البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
LEVOCETIRIZINE DIHYDROCHLORIDE
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE 0.5 mg/ml
ORAL SOLUTION
LEVOCETIRIZINE DIHYDROCHLORIDE 0.5 mg/ml
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2007-09-03
XYZAL 0.5 MG/ML ORAL SOLUTION Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XYZAL 0.5 MG/ML ORAL SOLUTION For adults and children aged 2 years and above Levocetirizine dihydrochloride READ 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 Xyzal is and what it is used for 2. What you need to know before you take Xyzal 3. How to take Xyzal 4. Possible side effects 5. How to store Xyzal 6. Contents of the pack and other information 1. WHAT XYZAL IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Xyzal. Xyzal is an antiallergic medication. For the treatment of signs of illness (symptoms) associated with: • allergic rhinitis (including persistent allergic rhinitis); • nettle rash (urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL DO NOT TAKE XYZAL - if you are allergic to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6). - if you have a severe kidney disease requiring dialysis. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Xyzal. If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice. If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Xyzal may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking Xyzal for several days before testing. اقرأ الوثيقة كاملة
XYZAL 0.5 MG/ML ORAL SOLUTION Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS XYZAL 0.5 MG/ML ORAL SOLUTION Page 2 of 11 1. NAME OF THE MEDICINAL PRODUCT Xyzal 0.5 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride. Excipients with known effect 0.675 mg methyl parahydroxybenzoate/ml 0.075 mg propyl parahydroxybenzoate/ml 0.4 g maltitol liquid/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xyzal 0.5 mg/ml oral solution is indicated for symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 2 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (10 ml of solution). _Elderly _ Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below). _Renal impairment _ The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate). Refer to the following table and adjust the dose as indicated. Dosing adjustments for patients with impaired renal function: Group eGRF (ml/min) Dosage and frequency Normal renal function ≥ 90 5 mg once daily Mildly decreased renal function 60 – < 90 5 mg once daily Moderately decreased renal function 30 – < 60 5 mg once every 2 days Severely decreased renal function 15 – < 30 (not requiring dialysis) 5 mg once every 3 days End stage renal disease (ESDR) < 15 (requiring dialysis treatment) Contra-indicated XYZAL 0.5 MG/ML ORAL SOLUTION Page 3 of 11 In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment. _Hepatic اقرأ الوثيقة كاملة