Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROXYZINE HYDROCHLORIDE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
HYDROXYZINE HYDROCHLORIDE
200ml mL
NEXTPHARMA SAS
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ ATARAX FILM-COATED TABLET/SYRUP Hydroxyzine Hydrochloride (25 mg, 2 mg/ml) 1 WHAT IS IN THIS LEAFLET 1. What ATARAX is used for 2. How ATARAX works 3. Before you use ATARAX 4. How to use ATARAX 5. While you are using it 6. Side Effects 7. Storage and Disposal of ATARAX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ATARAX IS USED FOR • Symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. • a sedative used as premedication and following general anaesthesia. • symptomatic treatment in atopic pruritus. HOW ATARAX WORKS Atarax belongs to the group of medicines called sedating antihistamines. It is thought to work by inhibiting some activity in the brain. BEFORE YOU USE ATARAX - _When you must not use it _ Do not take Atarax if: • You are allergic to hydroxyzine hydrochloride or any of the other ingredients of Atarax (see section PRODUCT DESCRIPTION ) • You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine • You are pregnant or breastfeeding • You have liver or kidney disease • You have prostate problems and you are unable to pass urine • You have increased pressure in the eye (glaucoma) • You have a condition called porphyria. (A blood disease that can cause stomach pain, vomiting and mental disturbances such as depression.) • Your child is under 12 months • You are taking medicines for depression called monoamine oxidase inhibitors • You have a heart condition known as prolonged QT interval causing irregular heart beat and/or palpitations • You have a known risk factor to QT interval prolongation including a known heart disease, significantly low potassium or magnesium ions in your blood, family history of sudden cardiac death, significant slow heart rate, concomitant use with drugs known to prolong the QT interval and/or ind Baca dokumen lengkap
ATARAX Hydroxyzine hydrochloride NAME OF THE MEDICINAL PRODUCT Hydroxyzine hydrochloride, 25 mg, film -coated tablet Hydroxyzine hydrochloride, 10 mg/5 ml, syrup QUALITATIVE AND QUANTITATIVE COMPOSITION Hydroxyzine hydrochloride, 25 mg, film -coated tablet Each film -coated tablet contains 25 mg of hydroxyzine hydrochloride. Hydroxyzine hydrochloride, 10 mg/5 ml, syrup Each ml of syrup contains 2 mg of hydroxyzine hydrochloride. Excipients Hydroxyzine hydrochloride, 25 mg, film -coated tablet Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Titanium dioxide (E171), H.P.M.C. 2910 (645), Macrogol 400 Hydroxyzine hydrochloride, 10 mg/5 ml, syrup Ethanol, Sucrose, Sodium benzoate, Levomenthol, Hazelnut flavour (containing a.o. propylene glycol, vanillin, ethyl vanillin, fenugreek seed extract, lovage oil), Purified water PHARMACEUTICAL FORM Hydroxyzine hydrochloride, 25 mg, film -coated tablet Baca dokumen lengkap