Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Topamax 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Yellow round tablets, 9 mm in diameter, “TOP” on one side, “100” on the other side. |
One tablet contains 100 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate.
One 100 mg tablet contains 123.40 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Topiramate |
Topiramate is classified as a sulfamate-substituted monosaccharide. The precise mechanism by which topiramate exerts its antiseizure and migraine prophylaxis effects are unknown. |
| List of Excipients |
|---|
|
Core tablet: Lactose monohydrate Film-coating: OPADRY yellow1 1 OPADRY contains: Hypromellose |
Opaque plastic bottle with tamper-evident closure containing 20, 28, 30, 50, 56, 60 or 100 tablets: bundle pack comprising 200 (2 × 100) tablets. In each bottle, there is a desiccant canister which should not be swallowed.
Blister pack of an aluminium/aluminium foil in strips. Pack sizes of 10, 20, 28, 30, 50, 56, 60 or 100 tablets: bundle pack comprising 200 (2 × 100) tablets. Individual (alu/alu) blister strips are packed inside a folding box.
Not all pack sizes may be marketed.
Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
PL 00242/0303
Date of first authorisation: 18 July 1995
Date of last renewal: 30 June 2010
| Drug | Countries | |
|---|---|---|
| TOPAMAX | Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
