Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
DICLOFENAC POTASSIUM
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
M01AB05
DICLOFENAC POTASSIUM 50 mg
COATED TABLET
DICLOFENAC POTASSIUM 50 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2005-07-24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CATAFLAM ® 25 mg sugar-coated tablets. CATAFLAM ® 50 mg sugar-coated tablets. DICLOFENAC POTASSIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 affects 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 Catatflam Tablets are and what they are used for 2 What you need to know before you take Cataflam Tablets 3 How to take Cataflam Tablets 4 Possible side effects 5 How to store Cataflam Tablets 6 Contents of the pack and other information 1 WHAT CATAFLAM TABLETS ARE AND WHAT THEY ARE USED FOR Diclofenac potassium, the active ingredient in Cataflam Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation by blocking synthesis of the molecules (prostaglandins). Cataflam Tablets relieve pain, reduce swelling, reduce fever and ease inflammation in: • Painful syndromes of the vertebral column for example low back pain • Migraine • Conditions affecting the joints and muscles such as sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations, and fractures, and other forms of soft-tissue rheumatism. • Conditions affecting the tendons for example tendonitis, tenosynovitis bursitis. • Painful inflammatory conditions in gynaecology, including painful menstrual periods. • Infections of the ear, nose, or throat. They are also used to treat pain and inflammation associated with orthopaedic, dental and other minor surgery. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CATAFLAM TABLETS Tell your doctor if you recentl Aqra d-dokument sħiħ
Novartis Pharma Services Inc Malta CATAFLAM ® (DICLOFENAC POTASSIUM) 25 mg and 50 mg Sugar-coated tablets SUMMARY OF PRODUCT CHARACTERISTICS Novartis Page 2 Cataflam® 25mg & 50mg Coated Tablets 1 TRADE NAME(S) CATAFLAM 25 mg sugar-coated tablets. CATAFLAM 50 mg sugar-coated tablets. 2 DESCRIPTION AND COMPOSITION The active substance diclofenac potassium. One sugar-coated tablet contains 25 mg or 50 mg of diclofenac potassium. In Cataflam the sodium ion of diclofenac sodium (Voltaren) has been replaced by a potassium ion. For a full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 INDICATIONS Short-term treatment in the following acute conditions: • Post-traumatic pain, inflammation and swelling, e.g. due to sprains. • Post-operative pain, 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. • Painful syndromes of the vertebral column. • Non-articular rheumatism. • As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. 4.2 DOSAGE AND ADMINISTRATION DOSAGE 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). GENERAL TARGET POPULATION: ADULTS Novartis Page 3 Cataflam® 25mg & 50mg Coated Tablets The recommended initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient. The total daily dose should generally be divided in 2 to 3 doses. In primary dysmenorrhoea, the daily dose should be individually adjusted and is generally 50 to 150 Aqra d-dokument sħiħ