Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cetirizine hydrochloride
Accord-UK Ltd
R06AE07
Cetirizine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5012617015815
148x210 Leaflet Reel Fed Profile (BST) _Continued over page_ _Continued top of next column_ Cetirizine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1 WHAT POLLENSHIELD HAYFEVER RELIEF IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE POLLENSHIELD HAYFEVER RELIEF 3 HOW TO TAKE POLLENSHIELD HAYFEVER RELIEF 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE POLLENSHIELD HAYFEVER RELIEF 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT POLLENSHIELD HAYFEVER RELIEF IS AND WHAT IT IS USED FOR Pollenshield Hayfever Relief contains cetirizine hydrochloride which belongs to a group of medicines called antihistamines. Pollenshield Hayfever Relief may be used to relieve: • long-term runny nose and watery eyes • hayfever (runny and blocked-up nose, sneezing, watery eyes) • a skin reaction with pale or red irregular raised patches and severe itching. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE POLLENSHIELD HAYFEVER RELIEF DO NOT TAKE Pollenshield Hayfever Relief if you: • are ALLERGIC to cetirizine, hydroxyzine, any piperazine derivatives or any of the other ingredients in this medicine (listed in section 6). • have SEVERE KIDNEY problems. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST before taking Pollenshield Hayfever Relief if you: • have EPILEPSY. • have DIFFICULTY IN PASSING WATER or any risk factors associated with this. If you are scheduled for allergy testing, ask your doctor if you should stop taking Pollenshield read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT POLLENSHIELD HAYFEVER RELIEF Cetirizine hydrochloride 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg Cetirizine hydrochloride. Excipient with known effect: Each tablet contains 117.00mg lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet (Tablets). Film-coated, white or almost white convex, elliptical, tablets. 5.7 x 11.4mm. The letter “C” on one side and the letters “J” and “E” on either side of a central division line on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and paediatric patients 6 year and above: - Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE_: 10mg once daily (1 tablet). _CHILDREN AGED FROM 6 TO 12 YEARS_: 5mg twice daily (a half tablet twice daily). _ELDERLY SUBJECTS_: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. _PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT_: there are no data to document the efficacy/safety ratio in patients with renal impairement. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: CL cr = [140 − _age(years_)] _x weight(kg_) (_x0.85 for women_) (72 _x serum creatinine (mg_/_dl_) Dosing adjustments for adult patients with impaired renal read_full_document