BIOCHETASI OS GRAT EFF 18BUST

BIOCHETASI

active ingredients

Effervescent granulate. A bag contains: Active ingredients: sodium citrate mg 425 potassium citrate mg 50 tiamina diphosphate ester free mg 50 riboflavin 5-monophosphate monosodium mg 25 (equal to mg 23.8 free acid) vitamin B₆ hydrochloride mg 12.5 citric acid mg 100 Eccipients with known effects: sorbitol (E420), sucrose, fructose, glucose, sodium. A bag contains: sorbitol (E420): mg 125 sucrose: g 1.7 fructose: mg 650 glucose: g 1.4 sodium: mg 142 Effervescent tablets. An effervescent tablet contains: Active ingredients: sodium citrate mg 425 potassium citrate mg 50 tiamina diphosphate ester free mg 50 riboflavin 5-monophosphate monosodium mg 25 vitamin B6 hydrochloride mg 12.5 citric acid mg 70 Eccipients with known effects: aspartame (E951), sucrose, sodium. An effervescent tablet contains: aspartame (E951): mg 20 sucrose: mg 737,5 sodium mg 238

Excellent

Effervescent granulate malic acid; sorbitol; tartaric acid; sodium bicarbonate; polyvinylpyrrolidone; orange aroma; saccharin; sodium edetate; propile gallate; sucrose; fructose; glucose. Effervescent tablets tartaric acid; aspartame; orange aroma; sucrose; insoluble polyvinylpyrrolidone; polyvinylpyrrolidone; talc; silica precipitated; sodium bicarbonate.

Therapeutic indications

- Hyperacidity - Digestive difficulty - Hepatic insufficiency - ketone states - Nausea gravidica.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1.

Population

Adults and children over the age of 12: 2 sachets or 2 effervescent tablets 3 times a day, dissolved in half a glass of water. Children under 12 years of age: half dose. Special popularity. Patients with liver failure: Biochetasis studies have not been conducted in patients with liver failure. Patients with kidney failure: No studies have been conducted with Biochetasis in patients with kidney failure.

Conservation

This medicine does not require any special condition of conservation.

Warnings

If symptoms persist you should consider a clinical revaluation. Medicines containing vitamin B1 or its derivatives may, especially if administered by parental means, induce the occurrence of atopic manifestations in patients with hypersensitivity. Important information about some excipients BIOCHETASI effervescent granulate contains sorbitol and fructose. Patients with hereditary fructose intolerance should not be given this medicine. The additive effect of co-administration of medicinal products containing sorbitol or fructose and the daily intake of sorbitol or fructose with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. BIOCHETASI effervescent granulate contains glucose. Patients suffering from rare problems of glucose-galactosis do not have to take this medicine. BIOCHETASI effervescent granulate contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure should not take this medicine. BIOCHETASI effervescent granulate contains about 1.7 g sucrose and 1.4 g glucose per dose (button). This is taken into account in diabetic patients and patients who follow hypocaloric dietary regimes. BIOCHETASI effervescent granulate contains 142 mg sodium per sachet equivalent to 7.1% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The maximum daily dose of this product is 42.6% of the maximum daily sodium intake recommended by the WHO. BIOCHETASI effervescent granulate is considered to be high in sodium. To be considered especially in people who follow a low-sodium diet. BIOCHETASI effervescent tablets contains aspartame, source of phenylalanine, which can be harmful to the patient suffering from phenylchetonuria. No clinical or non-clinical studies are available on the use of aspartame in children under 12 weeks of age. BIOCHETASI effervescent tablets contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. BIOCHETASI effervescent tablets contain 238 mg of sodium per dose equivalent to 11.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The maximum daily dose of this product is 71.4% of the maximum daily sodium intake recommended by the WHO. BIOCHETASI effervescent granulate is considered to be high in sodium. To be considered especially in people who follow a low-sodium diet.

Interactions

Riboflavin absorption is influenced by bromuro propanine. Particular caution is required in patients suffering from Parkinson treated with levodopa because vitamin B6 (piridossina) can antagonize therapeutic effects. The use of citrate-based preparations can increase the gastrointestinal absorption of aluminium (e.g. antacids containing aluminum).

Effects

Below are the side effects organized according to the classification for MedDRA Systems and Organs. Adverse reactions come from literature data and post marketing reports. As it has not been possible to calculate the frequency is indicated as not known (the frequency cannot be defined on the basis of the available data). Immune system disorders: Orticaria. Anaphylactic Shock have been reported in patients treated with tiamina by parental means. Gastrointestinal diseases: Nausea. Pathologies of skin and subcutaneous tissue: Skin rash, lip edema. Kidney and urinary pathologies: Chromaturia. 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

Prolonged use of pyridoxin to high dosages can cause neuropathy. High doses of potassium-containing products can cause hyperkaliemia and alkalosis, especially in patients with kidney failure. High doses of citrate-based preparations may have a saline laxative effect when administered orally.

BIOCHETASI is administered both in case of pregnancy and during breastfeeding.

Source: Farmadati