Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cetirizine hydrochloride
Alliance Healthcare (Distribution) Ltd
R06AE07
Cetirizine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
PACKAGE LEAFLET: Information for the user CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS Cetirizine dihydrochloride 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 have 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 Cetirizine Dihydrochloride 10mg film-coated Tablets are and what they are used for 2. What you need to know before you take Cetirizine Dihydrochloride 10mg film-coated Tablets 3. How to take Cetirizine Dihydrochloride 10mg film-coated Tablets 4. Possible side effects 5. How to store Cetirizine Dihydrochloride 10mg film-coated Tablets 6. Contents of the pack and other information 1. WHAT CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Cetirizine dihydrochloride is the active ingredient of Cetirizine Dihydrochloride 10mg film-coated Tablets. Cetirizine Dihydrochloride 10mg film-coated Tablets is an antiallergic medication. In adults and children aged 6 years and above, Cetirizine Dihydrochloride 10mg film-coated Tablets is indicated - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the relief of urticaria. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE DIHYDROCHLORIDE FILM-COATED 10MG TABLETS DO NOT TAKE CETIRIZINE DIHYDROCHLORIDE FILM-COATED 10MG TABLETS • if you are allergic to cetirizine dihydrochloride, to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active ingredients of other medicines). • if you have a severe Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetirizine Hydrochloride 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10mg of Cetirizine Hydrochloride. Excipient: 81,80 mg lactose /film-coated tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. White, oblong, scored on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and paediatric patients 6 years 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 Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily) Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet) Elderly patients 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 impairment. 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) _ _ _ _72 x serum creatinine (mg/dl) _ Dosing adjustments for adult patients with impaired renal function Group Creatinine clearance (ml/min) Dosage and frequency Normal Mild Moderate Severe End-stage renal disease- Patients undergoing dialysis ≥ 80 50-79 30-49 <30 <10 10 mg once daily 10 mg once daily 5 mg once daily 5 mg once every 2 days Contra-indicated Prečítajte si celý dokument