Vivacia Folate 400 mkg (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Folate 400 mkg

Tablets: 50 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 250 mg.

^# recommended daily intake.

Auxiliary substances : volume-forming agents (microcrystalline cellulose, dicalcium phosphate), anti-caking agent (magnesium stearate).

Nutritional value (100 g): proteins – 0.0 g, fats – 0.0 g, carbohydrates – 0.0 g.
Energy value (100 g): 29 kJ/8 kcal.

50 pcs. – bottles (1).

Therapeutic Category

Dietary supplement – source of folic acid

Dosage Regimen

The recommended dosage for adults is one tablet (400 mcg) per day, unless otherwise directed by a healthcare professional.

The tablet should be taken orally with a meal and a full glass of water to enhance absorption and minimize potential gastrointestinal discomfort. Adherence to a consistent daily intake schedule is crucial for maintaining stable folate levels in the body.

For specific populations, such as women planning pregnancy or during the first trimester, the dosage may be adjusted by a physician. Do not exceed the recommended daily dose unless under medical supervision.

Adverse Reactions

Vivacia Folate 400 mcg is generally well-tolerated when taken at the recommended dosage. However, like any supplement, it may cause adverse reactions in some individuals.

Allergic reactions are rare but possible. Signs may include skin rash, itching, urticaria, and in severe cases, difficulty breathing or swelling of the face, lips, tongue, or throat. Discontinue use immediately and seek medical attention if any signs of an allergic reaction occur.

Gastrointestinal side effects, such as nausea, loss of appetite, bloating, flatulence, or a bitter taste in the mouth, have been reported infrequently. These symptoms are usually mild and transient.

At very high doses exceeding 1000 mcg (1 mg) per day, there is a potential for masking the hematological symptoms of vitamin B12 deficiency (pernicious anemia), allowing neurological complications to progress undetected. Long-term use of high doses may also lead to insomnia, irritability, or excitability.

Indications

• To supplement the diet with folic acid for the maintenance of good health.
• For individuals with an increased need for folate due to dietary habits or lifestyle factors.
• For women of childbearing age to support neural tube development in the fetus during the early stages of pregnancy. Adequate folate intake is crucial before conception and during the first trimester to reduce the risk of neural tube defects.

Drug Interactions

Folic acid can interact with several medications, which may alter the effectiveness of either the supplement or the drug. It is essential to inform your healthcare provider about all the products you are taking.

Concomitant use with antiepileptic drugs (e.g., phenytoin, phenobarbital, primidone, carbamazepine, valproate) may reduce the serum concentrations of these anticonvulsants, potentially leading to increased seizure frequency. Conversely, some antiepileptics can lower folate levels.

Methotrexate, used for cancer and autoimmune diseases, is a folate antagonist. High-dose folic acid can interfere with its antitumor efficacy, while low-dose supplementation is sometimes used to mitigate its side effects; this requires strict medical supervision.

Folic acid may decrease the plasma concentration and effectiveness of fosphenytoin and phenytoin. Sulfasalazine, cholestyramine, and certain antacids may impair the absorption of folic acid, reducing its bioavailability. Regular use of alcohol can also interfere with folate metabolism and increase the body’s requirement for it.

Contraindications

• Hypersensitivity to folic acid or any of the auxiliary components of the dietary supplement (microcrystalline cellulose, dicalcium phosphate, magnesium stearate).
• Untreated cobalamin deficiency (e.g., pernicious anemia, vitamin B12 deficiency). Folic acid supplementation can correct the megaloblastic anemia caused by B12 deficiency but will not prevent, and may even exacerbate, the associated neurological damage.
• Patients with confirmed malignant neoplasms, unless specifically recommended by an oncologist, as folate may stimulate the growth of certain tumors.

Overdose

Acute overdose with folic acid is unlikely due to its water-soluble nature; any excess is typically excreted in the urine. However, chronic intake of doses significantly exceeding the upper tolerable intake level (1000 mcg for adults) can lead to adverse effects.

The primary risk of prolonged excessive folic acid intake is the masking of vitamin B12 deficiency. This can allow the underlying B12 deficiency to progress, leading to irreversible neurological damage, such as subacute combined degeneration of the spinal cord, while the anemia is corrected by folate.

Other potential consequences of very high chronic intake include gastrointestinal disturbances, sleep disorders, cognitive impairment, and a general feeling of malaise. In case of suspected overdose, discontinue use and consult a healthcare professional. Treatment is supportive and may include cessation of the supplement and assessment of vitamin B12 status.

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.