Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CETIRIZINE DIHYDROCHLORIDE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
CETIRIZINE DIHYDROCHLORIDE
10ml mL
Aesica Pharmaceuticals S.R.L
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ZYRTEC FILM-COATED TABLET/ORAL SOLUTION/ORAL DROPS Cetirizine dihydrochloride (10mg, 1mg/ml, 10mg/ml) 1 WHAT IS IN THIS LEAFLET 1. What ZYRTEC is used for 2. How ZYRTEC works 3. Before you use ZYRTEC 4. How to use ZYRTEC 5. While you are using it 6. Side Effects 7. Storage and Disposal of ZYRTEC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ZYRTEC IS USED FOR Zyrtec is used to treat adults and children aged 2 and over who have 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). HOW ZYRTEC WORKS Cetirizine dihydrochloride, the active ingredient of Zyrtec is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions. Antihistamines like Zyrtec relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes. BEFORE YOU USE ZYRTEC - _When you must not use it _ Do not take Zyrtec if: • You are allergic (hypersensitive) to cetirizine dihydrochloride • You are allergic (hypersensitive) to any of the other ingredients of Zyrtec • You are breast-feeding • You have severe kidney failure (Glomerular Filtration Rate below 15 ml/min). • You have problems of urinary retention. • For Zyrtec oral solution: You have fructose intolerance. • For Zyrtec tablets: You have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption If any of the above applies to you talk to your pharmacist. - _Before you start to use it _ Check with your pharmacist before taking Zyrtec if: • You have problems with your kidneys • You have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine i Прочитать полный документ
[GSK logo] Zyrtec® Cetirizine dihydrochloride NAME OF THE MEDICINAL PRODUCT Cetirizine dihydrochloride, 10 mg, film-coated tablet Cetirizine dihydrochloride, 1 mg/ml, oral solution Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution QUALITATIVE AND QUANTITATIVE COMPOSITION Cetirizine dihydrochloride, 10 mg, film-coated tablet Each film-coated tablet contains 10 mg of cetirizine dihydrochloride. Cetirizine dihydrochloride, 1 mg/ml, oral solution Each 1 ml contains 1 mg of cetirizine dihydrochloride. Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution Each 1 ml contains 10 mg of cetirizine dihydrochloride. Excipients Cetirizine dihydrochloride, 10 mg, film-coated tablet Microcrystalline cellulose, Lactose monohydrate, Colloidal anhydrous silica, Magnesium stearate, Opadry Y-1-7000 which consists of, Hydroxypropylmethylcellulose (E464), Titanium dioxide (E171), Macrogol 400. Cetirizine dihydrochloride, 1 mg/ml, oral solution Sorbitol solution at 70 % (non crystallizing), Glycerol (85%), Propylene glycol, Sodium saccharinate, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Banana flavour 54.330/A , Sodium Acetate, Glacial Acetic Acid, Purified water. Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution Glycerol (85%), Propylene glycol, Sodium saccharinate, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium acetate, Glacial acetic acid, Purified water. PHARMACEUTICAL FORM Cetirizine dihydrochloride, 10 mg, film-coated tablet White, oblong, film-coated tablet, with a bisect line and Y-Y logo. Cetirizine dihydrochloride, 1 mg/ml, oral solution Banana flavoured clear colourless liquid. Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution Clear and colourless liquid. CLINICAL INFORMATION Indications Commented [AS1]: Administrative Update Commented [AS2]: Administrative Update Прочитать полный документ