Elevit Pronatal

Therapeutic indications

Prevention and treatment of vitamins, minerals and trace elements deficiencies throughout pregnancy and lactation.

Prophylaxis of embryonic neural tube defects.

Prophylaxis of iron and folic acid deficiency anaemla.

Posology and method of administration One tablet dally to be taken with a glass of water

In case of morning sickness. It Is recommended that the tablet is taken at noon, or if necessary in the evening.

The recommended duration of administration Is to take Eevlt Pronatal if possible when planning a pregnancy, throughout the who!© pregnancy, lactation and 3 months after.

 Contra-Indications i

Elevlt® Pronatal should not be used by patients with pre-existing hyper-vitaminosis A and/or D or with impaired renal function, iron accumulation and Iron utilization disorders, hypercalcemia or hypercalcluria, and hypersensitivity to any Ingredient of the product. 1

Special warnings and special precautions for use

The recommended dosage should not be exceeded and the drug should not be taken together with other drugs and/or food containing Vitamin A and/or Vitamin D in order to avoid overdosage of these vitamins.

interaction with other medicinal products and other forms of Interaction

Concurrent administration of antacids with oral iron preparations may decrease iron absorption.

Antacids and oral iron preparations should be administered as far apart as possible. Oral administration of iron preparations Inhibits absorption of tetracyclines from the gastrointestinal tract and vice versa, leading to decreased serum concentrations of both the antibiotic and iron. If simultaneous administration of the drugsJs necessary, patients should receive the tetracycline 2 hours after or 2 hours before oral iron administration.

Use during pregnancy and lactation

Elevlt® Pronatal is Indicated during pregnancy and lactation.

Effects on ability to drive and use machines

Undesirable effects

Elevlt Pronatal is well tolerated. In rare cases gastrointestinal disturbances (e.g. constipation) may occur, bot these generally do not necessitate withdrawal of therapy.

Elevit Pronatal contains Iron, which may lead to a black colouring of the stool. This does not have any clinicai relevance.

Overdose

There is no risk of overdose with nutritive doses of vitamins and minerals contained In Elevit® Pronatol.

PHARMACOLOGICAL PROPERTIES 

Pharmacodynamic properties

Phafmacotheropeutic group: multivitamins and minerals / trace elements Elevtt*Pronotal Is a multivltamin/multlmlneral preparation containing 12 vitamins In combination with 3 minerals and 4 trace elements specialty designed to ensure an optimal micronutrient supply for both the unborn child and the mother-to-be. Vitamins are essential nutrients. They are indispensable for the normal development and growth of the foetus and the Infant, for the metabolism ar>d formation of carbohydrates, energy, lipids, nucleic acids and proteins, as well as for the synthesis of amino acids, collagen and neurotransmltters.

Multtvitamins/multtmineral preparations are indicated to prevent and correct nutiltional micronutrient deficiencies. Pregnancy and lactation represent periods with increased micronutrient requirements and, as a consequence, Increased risks of micronutrient deficiencies for both the mother and the child. Especially during pregnancy, micronutrient deficiencies exhibit a more serious health risk, as they may also Impair the normal development of the unborn child.

Specifically, Elevlt* Pfonatal Is recommended to prevent iron and folic acid deficiency anaemia during pregnancy. Moreover, a growing body do data shows that muttlvltamln preparations containing folic acid reduce the risk of neural tube defects as well so the risk of some other congenital malformations (e.g. urinary tract anomalies, cardiovascular defects, limb deficiencies and hypertrophic pyloric stenosis).

Before conception: Since neutral tube defects develop In the first weeks after conception, before pregnancy Moy even been diagnosed, supplementation with Elavil* Prenatal should be recommended to women when planning a pregnancy. During the first trimester, Elevlt® Prorratal lowers the risk of neural tube defects and other congenital matformatlons of the embryo. It also significantly, reduces th© maternal ailments common during this period (fatigue, di22lness, !nauseo and vomiting).

During the second trimester, Elevit*Pronatal covers the Increase In!requirements without drawing on maternal reserves. +

During the third trimester, Elevlt® Pronatal prepares mother and baby tor delivery by ensuring that both are in optimal mlcronutrlent status.

This enables the mother to replenish her reserves more rdpidly during post partum period, with particular regard to iron,

During lactation, Elevit® Pronatal enhances milk quality and hence contributes to the balanced development of the breast- fed infant.

Pharmacoldnetlc properties

The active ingredients of Elevit® Pronatal, vitamins, mineral and trace elements, are essential micronutrients which are widely distributed in the human body. The discrimination between the physiological nutrient concentration in the plasma and its changes after additional intake of corresponding pharmaceutical peeporatfons is on the one hand, difficult to assess, and conveys, on the© other hand, little or no Information on the biological activity of the© nutrient In the target tissue. The plasma and tissue levels of micronutrients are homeostatic ally regulated and affected by various factors such as diurnal fluctuations, nutritional status, growth, and pregnancy and lactation.