Active ingredients: Vitamins, Mineral salts
BIOCHETASE effervescent granules
BIOCHETASE effervescent tablets
Biochetase package inserts are available for packs: - BIOCHETASE effervescent granules, BIOCHETASE effervescent tablets
- BIOCHETASE Vials
- BIOCHETASE suppositories
Indications Why is Biochetasi used? What is it for?
What is it
The BIOCHETASE is a polycompound with antacidosic action, for the restoration of intracellular potassium and for a correct functioning of the metabolic cycles and a reintegrator of the substances with enzymatic and coenzymatic action.
Why is it used
BIOCHETASE is used in case of:
- gastric hyperacidity
- digestive difficulties
- liver failure
- ketonemic states
- nausea during pregnancy.
Contraindications When Biochetase should not be used
BIOCHETASE should not be used in case of hypersensitivity to the components or other closely related substances from a chemical point of view.
Precautions for use What you need to know before taking Biochetase
The product contains sugars. This should be taken into account in diabetic patients and in patients who follow low-calorie diets.
Interactions Which drugs or foods can modify the effect of Bioketase
There are no known interactions with other drugs or with food.
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
BIOCHETASE can also be administered during pregnancy and breastfeeding.
The medicine is not contraindicated for people with celiac disease.
Dose, Method and Time of Administration How to use Bioketase: Dosage
How many
Warning: do not exceed the indicated doses without medical advice.
Adults: 2 sachets or 2 effervescent tablets 3 times a day.
Children under 12 years: 1 sachet or 1 effervescent tablet 3 times a day.
When and for how long
Warning: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
The tablets and sachets must be dissolved in half a glass of water.
Side Effects What are the side effects of Biochetase
Not reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects.
Request and fill in the undesirable effects report form available at the pharmacy (form B).
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach of children.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
Composition
Effervescent granules
One sachet contains:
Active principles:
- sodium citrate mg. 450.0
- potassium citrate mg. 50.0
- thiamine diphosphate free ester mg. 50.0
- monosodium riboflavin 5-monophosphate (equal to 23.8 mg of free acid) mg. 25.0
- vitamin B6 hydrochloride mg. 12.5
- citric acid mg. 100.0
Excipients:
malic acid, sorbitol, tartaric acid, sodium bicarbonate, polyvinylpyrrolidone, orange flavor, saccharin, glucose, sodium edetate, propyl gallate, sucrose, fructose.
Effervescent tablets
One effervescent tablet contains:
Active principles:
- sodium citrate 425.0 mg
- potassium citrate 50.0 mg
- thiamine diphosphate free ester mg 50.0
- monosodium riboflavin 5-monophosphate mg 25.0
- vitamin B6 hydrochloride 12.5 mg
- citric acid mg 70.0
Excipients:
tartaric acid, aspartame, orange flavor, sucrose, insoluble polyvinylpyrrolidone, polyvinylpyrrolidone, talc, precipitated silica, sodium bicarbonate.
How it looks
BIOCHETASE effervescent granules comes in the form of granules in sachets; the contents of the package are 20 sachets.
BIOCHETASE effervescent tablets comes in the form of effervescent tablets; the contents of the pack are 10 and 20 effervescent tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BIOCHETASE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Effervescent granules
One sachet contains:
Active principles:
sodium citrate 425.0 mg;
potassium citrate 50.0 mg;
free ester thiamine diphosphate 50.0 mg;
monosodium riboflavin 5-monophosphate 25.0 mg (equal to 23.8 mg of free acid);
vitamin B6 hydrochloride 12.5 mg;
citric acid 100.0 mg.
Effervescent tablets
One effervescent tablet contains:
Active principles:
sodium citrate 425.0 mg;
potassium citrate 50.0 mg;
free ester thiamine diphosphate 50.0 mg;
monosodium riboflavin 5-monophosphate 25.0 mg;
vitamin B6 hydrochloride 12.5 mg;
citric acid 70.0 mg.
03.0 PHARMACEUTICAL FORM
Effervescent granules in sachets and effervescent tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
- Hyperacidity
- Digestive difficulties
- Hepatic insufficiency
- Ketonemic states
- Nausea during pregnancy
04.2 Posology and method of administration
Adults: 2 sachets or 2 effervescent tablets 3 times a day, dissolved in half a glass of water.
Children: half dose.
Do not exceed the recommended dose
04.3 Contraindications
Hypersensitivity to the components of the product.
04.4 Special warnings and appropriate precautions for use
After a short period of treatment with no appreciable results, consult your doctor.
The product contains sugars. This should be taken into account in diabetic patients and in patients who follow low-calorie diets.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known phenomena of interactions with other drugs.
04.6 Pregnancy and lactation
The BIOCHETASE can be administered both in case of pregnancy and during lactation.
04.7 Effects on ability to drive and use machines
The product has never had a negative effect on the ability to drive or on the use of machines.
04.8 Undesirable effects
The administration of BIOCHETASE never caused undesirable effects.
04.9 Overdose
There have never been any overdose symptoms of the drug.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
The alterations of the metabolism can have at their base various causes both external to the organism and internal to it. They can manifest themselves with a state of acidosis, as occurs in childhood and pregnancy, of intoxication, as occurs in febrile states and in " hepatic insufficiency and digestive difficulties with relative post-prandial heaviness. The well-studied formulation of BIOCHETASE allows to counteract such situations by detoxifying the body and restoring the normal function of the digestive system.
Thiamine diphosphate has a role in favoring the utilization of sugars, fats and proteins. Riboflavin-5 "-phosphate restores impaired glucose and lipid metabolism.
Vitamin B6 is essential for many biochemical reactions to take place.
Citric acid, sodium and potassium citrate, act as antacids and detoxifiers.
In summary, BIOCHETASE intervenes on several levels and is therefore able to act continuously in the complex alterations to which the organism is subject.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Effervescent granules:
malic acid; sorbitol; tartaric acid; sodium bicarbonate; polyvinylpyrrolidone; orange flavor; saccharin; sodium edetate; propyl gallate; sucrose; fructose; glucose.
Effervescent tablets:
tartaric acid; aspartame; orange flavor; sucrose; insoluble polyvinylpyrrolidone; polyvinylpyrrolidone; talc; precipitated silica; sodium bicarbonate.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
They are not necessary.
06.5 Nature of the immediate packaging and contents of the package
Box of 20 sachets of 5 g of effervescent granules.
Box of 10 effervescent tablets in aluminum / aluminum strips.
Box of 20 effervescent tablets in aluminum / aluminum strips.
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - 00144 Rome
Via Pontina km 30,400 - 00040 Pomezia (Rome)
Dealership for sale:
Avantgarde S.p.A.
Via Pontina km 30,400 - 00040 Pomezia (Rome)
08.0 MARKETING AUTHORIZATION NUMBER
Box of 20 sachets of AIC effervescent granules n. 015784034
Box of 10 effervescent tablets AIC n. 015784059
Box of 20 effervescent tablets AIC n. 015784061
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Effervescent granules: December 1970
10 Effervescent tablets: January 2000
20 Effervescent tablets: November 2001
10.0 DATE OF REVISION OF THE TEXT
July 2014
