Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
Brillpharma (Ireland) Limited
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Piperazine derivatives; levocetirizine
Marketed
2012-09-07
PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS 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. THE NAME OF YOUR MEDICINE IS LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS. HERE AFTER IT WILL BE REFERRED TO AS LEVOCETIRIZINE TABLETS THROUGHOUT THE LEAFLET. WHAT IS IN THIS LEAFLET: 1. What Levocetirizine Tablets are and what they are used for 2. What you need to know before you take Levocetirizine Tablets 3. How to take Levocetirizine Tablets 4. Possible side-effects 5. How to store Levocetirizine Tablets 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Levocetirizine 5 mg Film-coated Tablets and the active substance is Levocetirizine dihydrochloride. Levocetirizine Tablets 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 LEVOCETIRIZINE TABLETS DO NOT TAKE LEVOCETIRIZINE TABLETS: 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 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 Tablets. If you are likely Lestu allt skjalið
Health Products Regulatory Authority 15 December 2020 CRN009YPR Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine dihydrochloride 5 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride. Excipient with known effect: Also contains, Lactose Monohydrate 70.0mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablets White to off white, oval, biconvex film coated tablets with 'BL' debossed on one side and '5' debossed on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levocetirizine is 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: GROUP CREATININE CLEARANCE (ML/MIN) DOSAGE AND FREQUENCY Normal ≥80 1 tablet once daily Mild 50 – 79 1 tablet once daily Moderate 30 – 49 1 tablet once every 3 days Severe < 30 1 tablet once every 3 days End-stage renal disease - Patients undergoing dialysis < 10- Contra-indicated 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 d Lestu allt skjalið