual components of the drug with other drugs are described.

Absorption of iron can be suppressed with the simultaneous use of antacids, drugs that reduce the acidity of gastric juice, fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, tetracycline antibiotics or tridentine; if simultaneous administration of drugs is necessary, they should be used at intervals of 2-3 hours.

Medicines containing calcium, magnesium, copper or zinc can interact with antacids, antibiotics (tetracyclines and fluoroquinolones), levodopa, bisphosphonates, penicillamine, thyroxine, trientine, digitalis, antiviral drugs and thiazide diuretics taken; patients taking both drugs must use them with an interval of 2 hours.

Thiazide diuretics are able to retain calcium in the body, therefore, the risk of hypercalcemia increases.

Folic acid enhances phenytoin metabolism.

Vitamin C enhances the effect and side effects of the antimicrobial drugs of the sulfonamide group.

Absorption of vitamin E can be disrupted by iron and silver preparations.

Interaction with food.Since oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) can inhibit calcium absorption, it is not recommended to use this drug within 2 hours after eating foods containing high levels of oxalic and phytic acids.

Overdose

When used in recommended doses of elevit® pronatal, there is no risk of overdose.

Cases of overdose are mainly associated with the concomitant use of high doses of single drugs or multivitamins. Acute or long-term overdose can cause hypervitaminosis A and D, hypercalcemia, as well as the toxic effect of iron and copper.

Signs of acute poisoning can be nonspecific symptoms: a headache that starts suddenly, depression of consciousness and gastrointestinal disturbances (constipation, diarrhea, nausea and vomiting). If such symptoms occur, treatment should be discontinued and a doctor should be consulted.

An overdose of vitamin C (use in a dose exceeding 15 g) can lead to hemolytic anemia in certain individuals with a deficiency of glucose-6-phosphate dehydrogenase.

With prolonged use in high doses, irritation of the digestive tract mucous membrane, arrhythmia, paresthesia, hyperuricemia, decreased glucose tolerance, hyperglycemia, transient increase in activity of AcAT, LDH, alkaline phosphatase, impaired renal function, dryness and cracks in the palms and feet, hair loss can occur , seborrheic rash.

Storage conditions

In the original packaging at temperatures up to 25 ° C.

Tags: Elevit pronatal