Benexol 20 Gastro-resistant Tablets

Posology and method of use of Benexol Tablets

In adults and children over 12 years of age: take 1 Benexol tablet a day.

The Benexol tablets should be swallowed with a sip of liquid, without chewing or dissolving them beforehand. The product is generally prescribed for periods of one or more weeks. In some cases, the doctor may extend the treatment up to a few months.

Active ingredient Thiamine hydrochloride (Vit. B1) 250 mg, pyridoxine hydrochloride (Vit. B6) 250 mg, cyanocobalamin (Vit. B12) 500 µg.
Excipients Colloidal hydrated silica, povidone, magnesium stearate, pregelatinised starch, mannitol, talc, methacrylic acid - ethyl acrylate copolymer (1:1), carmellose sodium, macrogol 6000, glycerol triacetate.

Hypersensitivity to the active ingredients of Benexol Tablets or to any of the excipients:

• In pregnancy and while breastfeeding
• In children under 12 years of age
• In patients with renal or hepatic insufficiency

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 disorders: Diarrhea, dyspepsia, nausea, vomiting, gastrointestinal and abdominal pain.
  
  
• Immune system disorders: Allergic reaction and anaphylactic reaction. Hypersensitivity reactions with corresponding laboratory findings and clinical manifestations, including asthma syndrome, mild to moderate reactions affecting the skin and/or respiratory tract, gastrointestinal tract and/or cardiovascular system. Symptoms may include facial edema (a secondary mechanism), dyspnea, urticaria, angioedema, pruritus, and cardiorespiratory distress. If an allergic reaction occurs, stop treatment and consult a doctor.
  
  
• Renal and urinary disorders: Abnormal smelling urine
  
  
• Nervous system disorders: Peripheral neuropathy and polyneuropathy, paraesthesia
  
  
• Skin and subcutaneous tissue disorders: Photosensitivity reaction, rash, erythema, pruritus, urticaria and bullous dermatitis.

Special Warnings Benexol Tablets

Do not exceed the recommended dose and treatment duration. Due to the high dosage of pyridoxine hydrochloride (vitamin B6), the product should not be taken in higher doses or for longer periods than recommended, as improper use can be associated with severe neurotoxicity. Particular caution should be used if the product is prescribed together with levodopa for the treatment of Parkinson's disease, as pyridoxine in high doses can antagonize its therapeutic effect.

Repeated intramuscular administration of vitamin B1 preparations can in rare cases cause anaphylactic reactions in predisposed patients. The clinical picture can in some respects simulate anaphylactic shock. In order to avoid these rare anaphylactic reactions, oral administration should always be preferred, whenever possible. If this is not possible, the intramuscular injection should be carried out as slowly as possible by qualified and experienced personnel

Overdose Benexol Tablets

Pregnancy and breastfeeding Benexol Tablets

Can I take Benexol Tablets sachets when pregnant or breastfeeding?

Benexol in pregnancy and breastfeeding
The product is contraindicated during pregnancy and lactation due to the high dosage of vitamin B6, which far exceeds the recommended dietary dosage.

Expiration and storage of Benexol Tablets

How to store Benexol Tablets?

Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not exceeding 25°C.

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