Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Trileptal 150 mg Film-coated Tablets.
Trileptal 300 mg Film-coated Tablets.
Trileptal 600 mg Film-coated Tablets.
Oxcarbazepine 150mg Film-coated Tablets.
Oxcarbazepine 300mg Film-coated Tablets.
Oxcarbazepine 600mg Film-coated Tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. 150 mg: pale grey green, ovaloid slightly biconvex tablets, scored on both sides. Embossed with T/D on one side and C/G on the other side. 300 mg: yellow, ovaloid slightly biconvex tablets, scored on both sides. Embossed with TE/TE on one side and CG/CG on the other side. 600 mg: light pink, ovaloid slightly biconvex tablets scored on both sides. Embossed with TF/TF on one side and CG/CG on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each film-coated tablet contains 150 mg, 300 mg or 600 mg of oxcarbazepine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Oxcarbazepine |
The pharmacological activity of oxcarbazepine is primarily exerted through the metabolite (MHD). The mechanism of action of oxcarbazepine and MHD is thought to be mainly based on the blockade of voltage-sensitive sodium channels. |
| List of Excipients |
|---|
|
Tablet core: silica, colloidal anhydrous Tablet coating: hypromellose 150 mg tablet coating only: macrogol 4000 300 mg tablet coating only: macrogol 8000 |
Blister containing 10 tablets. Blister material: PVC/PE/PVDC with aluminium foil backing.
Tablets 150 mg: blister pack of 30, 50, 100, 200 and/or 500 tablets.
Tablets 300 mg: blister pack of 30, 50, 100, 200 and/or 500 tablets.
Tablets 600 mg: blister pack of 30, 50, 100, 200 and/or 500 tablets.
Not all pack sizes may be marketed.
Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Trileptal Tablets 150mg: PL 23860/0037
Trileptal Tablets 300mg: PL 23860/0038
Trileptal Tablets 600mg: PL 23860/0039
Date of first authorisation: 7 January 2000
Date of latest renewal: 26 October 2016
| Drug | Countries | |
|---|---|---|
| TRILEPTAL | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, 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.
