Kraj: Cypr
Język: grecki
Źródło: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
DICLOFENAC SODIUM
MEDILINK PHARMACEUTICALS LTD (0000003162) 30 ARMENIAS, STROVOLOS, 1640, 26576
M01AB05
DICLOFENAC
100MG
MODIFIED-RELEASE CAPSULE, HARD
DICLOFENAC SODIUM (0015307796) 100MG
ORAL USE
Εθνική Διαδικασία
DICLOFENAC
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 CAPS IN BLISTER(S) (220005901) 10 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 CAPS IN BLISTER(S) (220005902) 28 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
Package leaflet: information for the user DIFENE DUAL RELEASE 100MG Modified-release capsule, hard 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 Difene Dual Release 100mg is and what it is used for 2. What you need to know before you take Difene Dual Release 100mg 3. How to take Difene Dual Release 100mg 4. Possible side effects 5. How to store Difene Dual Release 100mg 6. Contents of the pack and other information 1. WHAT DIFENE DUAL RELEASE 100MG IS AND WHAT IT IS USED FOR Difene Dual Release 100mg is a pain-relieving and anti-inflammatory medicine, one of the group of non-steroidal anti-inflammatory/anti-rheumatic agents (NSAIDs). Areas of indication for Difene Dual Release 100mg Symptomatic treatment of pain and inflammation in: − Acute inflammations of the joints (acute arthritis), including attacks of gout − Chronic inflammation of the joints (chronic arthritis), especially in rheumatoid arthritis (chronic polyarthritis) − Ankylosing spondylitis (Bechterew’s Disease) and other inflammatory rheumatic diseases of the spinal column − Painful conditions associated with degenerative diseases of joints and the spinal column (arthritis and spondylarthropathy) − Inflammatory rheumatic diseases of soft tissue − Painful swelling or inflammation after injury. Because the release of the active substance diclofenac is delayed, Difene Dual Release 100mg is not suitable for starting treatment in conditions where rapid onset of action is needed. 2. WHAT YOU NEED Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Difene Dual Release 100 mg modified-release capsule, hard Diclofenac sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified -release capsule, hard contains 100 mg diclofenac sodium. (25 mg diclofenac sodium in gastroresistant form, 75 mg diclofenac sodium in prolonged-release form). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified -release capsule, hard Hard gelatine capsule, size 1, with a blue opaque capsule cap and colourless transparent body and white print "D100M", filled with white to cream-coloured pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain and inflammation in − Acute arthritis (including attacks of gout) − Chronic arthritis, including rheumatoid arthritis (chronic polyarthritis) − Ankylosing spondylitis (Bechterew’s Disease) and other inflammatory rheumatic diseases of the spinal column − Painful conditions associated with arthritis and spondylarthropathy − Inflammatory rheumatic diseases of soft tissue − Painful swelling or inflammation after injury. Because the release of active substance from Difene Dual Release 100mg is delayed, this preparation is not suitable for starting treatment in conditions where rapid onset of action is needed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage: The dose of diclofenac depends on the severity of the condition. The recommended dose range for adults lies between 50 and 100 mg diclofenac sodium per day. Age: Single dose: Number of Difene Dual Release 100mg modified -release capsules, hard Total daily dose: Number of Difene Dual Release 100mg modified -release capsules, hard Adults 1 (equivalent to 100 mg diclofenac sodium) 1 (equivalent to 100 mg diclofenac sodium) Method and duration of administration: Difene Dual Release 100mg is taken without chewing and with plenty of fluid. Those with sensitive stomachs are recommended to take Difene Dual Release 100mg during meals. Page 1 of 9 The patient’s Przeczytaj cały dokument