Benadon 300 Mg Pyridoxine Hydrochloride Vitamin B6 10 Tablets

Tablets based on pyridoxine hydrochloride.

Therapeutic indications

Benadon 300 mg Tablets are used in case of:

• Therapy and prophylaxis of vitamin B6 deficiencies (malnutrition, alcoholism, etc.).
• Treatment and prophylaxis of neuritis in case of therapy with isoniazid, hydralazine, penicillamine, cycloserine.
• Pyridoxine-sensitive anemias.
• Adjuvant therapy of pellagra (in association with vitamin PP) and during radiotherapy.

Dosage and Posology

Benadon 300 mg should be taken in the following doses and methods:

• Adults and adolescents from 12 years of age: 300 mg per day, orally as directed by the doctor.

In pyridoxine-sensitive seizures and anemias, higher doses (600 mg per day or more) may be needed in some patients. Due to the high dosage of vitamin B6, which far exceeds the recommended dietary dosage, the product is not suitable for use in pregnancy and lactation and in patients with renal and hepatic insufficiency.

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

Overdose

High doses of vitamin B6 for prolonged periods may in rare cases lead to peripheral sensory 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.

Contraindications

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

Side effects

The adverse reactions listed below are derived from spontaneous reports and therefore an organization by frequency categories is not possible.

• Gastrointestinal disorders: Nausea, vomiting
• Immune system disorders: hypersensitivity reactions may occur in predisposed individuals.
• Nervous system disorders: peripheral neuropathy with symptoms such as paraesthesia.
• Skin and subcutaneous tissue disorders: photosensitivity with symptoms such as rash, itching, urticaria and bullous dermatitis.

Pregnancy and breastfeeding

Benadon 300 mg is contraindicated during pregnancy and lactation, due to the high dosage of vitamin B6, which greatly exceeds the recommended dietary dosage.

Special warnings

Vitamin B6 should not be taken in doses higher than those recommended, nor for longer periods. 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 can occur.

Oral administration is always preferred. If this is not possible, intramuscular or intravenous injection should be performed by qualified and experienced personnel and administration should take place as slowly as possible. Particular caution should be observed in Parkinsonian patients simultaneously treated with Ldopa, since vitamin B6 in high doses can antagonize its effects.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. This medicinal product does not require any special storage conditions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One Benadon 300 mg tablet contains:

Active principle

Pyridoxine hydrochloride (vitamin B6) 300 mg.

Excipients

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