Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
Denk Pharma GmbH & Co. KG
M01AB05
diclofenac (diclofenac sodium)
100mg
tablets prolonged-release
(10/1x10/) and (100/10x10/) in blister
Prescription
Registered
2018-04-17
_Diclo-Denk 100 Retard_ Prolonged-release tablet – oral use Non-steroidal antiphlogistic/antirheumatic Active substance: Diclofenac sodium Package leaflet: Information for the user READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAK- ING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFOR- MATION 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 phar- macist. This includes any possible side effects not list- ed in this leaflet. See section 4. What is in this leaflet 1. WHAT DICLO-DENK 100 RETARD IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLO-DENK 100 RETARD 3. HOW TO TAKE DICLO-DENK 100 RETARD 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DICLO-DENK 100 RETARD 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What Diclo-Denk 100 Retard is and what it is used for Diclo-Denk 100 Retard is a pain-relieving and anti-inflamma- tory drug and belongs to the class of non-steroidal antiphlo- gistic/antirheumatic agents (NSAIDs). Therapeutic indications Symptomatic treatment of pain and inflammation in case of: • acute joint inflammation (acute arthritides) including gout attack • chronic joint inflammation (chronic arthritides), especial - ly in case of rheumatoid arthritis (chronic polyarthritis) • Bechterew’s disease (ankylosing spondylitis) and other in - flammatory rheumatoid disorders of the spine • acute inflammatory condition of degenerative joint or spi - nal disorders (arthroses and spondylarthroses) • inflammatory soft tissue rheumatisms • painful swelling or inflammation after injuries. Due to the delayed release of the active ingredient diclofenac, Diclo-Denk 100 Retard is not suitable for initiating therapy in patients where a rapid onset of effect is required. 2. What you need to kno Lees het volledige document
_ _ 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diclo-Denk 100 Retard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: diclofenac sodium Each prolonged-release tablet contains 100 mg diclofenac sodium. Excipient with known effect: Each prolonged-release tablet contains 119.0 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Round, brown-red biconvex tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain and inflammation in case of: - acute arthritides (including gout attack) - chronic arthritides, especially rheumatoid arthritis (chronic polyarthritis) - ankylosing spondylitis (Bechterew’s disease) and other inflammatory rheumatoid disorders of the spine - acute inflammatory condition of arthroses and spondylarthroses - inflammatory soft tissue rheumatisms - painful swelling or inflammation after injuries. Due to the delayed release of active ingredient from Diclo-Denk 100 Retard, this preparation is not suitable for initiating therapy in patients where a rapid onset of effect is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of diclofenac depends on the severity of the illness. The recommended daily dose for adults is between 50 mg and 150 mg of diclofenac sodium. AGE SINGLE DOSE TOTAL DAILY DOSE Adults 1 prolonged-release tablet (equivalent to 100 mg diclofenac sodium) 1 prolonged-release tablet (equivalent to 100 mg diclofenac sodium) _ _ 2 Method of administration Diclo-Denk 100 Retard is swallowed whole with ample fluids. Patients with sensitive stomachs are advised to take Diclo-Denk 100 Retard with meals. Do not break the tablets. The attending doctor will decide how long the treatment should take. Prolonged intake of Diclo-Denk 100 Retard can be necessary for rheumatic diseases. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). SPECIAL PATIENT GROUPS Lees het volledige document