Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
CETIRIZINE HYDROCHLORIDE
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
10 Milligram
Film Coated Tablet
2001-08-24
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zynor Allergy 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 Allergy 10 mg 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. Citiți documentul complet