BENEXOL 20CPR GASTR FL

BENEXOL

active ingredients

Benexol gastro-resistant tablets A gastro-resistant tablet contains: thiamin hydrochloride (Vit. B₁) 250 mg, pyridoxine hydrochloride (Vit. B₆250 mg, cyanocobalamin (Vit. B₁₂500 mcg. Benexol low dose powder and solvent A vial of powder contains: vitamin B₁ (such as cocarboxylase) 38 mg, pyridoxine hydrochloride (Vit. B₆) 200 mg, hydroxocobalamine (Vit. B₁₂) 1000 mcg (such as acetate hydroxocobalamine). Benexol high dose powder and solvent A vial of powder contains: vitamin B₁ (such as cocarboxylase) 38 mg, pyridoxine hydrochloride (Vit. B₆) 300 mg, hydroxocobalamin (Vit. B₁₂) 5000 mcg (such as acetate hydroxocobalamine). For the full list of excipients, see paragraph 6.1.

Excellent

Benexol gastro-resistant tablets colloidal silica moisturizes, povidone, magnesium stearate, pregelatinized starch, mannitol, talc, metacrilic acid - acrylate copolimer (1:1), sodium carmellose, macrogol 6000, triacetate glycerol. Benexol low dose powder and solvent for injectable solution for intramuscular use The powder vial contains: methyl parahydroxybenzoate, propile parahydroxybenzoate, sodium hydroxide. A solvent vial contains: water for injectable preparations Benexol high dose powder and solvent for injectable solution for intramuscular use The powder vial contains: methyl parahydroxybenzoate, propile parahydroxybenzoate, sodium hydroxide. A solvent vial contains: water for injectable preparations

Therapeutic indications

B vitamin deficiency states₁, B₆ and B₁₂ and their different clinical forms (failurential hypolineritis, ongoing nevriti treatment with isoniazis and other antagonists of vitamin B6). Coadjuvant therapy in non-failing and radiotherapy neuropathies.

Contraindications

• Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. • Pregnancy and nursing • Children under 12 years • Renal or hepatic insufficiency.

Population

Benexol is indicated in adults and teens from 12 years of age Population Benexol gastro-resistant tablets 1 tablet per day. The product is generally prescribed for periods of one or more weeks. In some cases, the doctor may extend the treatment until a few months. Benexol low dose powder and solvent Benexol low dosage is indicated when the absorption is markedly reduced and for the treatment of hypovitaminoses. The dose is of a vial per day, except for different prescription. Benexol high dose powder and solvent Benexol high dosage is indicated for the initial therapy of particularly intense symptomatology forms. The dose is of a vial per day, except for different prescription.Method of administration: Benexol gastro-resistant tablets Benexol tablets should be swallowed with a sip of liquid, without chewing or melting them in advance. Benexol low dose powder and solvent The injection must be done intramuscularly deep by qualified and experienced personnel and the administration must take place as slowly as possible. The solution to be injected is prepared at the moment, melting the lyophilized dry substance with the special solvent contained in the package. Benexol high dose powder and solvent The injection must be done intramuscularly deep by qualified and experienced personnel and the administration must take place as slowly as possible. The solution to be injected is prepared at the moment, melting the lyophilized dry substance with the special solvent contained in the package.

Conservation

Benexol low dose powder and solvent for injectable solution for intramuscular use This medicine does not require any special condition of conservation. Benexol high dose powder and solvent for injectable solution for intramuscular use: Do not store at temperature above 25 °C Benexol gastro-resistant tablets: Do not store at temperature above 25 °C

