Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC DIETHYLAMMONIUM
GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.
DICLOFENAC DIETHYLAMMONIUM
50gm mcg/mL; 30gm mcg/mL; 20gm mcg/mL; 10 gm mcg/mL; 20 gm mcg/mL; 50 gm mcg/mL
NOVARTIS PHARMA PRODUKTIONS GMBH
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) VOLTAREN EMULGEL 1% Diclofenac diethylamine (11.6mg/g) 1 WHAT IS IN THIS LEAFLET 1. What Voltaren Emulgel 1% is used for 2. How Voltaren Emulgel 1% works 3. Before you use Voltaren Emulgel 1% 4. How to use Voltaren Emulgel 1% 5. While you are using it 6. Side effects 7. Storage and disposal of Voltaren Emulgel 1% 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VOLTAREN EMULGEL 1% IS USED FOR Voltaren Emulgel 1% contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin. Voltaren Emulgel 1% is used to relieve pain and reduce inflammation and swelling in a number of painful conditions affecting the joints and muscles. It can be used to treat: Muscle, joints, tendons, ligaments injuries (e.g. sprains, strains, bruises, backache, sports injuries); tendonitis (e.g. tennis elbow); mild arthritis of the knee or fingers. HOW VOLTAREN EMULGEL 1% WORKS Diclofenac is a non-steroidal anti- inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin synthesis is the primary mechanism of action of diclofenac. Voltaren Emulgel is an anti- inflammatory and analgesic preparation designed for topical application. In inflammation and pain of traumatic or rheumatic origin. Voltaren Emulgel 1% relieves pain and decreases swelling. BEFORE YOU USE VOLTAREN EMULGEL 1% - _When you must not use Voltaren _ _Emulgel 1% _ If you are allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid (a substance also used to prevent blood clotting), or any of the other ingredients of Voltaren Emulgel 1% listed at the end of this leaflet. If you are not sure, ask your doctor or pharmacist. Symptoms of an allergic reaction to these medicines may include: wheezing or Baca dokumen lengkap
MY -SG 317951 – XXXXXX 1. BRAND OR PRODUCT NAME Voltaren Emulgel 1% 2. NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) One gram of Voltaren Emulgel 1% contains 11.6 mg (1.16%) of diclofenac diethylamine, which corresponds to 10 mg (1%) of diclofenac sodium. 3. PRODUCT DESCRIPTION White to practic ally white, soft, homogeneous, cream -like gel. 4.PHARMACODYNAMICS ATC code: M02A A15 Mechanism of action and pharmacodynamic effects: Diclofenac is a non -steroidal anti -rheumatic drug (NSAR) with marked analgesic, anti - inflammatory and antipyretic properties. Voltaren Emulgel is an anti -inflammatory and analgesic preparation for external use. The white cream, non -greasy Emulgel is easily rubbed into the skin and has, thanks to the aqueous -alcoholic basis, a soothing, cooling effect. The demonstrated inhibition of prostaglandin biosynthesis by diclofenac is considered as an important part of its mechanism of action. 5. 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 and the degree of skin hydration. Absorption amounts to about 6% of the applied dose of diclofenac after topical application of 2.5 g Voltaren Emulgel 1% on 500 cm2 skin, determined by total renal elimination, compare d with Voltaren 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 a di clofenac diethylamine gel to hand and knee joints. Baca dokumen lengkap