Instructions for Elevit Pronatal film-coated tablets blister pack No. 30
Composition
1 film-coated tablet contains:
Vitamin A - 3600 IU; Vitamin B1 - 1.6 mg; Vitamin B2 - 1.8 mg; Vitamin B6 - 2.6 mg; Vitamin B12 - 4 mcg; Vitamin C (as calcium ascorbate dihydrate) - 100 mg; Vitamin D3 - 500 IU; Vitamin E - 15 mg; Calcium pantothenate - 10 mg; Biotin - 0.2 mg; Nicotinamide - 19 mg; Folic acid - 0.8 mg; Calcium (as calcium ascorbate dihydrate, calcium pantothenate, calcium hydrogen phosphate anhydrous) - 125 mg; Magnesium (as magnesium oxide, magnesium hydrogen phosphate trihydrate, magnesium stearate) - 100 mg; Phosphorus (as calcium hydrogen phosphate anhydrous, magnesium hydrogen phosphate trihydrate) - 125 mg; Iron (as ferrous fumarate) - 60 mg; Zinc (as zinc sulfate monohydrate) - 7.5 mg; Manganese (as manganese sulfate monohydrate) - 1 mg; Copper (as copper sulfate anhydrous) - 1 mg;
excipients:
tablet core: lactose monohydrate, mannitol (E 421), ethylcellulose, macrogol 400, glycerol distearate, gelatin, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, povidone K 90, povidone K 30;
tablet shell: hypromellose, ethylcellulose aqueous dispersion, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172).
Dosage form
Film-coated tablets.
Main physicochemical properties: grayish-yellow oval tablets, film-coated, with a breakline.
Pharmacotherapeutic group
Multivitamins with other minerals, including combinations.
ATX code A11A A03.
Pharmacological properties
Pharmacodynamics
Elevit Pronatal is a multivitamin and mineral preparation containing 12 vitamins in combination with three minerals and four 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 the metabolism and 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 deficiencies of micronutrients. Pregnancy and breastfeeding are periods of increased need for micronutrients, which increases the risk of micronutrient deficiencies for both mother and child. Micronutrient deficiencies pose a more serious threat to health, especially during pregnancy, as they can also disrupt the normal intrauterine development of the fetus.
When evaluating the efficacy and safety of Elevit Pronatal during the pregnancy planning period (one month before conception and up to the third month of gestation), no neural tube defects were detected compared to 6 cases in the placebo group. The difference was statistically significant and confirmed in a subsequent pharmacoepidemiological two-cohort study, in which 1 case of neural tube defect was observed in the Elevit Pronatal group compared to 9 cases in the control group without vitamin support. In addition, in both studies, the overall rate of severe malformations (e.g., defects of the urinary system, cardiovascular system, limbs, and hypertrophic pyloric stenosis) was found to be lower in the Elevit Pronatal group compared to the placebo group or the control group without vitamin supplementation, respectively. It was also found that the group taking Elevit Pronatal had 2 times fewer cases of nausea, vomiting, and dizziness compared to the placebo group.
The level of folate in the red blood cells of a pregnant woman is an indicator of the possible development of a neural tube defect in the fetus. The threshold values of folate content associated with the lowest risk of developing neural tube defects were 906 nmol/L.
The addition of the drug Elevit Pronatal is recommended for women planning a pregnancy because neural tube defects occur in the first weeks after conception, even before pregnancy can be diagnosed.
Pharmacokinetics
Pharmacokinetic studies of the drug Elevit Pronatal have not been conducted.
Indication
For the prevention and correction of vitamin and mineral deficiencies during pregnancy planning, during pregnancy and during breastfeeding.
Use of the drug at least 1 month before conception to reduce the risk of neural tube defects and other birth defects.
To prevent the development of anemia associated with iron and folic acid deficiency during pregnancy and breastfeeding.
To reduce the frequency of nausea and vomiting in the early stages of pregnancy.
