מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
DCH AURIGA (MALAYSIA) SDN. BHD.
DESLORATADINE
3x10tablet Tablets; 10x10tablet Tablets; 1x10 Tablets
Actavis Ltd.
_Consumer Medication Information Leaflet (RiMUP)_ DEZAL TABLET 5MG Desloratadine (5 mg) 1 WHAT IS IN THIS LEAFLET 1. What Dezal is used for 2. How Dezal works 3. Before you use Dezal 4. How to take Dezal 5. While you are using Dezal 6. Side Effects 7. Storage and Disposal of Dezal 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DEZAL IS USED FOR Dezal relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. Dezal is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep. HOW DEZAL WORKS Dezal is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE DEZAL _-When you must not take it_ Do not use Dezal if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Dezal or to loratadine. _-Before you start to take it _ Efficacy and safety of Dezal in children under 12 years of age have not been established. Pregnancy and breast-feeding • Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding. • If you are pregnant or nursing a baby, taking Dezal is not recommended. _ _ _-Taking other medicines _ There are no known interactions of Dezal with other medicines. Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO TAKE DEZAL _-How much to take _ Adults and adolescents (12 years of age and older): take one tablet once a day. _-When to take it _ Swallow the tablet whole with water, with or without food. _-How long to take it _ Y קרא את המסמך השלם
PRODUCT NAME Dezal Tablet 5mg COMPOSITION NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each tablet contains 5mg desloratadine PRODUCT DESCRIPTION 5mg tablet: Blue, round, 6mm, biconvex, film-coated tablets with “LT” debossed on one face. PHARMACOLOGY Actions: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H 1 -receptor antagonist activity. It has demonstrated anti-allergic, antihistaminic and anti-inflammatory activity. Pharmacodynamics: After oral administration, desloratadine selectively blocks peripheral histamine H 1 - receptors because the drug is effectively excluded from entry to the central nervous system (CNS). In addition to antihistaminic activity, desloratadine has demonstrated anti-allergic and anti-inflammatory activity. Desloratadine does not readily penetrate the CNS. At the recommended dose of 5mg daily, there was no excess incidence of somnolence. Desloratadine tablet even at a dose of 7.5 mg daily, did not affect psychomotor performance. A single dose of desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying. In adult and adolescent patients with seasonal allergic rhinitis (SAR), Desloratadine tablet, was effective in relieving symptoms eg, sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, and itching of palate. Desloratadine tablet effectively controlled symptoms for 24 hrs. PHARMACOKINETICS Desloratadine plasma concentrations can be detected within 30 min of desloratadine administration. It is well absorbed with maximum concentration achieved after approximately 3 hrs; the terminal phase half-life is approximately 27 hrs. The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hrs) and a once-daily dosing frequency. In adults and adolescents, the bioavailability of desloratadine was dose proportional over the range of 5-20 mg. Desloratadine is moderat קרא את המסמך השלם