BIOCHETASI*OS FREE EFF 18BUST

• Hyperacidity • Digestive difficulties • Hepatic insufficiency • Ketonemic states • Pregnancy nausea.

Therapeutic indications

• Hyperacidity • Digestive difficulties • Hepatic insufficiency • Ketonemic states • Pregnancy nausea.

Dosage and method of use

Adults and children over 12 years of age: 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 populations Patients with hepatic insufficiency: No studies have been conducted with Bioketase in patients with hepatic insufficiency. Patients with renal insufficiency: No studies have been conducted with Bioketase in patients with renal insufficiency.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Side effects

The undesirable effects organized by MedDRA System Organ Classification are listed below. The adverse reactions derive from literature data and post-marketing reports. As the frequency could not be calculated they are indicated as not known (frequency cannot be estimated from the available data). Immune system disorders Urticaria. Anaphylactic shock has been reported in patients receiving parenteral thiamine. Gastrointestinal disorders Nausea. Skin and subcutaneous tissue disorders Rash, Lip oedema. Renal and urinary disorders Chromaturia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Special warnings

If symptoms persist, a clinical reassessment should be considered. Medicinal products containing vitamin B1 or its derivatives may, especially when administered parenterally, induce the onset of atopic manifestations in patients with hypersensitivity. Important information about some of the excipients BIOCHETASI effervescent granules contain sorbitol and fructose. Patients with hereditary fructose intolerance should not be given this medicinal product. The additive effect of co-administration of medicinal products containing sorbitol or fructose and the daily dietary intake of sorbitol or fructose should be considered. The sorbitol content in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. BIOCHETASI effervescent granules contain glucose. Patients with rare glucose-galactose malabsorption problems should not take this medicine. BIOCHETASI effervescent granules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. BIOCHETASI effervescent granules contain approximately 1.7 g of sucrose and 1.4 g of glucose per dose (sachet). This should be taken into account in diabetic patients and in patients on low-calorie diets. BIOCHETASI effervescent granules contain 142 mg of sodium per sachet equivalent to 7.1% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. The maximum daily dose of this product is equivalent to 42.6% of the WHO recommended maximum daily intake for sodium. BIOCHETASI effervescent granules are considered high in sodium. To be taken into consideration especially in people on a low sodium diet. BIOCHETASI effervescent tablets contain aspartame, a source of phenylalanine, which can be harmful for patients with phenylketonuria. There are no non-clinical or clinical studies on the use of aspartame in infants younger than 12 weeks of age. BIOCHETASI effervescent tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. BIOCHETASI effervescent tablets contain 238 mg of sodium per dose equivalent to 11.9% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. The maximum daily dose of this product is equivalent to 71.4% of the WHO recommended maximum daily intake for sodium. BIOCHETASI effervescent granules are considered high in sodium. To be taken into consideration especially in people on a low sodium diet.

Pregnancy and breastfeeding

BIOCHETASI can be administered both in case of pregnancy and during breastfeeding.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

Riboflavin absorption is affected by propantheline bromide. Particular caution is required in Parkinson's patients treated with levodopa because vitamin B6 (pyridoxine) may antagonize the therapeutic effects. The use of citrate preparations may increase the gastrointestinal absorption of aluminum (e.g. aluminium-containing antacids).

Overdose

Prolonged use of pyridoxine in high dosages can cause neuropathies. High doses of potassium-containing products can cause hyperkalaemia and alkalosis, particularly in patients with renal insufficiency. High doses of citrate preparations may have a saline-like laxative effect when administered orally.

Active principles

Effervescent granules One sachet contains: Active ingredients: sodium citrate 425 mg potassium citrate 50 mg thiamin diphosphate ester free 50 mg riboflavin 5-monosodium monophosphate 25 mg (equal to 23.8 mg of free acid) vitamin B ₆ hydrochloride 12.5 mg acid citric acid 100 mg Excipients with known effect: sorbitol (E420), sucrose, fructose, glucose, sodium. One sachet contains: sorbitol (E420): 125 mg sucrose: 1.7 g fructose: 650 mg glucose: 1.4 g sodium: 142 mg Effervescent tablets One effervescent tablet contains: Active ingredients: sodium citrate 425 mg potassium citrate 50 mg thiamine free diphosphate ester 50 mg riboflavin 5-monophosphate monosodium 25 mg vitamin B6 hydrochloride 12.5 mg citric acid 70 mg Excipients with known effect: aspartame (E951), sucrose, sodium. One effervescent tablet contains: aspartame (E951): 20 mg sucrose: 737.5 mg sodium 238 mg

Excipients

Malic acid effervescent granules; sorbitol; tartaric acid; sodium bicarbonate; polyvinylpyrrolidone; orange flavor; saccharin; sodium edetate; propyl gallate; sucrose; fructose; glucose. Tartaric acid effervescent tablets ; aspartame; orange flavor; sucrose; insoluble polyvinylpyrrolidone; polyvinylpyrrolidone; talc; precipitated silica; sodium bicarbonate.