Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
CETIRIZINE HYDROCHLORIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
R06AE07
CETIRIZINE HYDROCHLORIDE 10 mg
FILM-COATED TABLET
CETIRIZINE HYDROCHLORIDE 10 mg
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2013-12-19
PACKAGE LEAFLET: INFORMATION FOR THE USER CETIRIZINE AUROBINDO 10 MG FILM-COATED TABLETS Cetirizine dihydrochlorideREAD 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. Baca dokumen lengkapREAD ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. WHAT IS IN THIS LEAFLET : 1. What Cetirizine Aurobindo is and what it is used for 2. What you need to know before you take Cetirizine Aurobindo 3. How to take Cetirizine Aurobindo 4. Possible side effects 5. How to store Cetirizine Aurobindo 6. Contents of the pack and other information 1. WHAT CETIRIZINE AUROBINDO IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Cetirizine Aurobindo. Cetirizine Aurobindo is an antiallergic medication. In adults and children aged 6 years and above, Cetirizine Aurobindo 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 BEFO
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cetirizine Aurobindo 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg cetirizine dihydrochloride. Excipient with known effect: Each film-coated tablet contains 107.020 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, film-coated, off-rectangular tablets, debossed with "10" on one side and plain on the other side. Score line between '1' and ‘0’. The tablet can be divided into equal doses. 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 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. Dosing adjustments for adult patients with impaired renal function GROUP ESTIMATED GLOMERULAR FILTRATION RATE(EGFR) (ML/MIN) DOSAGE AND FREQUENCY Page 2 of 9 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 Hepatic impairment: N Baca dokumen lengkap