BENADON 300 MG GASTRO-RESISTANT TABLETS 10 TABLETS

Name
Benadon®® 300 mg gastro-resistant tablets
vitamin B6


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

Talk to your doctor if you do not feel better or 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 renal or hepatic insufficiency (reduced kidney or liver function).


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

Do not take Benadon in doses higher than recommended, nor 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 break of at least 25 days is required.

Failure to follow these recommendations may result in serious neurotoxicity (risk of overdose, see "If you take more Benadon than you should").

Take particular care if you suffer from Parkinson's disease and are being treated with L-dopa at the same time, since vitamin B6 in high doses may antagonise 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 adverse reactions have been observed in association with the use of Benadon, resulting from spontaneous reports. Because these reactions are reported voluntarily, their frequency cannot be estimated.

Effects on the gastrointestinal system
-nausea,
-vomit.

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

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

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

Reporting of side effects
If you experience 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.