BIOCHETASIS * OS GRAT EFF 18BUST

  • Alfasigma S.p.A.
  • 015784097
Biochetasi is a drug based on the active ingredient sodium citrate + potassium citrate + anhydrous citric acid + vitamin complex, belonging to the category of Antacids and specifically Other vitamin preparations, associations. Bioketase can be prescribed with OTC Recipe - self-medication medicine. Hyperacidity Digestive difficulties Hepatic insufficiency Ketonemic states Nausea during pregnancy.
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BIOCHETASIS * OS GRAT EFF 18BUST

Therapeutic indications

- Hyperacidity - Digestive difficulties - Liver failure - 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: Studies with bioketase have not been conducted in patients with hepatic insufficiency. Patients with renal insufficiency: Studies with bioketase have not been conducted 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 following are the undesirable effects organized according to the MedDRA System and Organ classification. Adverse reactions are derived from literature data and post marketing reports. As it was not possible to calculate the frequency, they are reported as not known (the frequency cannot be estimated from the available data).Disorders of the immune system: Hives. Anaphylactic shock has been reported in patients treated with parenteral thiamine.Gastrointestinal disorders:Nausea.Skin and subcutaneous tissue disorders: Rash, Edema of the lips.Renal and urinary disorders:Chromaturia.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Special warnings

If symptoms persist, a clinical re-evaluation should be considered. Medicinal products containing vitamin B1 or its derivatives can, especially if administered parenterally, induce the onset of atopic manifestations in patients with hypersensitivity. Important information about some of the ingredients BIOCHETASE effervescent granules 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 dietary intake of sorbitol or fructose must be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. BIOCHETASE effervescent granules contains glucose. Patients with rare glucose-galactose malabsorption problems should not take this medicine. BIOCHETASE effervescent granules contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. BIOCHETASE effervescent granules contains 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 who follow low-calorie diets. BIOCHETASE effervescent granules contains 142 mg of sodium per sachet equivalent to 7.1% of the maximum daily intake recommended by the WHO 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 sodium intake. BIOCHETASE effervescent granules is considered to be high in sodium. Especially to be taken into consideration in people on a low sodium diet. BIOCHETASE effervescent tablets contain aspartame, a source of phenylalanine, which may be harmful to the patient with phenylketonuria. Neither non-clinical nor clinical studies are available on the use of aspartame in children below 12 weeks of age. BIOCHETASE effervescent tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. BIOCHETASE 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 of sodium for an adult. The maximum daily dose of this product is equivalent to 71.4% of the WHO recommended maximum daily sodium intake. BIOCHETASE effervescent granules is considered to be high in sodium. Especially to be taken into consideration in people on a low sodium diet.

Pregnancy and breastfeeding

BIOCHETASE can be administered both in case of pregnancy and during breastfeeding with breast milk.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Absorption of riboflavin is affected by propantheline bromide. Particular caution is required in Parkinson's patients treated with levodopa because vitamin B6 (pyridoxine) can antagonize the therapeutic effects. The use of citrate preparations may increase the gastrointestinal absorption of aluminum (e.g. aluminum-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 can have a saline laxative effect when administered orally.

Active principles

Effervescent granules.One sachet contains:Active principles: sodium citrate 425 mg potassium citrate 50 mg thiamine diphosphate free ester 50 mg riboflavin 5-monosodium monophosphate 25 mg (equal to 23.8 mg of free acid) vitamin B6hydrochloride 12.5 mg citric acid 100 mg Excipients with known effects: 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 mgEffervescent tablets. One effervescent tablet contains:Active principles: sodium citrate 425 mg potassium citrate 50 mg thiamine diphosphate free ester 50 mg riboflavin monosodium 5-monophosphate 25 mg vitamin B6 hydrochloride 12.5 mg citric acid 70 mg Excipients with known effects: aspartame (E951), sucrose, sodium. One effervescent tablet contains: aspartame (E951): 20 mg sucrose: 737.5 mg sodium 238 mg

Excipients

Effervescent granulesmalic acid; sorbitol; tartaric acid; sodium bicarbonate; polyvinylpyrrolidone; orange flavor; saccharin; sodium edetate; propyl gallate; sucrose; fructose; glucose.Effervescent tabletstartaric acid; aspartame; orange flavor; sucrose; insoluble polyvinylpyrrolidone; polyvinylpyrrolidone; talc; precipitated silica; sodium bicarbonate.

015784097

Data sheet

Packaging
effervescent granules 18 sachets
Product Type
HUMAN DRUG
ATC code
A11JB
ATC description
Vitamins associated with mineral salts
Therapeutic Group
Antacids
Active principle
sodium citrate + potassium citrate + anhydrous citric acid + vitamin complex
Class
C.
Pharmaceutical form
effervescent granules
Type of Administration
oral
Container
sachet in box
Quantity
18 sachet
Recipe required
OTC - self-medication medicine
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