Instructions Hofitol film-coated tablets 200 mg blister No. 180
Composition
active ingredient: dry aqueous extract of field artichoke leaves (Cynara scolymus);
1 film-coated tablet contains 200 mg of dry aqueous extract of field artichoke leaves (Cynara scolymus);
excipients: magnesium trisilicate, pregelatinized corn starch, talc, magnesium stearate; coating: shellac, rosin, talc, gelatin, sucrose, calcium carbonate, carnauba wax, polysorbate 80, disperse dye (sucrose, yellow iron oxide (E 172), black iron oxide (E 172), brown iron oxide (E 172), methyl parahydroxybenzoate (E 218), ethyl parahydroxybenzoate (E 214)).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated with a brown coating. On the surface of the tablets, inclusions of a less intense color than the main one are allowed.
Pharmacotherapeutic group
Drugs used in diseases of the liver and biliary tract. Other drugs used in biliary pathology.
ATX code A05A X.
Pharmacological properties
Pharmacodynamics
Pharmacological properties are due to the action of a complex of biologically active substances that are part of the leaves of the field artichoke. It has a choleretic, hepatoprotective and diuretic effect, and also reduces the content of urea in the blood. Inulin and other components contained in the artichoke improve metabolic processes in the body.
Pharmacokinetics
The action of the drug Hofitol is the combined effect of its components, therefore kinetic observations are impossible; all components together cannot be traced using markers or bioassays. For the same reason, it is impossible to detect the metabolites of the drug.
Indication
To improve choleretic and diuretic function in diseases of the liver, biliary tract and kidneys, such as: chronic hepatitis, cirrhosis of the liver, chronic non-calculous cholecystitis, hypokinetic biliary dyskinesia, chronic nephritis, chronic renal failure.
Contraindication
Hypersensitivity to the components of the drug, in particular to methyl parahydroxybenzoate or ethyl parahydroxybenzoate, to plants of the Astraceae family (composite flowers); biliary obstruction, cholangitis, suppuration (empyema) of the gallbladder, cholelithiasis or other biliary tract diseases, acute liver diseases, severe liver failure; urinary tract obstruction, acute kidney diseases.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
Use with caution in diseases that may lead to biliary obstruction and in severe liver disease. If diarrhea or abdominal pain occurs, treatment should be discontinued and a doctor should be consulted.
The drug contains sucrose. Therefore, patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not use the drug.
The drug contains parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Contains methyl parahydroxybenzoate (E 218), ethyl parahydroxybenzoate (E 214) as a dye. One tablet contains 0.08 g of sucrose.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug is used only as prescribed by a doctor, if the expected benefit to the woman outweighs the potential risk to the fetus or child.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving or working with other mechanisms.
Method of administration and doses
It is used internally for adults and children over 6 years of age. It is taken before meals.
Adults and children over 12 years of age are prescribed 1-2 tablets 3 times a day.
Children aged 6-12 years - 1 tablet 3 times a day.
The course of treatment is determined by the doctor individually, depending on the nature and course of the disease. Usually the course of treatment is 2-3 weeks. Repeated courses of treatment are possible after consultation with the doctor.
Children
Used in children over 6 years of age as prescribed by a doctor.
Overdose
Possible increased side effects.
Adverse reactions
In case of prolonged use of the drug in high doses, diarrhea is possible, as well as abdominal cramps, indigestion, nausea, and heartburn.
Allergic reactions are possible, including urticaria, skin rashes, hyperemia, itching.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in a place inaccessible to children.
Packaging
30 film-coated tablets in a blister, 2 or 6 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Galenic Vernin Laboratories.
Location of the manufacturer and address of its place of business
20 rue Louis Charles Vernin, 77190 DAMMARY-LES-LYS, France.
