البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
SPG PHARMA (MALAYSIA) SDN BHD
DICLOFENAC SODIUM
25 gm
SIAM BHEASACH CO LTD
_ _ _ _ _ _ _ Consumer Medication Information Leaflet (RiMUP)_ DOSANAC ® EMULSION GEL Diclofenac Diethylammonium (1%w/w) 1 WHAT IS IN THIS LEAFLET 1. What DOSANAC is used for 2. How DOSANAC works 3. Before you use DOSANAC 4. How to use DOSANAC 5. While you are using DOSANAC 6. Side effects 7. Storage and Disposal of DOSANAC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DOSANAC IS USED FOR DOSANAC is a topical gel used for the relief of pain and inflammation affecting the joints and muscles. It can be used to treat:- muscle, joints, tendons, ligaments injuries tendonitis or tennis elbow mild arthritis of the knee or fingers HOW DOSANAC WORKS DOSANAC belongs to a class of medicines known as non- steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties. It works by inhibiting prostaglandin synthesis to relieve pain, reduce inflammation and swelling of the painful joints and muscles. BEFORE YOU USE DOSANAC _When you must not use it _ Do not use DOSANAC if you are: allergic to NSAID that used to treat pain, fever and inflammation, such as aspirin or ibuprofen allergic to diclofenac or any other ingredients in this medicine in the last 3 months of pregnancy _Before you start to use it _ Tell your doctor or pharmacist before using DOSANAC if you are: having skin conditions such as cuts, open wounds, rash or eczema using other NSAID medications pregnant, especially during the last 3 months of pregnancy breast-feeding or plan to start breast-feeding _Taking other medicines _ Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including traditional products bought without a prescription. HOW TO USE DOSANAC _How much to use _ For topical application only. Apply DOSANAC emulsion gel 3 to 4 times daily on the affected area. Gentle massage on the area is recommended to ensure drug absorption into the skin. You may notice a slight cooling effect when you rub اقرأ الوثيقة كاملة
Drawing No. DOS-EMU-GEL-1-04-L-MY-A0005 Sent date 30/03/2020 NAME AND STRENGTH OF ACTIVE SUBSTANCE Each 1 g contains 11.6 mg diclofenac diethylammonium, which corresponds to 10 mg diclofenac sodium (Preservative: 0.025%w/w sodium metabisulphite and 0.5%w/w benzyl alcohol ; Solvent: 5%w/w isopropyl alcohol) PRODUCT DESCRIPTION White to creamy white cream like gel PHARMACODYNAMICS Mechanism of action Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with effective analgesic, anti-inflammatory and antipyretic properties. Diclofenac exerts its therapeutic effects primarily through inhibition of prostaglandin synthesis by cyclo-oxygenase 2 (COX-2). Diclofenac gel 1% is an anti-inflammatory and analgesic preparation designed for topical application. In inflammation and pain of traumatic or rheumatic origin, diclofenac gel 1% relieves pain and decreases swelling. PHARMACOKINETICS Absorption The quantity of diclofenac absorbed through the skin is proportional to the size of the treated area, and depends on both the total dose applied as well as the degree of skin hydration. Absorption amounts to about 6% of the applied dose of diclofenac after topical application of 2.5 g diclofenac gel 1% on 500 cm 2 skin, determined by total renal elimination, compared with diclofenac tablets. A 10-hour occlusion leads to a three-fold increase in the amount of diclofenac absorbed. Distribution Diclofenac concentrations have been measured from plasma, synovial tissue and synovial fluid after topical administration of diclofenac gel to hand and knee joints. Maximum plasma concentrations are approximately 100 times lower than after oral administration of the same quantity of diclofenac. 99.7% of diclofenac is bound to serums, mainly albumin (99.4%). Diclofenac accumulates in the skin which acts as reservoir from where there is a sustained release of drug into underlying tissues. From the skin and underlying tissue, diclofenac preferentially distributes and persists in deep inflamed tissues (such as the joint), rather than in th اقرأ الوثيقة كاملة