Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Cetirizine dihydrochloride
UCB (Pharma) Ireland Limited
R06AE; R06AE07
Cetirizine dihydrochloride
10 milligram(s)
Film-coated tablet
Oral use
Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.
Product not subject to medical prescription
UCB Pharma Ireland Ltd
Piperazine derivatives
Piperazine derivatives; cetirizine
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.
Marketed
2015-03-27
PACKAGE LEAFLET: INFORMATION FOR THE USER ZIRTEK ALLERGY RELIEF 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 side effects not listed in this leaflet. 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 Zirtek Allergy Relief is and what it is used for 2. What you need to know before you take Zirtek Allergy Relief 3. How to take Zirtek Allergy Relief 4. Possible side effects 5. How to store Zirtek Allergy Relief 6. Contents of the pack and other information 1. WHAT ZIRTEK ALLERGY RELIEF IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Zirtek Allergy Relief. Zirtek Allergy Relief is an antiallergic medication. In adults and children aged 6 years and above, Zirtek Allergy Relief 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 ZIRTEK ALLERGY RELIEF DO NOT TAKE ZIRTEK ALLERGY RELIEF if you have an end-stage kidney disease (severe renal failure requiring dialysis); 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). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zirtek Allergy Relief. If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor. If you have pro Lees het volledige document
Health Products Regulatory Authority 27 September 2021 CRN00C916 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirtek Allergy Relief 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 66.40 mg lactose-monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets White oblong, film-coated tablet, with breakline and Y-Y logo. The tablet can be divided into 2 equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in adults and paediatric patients 6 years 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 individualised according to renal function. Refer to the following table and adjust the dose as indicated. Dosing adjustments for adult patients with impaired renal function Group GFR (ml/min) Dosage and frequency Normal renal function ≥90 10 mg once daily Mildly decreased renal function 60 – < 90 10 mg once daily Moderately decreased renal function 30 – < 60 5 mg once daily Severely decreased renal function 15 - <30 not requiring dialysis treatment 5 mg once every 2 days End-stage renal disease <15 requiring dialysis treatment Contra-indicated Health Products Regulatory Authority 27 September 2021 CRN00C916 Page 2 of 8 _Hepatic impa Lees het volledige document