Contraindication
Hypersensitivity to any of the components of the drug, hypervitaminosis A and/or D, simultaneous use with drugs containing vitamin A and/or D, treatment with vitamin A or synthetic isomers of isotretinoin and etretinate or beta-carotene (beta-carotene is considered a source of vitamin A), simultaneous use of retinoids; severe renal dysfunction, impaired iron and/or copper metabolism, hypercalcemia, severe hypercalciuria, history of sarcoidosis, active forms of pulmonary tuberculosis, gastric and duodenal ulcer in the acute stage, hypervitaminosis E.
Interaction with other medicinal products and other types of interactions
If the drug is used according to recommendations, no nonspecific interactions are expected.
However, when using Elevit Pronatal with other drugs, it is recommended to consult a doctor.
Cases of interaction of individual components of the drug with other drugs have been described:
Iron absorption may be inhibited by concomitant use of antacids, drugs that reduce gastric acidity, fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, tetracycline antibiotics, or trientine; if concomitant administration is necessary, they should be administered 2–3 hours apart; medications containing calcium, magnesium, copper, or zinc may interact with antacids, antibiotics (tetracyclines and fluoroquinolones), levodopa, bisphosphonates, penicillamine, thyroxine, trientine, digitalis, antivirals, and orally administered thiazide diuretics; patients taking both medications should administer them 2 hours apart; thiazide diuretics can retain calcium in the body, increasing the risk of hypercalcemia; Folic acid enhances the metabolism of phenytoin, so the combination of high doses of folic acid with antiepileptic/anticonvulsant drugs, such as carbamazepine, phenytoin, primidone, and barbiturates, may lead to a decrease in their effectiveness; vitamin C enhances the effect and side effects of antimicrobial drugs from the sulfonamide group; vitamin E absorption may be impaired by iron and silver preparations.
Food Interactions: Because oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) may inhibit calcium absorption, it is not recommended to take this medication within 2 hours of eating foods high in oxalic acid or phytic acid.
Application features
Do not exceed recommended doses.
Very high doses of some ingredients, especially vitamin A, vitamin D, iron, copper, may be harmful to health. If you are taking other vitamins, either alone or in multivitamins or with any other medications, consult your doctor before using this product to prevent possible overdose.
It should be used with extreme caution together with other products containing vitamin A, synthetic isomers of isotretinoin and etretinate or beta-carotene, as large doses of these components are considered harmful to the fetus and may cause hypervitaminosis A; it should be used with caution together with other products containing vitamin D, as high daily doses may cause hypervitaminosis D. Calcium, ascorbic acid and vitamin D may cause the formation of stones in susceptible individuals, therefore patients with nephrolithiasis and urolithiasis should use vitamin and mineral preparations with caution.
This medicine should be used with caution under the supervision of a physician in liver damage, chronic glomerulonephritis, thromboembolism, thyrotoxicosis, cardiac decompensation, thrombophlebitis, gout, hyperuricemia, erythremia, erythrocytosis.
This medicinal product contains lactose and mannitol. Lactose-containing products 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 has been told that he or she has an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine does not contain iodine. Adequate iodine intake should be maintained during pregnancy or breastfeeding.
Use with caution in peptic ulcer of the stomach and duodenum, cholelithiasis, chronic pancreatitis, diabetes mellitus, and neoplasms.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect on the ability to drive or operate other mechanisms has been identified.
Use during pregnancy or breastfeeding
One tablet of the drug Elevit Pronatal contains a dose of vitamin A that meets the daily requirement. A controlled clinical study involving more than 2,100 women, conducted to study the effect of vitamins on the prevention of neural tube defects, found that taking the drug Elevit Pronatal during the first trimester of pregnancy according to the recommendations is safe for the fetus. Use during the second and third trimesters of pregnancy was also not accompanied by risks, and adverse effects on the fetus are unlikely.
Pregnancy.
Vitamin A in doses above 10,000 IU per day administered during the first trimester of pregnancy may have a teratogenic effect. Therefore, this drug should be taken with extreme caution together with other drugs containing vitamin A, the synthetic isomers isotretinoin and etretinate, or beta-carotene, as the above components are considered harmful to the fetus.
