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Instructions for medical use
ELEVIT® PRONATAL
Elevit® Pronatal
International nonproprietary name
No
Dosage form
Film-coated tablets
One tablet includes:
active substance: vitamin A (retinol palmitate) – 3600 MU, vitamin B1 thiamine hydrochloride in the form ofthiamine nitrate) – 1.6 mg, vitamin B2 (riboflavin) – 1.8 mg, vitamin PP (nicotinamide) – 19 mg, vitamin B5 (calcium pantotenat) – 10 mg, vitamin B6 (pyridoxine chlorhydrate) – 2.6 mg, bionin – 200 µg, vitamin B9 (folic acid) – 0.8 mg, vitamin B12 (cyanocobalamine) – 5 µg, vitamin C (in the form of calcium ascorbate dehydrate) – 100 mg, vitamin D3 (cholecalciferol) – 500 MU, vitamin E (α-tocopheryl acetate) – 15 mg, calcium (in the form of anhydrous calcium hydrophosphate) – 125 mg, copper (in the form of anhydrous copper sulfate) – 1 mg, ferrum (in the form of ferrous fumarate) – 60 mg, magnesium (in the form of light magnesium oxide, trihydrate, magnesium stearate) – 100 mg, manganese (in the form of manganese sulphate monohydrate) – 1 mg, phosphorus (in the form of anhydrous calcium hydrophosphate,magnesium hydrophosphate trihydrate) – 125 mg, zinc (in the form of zinc sulphate monohydrate) – 7.5 mg;
adjuvants: lactose monohydrate, mannitol, macrogol 400, glycerol distearate, gelatin, microcrystalline cellulose, ethylcellulose, sodium starch glycolate, magnesium stearate, povidone K90, povidone K30, hypromellose, ethylcellulose water dispersion, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172).
Grayish-yellow oblong convexo-convexe film-coated tablets with breaking cut on one side.
Pharmacotherapeutic group
Vitamins. Polyvitamins. Polyvitamins with mineral substances. Polyvitamins with other minerals and their compositions.
Code АТХ А11АА03
Pharmacological properties
Pharmacokinetics
Effect of Elevit Pronatal is cumulative effect of its components therefore pharmacokinetic observations are not possible: all components cannot be observed using markers or biological studies.
Pharmacodynamics
Elevit Pronatal is multivitamin/ polymineral drug containing vitamins in combinations with minerals and microelements developed specially for adequate provision of microelements and vitamins for fetus as well as for pregnant woman. Vitamins are necessary for normal development and growth of fetus and child for metabolism and synthesis of carbonhydrates, power, lipids, nucleic acid and proteins as well as for synthesis ofamino acids, collagen and neurotransmitters. Pregnancy and lactation is periods of increased need in nutrients and correspondently there is increased risk of deficit of nutrients for mother as well as for child. Especially during pregnancy deficit of nutrients leads to high risk for health, because can influence on normal development of fetus. Before pregnancy and during pregnancy Elevit Pronatal meets demand in vitamins, macro- and microelements necessary for normal pregnancy course. For decrease of risk of development of birth defects including defects of nervous system it is recommended to take folic acid or multivitamins containing folic acid. Defects of nervous system are developed in the first weeks of pregnancy, in the period when pregnancy is not detected, so additional use of folic acid is necessary at stage of planning for pregnancy.
Vitamin A participates in synthesis of various substances (proteins, lipids, mucopolysaccharide) and provide normal function of skin, mucous membrane as well as visual organs.
Vitamin B1 regulates heart activity and support normal function of nervous system.
Vitamin B2 supports tissue regeneration including regeneration of skin cells.
Vitamin B6 supports structures and function of bones, teeth, gums, pays influence on erythropoiesis, support normal function of nervous system.
Vitamin B9 (folic acid) stimulates erythropoiesis, decreases risk of development of birth defects including defects of nervous system.
Vitamin B12 participates in erythropoiesis, supports normal function of nervous system.
Vitamin B complex participates in formation various enzymes regulating varius types of metabolism in body, supports decrease of nausea and vomit of pregnant women.
Vitamin C participates in oxidation of range of biological active substances, regulation of metabolism in connective tissue, carbohydrate metabolism, blood coagulability and tissue regeneration, stimulates formation of steroid hormones, regulates capillary permeability. Vitamin C increases resistance of body to infections decreases inflammatory response.
