Benadon 300 mg 10 gastro-resistant tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Treatment and prophylaxis of vitamin B deficiencies₆ (malnutrition, alcoholism, etc.). Treatment and prophylaxis of neuritis in case of therapy with isoniazid, hydralazine, penicillamine, cycloserine. Pyridoxine-sensitive anemias. Adjuvant therapy during radiotherapy.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

Vitamin B6 should not be taken at doses higher than those 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 suspension of at least 25 days is necessary. If these recommendations are not followed, serious neurotoxicity may occur (danger of overdose, see section 4.9). Particular caution must be observed in parkinsonian patients simultaneously treated with L-dopa, since vitamin B₆ at high doses it can antagonize its effects.

INTERACTIONS

Interactions with other medicines Several drugs interfere with vitamin B6 and can decrease its plasma levels. These include: • Cycloserine • Hydralazine • Isoniazid • Deoxypyridoxine • D–penicillamine • Oral contraceptives • Alcohol Vitamin B6 may reduce the effectiveness of the drugs listed below: • L–Dopa: This interaction does not occur when carbidopa is used together with Levodopa. • altretamine • Phenobarbital • Phenytoin Amiodarone: concomitant administration of Vitamin B6 could exacerbate photosensitivity induced by amiodarone. Interactions with laboratory tests • Urobilinogen: Pyridoxine may cause a false positive in the Ehrlich reagent test.

SIDE EFFECTS

The adverse reactions listed below are derived from spontaneous reports. Since these reactions are reported on a voluntary basis, it is not possible to estimate their frequency. Gastrointestinal disorders Nausea, vomiting Immune system disorders Hypersensitivity reactions may occur in predisposed individuals. Nervous system disorders Peripheral neuropathy and polyneuropathy, paraesthesia. Pathologies of the skin and subcutaneous tissue Photosensitivity reactions. Skin rash, itching, urticaria and bullous dermatitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency. Website: http: // www.agenziafarmaco.gov.it/it/responsabili.