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Vitagynal® (Capsules) Instructions for Use

Therapeutic Category

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

Properties

Vitagynal® Mama and Baby Besins® is a dietary supplement for women planning pregnancy, during pregnancy, after childbirth and breastfeeding. It is known that during preparation and throughout pregnancy and lactation, a woman’s body requires a greater amount of vitamins and trace elements, the deficiency of which can lead to negative changes in the mother’s body or the fetus. In such a situation, their additional intake seems rational not only during pregnancy but also at the stage of its planning and during lactation.

Intake of the balanced basic complex of essential elements Vitagynal® Mama and Baby Besins® helps to replenish the existing deficiency of necessary components of a healthy diet, which has a beneficial effect both on the woman’s health and on the development of the fetus.

Folates (Folic acid (vitamin B9) + L-methylfolate) play a crucial role in the development of the fetal nervous system and ensuring its normal growth. In early pregnancy, it reduces the risk of neural tube defects in the fetus, as well as the risk of defects in the maxillofacial region and cardiovascular system, spontaneous abortion, and the birth of children with Down syndrome. Folates are involved in the synthesis of amino acids, nucleotides and nucleic acids; they are necessary for the renewal and maturation of erythrocytes; during pregnancy, they perform a certain protective function against the action of adverse factors, which is especially necessary during the period of intensive fetal growth for cell growth and division. L-methylfolate is a modern form of folic acid that does not require additional activation by enzymes, is a biologically active form of folate, participates in the process of hematopoiesis, during pregnancy it is involved in the formation of placental tissue and uterine blood vessels, and participates in the conversion of homocysteine to methionine. Methionine, in turn, is a beneficial substance that is involved in the synthesis of proteins and DNA, and also provides protection for the latter from mutations. L-methylfolate is used by the body as a co-factor for the modification of hormones such as serotonin, dopamine and norepinephrine, which are neurotransmitters and are involved in mood regulation.

Vitamin D3 (cholecalciferol) regulates the metabolism of calcium and phosphorus in the body, normalizes the formation of the bone skeleton and teeth; prevents the development of rickets in children. Its intake also helps prevent the decrease in bone mass in the mother and reduces the risk of developing osteoporosis. Vitamin D intake during pregnancy may have some positive effects on pregnancy outcomes (reducing the risk of preeclampsia, gestational diabetes and the risk of having a low birth weight baby).

Iodine is a vital trace element necessary for the normal functioning of the mother’s thyroid gland. Thyroid hormones perform many functions, including regulating the metabolism of proteins, fats, carbohydrates and energy in the body, the activity of the brain, nervous and cardiovascular systems, gonads and mammary glands, as well as the growth and development of the fetus.

DHA (docosahexaenoic acid) is a polyunsaturated fatty acid belonging to the omega-3 family. It plays an indispensable role in the development of the child’s brain and retina. Its deficiency in the mother’s body is also associated with an increased risk of preterm birth and low fetal birth weight. During pregnancy and breastfeeding, the need for DHA increases 2.5 times compared to the usual physiological requirement, so during this period of a woman’s life, its additional intake is required.

Vitamin E (D-alpha-tocopherol) is a natural antioxidant, has antioxidant activity towards DHA. It is involved in the process of cell growth, the most important processes of tissue metabolism, the synthesis of proteins and hemoglobin. It has a positive effect on the functions of skeletal muscles, heart and blood vessels, and gonads. It prevents increased blood clotting and has a beneficial effect on peripheral circulation. Vitamin E deficiency in early pregnancy can cause miscarriage.

Scope of Application

Of the product Vitagynal® Mama and Baby Besins®

  • As a dietary supplement – an additional source of omega-3 docosahexaenoic acid, vitamins D, E, folic acid and iodine for women during pregnancy preparation (1-2 months before planned conception), during pregnancy, after childbirth and during breastfeeding.

ICD codes

ICD-10 code Indication
O25 Nutritional deficiencies in pregnancy
Z39.1 Care and examination of lactating mother

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Capsules

Orally. For women, 1 capsule once/day with meals.

Biologically active substances Content in daily dose (1 capsule) For breastfeeding women* For women during pregnancy preparation
I trimester of pregnancy II trimester of pregnancy III trimester of pregnancy
Docosahexaenoic acid 200 mg 100 28.6***
Vitamin D3 15 mcg 100 300**(****)
Vitamin E 12 mg TE 80 70.6 63.2 120**(****)
Folic acid (incl., in the form of L-methylfolate) 400 mcg 66.6 80 100**
Iodine 150 mcg 100 68.2 51.7 100**

* According to MR 2.3.1.0253-21 “Norms of physiological needs for energy and nutrients for various groups of the population of the Russian Federation”.
** Recommended daily intake level, TR TS 022/2011 “Food products regarding their labeling”.
*** Adequate intake level, according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, appendix 5.
**** Does not exceed the upper permissible intake level, according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, appendix 5.

Contraindications

  • Individual intolerance to the components.

Not recommended for women with thyroid diseases.

Special Instructions

Dietary supplement, not a medicinal product.

Consult a doctor before use.

Dispensing Status

Through pharmacy network and specialized stores, departments of the trade network.

Storage Conditions

The product should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 24 months. Do not use after the expiration date printed on the packaging.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Besin Healthcare Rus, LLC (Russia)

Manufactured By

Capsugel Ploermel (France)

Labeled By

DELPHARM EVREUX (France)

For

BESINS HEALTHCARE MONACO, S.A.M. (Belgium)

Contact Information

BESINS HEALTHCARE RUS LLC (Russia)

Dosage Form

Bottle OTC Icon Vitagynal® Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 430 mg.

Composition fish oil, fish gelatin, glycerol (glycerin) (E422), refined rapeseed oil, natural D-α-tocopherol concentrate, colloidal silicon dioxide (E551), water, titanium dioxide (E171), folic acid, vitamin D3, potassium iodide, patent blue V (E131).

1 caps.
Vitamin B9 (folic acid) 400 mcg
Vitamin D3 (cholecalciferol) 5 mcg
Iodine 150 mcg
Docosahexaenoic acid 200 mg
Vitamin E (D-α-tocopherol) 12 mg TE

Nutritional value (1 caps.): proteins – 0.14 g, fats – 0.4 g, carbohydrates – 0.06 g.
Energy value (1 caps.): 4.4 kcal (18.1 kJ).

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

Marketing Authorization Holder

Besin Healthcare Rus, LLC (Russia)

Manufactured By

Besins Healthcare Brasil Comercial e Distribuidora de Medicamentos, Ltda (Brazil)

Contact Information

BESINS HEALTHCARE RUS LLC (Russia)

Dosage Form

Bottle OTC Icon Vitagynal® Mama and Baby Besins® Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 0.749 g.

Composition fish oil, gelatin, glycerin (humectant), water, silicon dioxide (anticaking agent), natural d-alpha-tocopherol (vitamin E), soy lecithin, candurin orange (color), cholecalciferol (vitamin D3), yellow iron oxide (color), calcium methylfolate, folic acid, potassium iodide.

Nutritional value (1 caps.): proteins – 0.14 g, fats – 0.4 g, carbohydrates – 0.06 g.
Energy value (1 caps.): 4.4 kcal/18.1 kJ.

15 pcs. – blisters (2) – cardboard packs.

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