Alvityl^® (Tablets) Instructions for Use

Marketing Authorization Holder

Solvay Pharmaceuticals S.A.S. (France)

ATC Code

A11BA (Multivitamins)

Dosage Form

Alvityl®

Coated tablets: 50 pcs.

Dosage Form, Packaging, and Composition

50 pcs. – polyethylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Multivitamins

Pharmacotherapeutic Group

Multivitamin

Indications

• Prevention and treatment of vitamin deficiencies in adults and children over 12 years of age, particularly in conditions associated with increased requirements or reduced intake of vitamins.
• Supportive therapy during periods of convalescence after serious illnesses, surgeries, or infectious diseases to aid in recovery and replenish nutrient stores.
• Nutritional supplementation in cases of inadequate or unbalanced dietary intake, malnutrition, or malabsorption syndromes to ensure sufficient levels of essential vitamins.
• Compensation for increased metabolic demands during periods of intense physical or mental stress, fatigue, or general asthenia to support overall metabolic function.

Contraindications

• Hypersensitivity to any of the active substances or to any of the excipients listed in the product composition. Allergic reactions can range from mild skin rashes to severe anaphylaxis.
• Hypervitaminosis A or D, or conditions associated with excessive levels of these vitamins, due to the risk of exacerbating toxicity symptoms such as liver damage or hypercalcemia.
• Severe renal impairment or end-stage renal disease, as impaired excretion can lead to accumulation of vitamins and their metabolites, potentially causing adverse effects.
• Hypercalcemia (elevated blood calcium levels) or conditions predisposing to it, as vitamin D component can increase intestinal calcium absorption and worsen this condition.
• Treatment with retinoids (e.g., isotretinoin, acitretin) or other vitamin A derivatives, due to the additive risk of hypervitaminosis A and associated toxicities.

Dosage Regimen

The standard dosage for adults and children over 12 years of age is one coated tablet per day. The tablet should be taken whole with a sufficient amount of water, preferably during or after a meal to enhance absorption and minimize potential gastrointestinal discomfort.

The duration of treatment is determined by the prescribing physician based on the individual’s clinical needs, underlying condition, and response to therapy. Self-medication beyond the recommended period is not advised. Do not exceed the stated dose unless specifically instructed by a healthcare professional.

For populations such as the elderly or patients with specific comorbidities, dosage adjustment is generally not required; however, a physician’s assessment is recommended to ensure suitability. The use of Alvityl in children under 12 years of age is not recommended due to the lack of data on safety and efficacy in this pediatric population.

Adverse Reactions

Adverse reactions to Alvityl are generally rare and mild when the product is used at the recommended dosage. However, in individuals with particular sensitivities or in cases of excessive intake, the following reactions have been reported, primarily affecting the gastrointestinal system and skin.

Gastrointestinal disorders may include nausea, abdominal pain, epigastric discomfort, diarrhea, or constipation. These symptoms are usually transient and may be alleviated by taking the tablet with food. Skin and subcutaneous tissue disorders such as rash, urticaria (hives), and pruritus (itching) have been reported, typically in the context of hypersensitivity to one or more components.

In very rare instances, allergic reactions, including anaphylaxis and severe dermatological reactions, can occur. Discontinuation of the product is necessary if any signs of allergy appear. With prolonged use of doses significantly exceeding the recommended daily intake, symptoms of hypervitaminosis may develop, particularly for fat-soluble vitamins A and D, which can include headache, drowsiness, visual disturbances, and hypercalcemia.

Drug Interactions

Concomitant use of Alvityl with other vitamin supplements, especially those containing vitamins A and D, should be avoided to prevent additive effects and the potential for hypervitaminosis. Patients should inform their healthcare provider about all nutritional supplements they are taking.

The vitamin B6 (pyridoxine) component may reduce the efficacy of levodopa when administered without a peripheral decarboxylase inhibitor, potentially worsening Parkinsonian symptoms. Vitamin C (ascorbic acid) in high doses can interfere with the anticoagulant effect of warfarin and may increase the absorption of iron supplements. It may also cause false-negative results in certain stool occult blood tests.

Colestyramine and mineral oil can reduce the absorption of fat-soluble vitamins (A, D, E). A time interval of at least 2-3 hours should be maintained between the administration of Alvityl and these agents. The folic acid content may decrease the serum concentration of phenytoin and other anticonvulsants, potentially reducing their therapeutic effect and necessitating monitoring.

Overdose

Acute overdose with a single, very high dose of Alvityl is unlikely to cause serious toxicity in healthy adults, though it may result in transient gastrointestinal upset such as nausea, vomiting, and diarrhea. Gastric lavage and symptomatic treatment are recommended in such cases.

Chronic overdose, resulting from prolonged ingestion of doses significantly above the recommended level, is of greater concern, primarily due to the accumulation of fat-soluble vitamins A and D. Symptoms of hypervitaminosis A may include severe headache, dizziness, blurred vision, drowsiness, irritability, bone and joint pain, and in severe cases, liver damage and increased intracranial pressure. Symptoms of hypervitaminosis D are dominated by hypercalcemia, which can manifest as anorexia, nausea, vomiting, constipation, polyuria, polydipsia, lethargy, and in prolonged cases, renal calcification and impaired renal function.

Treatment of chronic overdose involves immediate discontinuation of the product, a low-calcium diet, and measures to correct hypercalcemia, which may include hydration, loop diuretics, and in severe cases, corticosteroids or bisphosphonates under medical supervision. Specific treatment should be guided by a physician based on the prevailing symptoms and laboratory findings.

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

Rx Only

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.