Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
Glenmark Pharmaceuticals Europe Limited
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; levocetirizine
Not marketed
2010-05-28
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 Levocetirizine Glenmark is and what it is used for 2. What you need to know before you take Levocetirizine Glenmark 3. How to take Levocetirizine Glenmark 4. Possible side effects 5. How to store Levocetirizine Glenmark 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Levocetirizine Glenmark 5mg film-coated tablets Levocetirizine Glenmark 5mg Film-coated tablets is an antiallergic medication. For the treatment signs of illness (symptoms) associated with : ● allergic rhinitis (including persistent allergic rhinitis); ● nettle rash (urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS DO NOT TAKE LEVOCETIRIZINE GLENMARK 5MG FILM- COATED TABLETS: ● if you are allergic to levocetirizine dihydrochloride, to cetirizine, to hydroxuzine or any of the other ingredients of this medicine (listed in section 6). ● If you have A SEVERE IMPAIRMENT OF KIDNEY FUNCTION (severe renal failure with creatinine clearance below 10 ml/min) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Levocetirizine Glenmark 5 mg Film-coated tablets. 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 Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 27 November 2020 CRN009HC8 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine Glenmark 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipients: 60.27 mg lactose per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White oval film coated biconvex tablets, one side embossed with G breakline G and the other side plain. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levocetirizine Glenmark 5 mg film-coated tablets are indicated in the symptomatic treatment of ALLERGIC RHINITIS (INCLUDING PERSISTENT ALLERGIC RHINITIS) AND urticaria in adults and children aged 6 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 (1 film-coated tablet). _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. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: Dosing adjustments for patients with impaired renal function: Health Products Regulatory Authority 27 November 2020 CRN009HC8 Page 2 of 9 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 impairment: _ No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and Olvassa el a teljes dokumentumot