Vitamin D3 takes important part in support of balance of calcium and phosphorus in body of pregnant woman. If it is not sufficient there is risk of rachitis of children and decrease of calcium in bone tissue of adults (osteoporosis).
Vitamin E is natural antioxidant. It prevents from increased blood coagulability and pays positive influence on peripheric circulation. It participates in synthesis of proteins and hematoglobulin, in cell growth, function of sceletal muscles, heart and vessels, sexual glands. Deficit of vitamin E in early stages of pregnancy can lead to miscarriage.
Biotin take part in metabolism, supports protein fixation.
Calcium pantotenat takes part in metabolism of fats, proteins and carbonhydrates.
Nicotinamide takes part in oxidation-reduction processes, provides transfer of hydrogen and phosphates.
Calcium participates in formation of bone tissue, blood coagulability, neurotransmission, activity of sceletal muscles and unstriped muscles, normal heart performance.
Magnesium participates in formation of muscle and bone tissue as well as take part in synthesis of protein.
Ferrum is part of hematoglobulin molecule, takes part in transfer of oxygen in body and prevents development of anemia of pregnant women, especially in II and III trimester.
Phosphorus together with calcium participates in formation of bones and teeth as well as takes part in process of energetic metabolism.
Manganese supports correct bone mineralization.
Copper is necessary for normal function of erythrocytes and ferrum metabolism.
Zinc is necessary for normal formation of fetal skeleton and tissue regeneration, included in composition of some hormones including insulin, deceases possibility of some pre-natal anomalies.
Indications
- prophylaxis and treatment of hypovitaminosis, vitamin deficiency, lack of mineral substances during planning for pregnancy, during pregnancy and lactation period.
- decrease of risk of development of defects of nerve tube and other birth defects when use of the drug is started one month prior to pregnancy.
- prophylaxis of iron-deficient anemia and anemia connected with deficit of folic acid during pregnancy and lactation period.
- decrease of nausea and vomit in early stages of pregnancy, especially in cases when the drug is used during planning for pregnancy.
Dosage and methods of use
Ingest one tablet per day with small amount of water with food. In case of morning nausea, ingest a tablet during day or in the evening.
It is recommended to use the drug one month prior to planned pregnancy, during pregnancy and lactation period.
The drug is contraindicated to patients with expressed renal disorder. Patients with liver function abnormality shall use the drug with care and under supervision of a doctor.
Older persons: the drug is prescribed to woman of childbearing age. It is inappropriate for older persons.
Prior to use of the drug, it is required to consult with a doctor.
Adverse reaction
The listed adverse reaction of the drug is based on spontaneous reports. In the whole the drug is well tolerated.
In rare cases:
gastroenteric upset - discomfort in the area of stomach, retention of feces, drum belly, vomit, diarrhea and nausea;
disorders of central nervous system – possible headache, dizziness, insomnia, soreness;
metabolism and eating disorder – hypercalciuria.
In individual cases:
allergic reactions - nettle rash, facial oedema, hissing respiration, flushed skin, pomphus, rash and shock.
Contraindications
- increased individual sensibility to components of the drug
- hypervitaminosis A or D
- patients passing treatment with vitamin A or treatment with synthetical isomers of isotretinoin and etretinate. Beta-carotene is considered as source of vitamin A.
- expressed renal insufficiency
- hypercalcemia
- expressed hypercalciuria
- metabolic imbalance of ferrum and copper.
Drug interaction
There is no any marked specific interaction during use of recommended doses of the drug.
Various possible interactions are described in literature for each separate component, so, women receiving any other treatment shall consult with a doctor prior to use of the drug.
Adoption of ferrum can be decreased in case of parallel use with antacids, drugs inhibiting intragastric acidity, fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, antibiotic of tetracycline complex or trientine. If simultaneous use of these drugs is necessary, they should be used separately in 2-3 hours.
Products containing calcium, magnesium, ferrum, copper and zinc can interact in case of oral use with antacids, antibiotics (tetracyclines, fluoroquinolones), levodopa,biophosphonates, penicillamine, thyroxin, trientine, foxglove, virus inactivating agent and thiazide diuretics. . If simultaneous use of is necessary, they should be used separately in 2 hours.
So oxalic acid (included in spinach and rheum) and phytic acid (included in whole grain) can prevent from adoption of calcium, it is not recommended to use Elevit Pronatal within two hours after use of product containing high concentration of oxalic acid or phytic acid.
