Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand,1685, South Africa
URBANOL 5 mg CAPSULES.
URBANOL 10 mg TABLETS.
| Pharmaceutical Form |
|---|
URBANOL 5 mg CAPSULESURBANOL 5 mg CAPSULES: opaque blue and white unprinted capsules (size no.4) containing a white powder. URBANOL 10 mg TABLETSURBANOL 10 mg TABLETS: white bi-planar round tablets scored and engraved with “CBZ” and “10” on one side, and plain on the other side. |
URBANOL 5 mg CAPSULES: Each capsule contains 5 mg clobazam as active ingredient. Contains sugar (lactose): 127 mg.
For a full list of excipients, see section 6.1.
URBANOL 10 mg TABLETS: Each tablet contains 10 mg clobazam as active ingredient. Contains sugar (lactose monohydrate): 72,3 mg.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Clobazam |
Clobazam is a 1,5-benzodiazepine and the pharmacodynamic activity is qualitatively similar to that of other compounds of the class of Muscle relaxant, Anxiolytic, Sedative, Hypnotic, Anticonvulsant, Amnesic. |
| List of Excipients |
|---|
URBANOL 5 mg CAPSULESExcipients: Lactose Capsule shell: Gelatine URBANOL 10 mg TABLETSExcipients: Maize starch |
URBANOL is available as 5 mg capsules and 10 mg tablets packed into opaque white PVC/acetochloride and aluminium blister packs, inserted into outer printed cardboard cartons, containing 100 capsules/tablets each (5x 20 blister packs).
sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand,1685, South Africa
URBANOL 5 mg CAPSULES: L/2.6/52
URBANOL 10 mg TABLETS: M/2.6/128
URBANOL 5 mg CAPSULES: 8 November 1978
URBANOL 10 mg TABLETS: 20 July 1979
| Drug | Countries | |
|---|---|---|
| URBANOL | South Africa |
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