Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, Cork, P43 FA46, Ireland
Sibelium 5 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White, oblong tablet inscribed ‘J-C’ on one side and ‘FL 5’ on the other side. |
Each tablet contains 5 mg of flunarizine as flunarizine dihydrochloride.
Excipients with known effect: Each tablet also contains 57.42 mg lactose monohydrate.
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Flunarizine |
Flunarizine is a selective calcium entry blocker with calmodulin binding properties and histamine H1 blocking activity. It is effective in the prophylaxis of migraine, occlusive peripheral vascular disease, vertigo of central and peripheral origin, and as an adjuvant in the therapy of epilepsy. |
| List of Excipients |
|---|
|
Lactose monohydrate |
The tablets are supplied in PVC/Aluminium blister packs in a carton containing 20 tablets.
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, Cork, P43 FA46, Ireland
PA22612/011/001
Date of first authorisation: 30th January 2009
Date of last renewal: 29th January 2014
| Drug | Countries | |
|---|---|---|
| SIBELIUM | Austria, Spain, France, Ireland, Malta, Mexico, Netherlands, Romania, Turkey, South Africa |
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