ZYNOR Film Coated Tablet 10 Milligram
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
03-05-2024
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Ingredient activ:
CETIRIZINE HYDROCHLORIDE
Disponibil de la:
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
Dozare:
10 Milligram
Forma farmaceutică:
Film Coated Tablet
Data de autorizare:
2001-08-24
Caracteristicilor produsului
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zynor 10mg Film coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cetirizine dihydrochloride 10 mg.
Also contains 100 mg Lactose (as monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
White circular film coated tablets with ‘CTZ 10’ embossed on one side and with a breakline on the other side.
The scoreline on the tablet is only to facilitate the ease of breaking or swallowing and not to divide in equal doses’ the
tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of seasonal and perennial allergic rhinitis, urticaria, senile pruritus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration.
_Adults and children aged over 12 years_
Usual dose is 10 mg daily to be given in the evening.
_Patients with renal problems_
Dosage should be reduced to 5 mg daily.
The dosage should be halved and taken twice daily for patients who experience mild side-effects.
4.3 CONTRAINDICATIONS
Zynor 10mg Tablets are contraindicated in patients with a history of hypersensitivity to any of the constituents.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/01/2008_
_CRN 2045090_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
The side effects reported include headache, dizziness, dry mouth and sedation and in some patients, reversible
changes in liver function may occur. For those affected the usual dosage should be halved and taken twice daily.
2.
The dosage should be reduced and drug used with caution in patients with significant renal impairment.
3.
For patients with
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