Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
CETIRIZINE HYDROCHLORIDE
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
R06AE07
CETIRIZINE HYDROCHLORIDE 10 mg
FILM-COATED TABLET
CETIRIZINE HYDROCHLORIDE 10 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2005-07-27
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYRTEC 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. 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 Zyrtec is and what it is used for 2. What you need to know before you take Zyrtec 3. How to take Zyrtec 4. Possible side effects 5. How to store Zyrtec 6. Content of the pack and further information 1. WHAT ZYRTEC IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Zyrtec. Zyrtec is an antiallergic medication. In adults and children aged 6 years and above, Zyrtec 10 mg film-coated 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 ZYRTEC DO NOT TAKE ZYRTEC - if you have a severe kidney disease 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 Zyrtec. 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. Page 2 of 6 If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice. If you are an epileptic patient or a pat Citiți documentul complet
Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Zyrtec 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 individualized according to renal function. Refer to the following table and adjust the dose as indicated. Page 2 of 10 Dosing adjustments for adult patients with impaired renal function Group Estimated Glomerular Filtration Rate (eGFR) (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 Contraindicated _Hepatic impairment_ No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impair Citiți documentul complet