Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
Salagen 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Salagen film-coated tablets are white, round biconvex tablets, marked “SAL” on one side and “5” on the other side. |
Each film-coated tablet contains 5 mg of pilocarpine hydrochloride.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pilocarpine |
Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by exocrine glands such as the sweat, salivary, lacrimal, gastric, pancreatic and intestinal glands and the mucous cells of the respiratory tract. |
| List of Excipients |
|---|
|
Binder/diluent: Microcrystalline cellulose Acidifier/lubricant: Stearic acid Film coating: Opadry White, OY-7300, containing hypromellose, macrogol 400 and titanium dioxide (E171) Polish: Carnauba wax |
Salagen is distributed for sale in perforated Al/PVC/PVDC blisters.
Each blister contains 14 or 21 tablets.
A carton contains 1, 2 or 6 of the 14-tablet blisters, or 1 or 4 of the 21-tablet blisters.
Not all pack sizes may be marketed.
Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
PL 20011/0069
Date of first authorisation: 01 July 2001
Date of last renewal: 01 July 2006
| Drug | Countries | |
|---|---|---|
| SALAGEN | Austria, Canada, Estonia, Spain, Finland, France, Israel, Japan, Malta, Netherlands, Singapore, Turkey, United Kingdom, United States |
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