Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Levocetirizine Dihydrochloride
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
Levocetirizine Dihydrochloride
50 Tablets; 50 Tablets
UCB FARCHIM S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 XYZAL FILM COATED TABLET Levocetirizine dihydrochloride (5 mg) WHAT IS IN THIS LEAFLET 1. What XYZAL is used for 2. How XYZAL works 3. Before you use XYZAL 4. How to use XYZAL 5. While you are using it 6. Side Effects 7. Storage and Disposal of XYZAL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT XYZAL IS USED FOR Xyzal is used to treat the symptoms of: • Allergic rhinitis (inflammation of the mucous membrane inside the nose) including persistent allergic rhinitis • Chronic idiopathic urticaria (a raised, itchy rash of unknown cause) HOW XYZAL WORKS Xyzal contains the active ingredient levocetirizine dihydrochloride Xyzal is an antiallergic medication. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. BEFORE YOU USE XYZAL - _When you must not use it_ _ _ Do not take Xyzal • if you are allergic (hypersensitive) to the active substance, levocetirizine dihydrochloride, cetirizine, hydroxyzine or to an antihistamine, or any of the other ingredients of Xyzal (see section PRODUCT DESCRIPTION ) • if you have a severe kidney impairment with creatinine clearance below 10 ml/min. The use of Xyzal is not recommended for infants and children under 6 years. _Pregnancy and breastfeeding _ Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant, trying to get pregnant or breastfeeding. Levocetirizine is excreted in human milk. Talk to your doctor or pharmacist before taking this medicine if you are breastfeeding. - _Before you start to use it_ _ _ Tell your doctor if you have any of the following conditions: • If you have difficulties emptying your bladder due to factors such as spinal cord lesion or prostatic hyperplasia (enlargement of the prostate gland). • If you have been told by your doctor that you have an intolerance to some sugars. This tablet contains lactose. • If you have ep Lugege kogu dokumenti
[GSK logo] XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE QUALITATIVE AND QUANTITATIVE COMPOSITION _Levocetirizine dihydrochloride, 5 mg, film-coated tablet_ Film-coated tablet containing 5 mg of levocetirizine dihydrochloride EXCIPIENTS _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ Microcrystalline cellulose, Lactose monohydrate, Colloidal anhydrous silica, Magnesium stearate, Hypromellose, Titanium dioxide, Macrogol 400 PHARMACEUTICAL FORM _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ White to off-white, oval, film-coated tablet with a Y logo on one side. CLINICAL INFORMATION INDICATIONS Levocetirizine is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. DOSAGE AND ADMINISTRATION _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake. _Duration of use _ Intermittent allergic rhinitis (symptoms < 4 days/week or for less than 4 weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms > 4 days/week or for more than 4 weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens. There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. In chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year. ROUTE OF ADMINISTRATION For oral use. ADULTS AND ADOLESCENTS 12 YEARS AND ABOVE _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ The daily recommended dose is 5 mg (1 film-coated tablet). CHILDREN _Children aged 6 to 12 years _ _Levocetirizine dihydrochloride, 5 mg, film-coated tablet _ The daily recommend Lugege kogu dokumenti