Chronic overdose of vitamin D can be harmful to the fetus.
Vitamin D overdose should be avoided, as persistent hypercalcemia can lead to delayed physical and mental development, supravalvular and aortic stenosis, and retinopathy in children.
In animals, excessive vitamin D intake during pregnancy has been shown to be teratogenic. There is no evidence that vitamin D at recommended doses can cause teratogenic effects in humans.
Breast-feeding.
Chronic overdose of vitamin D can be harmful to the newborn. Vitamins and minerals pass into breast milk. This should be taken into account if the newborn is receiving appropriate medications.
For women during pregnancy or breastfeeding, the upper limit of vitamin D intake is 2000 IU per day, which is considered safe. Elevit Pronatal contains 500 IU of vitamin D per tablet.
Fertility: There are no data on the effect of this medicinal product on fertility.
Method of administration and doses
Take 1 tablet of Elevit Pronatal daily in the morning with a meal, washed down with 1 glass of water. Do not chew.
In case of morning sickness, it is recommended to take the tablet in the afternoon or evening.
The recommended duration of use is 1 month before planned pregnancy, during pregnancy or breastfeeding. This medicine is intended for use in women of reproductive age.
Children
There is no data on the use of Elevit Pronatal in children.
Overdose
When using the recommended doses of the drug Elevit Pronatal, there is no risk of overdose.
Overdose cases are mostly associated with concomitant use of high doses of mono-drugs or multivitamins. Acute or long-term overdose can cause hypervitaminosis A and D, hypercalcemia, as well as iron and copper toxicity.
Acute poisoning may be characterized by nonspecific symptoms: sudden onset headache, depression of consciousness and gastrointestinal disorders (constipation, diarrhea, nausea and vomiting). If such symptoms occur, treatment should be discontinued and a doctor should be consulted.
Overdose of vitamin C (use in doses exceeding 15 g) can lead to hemolytic anemia in certain individuals with glucose-6-phosphate dehydrogenase deficiency.
With prolonged use in high doses, irritation of the digestive tract mucosa, arrhythmia, paresthesia, hyperuricemia, decreased glucose tolerance, hyperglycemia, transient increase in the activity of AST, lactate dehydrogenase, alkaline phosphatase, impaired renal function, dryness and cracks on the palms and soles, hair loss, seborrheic rashes may occur.
Adverse reactions
The drug is generally well tolerated. The following adverse reactions have been observed during post-marketing experience. Because they are reported randomly from a population of uncertain size, it is not always possible to estimate their frequency.
Gastrointestinal: Dyspeptic disorders, including stomach discomfort, gastrointestinal and abdominal pain, constipation, diarrhea, bloating, vomiting and nausea.
Immune system disorders: Allergic reactions (including anaphylactic reactions), including urticaria, facial swelling, shortness of breath, asthmatic syndrome, skin redness, rash, itching, blisters and shock. If allergic reactions occur, the patient should discontinue treatment and consult a doctor.
Metabolic disorders. Hypercalciuria, hypercalcemia.
From the nervous system. Headache, dizziness, increased excitability, insomnia, drowsiness, hyperthermia may occur. If increased excitability is observed when using the drug Elevit Pronatal, it should not be used in the evening.
A slight yellow discoloration of urine is possible. This effect is safe for health and is a consequence of the vitamin B2 content in the preparation.
In a placebo-controlled clinical study, pregnant women took Elevit Pronatal 1 tablet daily for 6 months. The following adverse reactions were observed: constipation - 1.8%; diarrhea - 1.4%; exanthema (skin rash) - 0.08%. The percentage of subjects who experienced these symptoms in the placebo group was not statistically different.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister, 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Rottendorf Pharma GmbH.
Location of the manufacturer and its business address
Ostenfelder Strasse 51-61, Ennigerloch, North Rhine-Westphalia, 59320, Germany.
