البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Cetirizine hydrochloride
Chanelle Medical
R06AE; R06AE07
Cetirizine hydrochloride
10 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Piperazine derivatives; cetirizine
Not marketed
2004-02-06
ID: PL14M IRL (MAH) Version: 10 Revision Date: 28/09/2020 Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER TIRITEK ALLERGY 10 MG 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 Tiritek Allergy is and what it is used for 2. What you need to know before you take Tiritek Allergy 3. How to take Tiritek Allergy 4. Possible side effects 5. How to store Tiritek Allergy 6. Contents of the pack and other information 1. WHAT TIRITEK ALLERGY IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Tiritek Allergy 10 mg Tablets. Tiritek Allergy 10 mg Tablets is an antiallergic medication. In adults and children aged 6 years and above, Tiritek Allergy 10 mg Tablets are 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 TIRITEK ALLERGY DO NOT TAKE TIRITEK ALLERGY: if you have severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min). if you are allergic to Cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active ingredients of other medicines). ID: PL14M IRL (MAH) Version: 10 Revision Date: 28/09/2020 Page 2 of 7 WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tiritek Allergy If you are a patient with renal insu اقرأ الوثيقة كاملة
Health Products Regulatory Authority 14 December 2020 CRN009ZQN Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tiritek Allergy 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg Cetirizine dihydrochloride. Excipients with known effect: one film-coated tablet contains 101.83 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White circular biconvex film-coated tablets, embossed ‘A’ on one side and a deep score on the other. The tablet can be divided into 2 equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in adults and paediatric patients 6 year and above: ● for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. ● for the relief of symptoms of chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 10 mg once daily (1 tablet). Special population _Elderly_: Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. _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: Dosing adjustments for adult patients with impaired renal function Health Products Regulatory Authority 14 December 2020 CRN009ZQN Page 2 of 9 Group Creatinine clearance (ml/min) Dosage and frequency Normal ≥80 10 mg once daily Mild 50 – 79 10 mg once daily Moderate 30 – 49 5 mg once d اقرأ الوثيقة كاملة