BENADON*10TB GASTRORES 300MG

Benadon 300 mg gastro-resistant tablets
Vitamin B6

What it is and what it is used for
Benadon contains pyridoxine hydrochloride (vitamin B6).
Benadon belongs to the category of vitamin-based medicines.
Benadon is indicated in the following cases:
• treatment and prevention of vitamin B6 deficiencies (malnutrition, alcoholism, etc.);
• treatment of anemias sensitive to vitamin B6;
• treatment and prevention of nerve inflammations (neuritis) in case of therapy with isoniazid (a drug for tuberculosis), hydralazine (antihypertensive, a drug for arterial hypertension), penicillamine (a drug for rheumatoid arthritis), cycloserine (an antibiotic);
• adjunctive therapy during radiotherapy.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not take Benadon
• if you are allergic to pyridoxine hydrochloride (vitamin B6) or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if you are under 12 years of age;
• if you suffer from kidney or liver failure (reduced kidney or liver function).

Warnings and precautions
Talk to your doctor or pharmacist before taking Benadon.

Do not take Benadon at doses higher than recommended, or for longer periods. At daily doses of 300 mg (1 tablet) 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, severe neurotoxicity may occur (risk of overdose, see “If you take more Benadon than you should”).
Exercise particular caution if you suffer from Parkinson's and are concurrently treated with L-dopa, as high doses of vitamin B6 can antagonize its effects (see “Other medicines and Benadon”).

Children and adolescents
This medicine should not be taken by children and adolescents under 12 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed in association with the use of Benadon, which derive from spontaneous reports. As these reactions are reported voluntarily, it is not possible to estimate their frequency.

Effects on the gastrointestinal tract
- nausea,
- vomiting.

Effects on the immune system
- allergic reactions (in predisposed individuals).

Effects on the nervous system
- peripheral neuropathy (disease affecting peripheral nerves) and polyneuropathy (disease simultaneously affecting multiple peripheral nerves),
- paresthesia (altered sensation in the limbs or other parts of the body, e.g., tingling).

Effects on the skin
- photosensitivity reactions (allergic skin reactions to sunlight, such as sunburn),
- rash,
- itching,
- urticaria (itching and small spots on the skin),
- bullous dermatitis.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.