Warnings

Do not exceed the recommended dose and duration of treatment. The product should not be taken at higher doses or longer periods than recommended, since overdosing may be associated with severe neurotoxicity (see paragraph 4.9). Particular caution should be used if the product is prescribed along with levodopa for Parkinson's disease therapy, as pyridoxin with high dosages may antagonize its therapeutic effect (see paragraph 4.5) Repeated administrations of preparations containing vitamin B1 intramuscularly may in rare cases cause anaphylactic reactions. The clinical picture can simulate an anaphylactic shock (see paragraph 4.8) In order to avoid these rare anaphylactic reactions, oral administration should always be preferred whenever possible. If this is not possible, intramuscular injection must take place as slowly as possible and must be done by qualified and experienced personnel (see paragraph 4.2). Important information about some excipients Benexol gastro-resistant tablets This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “without sodium”. Benexol low dose powder and solvent for injectable solution for intramuscular use This medicine contains benzoate parahydroxys. It can cause allergic reactions (also delayed) and, exceptionally, bronchospasm. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “without sodium”. Benexol high dose powder and solvent for injectable solution for intramuscular use This medicine contains benzoate parahydroxys. It can cause allergic reactions (also delayed) and, exceptionally, bronchospasm. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “without sodium”.

Interactions

Interactions with other medicines: Vitamin B₁ (title) The medicinal products listed below inhibit thymine activity: • Tiosemicarbazone • 5-fluorouracile Vitamin B6 (pyridosin) Several drugs interfere with pyridoxin and can reduce plasma levels. Among these: • Cicloserina • Hydralazine • Isoniazide • Desossipiridossina • D-penicillamina • Oral contraceptives • Alcohol. Vitamin B6 can reduce the effectiveness of the following medicines: • Levodopa: piridossina enhances the metabolization of the levodopa in dopamine and therefore reduces its antiparkinson therapeutic effects to the usual doses used. This interaction however does not occur when the carbidopa is used along with the levodopa. • Othertamine • Fenobarbital • Fenitoine • Amiodarone: co-administration can aggravate the photosensitivity induced by amyodarone. Vitamin B12 (cyanocobalamin) Aminoglycosides, antihistamines (anti-H₂), metformin and other related biguanids, oral contraceptives, aminosalicylic acid and protonic pump inhibitors can reduce the absorption of vitamin B₁₂ from the gastrointestinal tract. Therefore, in patients taking these medicines, the need for vitamin B₁₂ can be increased. Cloramfenicolo can delay or interrupt the response of reticulocytes to vitamin B12. Therefore it is necessary to monitor the hemochrome in case of concurrent intake. Interactions with laboratory tests: Vitamin B₁ (title) • Tiamina can give rise to false positives in the determination of urobilinogen with Ehrlich reagent. • High doses of thiamin can interfere with the spectrophotometric determination of serum theophylline. Vitamin B6 (pyridosin) • Urobilinogen: pyridoxin can cause a false positive test with Ehrlich reagent.

Effects

The adverse reactions listed below derive from spontaneous reports. Since these reactions are reported on a voluntary basis it is not possible to estimate the frequency Gastrointestinal diseases Diarrhea, dyspepsia, nausea, vomiting, gastrointestinal pain and abdominal. Immune system disorders Allergic reaction and anaphylactic reaction. Reactions of hypersensitivity with the corresponding laboratory paintings and clinical manifestations, which include asthmatic syndrome, mild to moderate intensity reactions to the skin and/or respiratory tract, gastrointestinal tract and/or cardiovascular system. Symptoms may include edema to the face (secondary mechanism), dispnea, hives, angioedema, itching and cardiorespiratory distress. If an allergic reaction appears, stop treatment and consult a doctor. Only for the injectable solution: serious reactions that include anaphylactic shock with possible fatal outcome were associated with parental use. Kidney and urinary pathologies Urines with abnormal odor Diseases of the nervous system Peripheral and polyneuropatia, paresthesia Pathologies of skin and subcutaneous tissue Reaction of photosensitivity, rash, erythema, itching, hives and bollous dermatitis. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

At recommended doses Benexol does not cause hypervitaminosis. Symptoms of overdose include sensory and/or peripheral neuropathy and neuropathomies, nausea, headache, paresthesia, drowsiness, increased serum levels of AST (SGOT) and decreased serum levels of folic acid. These effects are generally reversible to the cessation of treatment.

Pregnancy The product is contraindicated during pregnancy (see paragraph 4.3) The product is contraindicated in breastfeeding (see paragraph 4.3) Women in fertile age must use effective contraceptive methods during treatment.

Source: Farmadati