البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
MEDISPEC (M) SDN.BHD
DESLORATADINE
120 ml
Neopharma
ACTILOR SYRUP desloratadine (2.5mg/5ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Actilor syrup_ is used for 2. How _Actilor syrup_ works 3. Before you use _Actilor syrup_ 4. How to use _Actilor syrup_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Actilor _ _syrup_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ACTILOR SYRUP_ IS USED FOR Actilor Syrup is indicated for the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness. Actilor Syrup is also indicated for the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives. HOW _ACTILOR SYRUP_ WORKS Actilor syrup is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE _ACTILOR SYRUP_ - _When you must not use it _ Do not use Actilor syrup if: • If you are hypersensitivity to the active substance, to any of the excipients, or to loratadine. _Pregnancy and lactation _ Do not take _Actilor syrup_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _Actilor syrup_ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it _ _Paediatric population: _ Tell doctors if you have renal insufficiency. _Convulsions:_ Tell the doctors if you have medical or familial history of seizures (mainly young children) _Desloratadine syrup contains sorbitol: _ Tell doctors if you have rare hereditary problems of fructose intolerance (HFI). _Desloratadine syrup contains sodium: _ Tell doctors if you are on sodium diet. - _Taking 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. Avoid alcohol when you t اقرأ الوثيقة كاملة
ACTILOR SYRUP 2.5 MG/ 5 ML (Desloratadine Syrup 2.5 mg/ 5 ml) Each ml of syrup contains 0.5 mg desloratadine. PRODUCT DESCRIPTION Clear, colorless, raspberry flavored solution, free from visible extraneous matter. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: antihistamines – H 1 antagonist, ATC code: R06A X27 Mechanism of action Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 -receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H 1 -receptors because the substance is excluded from entry to the central nervous system. Desloratadine has demonstrated antiallergic properties. These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells. The clinical relevance of these observations remains to be confirmed. PHARMACOKINETIC PROPERTIES Absorption Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg. The exposure (AUC) to desloratadine was about 6-fold higher and the C max was about 3 to 4 fold higher at 3-6 hours with a terminal half-life of approximately 120 hours. Exposure was the same in adult and paediatric poor metabolisers when treated with age-appropriate doses. The overall safety profile of these subjects was not different from that of the general population. The effects of desloratadine in poor metabolizers < 2 years of age have not been studied. At the recommended doses, paediatr اقرأ الوثيقة كاملة