Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
diclofenac sodium 50 mg
Novartis Pharmaceuticals UK Limited
M01AB05
diclofenac sodium
gastro-resistant tablet
Authorised
2005-10-25
VOLTAREN® TABLETS 25 AND 50MG (DICLOFENAC SODIUM) Patient information leaflet WHAT YOU NEED TO KNOW ABOUT VOLTAREN TABLETS. Your doctor has decided that you need this medicine to treat your condition. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IT CONTAINS IMPORTANT INFORMATION. Keep this leaflet in a safe place because you may need to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed only for you. Never give it to somebody else. It may not be the right medicines for them even if their symptoms seem to be the same as yours. If any of the side affects you severely, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 What Voltaren Tablets are, and what they are used for 2 Things to consider before you take Voltaren Tablets 3 How to take Voltaren Tablets 4 Possible side effects 5 How to store Voltaren Tablets 6 Further information 1 What Voltaren Tablets are, and what they are used for Diclofenac sodium, the active ingredient in Voltaren Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation, by blocking the synthesis of the molecules (prostoglandins) responsible for inflammation, pain and fever. It has no effect on the causes of inflammation or fever. Voltaren Tablets relieve pain, reduce swelling, reduce fever and ease inflammation in conditions affecting the joints, muscles and tendons including: Baca dokumen lengkapnya
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VOLTAREN ® 25 mg gastro-resistant tablets. VOLTAREN ® 50 mg gastro-resistant tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac sodium). One gastro-resistant tablet contains 25 mg or 50 mg of diclofenac sodium. EXCIPENTS Silica aerogel, cellulose microcryst., lactose, magnesium stearate, povidone sodium carboxymethyl starch, maize starch, hydroxypropyl methylcellulose, glyceryl polyethylene glycol oxystearate, yellow iron oxide (E 172), talc, titanium dioxide, methacrylic acid copolymer, macrogol 8000, simethicone emulsion, purified water, ethanol with 5% isopropyl alcohol. The 50mg tablets also contain red iron oxide (E 172). 3 PHARMACEUTICAL FORM Gastro-resistant tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. Acute attacks of gout. Symptomatic, short-term treatment of post-traumatic and post-operative pain (POP), inflammation and swelling, e.g. following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis. Symptomatic short-term treatment of pain related to inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis (ENT). In keeping with general therapeutic principles, the underlying disease should be treated with anti Baca dokumen lengkapnya