Folifebin prenatal (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Kvadrat-S LLC (Russia)

Dosage Form

Folifebin prenatal

Coated tablets: 30 pcs.

Dosage Form, Packaging, and Product Composition

Tablets, coated with a coating, with a mass of 130 mg.

¹ according to TR TS 022/2011 “Food products in part of its labeling” (Appendix 2).
² according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Chapter II, section 1, Appendix 5).
* does not exceed the upper permissible intake level according to ².

Auxiliary substances : microcrystalline cellulose (carrier), magnesium stearate (anti-caking agent).

Coating composition hydroxypropyl methylcellulose (thickener), polyethylene glycol (stabilizer), titanium dioxide (colorant), iron oxide yellow (colorant).

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

Therapeutic Category

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

Indications

• For use as a dietary supplement to food – an additional source of folic acid, cyanocobalamin, iron, and iodine.
• Intended to help meet the increased nutritional demands during specific physiological periods in women.
• Recommended for women planning a pregnancy to help create optimal nutrient reserves, particularly for the critical role of folic acid in the early stages of fetal neural tube development.
• Recommended for use throughout pregnancy to support maternal health and fetal growth, aiding in the prevention of deficiencies in iron (which can lead to anemia), iodine (essential for thyroid function and fetal brain development), and B vitamins.
• Recommended during breastfeeding (lactation) to support the nutritional quality of breast milk and replenish maternal nutrient stores depleted during pregnancy and childbirth.

Contraindications

• Individual intolerance to any of the components of the dietary supplement.
• Pregnancy and lactation period: Use is contraindicated in cases of established hyperthyroidism (overactive thyroid gland) without adequate therapeutic control, as the iodine content may exacerbate the condition.
• Conditions associated with iron overload such as hemochromatosis, hemosiderosis, or chronic hemolytic anemias where iron accumulation can occur.
• Patients with severe hepatic impairment or active inflammatory diseases of the gastrointestinal tract which may be aggravated by oral iron supplementation.
• Concomitant use with levodopa without medical supervision, as vitamin B₆ can reduce its efficacy, and with certain antipsychotic medications where the interaction profile is not well established.

Dosage Regimen

The standard recommended dosage for Folifebin prenatal is one tablet once per day.

The tablet should be taken orally, swallowed whole with a sufficient amount of water (approximately half a glass). It is advisable to take the tablet during or immediately after a meal to improve gastrointestinal tolerance, particularly to the iron component, which can sometimes cause discomfort when taken on an empty stomach.

For optimal absorption and to minimize potential interactions, it is recommended to avoid taking the supplement simultaneously with tea, coffee, milk, or dairy products, as they can inhibit iron absorption. A time gap of at least 1-2 hours is advisable between taking Folifebin prenatal and consuming these beverages or antacids.

The duration of use is determined by a healthcare professional based on individual needs. Typically, supplementation is recommended starting at least one month prior to planned conception and continuing throughout the entire pregnancy and lactation period.

Adverse Reactions

Folifebin prenatal is generally well-tolerated when used as directed. However, like any supplement, it may cause adverse reactions in some individuals.

Allergic reactions are possible, albeit rare, and may include skin rash, itching, urticaria (hives), or angioedema. Discontinue use immediately and seek medical attention if any signs of a hypersensitivity reaction occur.

From the gastrointestinal system, disturbances such as nausea, epigastric pain, constipation, or diarrhea may be observed, primarily associated with the iron content. These symptoms are often dose-dependent and may be mitigated by taking the tablet with food.

In individuals with a predisposition or pre-existing thyroid condition, the iodine content could potentially lead to the development or worsening of hyperthyroidism (symptoms may include palpitations, nervousness, weight loss). Patients with known thyroid disorders should use this supplement only under strict medical supervision.

The urine may acquire an intense yellow color; this is a harmless and temporary effect due to the excretion of riboflavin metabolites and is not a cause for concern.

Drug Interactions

Concurrent use of Folifebin prenatal with other products containing iron, iodine, or folic acid may lead to a cumulative effect and increase the risk of exceeding the upper tolerable intake levels, potentially leading to toxicity.

Iron contained in the supplement can form insoluble complexes with tetracycline and fluoroquinolone antibiotics, levodopa, levothyroxine, methyldopa, and bisphosphonates, significantly reducing the absorption of both the iron and the concomitant drug. A minimum interval of 2-3 hours between doses should be maintained.

Antacids containing calcium, magnesium, or aluminum, as well as cholestyramine, can decrease iron absorption and should be taken at least 2 hours apart from Folifebin prenatal.

Folic acid may reduce the serum concentration and efficacy of phenobarbital, phenytoin, and primidone, potentially leading to increased seizure frequency in epileptic patients. Plasma level monitoring of these anticonvulsants is recommended during concomitant therapy.

The iodine content can interfere with diagnostic tests for thyroid function and may affect the dosage requirements for thyroid medications (both thyroxine and antithyroid drugs). Patients on such therapies require careful monitoring by a physician.

Overdose

In case of accidental ingestion of a large number of Folifebin prenatal tablets, immediate medical attention is required. Overdose symptoms are primarily related to the iron content, especially in young children, for whom iron is a leading cause of fatal poisoning.

Early symptoms of iron overdose (within the first few hours) may include nausea, vomiting (sometimes bloody), abdominal pain, diarrhea, lethargy, and signs of dehydration. These may be followed by a latent period.

Severe poisoning can progress to metabolic acidosis, hypoglycemia, coagulopathy, shock, hepatic necrosis, and gastrointestinal scarring. Iodine overdose can cause a metallic taste, burning in the mouth and throat, severe gastrointestinal upset, and potentially thyroid dysfunction.

There is no specific antidote. Treatment is symptomatic and supportive and may include gastric lavage (if performed early), whole bowel irrigation, and administration of the specific iron chelator deferoxamine in a hospital setting for significant iron toxicity. Serum iron levels and other parameters should be monitored.

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.