País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ADAPALENE
RANBAXY (MALAYSIA) SDN. BHD.
ADAPALENE
1x15gm0 gm
Sun Pharmaceutical Industries Limited
DIFACLEAR Page 1 DIFACLEAR _Consumer Medication Information Leaflet (RiMUP)_ ADAPALENE GEL 0.1% W/W WHAT IS IN THIS LEAFLET 1. What DIFACLEAR is used for 2. How DIFACLEAR works 3. Before you use DIFACLEAR 4. How to use DIFACLEAR 5. While you are using DIFACLEAR 6. Side effects 7. Storage and Disposal of DIFACLEAR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DIFACLEAR IS USED FOR DIFACLEAR contains the active substance adapalene. DIFACLEAR is used for the treatment of acne (blackheads, white heads and pimples) on the face, chest or back. HOW DIFACLEAR WORKS DIFACLEAR acts against the abnormal skin processes associated with acne. It has an anti-inflammatory effect that reduces soreness and irritation. BEFORE YOU USE DIFACLEAR _WHEN YOU MUST NOT USE IT_ Do not use DIFACLEAR if you are allergic (hypersensitive) to adapalene or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). If you are not sure whether you should start using DIFACLEAR , talk to your doctor or pharmacist. Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. The expiry date refers to the last day of that month. If it has expired or is damaged, return it to your pharmacist for disposal. _BEFORE YOU START TO USE IT_ Talk to your doctor or pharmacist before using DIFACLEAR if you: • have cuts, scrapes or if you have a skin condition called eczema • have sunburned skin • have severe acne involving large areas of the body • have inherent sensitivity to sun Adapalene should not be used during pregnancy. If you become pregnant while using adapalene, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up. Adapalene can be used during breast- feeding. To avoid contact exposure of the infant, application of adapalene to the chest should be avoided. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, Llegiu el document complet
1 _For the use of a Registered Medical Practitioner only _ PRESCRIBING INFORMATION DIFACLEAR GEL 0.1% W/W (ADAPALENE GEL) COMPOSITION ADAPALENE PH EUR.....................0.1 % W/W PRESERVATIVE: METHYL HYDROXYBENZOATE BP.......0.1 % W/W IN AN AQUEOUS GEL BASE…………..QS PRODUCT DESCRIPTION DIFACLEAR GEL is white to off white viscous gel filled in aluminum based laminated tube DIFACLEAR GEL containing adapalene, is used for the topical treatment of acne vulgaris. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.52. Adapalene is represented by the following structural formula: STRUCTURAL FORMULA ADAPALENE 2 PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES MECHANISM OF ACTION PHARMACODYNAMICS Adapalene is a retinoid-like compound which reported to possess anti-inflammatory properties. Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Mechanically, adapalene binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin not to cytosolic receptor binding proteins. It has been reported that adapalene applied cutaneously is comedolytic and also has effects on the abnormal processes of epidermal keratinization and differentiation, both of which are present in the pathogenesis of acne vulgaris. The mode of action of adapalene is suggested to be a normalisation of differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Adapalene is reported to be superior to reference retinoids in standard anti-inflammatory assays. Mechanistically, it inhibits chemotactic and chemokinetic responses of human polymorphonuclear leucocytes and also the metabolism by lipoxidation of arachidonic acid to pro-inflammatory mediators. This profile suggests that the cell mediated inflammatory component of acne may be modified by adapalene. PHARMACOKINETICS Topical bioavailability is low. Biliary route is major route of excretion. The elimin Llegiu el document complet