Special indications
Recommended dose of the drug shall not be exceeded, because very high doses of some ingredients of the drug, particularly vitamin A, vitamin D, ferrum and copper can pay negative influence on the body.
Patients taking other vitamins/ polyvitamins or taking other treatment shall consult with a doctor prior to use of the drug.
The drug shall not be taken during use of other drugs that include accessory food substances/drinks containing vitamin A, synthetical isomers of isotretinoin and etretinate or beta-carotene, because high doses of the listed components can pay negative influence on fetus and lead to hypervitaminosis of vitamin A. The drug shall be used with extreme caution in case of use of other drugs including accessory food substance/drinks containing vitamin D, because high daily doses can lead to hypervitaminosis of vitamin D.
Calcium, ascorbic acid and vitamin D can pay influence on stone formation for patients with kidney stone disease therefore it should be care during use of vitamin products.
The drug include lactose and mannitol as excipients. Patients with innate intolerance of galactose, absence of Lapp-lactose, malabsorption of glucose and galactose.
Riboflavin in drug can lead to yellow color of urine that is completely harmless. Availability of ferrum in drug can lead to black color of fecal masses that is completely harmless and has no any clinical significance.
In case of allergic reaction, it is required to sop use of the drug and consult with a doctor.
Information for diabetics
The drug does not include sucrose; therefore it can be used by diabetics.
Pregnancy and lactation period
The drug can be used during pregnancy and lactation period; however recommended daily dose shall not be exceeded. In case of use of other drugs it is required to consult with a doctor prior to use.
Pregnancy
Due to the fact that dose of vitamin A exceeding 10000 MU per day has teratogenic effect in case of use in I trimester of pregnancy, Elevit Pronatal shall not be proscribed together with other drugs containing vitamin A, synthetic isomers of isotretinoin and etretinate or beta-carotene. Chronic overdosage of vitamin D has negative influence on fetus. It is required to avoid overdosage of vitamin D, because its constant hypercalcemia can lead to physical and mental handicap, supravalvular, aortic stenosis and retinopathy of child. Overdosage of vitamin D in pregnant animals led to teratogenic effects. There are not any evidences that vitamin D in recommended doses is teratogenic for people.
Lactation period
Permanent overosage of vitamin D can pay negative influence of infant.
Vitamin D and calcium are excreted with breast milk. It is necessary to take into account if child takes any correspondingaccessory food substances.
In case of use of Elevit Pronatal please, take into account food with vitamin A (for example, liver and liver products) and/or vitamin D and use of nutritional food and drink that can include high levels of these vitamins.
Effects on ability to drive and use potentially dangerous machines
No found.
Use of recommended doses of the drug does not lead to overdosage.
Overdosage in the most cases is connected with simultaneous use of other vitamins and polyvitamins in high doses. Acute or chronic overdosage can lead to hypervitaminosis of vitamin A, hypervitaminosis of vitamin D and hypercalcemia as well as intoxication with ferrum and copper.
Overdosage of vitamin C (more than 15 g) can lead to hemolytic anemia of some people with deficit of glucose-6-phosphate dehydrogenase.
Nonspecific symptoms of acute of overdosage: sudden commencement of headache, clouding of consciousness, disorders in digestive system – nausea, vomit, diarrhea.
Treatment: it is necessary to stop use of the drug and consult with a doctor. Symptomatic treatment.
Form of output and packing
10 tablets in blister made of polyvinylchloride film and aluminium foil.
3 or 10 blisters together with medical use instruction in Kazakh and Russian are placed in cardboard package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf life
2 years.
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Without a prescription
Name and country of manufacturer
Rottendorf Pharma GmbH, Ennigerloh, Germany
Name and country of packer
Rottendorf Pharma GmbH, Ennigerloh, Germany
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact data (telephone, fax, e-mail) of the organization receiving claims (offers) from consumers regarding the quality of products on the territory of the Republic of Kazakhstan:
“Bayer KAZ” LLP
Timiryazev Street, 42, Pav. 15, office 301
050057 Almaty, Republic of Kazakhstan
tel.: +7 727 258 80 40, fax: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Name, address and contact data (telephone, fax, e-mail) of the organization responsible for post-registration supervision over the drug safety on the territory of the Republic of Kazakhstan:
“Bayer KAZ” LLP
Timiryazev Street, 42, Pav. 15, office 301
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 (24 hours)
Tel.: +7 727 258 80 40, ext. 106 (during working hours)
Fax: +7 727 258 80 39
e-mail: pv.centralasia@bayer.com
