Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Malta Medicines Authority
DICLOFENAC SODIUM
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
M01AB05
DICLOFENAC SODIUM 50 mg
SUPPOSITORY
DICLOFENAC SODIUM 50 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2005-10-25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VOLTAREN ® 12.5 MG SUPPOSITORIES. VOLTAREN ® 50 MG SUPPOSITORIES. VOLTAREN ® 100 MG SUPPOSITORIES. DICLOFENAC SODIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What Voltaren suppositories are, and what they are used for 2 What you need to know before you take Voltaren Suppositories 3 How to take Voltaren Suppositories 4 Possible side effects 5 How to store Voltaren Suppositories 6 Contents of the pack and other 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 (prostaglandins) 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 joins, muscles and tendons including: • Rheumatoid arthritis, osteoarthritis and spondyloarthritis, acute gout, ankylosing spondylitis, and other types of rheumatism • Backache, frozen shoulder, soft tissue sports injuries, sprains and strains, dislocations and fractures • Tendonitis, tenosynovitis, bursitis • They are used to treat pain and inflammation associated with dental and minor surgery. • Voltaren Suppositories are used in painful inflammatory conditions in gynaecology, including menstrua Đọc toàn bộ tài liệu
VOLTAREN ® (DICLOFENAC SODIUM) Suppositories SUMMARY OF PRODUCT CHARACTERISTICS Novartis Page 2 Voltaren® 12.5mg, 50mg & 100mg suppositories 1 NAME OF THE MEDICINAL PRODUCT VOLTAREN12.5 mg suppositories. VOLTAREN 50 mg suppositories. VOLTAREN 100 mg suppositories. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is 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 spondyloarthritis, 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION As a general recommendation, the dose should be individually adjusted. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). Novartis Page 3 Voltaren® 12.5mg, 50mg & 100mg suppositories GENERAL TARGET POPULATION: ADULTS The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long- term therapy, 75 to 100 mg daily is usually sufficient. The total daily dose sh Đọc toàn bộ tài liệu