Benerva 300 mg 20 gastro-resistant tablets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Prophylaxis and treatment of vitamin B deficiency₁ from increased demand or reduced absorption (beriberi and its various clinical forms). Deficient (ethyl) polyneuritis. Myocardiopathies of alcoholics. At high doses, adjuvant therapy of non-deficient neuritis and polyneuritis.

ACTIVE INGREDIENTS

Benerva 300 mg gastro-resistant tablets. One tablet contains: thiamine hydrochloride (vitamin B₁) 300 mg. Benerva 100 mg/1 ml solution for injection for intramuscular use. One 1 ml ampoule contains: thiamine hydrochloride (vitamin B₁) 100 mg. For the full list of excipients, see 6.1.

EXCIPIENTS

Benerva 300 mg gastro-resistant tablets: Talc, povidone K90, magnesium stearate, methacrylic acid - ethyl acrylate copolymer (1:1), macrogol 6000, sodium carmellose. Benerva 100 mg/1 ml solution for injection for intramuscular use: Phenol, glycerol, sodium dihydrogen phosphate dihydrate, sodium bicarbonate, water for injections.

CONTRAINDICATIONS AND SIDE EFFECTS

Tablets Known hypersensitivity to the active substance or to any of the excipients. Vials Known or suspected hypersensitivity to the active substance or to any of the excipients.

DOSAGE

Oral administration. Mild and medium-severity cases: 100 mg every 24 hours. Severe cases: 600-1200 mg (2-4 Benerva 300 mg tablets) per day for 1-2 weeks, then 300 mg (1 Benerva 300 mg tablet) per day for several weeks. High-dose Benerva tablets (300 mg) allow you to establish an intensive treatment. Parenteral administration. Parenteral administration is reserved for cases with impaired intestinal absorption, as well as in the initial treatment of acute deficiencies, accompanied by polyneuritis, mental and cardiac disorders, in particular in chronic alcoholism: 50-200 mg i.m. per day.

CONSERVATION

Tablets Store in the original packaging. Vials Store at temperatures below 25°C, in the original packaging, protected from light.

WARNINGS

Vitamin B preparations₁ or derivatives, especially parenterally, can cause disorders in subjects who have had sensitization phenomena or pathological manifestations due to allergies. The risk of hypersensitivity reactions is increased with repeated intramuscular administration. Oral administration is therefore preferable, where possible.

INTERACTIONS

Thiosemicarbazone and 5-fluorouracil inhibit the activity of thiamine. Interferences with laboratory tests: • vitamin B₁ can give false positives in the determination of urobilinogen with the Ehrlich reagent; • high doses of vitamin B₁ may interfere with the spectrophotometric determination of serum theophylline.

SIDE EFFECTS

The side effects reported below derive from spontaneous reports and it is therefore not possible to classify them into frequency categories. Tablets. Immune system disorders: Allergic and anaphylactic reactions have been reported in individual cases, with symptoms such as pruritus, urticaria, angioedema, abdominal pain, breathing difficulties, tachycardia, palpitations and shock. Gastrointestinal disorders: Mild gastrointestinal disorders such as nausea, vomiting, diarrhea and abdominal pain have been reported. Vials. Systemic pathologies and conditions relating to the administration site: Pain at the injection site. Immune system disorders: Allergic and anaphylactic reactions with symptoms such as pruritus, urticaria, angioedema, abdominal pain, breathing difficulties, tachycardia, palpitations and shock have been reported, usually after intravenous, intramuscular or subcutaneous injection. These reactions are often preceded by sneezing or transient itching.

OVERDOSE

Tablets No cases of overdose have been reported. Vials Isolated clinical cases of toxic reactions to prolonged parenteral administration of thiamine probably represent hypersensitivity reactions.

PREGNANCY AND BREASTFEEDING

This product is not indicated for use during pregnancy or breastfeeding.

EFFECTS ON DRIVING ABILITY

No negative effects of the preparation on these activities have been reported or expected. However, patients should be advised to observe their reactions to the drug before driving or operating machinery.