Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
Rinozal 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White to off-white, oval, biconvex film-coated tablets, debossed with ‘L9CZ’ on one side and ‘5’ on the other side. |
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride (equivalent to 4.2 mg of levocetirizine).
Excipient with known effect: Each film-coated tablet contains 64.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levocetirizine |
Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Hypromellose (E464) |
PVC/PVDC:Al blisters or oPA/Al/PVC:Al blisters
Pack sizes:
Blisters containing 10, 14, 20, 28, 40, 50, 60, 80 or 100 tablets.
Unit dose blisters containing: 30x1 tablets.
Not all pack sizes may be marketed
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
PA0126/179/001
Date of first authorisation: 9th October 2009
Date of last renewal: 21st June 2012
| Drug | Countries | |
|---|---|---|
| RINOZAL | Ireland, Malta |
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