URSODEOXYCHOLIC ACID Tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Ursodeoxycholic acid 150 mg tablets.
Qualitative and quantitative composition
Each Ursodeoxycholic acid 150 mg Tablet contains 150 mg of ursodeoxycholic acid (UDCA). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Ursodeoxycholic acid 150 mg Tablets: White to off-white, round shaped uncoated tablets approximately 9.50 mm in size with breakline and G 442 engraved on one side and plain on the other side. ...
Therapeutic indications
1. The dissolution of cholesterol stones in patients: with one or more X-ray radiolucent (X-ray negative) gallstones, preferably with a diameter of not more than 2 cm, in a well-functioning gall bladder; ...
Posology and method of administration
Dosage The dosage should be calculated based on the patients body weight. The calculated dosage should be rounded to the nearest number of tablets. Dissolving of cholesterol stones Usual dosage: 8 to 10 ...
Contraindications
Ursodeoxycholic acid tablets should not be used in patients with: Acute inflammation of the gall bladder or bile ducts. Occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct). ...
Special warnings and precautions for use
Ursodeoxycholic acid tablets should be taken under medical supervision. During the first three months of the treatment liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the ...
Interaction with other medicinal products and other forms of interaction
Ursodeoxycholic acid tablets should not be used concurrently with colestyramine, colestipol, or an antacid, on the basis of aluminium hydroxide and/or smectite (aluminium oxide), because these preparations ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown reproductive toxicity during the early gestation phase (see section ...
Effects on ability to drive and use machines
Ursodeoxycholic acid has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare ...
Overdose
In the case of overdose diarrhoea may occur. In general, other symptoms of overdose are unlikely, because the absorption of the ursodeoxycholic acid decreases with increasing dose and therefore more is ...
Pharmacodynamic properties
Pharmacotherapeutic group: Bile acid preparations ATC code: A05AA02 Bile acids are among the most important components of the bile and play a role in the stimulation of bile secretion. Bile acids are also ...
Pharmacokinetic properties
About 90% of the therapeutic dose of the ursodeoxycholic acid is rapidly absorbed in the small intestine after oral administration. After the absorption, ursodeoxycholic acid is absorbed in the liver (there ...
Preclinical safety data
Acute toxicity Acute toxicity studies in animals have not revealed any toxic damage. Chronic toxicity Subchronic toxicity studies in monkeys showed hepatotoxic effects in the groups given high doses, including ...
List of excipients
Cellulose microcrystalline (Microcel 101) (E460) Polyvinyl pyrrolidone (Plasdone K-90) (E1201) Magnesium Stearate (E572) Sodium Starch Glycolate Type A (Primojel)
Incompatibilities
Not applicable.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Clear PVC/PVDC – plain aluminium foil. Pack size: 20, 30, 50, 60 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
Marketing authorization number(s)
PL 25258/0266
Date of first authorization / renewal of the authorization
Date of first authorization: 21/05/2018
Date of revision of the text
08/05/2019
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