Страна: Малта
Език: английски
Източник: Medicines Authority
diclofenac sodium 50 mg
Novartis Pharmaceuticals UK Limited
M01AB05
diclofenac sodium
suppository
Authorised
2005-10-25
VOLTAREN ® SUPPOSITORIES 12.5, 50 AND 100MG (DICLOFENAC SODIUM) PATIENT INFORMATION LEAFLET WHAT YOU NEED TO KNOW ABOUT VOLTAREN SUPPOSITORIES Your doctor has decided that your need this medicines to help 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 effects 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 suppositories are, and what they are used for 2 Things to consider before you take Voltaren Suppositories 3 How to take Voltaren Suppositories 4 Possible side effects 5 How to store Voltaren Suppositories 6 Further information 1 WHAT VOLTAREN SUPPOSITORIES ARE, AND WHAT THEY ARE USED FOR Diclofenac sodium, the active ingredient in Voltaren Suppositories, 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 Suppositories relieve pain, reduce swelling, reduce fever and ease inflammation in conditions affecting the j Прочетете целия документ
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VOLTAREN ® 12.5 mg suppositories. VOLTAREN ® 50 mg suppositories. VOLTAREN ® 100 mg suppositories. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac sodium). One suppository contains 12.5 mg, 50 mg, or 100 mg of diclofenac sodium. Excipients Hard fat. 3 PHARMACEUTICAL FORM Suppositories. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis (JRA), juvenile rheumatoid arthritis, 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 . Migraine attacks . Symptomatic short-term treatment of pain related to painful 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-infective basic therapy, as therapeutically appropriate. Fever alone without inflammatory component is not an indication. Page 2 of 15 4.2 POSOLOGY AND METHOD OF ADMINISTRATION As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration. The Прочетете целия документ