BENADON 10CPR GASTRORES 300MG

BENADON 300 MG COMPRESENTS

active ingredients

A gastro-resistant tablet contains: piridossina hydrochloride (vitamin B₆300 mg. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

Therapy and prophylaxis of vitamin B deficiency₆ (malnutrition, etylism, etc.). Treatment and prophylaxis of nevriti in case of treatment with isoniazide, plumlazine, penicillamine, cycloserine. Anemie pyridoxin–sensitive. Coadjuvant therapy in radiotherapy.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Pregnancy and nursing • Children under 12 years • Patients with kidney or liver failure.

Population

Benadon is suitable for adults and adolescents from 12 years of age. Population One tablet per day orally, following the doctor's instructions. In convulsions and pyridoxin–sensitive anemias, higher doses (600 mg per day or more) may be required in some patients. For the high dose of vitamin B6, which largely exceeds the recommended food dosage, the product is not indicated for use in pregnancy and breastfeeding and in patients with kidney and liver failure (see paragraph 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 a suspension of at least 25 days is required. Method of administration Way of administration: oral. Tablets should not be chewed and should be swallowed with enough water.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Vitamin B6 should not be taken at doses higher than recommended ones, nor for longer periods (see paragraph 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 required. If you do not adhere to these recommendations, severe neurotoxicity may occur (overdose danger, see paragraph 4.9). Particular caution should be observed in parkinsonian patients at the same time treated with L-dopa, since vitamin B₆ at high doses can antagonize its effects.

Interactions

Interactions with other medicinal products Several drugs interfere with vitamin B6 and may decrease plasma levels. Among these: • Cicloserina • Hydralazine • Isoniazide • Desossipiridossina • D–penicillamina • Oral contraceptives • Alcohol Vitamin B6 could reduce the effectiveness of the drugs listed below: • L–Dopa: this interaction does not occur when the carbidopa is used together with the Levodopa. • Othertamine • Fenobarbital • Fenitoine Amiodarone: concurrent administration of Vitamin B6 could exacerbate the photosensitivity induced by amyodarone. Interactions with laboratory tests • Urobilinogen: pyridoxin can cause a false positive test with Ehrlich reagent.

Effects

The adverse reactions listed below derive from spontaneous reports. Since these reactions are reported on a voluntary basis it is not possible to estimate the frequency. Gastrointestinal diseases Nausea, vomiting Immune system disorders In predisposed subjects, hypersensitivity reactions can occur. Diseases of the nervous system Peripheral and polyneuropatia, paresthesia. Pathologies of skin and subcutaneous tissue Photosensitivity reactions. Skin rash, itching, hives and bollous dermatitis. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the national reporting system of the Italian Pharmaco Agency / www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

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

Pregnancy:

The product is contraindicated during pregnancy. Nursing: The product is contraindicated in breastfeeding

Women in fertile age

: Women in fertile age must use effective contraceptive methods during treatment.

Source: Farmadati