Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
LEVOCETIRIZINE DIHYDROCHLORIDE
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
FILM-COATED TABLET
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2013-03-05
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ LEVOCETIRIZINE DIHYDROCHLORIDE FAIR-MED 5MG 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. WHAT IS IN THIS LEAFLET 1. What Levocetirizine dihydrochloride Fair-Med is and what it is used for 2. What you need to know before you take Levocetirizine dihydrochloride Fair-Med 3. How to take Levocetirizine dihydrochloride Fair-Med 4. Possible side effects 5. How to store Levocetirizine dihydrochloride Fair-Med 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE DIHYDROCHLORIDE FAIR-MED IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Levocetirizine dihydrochloride Fair-Med. Levocetirizine dihydrochloride Fair-Med 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 DIHYDROCHLORIDE FAIR-MED DO NOT TAKE LEVOCETIRIZINE DIHYDROCHLORIDE FAIR-MED: if you are allergic to levocetirizine dihydrochloride or to an antihistamine 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 dihydrochloride Fair-Med. The use of Levocetirizine dihydrochloride Fair-Med is not recommended in c Baca dokumen lengkap
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levocetirizine dihydrochloride Fair-Med 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval film-coated tablets, 2.90 mm to 3.50 mm thick, 7.8 mm to 8.2 mm long and 4.3 mm to 4.7 mm wide, with plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria. 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 Patients with renal impairment below). _Paediatric population _ Children aged 6 to 12 years: The daily recommended dose is 5 mg (1 film-coated tablet). For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocetirine. Due to the lack of data in this population, the administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended. Page 2 of 11 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 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: [140 − _age _(_years_)]_x weight _(_kg_) (x 0.85 _for women_) 72 x _serum creatinine _(_mg _/ _dl_) Dosing Adjustments for Patients with Impaired Renal Function: Group Creatinine clearance (ml/min) Dosage and frequency Normal ≥80 1 tablet once daily Mild 50 Baca dokumen lengkap