Страна: Малта
Език: английски
Източник: Medicines Authority
LEVOCETIRIZINE DIHYDROCHLORIDE
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
FILM-COATED TABLET
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2011-10-17
PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOCETIRIZINE TEVA 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,pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levocetirizine Teva 5 mg Film-coated Tablet is and what it is used for 2. What you need to know before you take Levocetirizine Teva 5 mg Film-coated Tablets 3. How to take Levocetirizine Teva 5 mg Film-coated Tablets 4. Possible side effects 5. How to store Levocetirizine Teva 5 mg Film-coated Tablets 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE TEVA 5 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Levocetirizine Teva 5 mg Film-coated Tablets belong to a group of medicines called antihistamines. They relieve the unpleasant symptoms and discomfort associated with the below conditions, such as sneezing, irritated runny or blocked up nose, itchy, red and watering eyes and skin rashes. Your doctor has prescribed Levocetirizine Teva 5 mg Film-coated Tablets to treat hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE TEVA 5 MG FILM COATED TABLETS DO NOT TAKE LEVOCETIRIZINE TEVA 5 MG FILM-COATED TABLETS - if you are allergic to Levocetirizine dihydrochlorideor any of the other ingredients of this medicine (listed in section 6). - if you have severe kidney problems (severe renal failure with creatinine clearance Прочетете целия документ
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine Teva 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride. Contains 63.50 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off white, film coated oval shaped tablet; One side of the tablet is debossed with "LC5". The other side of the tablet is plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levocetirizine is indicated for the symptomatic treatment of perennial allergic rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. _ _ _Adults and adolescents: _ The recommended dose is 5 mg once daily _Children aged between 6 and 12 years: _ The daily recommended dose is 5 mg once daily Levocetirizine Teva is not recommended for use in children below the age of 6 due to insufficient data on safety and efficacy. Older people:_ _ At present there are no data to suggest that the dose needs to be reduced in elderly subjects provided that their renal function is normal. _Patients with renal impairment: _ The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the Page 2 of 12 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 2 days Severe < 30 1 tablet once every 3 days End-stage renal disease - Patients undergoing dialysis < 10- Contra-indicated In Прочетете целия документ