Benadon 10 gastro-resistant tablets 300mg

BENADON * 10CPR GASTRORES 300MG

Therapeutic indications

Vitamin B deficiency therapy and prophylaxis₆(malnutrition, alcoholism, etc.). Treatment and prophylaxis of neuritis in case of therapy with isoniazid, hydralazine, penicillamine, cycloserine. Pyridoxine-sensitive anemias. Adjuvant therapy during radiotherapy.

Dosage and method of use

Benadon is indicated for adults and adolescents from 12 years of age.DosageOne tablet a day orally, following the doctor's instructions. In seizures and pyridoxine-sensitive anemias, higher doses (600 mg per day or more) may be needed in some patients. Due to the high dosage of vitamin B6, which largely exceeds the recommended dietary dosage, the product is not indicated for use in pregnancy and lactation 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, a suspension of at least 25 days is required.Method of administrationRoute of administration: oral. The tablets should not be chewed and should be swallowed with a sufficient amount of water.

Contraindications

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

Side effects

The adverse reactions listed below are derived from spontaneous reports. As these reactions are reported on a voluntary basis it is not possible to estimate their frequency.Gastrointestinal disordersNausea, vomitingDisorders of the immune systemHypersensitivity reactions may occur in predisposed subjects.Nervous system disordersPeripheral neuropathy and polyneuropathy, paraesthesia.Skin and subcutaneous tissue disordersReactions of photosensitivity. Skin rash, itching, hives and bullous dermatitis. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

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 required. If these recommendations are not followed, severe neurotoxicity may occur (danger of overdose, see section 4.9). Particular caution should be observed in parkinsonian patients simultaneously treated with L-dopa, since vitamin B₆in high doses it can antagonize its effects.

Pregnancy and breastfeeding

Pregnancy:The product is contraindicated during pregnancy. Lactation: The product is contraindicated in lactationWomen of childbearing age: Women of childbearing potential must use effective contraceptive methods during treatment.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Interactions with other medicinesSeveral 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 to Levodopa. • Altretamines • Phenobarbital • Phenytoin Amiodarone: concomitant administration of Vitamin B6 may exacerbate amiodarone-induced photosensitivity.Interactions with laboratory tests• Urobilinogen: Pyridoxine can cause a false positive in the test with Ehrlich's reagent.

Overdose

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

Active principles

One gastro-resistant tablet contains: pyridoxine hydrochloride (vitamin B₆) 300 mg. For the 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.