Vitagynal^® Mama (Capsules) Instructions for Use

Marketing Authorization Holder

Besin Healthcare Rus, LLC (Russia)

Manufactured By

Besins Healthcare Monaco, S.A.M. (Belgium)

At Production Facilities

NEXTPHARMA PLOËRMEL (France)

Contact Information

BESINS HEALTHCARE RUS LLC (Russia)

Dosage Form

Vitagynal® Mama

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules mass of 430 mg.

Composition fish oil, gelatin from fish, glycerin (E422, moisture-retaining agent), rapeseed oil refined, concentrate d-alpha-tocopherol natural (vitamin E), silicon dioxide colloidal (E551, anti-caking agent), water, candurin orange (E172/E555, colorant), iron oxide (E172, colorant), folic acid, vitamin D₃ (cholecalciferol), 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) – packs cardboard.

Therapeutic Category

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

Indications

• Vitagynal^® Mama is a dietary supplement intended for women as an additional source of folic acid, vitamin D, vitamin E, and iodine.
• It is specifically formulated to help meet the increased nutritional demands during the preconception period, throughout pregnancy, and while breastfeeding.
• The product is used to support maternal health and fetal development by providing essential micronutrients that play a critical role in cell division, neurological development, thyroid function, and antioxidant protection.

It is not a medicinal product and is not intended to diagnose, treat, cure, or prevent any disease.

Contraindications

• Hypersensitivity (allergy) to any of the components of the dietary supplement, including fish and soy (due to the presence of fish oil and rapeseed oil).
• Hyperthyroidism and other conditions where iodine intake is contraindicated or should be restricted, as the product contains potassium iodide.
• Conditions associated with hypercalcemia (elevated blood calcium levels) or hypercalciuria (elevated calcium in urine), due to the presence of vitamin D₃ which enhances calcium absorption.
• Concomitant use of other products containing vitamin D, vitamin A, or iodine to avoid the risk of exceeding the recommended upper intake levels, which can be harmful.

Consult a physician before use if you have any pre-existing medical conditions or are taking other medications or supplements.

Dosage Regimen

The recommended dosage for women during the period of pregnancy planning, pregnancy, and breastfeeding is one capsule per day.

The capsule should be taken orally with a meal and swallowed whole with a sufficient amount of water. Do not chew the capsule. Adherence to the recommended dosage is crucial to ensure the intended nutritional support and to avoid excessive intake of fat-soluble vitamins and iodine.

The duration of use is not limited to the periods indicated, but it is strongly recommended to consult with a healthcare professional to determine the appropriate duration of supplementation based on individual nutritional status and needs.

Adverse Reactions

Adverse reactions are uncommon when the product is used at the recommended dosage.

In rare cases, hypersensitivity reactions, such as skin rash, itching, or urticaria, may occur in individuals with known allergies to the ingredients. Gastrointestinal discomfort, including nausea, epigastric discomfort, or changes in bowel habits, may be experienced, particularly if taken on an empty stomach.

Long-term intake of doses exceeding the recommended level of iodine may lead to the development of iodine-induced hyperthyroidism. Excessive intake of vitamin D can cause hypercalcemia, manifesting as nausea, vomiting, constipation, weakness, and in severe cases, renal impairment.

If any adverse reactions occur, discontinue use immediately and consult a physician.

Drug Interactions

Concurrent use with other vitamin and mineral supplements, particularly those containing vitamins A, D, E, or iodine, can lead to additive effects and potential toxicity. It is essential to inform your doctor about all supplements you are taking.

Vitamin D may reduce the effectiveness of atorvastatin. Thiazide diuretics can reduce calcium excretion and, when combined with vitamin D, may increase the risk of hypercalcemia. Anticonvulsants (e.g., phenobarbital, phenytoin), corticosteroids, and certain weight-loss drugs (e.g., orlistat) may interfere with the absorption or metabolism of fat-soluble vitamins, including vitamin D and E.

Folic acid can interfere with the action of certain antifolate drugs, such as methotrexate and some antiepileptics (e.g., phenytoin, phenobarbital, primidone), potentially reducing their efficacy. Patients taking these medications should use this supplement only under strict medical supervision.

Overdose

In case of accidental intake of a significantly higher than recommended dose, seek immediate medical attention or contact a Poison Control Center.

Symptoms of acute overdose are most likely related to the fat-soluble vitamins and iodine content. Vitamin D overdose can lead to hypercalcemia, characterized by nausea, vomiting, constipation, polyuria, polydipsia, weakness, and mental status changes. Chronic overdose is more dangerous and can result in irreversible vascular and renal calcification.

Excessive iodine intake can cause metallic taste, burning in the mouth and throat, severe gastrointestinal upset, and can induce or exacerbate hyperthyroidism or hypothyroidism. Treatment is symptomatic and supportive; specific measures may include discontinuation of the supplement, a low-calcium diet, and ensuring adequate hydration.

Storage Conditions

Store at 2°C (36°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.