Biochetasi Os Effervescent Granules 18 Sachets

Biochetasi Os Effervescent Granules is an over-the-counter medicine used to treat digestive problems such as acidity, digestive difficulties, nausea and vomiting. This product is particularly indicated in cases of ketosis, common in situations of food imbalances, liver problems or metabolic disorders. Thanks to its effervescent formulation, Biochetasi acts quickly to relieve gastrointestinal discomfort.

ACTIVE INGREDIENTS

Active ingredients contained in Biochetasi Os Effervescent Granules 18 Sachets - What is the active ingredient of Biochetasi Os Effervescent Granules 18 Sachets?

Effervescent granules, one sachet contains, active ingredients: sodium citrate 425 mg, potassium citrate 50 mg, thiamine diphosphate free ester 50 mg, riboflavin 5-monophosphate monosodium 25 mg (equivalent to 23.8 mg of free acid), vitamin B6 hydrochloride 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 mg. Effervescent tablets, one effervescent tablet contains, active ingredients: sodium citrate 425 mg, potassium citrate 50 mg, free thiamine diphosphate ester 50 mg, monosodium riboflavin 5-monophosphate 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

Composition of Biochetasi Os Effervescent Granules 18 Sachets - What does Biochetasi Os Effervescent Granules 18 Sachets contain?

Effervescent granules: malic acid; sorbitol; tartaric acid; sodium bicarbonate; polyvinylpyrrolidone; orange flavour; saccharin; sodium edetate; propyl gallate; sucrose; fructose; glucose. Effervescent tablets: tartaric acid; aspartame; orange flavour; sucrose; insoluble polyvinylpyrrolidone; polyvinylpyrrolidone; talc; precipitated silica; sodium bicarbonate.

DIRECTIONS

Therapeutic indications Biochetasi Os Effervescent Granules 18 Sachets - Why is Biochetasi Os Effervescent Granules 18 Sachets used? What is it for?

Hyperacidity, digestive difficulties, liver failure, ketonemic states, nausea during pregnancy.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Biochetasi Os Effervescent Granules 18 Sachets - When should Biochetasi Os Effervescent Granules 18 Sachets not be used?

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

DOSAGE

Quantity and method of taking Biochetasi Os Effervescent Granules 18 Sachets - How do you take Biochetasi Os Effervescent Granules 18 Sachets?

Dosage. 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 the dose. Special populations. Patients with hepatic insufficiency: no studies have been conducted with Biochetasi in patients with hepatic insufficiency. Patients with renal insufficiency: no studies have been conducted with Biochetasi in patients with renal insufficiency.

CONSERVATION

Storage Biochetasi Os Effervescent Granules 18 Sachets - How do you store Biochetasi Os Effervescent Granules 18 Sachets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Biochetasi Os Effervescent Granules 18 Sachets - About Biochetasi Os Effervescent Granules 18 Sachets it is important to know that:

If symptoms persist, a clinical reassessment should be considered.Medicines 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 medicine. The concomitant administration of medicinal products containing sorbitol or fructose and the daily intake of sorbitol or fructose with the diet should be considered. The content of sorbitol in medicinal products for oral use may modify the bioavailability of other medicinal products for oral use co-administered. Biochetasi effervescent granules contain glucose. Patients with rare problems of glucose-galactose malabsorption 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 medicine. 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 a low-calorie diet. Biochetasi effervescent granules contain 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 maximum daily intake of sodium recommended by the WHO. Biochetasi effervescent granules are considered high in sodium. To be taken into account especially in people on a low-sodium diet. Biochetasi effervescent tablets contain aspartame, a source of phenylalanine, which may be harmful to patients with phenylketonuria. There are no non-clinical or clinical studies available on the use of aspartame in children under 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 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 of sodium for an adult. The maximum daily dose of this product is equivalent to 71.4% of the maximum daily intake of sodium recommended by the WHO. Biochetasi effervescent granules are considered high in sodium. To be taken into consideration especially by people following a low-sodium diet.

INTERACTIONS

Interactions Biochetasi Os Effervescent Granules 18 Sachets - Which medicines or foods can modify the effect of Biochetasi Os Effervescent Granules 18 Sachets?'

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. aluminum-containing antacids).

SIDE EFFECTS

Like all medicines, Biochetasi Os Effervescent Granules 18 Sachets can cause side effects - What are the side effects of Biochetasi Os Effervescent Granules 18 Sachets?

The following are the undesirable effects organized according to the MedDRA System Organ Class. Adverse reactions are derived from literature data and post-marketing reports. Since it was not possible to calculate the frequency, they are indicated as not known (the frequency cannot be estimated from the available data). Immune system disorders: urticaria. Anaphylactic shock has been reported in patients treated with 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 that occur after authorization of the medicinal product is important, as 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Biochetasi Os Effervescent Granules 18 Sachets

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