Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CETIRIZINE HYDROCHLORIDE
PCO Manufacturing
10 Milligram
Tablets
2000-10-13
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirtek 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of the active ingredient cetirizine hydrochloride. Excipients: lactose monohydrate _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet. White, oblong tablets scored and embossed ‘Y/Y’ on one face and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of seasonal and perennial allergic rhinitis, urticaria, senile pruitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral _Adults and children over the age of 12 years:_ The usual dosage is 10 mg daily given in the evening. _In renal insufficiency:_ Dosage should be reduced to 5 mg daily. For those patients who experience mild side-effects, the dosage should be halved and taken twice daily. 4.3 CONTRAINDICATIONS Zirtek 10 mg tablets are contra-indicated in patients with a hypersensitivity to any constituent of the tablets. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ○ In patients with significant renal impairment dosage should be reduced and the product used with caution. ○ Zirtek should be used with caution in patients with decreased hepatic function. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/03/2010_ _CRN 2080054_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Concomitant use with alcohol at a blood level of 0.8 g/L and diazepam at therapeutic doses has been tested and no potentiation was demonstrated. However, usual cautions remain advisable in case of CNS depressants in general due to insufficient experience for t Read the complete document