Vivacia Folic Acid 400 mkg (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Folic acid 400 mkg

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

^# recommended norm of consumption.

Auxiliary substances : fillers (dicalcium phosphate, microcrystalline cellulose), anti-caking agents (magnesium stearate, silicon dioxide).

Nutritional value (100 g): proteins – 0.0 g, fats – 0.0 g, carbohydrates – 0.0 g.
Energy value (100 g): 13 kJ/3 kcal.

60 pcs. – bottles (1) – cardboard packs.

Therapeutic Category

Dietary supplement – source of folic acid

Indications

• For the prevention of neural tube defects in the developing fetus. It is recommended for women of childbearing potential, particularly those planning a pregnancy, to initiate supplementation at least one month prior to conception and continue through the first trimester.
• To supplement the diet as an additional source of folic acid, which plays a crucial role in numerous physiological processes, including nucleic acid synthesis and cellular division.
• To support normal blood formation and contribute to the reduction of tiredness and fatigue, as folic acid is essential for the production of red blood cells.

Dosage Regimen

For adults, take one tablet (400 micrograms) once daily, unless otherwise directed by a healthcare professional.

The tablet should be taken orally, preferably with a glass of water. It can be taken with or without food. Adherence to the recommended dosage is critical; do not exceed the stated dose.

For women planning a pregnancy or who are pregnant, the standard dosage is one tablet daily. The timing of initiation and duration of therapy should be determined by a physician based on individual needs and clinical guidelines.

Contraindications

• Hypersensitivity to folic acid or to any of the auxiliary substances listed in the composition of the product. Signs of an allergic reaction may include rash, itching, or swelling.
• Pernicious anemia (Vitamin B12 deficiency) and other megaloblastic anemias where vitamin B12 is deficient. Folic acid can correct the anemia but may mask the underlying neurological damage caused by the B12 deficiency, allowing it to progress undetected.
• Malignant disease, as folic acid may potentially stimulate the growth of certain preneoplastic or neoplastic cells.

Adverse Reactions

Folic acid is generally well-tolerated at the recommended dosage of 400 micrograms per day. However, in rare cases, some individuals may experience adverse reactions.

Allergic reactions are possible and may manifest as skin rash, pruritus (itching), erythema (redness), and bronchospasm. Gastrointestinal disturbances such as nausea, abdominal bloating, and flatulence have been reported infrequently.

High doses of folic acid over long periods may lead to more significant side effects, including neurological symptoms in patients with an undiagnosed vitamin B12 deficiency. If any adverse reaction is severe or persistent, discontinue use and consult a healthcare provider.

Drug Interactions

Concomitant use of Vivacia Folic Acid with certain medications may lead to interactions that require monitoring or dose adjustment.

Antiepileptic drugs (e.g., phenytoin, phenobarbital, primidone, carbamazepine, valproate): Folic acid may decrease serum concentrations of these drugs, potentially reducing their anticonvulsant efficacy and increasing the risk of seizures. Conversely, these drugs can reduce folate levels.

Methotrexate, a folic acid antagonist used in cancer and autoimmune diseases, has its cytotoxic effects reduced by folic acid supplementation. The interaction is sometimes managed with specific dosing schedules under medical supervision.

Pyrimethamine, used for malaria and toxoplasmosis, is antagonized by folic acid. Sulfasalazine, trimethoprim, and triamterene may also interfere with folate metabolism or absorption. Inform your doctor about all medications you are taking, including prescription, over-the-counter, and other dietary supplements.

Overdose

Acute overdose with folic acid is unlikely to cause serious harm due to its water-soluble nature. However, chronic intake of excessively high doses (significantly above 1000 micrograms per day) can be harmful.

The primary risk of prolonged excessive folic acid intake is the masking of vitamin B12 deficiency (pernicious anemia). It can correct the hematological abnormalities of B12 deficiency, allowing the associated and potentially irreversible neurological damage to progress without diagnosis.

Other potential effects of very high doses include gastrointestinal upset and central nervous system effects. In case of suspected overdose, seek medical attention or contact a Poison Control Center immediately. Treatment is supportive and may include discontinuation of the supplement.

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.