INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo URSOTAN tablets
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

URSOTAN tablets

COMPOSITION
Per tablet:
Ursodeoxycholic acid 100 mg

PHARMACOLOGICAL CLASSIFICATION
A 34 Other

PHARMACOLOGICAL ACTION
Oral administration of URSOTAN promotes the dissolution of non-calcified, floating cholesterol gallstones.
URSOTAN increases the total bile acid pool and inhibits HMGCoA reductase activity. The resultant cholesterol unsaturation enhances the capacity of the bile to dissolve cholesterol gallstones.

INDICATIONS
Dissolution of radiolucent cholesterol gallstones in functioning gallbladders

CONTRA-INDICATIONS
URSOTAN should not be administered to patients with chronic liver disease nor with inflammatory diseases of the small intestine and colon.
Bile duct obstruction: URSOTAN should not be administered to patients with radio-opaque, calcified or bile pigment stones, nor to patients with non-functioning gallbladders. URSOTAN should not be administered to women who are pregnant or who may become pregnant.

DOSAGE AND DIRECTIONS FOR USE
Gallstone dissolution: The usual dose is 6 tablets (600 mg) daily in 3 divided doses, after meals.
Duration of treatment varies according to the size of the gallstones and their rate of dissolution, but is seldom less than 6 months.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Pruritus and dyspepsia or constipation have been reported. Dose related side-effects such as diarrhoea may occur but reduction and then gradual increase in dose usually eliminates this effect. Laboratory monitoring of serum enzyme levels and liver function tests should be performed.
The efficacy of URSOTAN may be adversely affected by concomitant use of oral contraceptives.
Phenobarbitone or antacids such as aluminium hydroxide and the activity of oral hypoglycemics may be enhanced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage with URSOTAN has not been reported. Treatment is symptomatic.

CONDITIONS OF REGISTRATION
Advertising to the profession only

IDENTIFICATION
Round white biconvex tablet, scored on one side

PRESENTATION
Tablets: 180'

STORAGE INSTRUCTIONS
Store below 25°C, well closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
N/34/203

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hoechst Marion Roussel Limited
16th Road, Midrand

DATE OF PUBLICATION ON OF THIS PACKAGE INSERT
8 April 1983

Hoechst Marion Roussel
Formula: Tokyo Tanabe, Tokyo, Japan

        D 15/03
Updated on this site: December 1999

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