Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Alfasigma S.p.A, Via Ragazzi del '99, n. 5, 40133 Bologna (BO), Italy
Zaditen 1 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablets. White, or yellow-tinged white, circular, flat, bevel-edged tablets with breakline, weighing 130mg, 7mm diameter. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each tablet contains 1mg ketotifen (as the hydrogen fumarate).
Excipients with known effect: each tablet contains 96.88 mg of lactose as lactose monohydrate.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ketotifen |
Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils. |
| List of Excipients |
|---|
|
Magnesium stearate |
PVC/PVDC blister pack, containing 7, 14 or 28 or 60 tablets.
Not all pack sizes may be marketed.
Alfasigma S.p.A, Via Ragazzi del '99, n. 5, 40133 Bologna (BO), Italy
PA2206/004/002
Date of first authorisation: 19 December 1979
Date of last renewal: 31 May 2009
| Drug | Countries | |
|---|---|---|
| ZADITEN | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa |
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