Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Malta Medicines Authority
CETIRIZINE HYDROCHLORIDE
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
R06AE07
CETIRIZINE HYDROCHLORIDE 1 mg/ml
ORAL SOLUTION
CETIRIZINE HYDROCHLORIDE 1 mg/ml
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2005-07-27
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYRTEC 1 MG/ML ORAL SOLUTION 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 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. Contents of the pack and other 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 2 years and above, Zyrtec 1 mg/ml oral solution 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 ZYRTEC DO NOT TAKE ZYRTEC - if you have a severe kidney disease requiring dialysis; - if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active ingredients of other medicines). WARNINGS 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 ep Đọc toàn bộ tài liệu
Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Zyrtec 1 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg cetirizine dihydrochloride. Excipients with known effect: - one ml of solution contains 450 mg sorbitol (solution at 70 %, non crystallizing) - one ml of solution contains 1.35 mg methylparahydroxybenzoate - one ml of solution contains 0.15 mg propylparahydroxybenzoate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral solution Clear and colorless liquid with slightly sweet taste and a banana flavour 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine dihydrochloride 1 mg/ml oral solution is indicated in adults and children aged 2 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 (10 ml oral solution (2 full spoons)). 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 eliminated 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 5 mg once every 2 days End-stage renal disease <15 requiring dialysis treatment Contraindicated _Hepatic impairment_ No dose adjustment Đọc toàn bộ tài liệu