Pregnoton Mama (Capsules) Instructions for Use

Marketing Authorization Holder

Akvion, JSC (Russia)

Manufactured By

Noventis s.r.o. (Czech Republic)

For

PHARMALINEA, d.o.o. (Slovenia)

Dosage Form

Pregnoton Mama

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules soft gelatin, weight 1120 mg.

Composition gelatin capsule (gelatin, humectant – glycerol, water, colorant – iron oxide), omega-3 polyunsaturated fatty acids (docosahexaenoic acid, antioxidant – tocopherol), liposomal iron Lipofer^® (corn starch, ferric pyrophosphate, emulsifier – sunflower lecithin), ascorbic acid, magnesium oxide, zinc citrate, soybean oil, alpha-tocopherol acetate, sodium selenite, niacinamide, emulsifier – soy lecithin, calcium pantothenate, anti-caking agent – amorphous silicon dioxide, cyanocobalamin, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin, Extrafolate^® (contains (6S)-5-methyltetrahydrofolate calcium (L-methylfolate calcium)), Folic acid, cholecalciferol, potassium iodide, Biotin.

^# omega-3 polyunsaturated fatty acids.
¹ in accordance with MR 2.3.1.2432-08 “Norms of physiological needs for energy and nutrients for various groups of the population of the Russian Federation”.
² % of the adequate intake level in accordance with the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” of the Customs Union of the Eurasian Economic Union (Chapter II, Appendix No. 5. Values of daily intake of food and biologically active substances for adults as part of specialized food products (SFPs) and dietary supplements).
* does not exceed the permissible intake level in accordance with the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” of the Customs Union of the Eurasian Economic Union (Chapter II, Appendix No. 5. Values of daily intake of food and biologically active substances for adults as part of specialized food products (SFPs) and dietary supplements).

10 pcs. – blisters (3) – cardboard packs.

Therapeutic Category

Dietary supplement – an additional source of vitamins and trace elements for pregnancy planning, during pregnancy and breastfeeding

Properties

B₁ (thiamine) as a coenzyme is involved in carbohydrate metabolism and the functioning of the nervous system.

Vitamin B₂ (riboflavin) is a key catalyst for cellular respiration and visual perception processes.

Vitamin B₆ (pyridoxine) as a coenzyme participates in protein metabolism and the synthesis of neurotransmitters.

Vitamin B₉ (Folates and Folic acid). The main danger of folate deficiency during pregnancy is neural tube defects. The neural tube is formed within the first 28 days after conception.

Taking folates during pregnancy reduces the risk of brain development disorders, malformations of the cardiovascular and urinary systems, cleft palate, limb defects, great artery defects, and umbilical hernia.

Furthermore, Folates reduce the likelihood of premature birth by 50-70%, miscarriage, preeclampsia, and other problems.

Folic acid is involved in the synthesis of amino acids, nucleotides, and nucleic acids; it is necessary for normal erythropoiesis.

Vitamin B₁₂ (cyanocobalamin) participates in the synthesis of nucleotides, is an important factor for normal growth, hematopoiesis, and the development of epithelial cells; it is necessary for the metabolism of folic acid and the synthesis of myelin.

Biotin (vitamin B₇, H) helps improve the condition of the skin and hair, is a source of sulfur for collagen synthesis, and has a positive effect on the body’s metabolic functions.

Iron is the main component of hemoglobin, the protein that delivers oxygen to all living cells.

During the second trimester of pregnancy, a woman’s blood volume increases by approximately 30%, and in the third trimester by 50%.

The consequences of iron deficiency include: iron deficiency anemia in the mother and fetus, spontaneous abortion, developmental delay, underweight, weakness and lethargy, and inflammatory processes.

Iodine is part of thyroid hormones, which, among other things, are actively involved in the formation of the brain.

Iodine deficiency during pregnancy is associated with the development of cretinism in the child, as well as goiter in the pregnant woman.

Eliminating iodine deficiency is a mandatory condition for normal childbirth.

Omega-3 PUFAs are essential fatty acids that are not synthesized in the human body.

The fatty acids that make up the human brain consist of 35% PUFAs, with 25% being docosahexaenoic acid (DHA).

This is why Omega-3 is critically necessary for brain formation.

Omega-3 is also required for the formation of the fetal nervous tissue, the immune system, ensures fetal growth and maturation, and the formation of the visual organs.

Omega-3 increases gestation periods, with DHA reducing the risk of premature birth, preeclampsia and miscarriage, and premature rupture of membranes during childbirth.

Scope of Application

As a dietary supplement to food – for women planning pregnancy, pregnant and lactating women.

ICD codes

Dosage Regimen

Take orally, with meals, once/day.

Side effects

Possible allergic reactions.

Contraindications

Hypersensitivity to the product components.

Use during pregnancy and lactation

Used during pregnancy and breastfeeding.

Special instructions

A dietary supplement to food, not a medicinal product.

Consult a physician before use.

Persons with thyroid diseases are advised to consult an endocrinologist.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.