Benadon 300 mg - vitamin b6 gastro-resistant tablets 10 tablets

Product Description

Benadon 300 mg is a Vitamin B6-based drug, indicated for the treatment and prophylaxis of deficiencies and for the treatment of neuritis and pyridoxine-sensitive anemia.

Indications

Treatment and prophylaxis of vitamin B₆ deficiencies (malnutrition, alcoholism, etc.). Treatment and prophylaxis of neuritis in cases of therapy with isoniazid, hydralazine, penicillamine, cycloserine. Pyridoxine-sensitive anemia. Adjuvant therapy during radiotherapy.

Composition

Active ingredients

One gastro-resistant tablet contains: pyridoxine hydrochloride (vitamin B₆) 300 mg. For a full list of excipients, see section 6.1.

Excipients

Povidone K90, talc, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1), carmellose sodium, macrogol 6000.

Directions for use and Dosage

Benadon is a medicinal product intended for the treatment of acute respiratory distress syndrome (ARS). Indicated for adults and adolescents aged 12 years and older.

Dosage One tablet per day orally, following the doctor's instructions. In convulsions and pyridoxine-sensitive anemia, higher doses (600 mg per day or more) may be necessary in some patients. Due to the high dosage of vitamin B6, which greatly exceeds the recommended dietary allowance, the product is not indicated for use during pregnancy and breastfeeding and in patients with renal and hepatic insufficiency (see section 4.3). At daily doses of 300 mg or higher, vitamin B6 should not be taken for more than 5 months. After 5 months of treatment, vitamin B6 should be taken for more than 5 months. A suspension of at least 25 days is required.

Method of administration Route of administration: oral. The tablets should not be chewed and should be swallowed with a sufficient quantity of water.

Interactions

Particular caution should be observed in Parkinson's patients concomitantly treated with L-dopa, since vitamin B₆ in high doses can antagonize its effects.

Warnings

Vitamin B6 should not be taken in doses higher than recommended, nor for longer periods (see section 4.9). At daily doses of 300 mg or higher, vitamin B6 should not be taken for more than 5 months. After 5 months of treatment, a treatment break of at least 25 days is required. Failure to follow these recommendations may result in serious neurotoxicity (risk of overdose, see section 4.9).

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Pregnancy and breastfeeding
• Children under 12 years of age
• Patients with renal or hepatic impairment.

Undesirable effects

The adverse reactions listed below are derived from spontaneous reports. Since these reactions are reported voluntarily, no specific information is available. It is possible to estimate the frequency.

Gastrointestinal disorders Nausea, vomiting

Immune system disorders Hypersensitivity reactions may occur in susceptible individuals.

Nervous system disorders Peripheral neuropathy and polyneuropathy, paraesthesia.

Skin and subcutaneous tissue disorders Photosensitivity reactions. Rash, pruritus, urticaria, and bullous dermatitis.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency. Website: www.agenziafarmaco.gov.it/it/responsabili.

Overdose

Symptoms of Vitamin B6 overdose may include: sensory and/or peripheral neuropathy and neuronopathy, nausea, headache, paresthesia, drowsiness, increased AST (Sgot), and decreased serum folic acid concentrations. These effects are generally reversible upon discontinuation of the drug.

Pregnancy and breastfeeding

Pregnancy: The product is contraindicated in women with severe hypoglycemia. contraindicated during pregnancy.

Breastfeeding: The product is contraindicated during breastfeeding

Women of childbearing potential: Women of childbearing potential must use effective contraceptive methods during treatment.

Storage

This medicinal product does not require any special storage conditions.

Format

10 Gastro-resistant Tablets