BENEXOL*20TAB GASTR RES

Benexol gastro-resistant tablets
Vitamins B1+B6+B12

What it is and what it is used for
Benexol tablets belong to the therapeutic category of vitamins based on vitamin B1+ B6+ B12. This medicine is used in vitamin B1, B6, B12 deficiency states and their various clinical manifestations: deficiency polyneuritis (inflammation of the peripheral nerves due to vitamin deficiency), neuritis (inflammation of the peripheral nerves) during treatment with isoniazid (an anti-tuberculosis drug) and other vitamin B6 antagonists (medicines that hinder the action of vitamin B6).

Benexol tablets are also indicated as adjuvant therapy for non-deficiency neuritis (inflammation of the peripheral nerves not due to vitamin deficiency) and during radiotherapy.

Consult your doctor if you do not feel better or feel worse after a period of treatment.

What you need to know before taking the medicine
Do not take Benexol tablets
- if you are allergic to vitamins B1, B6 or B12 or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from kidney or liver failure (reduced kidney or liver function);
- if you are pregnant or breastfeeding (see Pregnancy and breastfeeding);
- if you are under 12 years of age (see Children and adolescents).

Warnings and precautions
Consult your doctor or pharmacist before taking Benexol tablets.

Do not take Benexol tablets at higher doses or for longer periods than recommended, as an overdose can be associated with severe neurotoxicity (damage to the nervous system) (risk of overdose, see If you take more Benexol tablets than you should).

Pay particular attention if you are taking levodopa (medicine for the treatment of Parkinson's disease) at the same time, as pyridoxine (vitamin B6) at high doses can antagonise its therapeutic effect (see Other medicines and Benexol tablets).

Children and adolescents
Due to the high dosage of vitamin B6, Benexol tablets must not be administered to children and adolescents under 12 years of age (see Do not take Benexol tablets).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The adverse reactions listed below are derived from spontaneous reports and their frequency cannot be estimated.

Effects on the gastrointestinal system
- diarrhoea,
- dyspepsia (indigestion),
- nausea,
- vomiting,
- gastrointestinal and abdominal pain (stomach ache).

Effects on the immune system
- allergic reaction and anaphylactic reaction,
- allergic reactions manifestations including asthmatic syndrome, mild to moderate reactions affecting the skin and/or respiratory tract, gastrointestinal tract and/or cardiovascular system. Symptoms may include facial oedema (swelling), dyspnoea (difficulty breathing), urticaria (itching and small spots on the skin), angioedema (swelling of the facial skin and mucous membranes), pruritus and cardiorespiratory distress (severe and acute respiratory failure).
If an allergic reaction occurs, stop treatment immediately and consult your doctor.

Effects on the kidneys and urinary tract
- abnormal urine odour.

Effects on the nervous system
- peripheral neuropathy and polyneuropathy,
- paraesthesia (altered sensation, e.g. tingling).

Effects on the skin
- photosensitivity reaction (sunburn-like),
- rash,
- erythema (redness),
- pruritus,
- 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, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-adverse.
By reporting side effects, you can help provide more information on the safety of this medicine.