দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy
M01AE03
KETOPROFEN 50 mg
GRANULES FOR ORAL SOLUTION
KETOPROFEN 50 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-17
PAGE 1 OF 8 PACKAGE LEAFLET PAGE 2 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE USER KETOPROFEN DOMPÉ 50 MG GRANULES FOR ORAL SOLUTION IN SACHET ketoprofen (as lysine salt) 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, 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 Ketoprofen Dompé is and what it is used for 2. What you need to know before you use Ketoprofen Dompé 3. How to use Ketoprofen Dompé 4. Possible side effects 5. How to store Ketoprofen Dompé 6. Contents of the pack and other information 1. WHAT KETOPROFEN DOMPÉ IS AND WHAT IT IS USED FOR Ketoprofen Dompé 50 mg granules for oral solution in sachet contains the active substance ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation. Ketoprofen Dompé is used in ADULTS for symptomatic treatment of pain and inflammation in conditions such as: - rheumatoid arthritis (chronic, inflammatory disease that causes the immune system to attack the joints) - long-term inflammation of the joints of the spine - painful inflammation of joints - rheumatic disease affecting the structures outside the joints - inflammation after injury - painful inflammatory conditions in the mouth or teeth, throat, nose, ears, urinary tract and respiratory track. ADOLESCENTS AGED 16 YEARS AND ABOVE for symptomatic and short-term treatment of pain and inflammation, with or without fever, such as: - conditions affecting bones and joints - pain after surgery - ear inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KETOPROFEN সম্পূর্ণ নথি পড়ুন
PAGE 1 OF 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ketoprofen Dompé 50 mg granules for oral solution in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoprofen Dompé 50 mg granules for oral solution in sachet Each bipartite sachet contains: 50 mg of ketoprofen (equivalent to 80 mg of ketoprofen lysine salt). Excipients with known effect: Mannitol (E421) 1700 mg Sodium 9,55 mg Sucrose 9 mg For the full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Granules for oral solution in sachet White to ivory granules with light mint odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Ketoprofen Dompé is indicated in adults for the symptomatic treatment of inflammatory states associated with pain, among which: rheumatoid arthritis, ankylosing spondylitis, painful arthritis, extraarticular rheumatism, post-traumatic inflammation, painful inflammatory conditions in dentistry, otorhinolaryngology, urology and pneumology. Paediatric population Ketoprofen Dompé 50 mg is indicated in adolescents aged 16 years and older for the symptomatic and short- term treatment of pain and inflammation, with or without fever, in conditions such as those affecting the osteoarticular system, post-operative pain and otitis. 4.2 POSOLOGY AND ROUTE OF ADMINISTRATION Posology Undesirable effects may be minimised by using the shortest duration necessary to control symptoms (see section 4.4). PAGE 2 OF 16 _Adults and adolescents aged 16 years and older _ It is recommended to take one whole bipartite sachet, equivalent to 50 mg of ketoprofen, corresponding to 80 mg ketoprofen lysine salt, three times a day, preferably with meals. The maximum daily dosage is 200 mg of ketoprofen, corresponding to 320 mg of ketoprofen lysine salt. The risk-benefit ratio should be carefully considered before starting treatment with the daily dose of 200 mg of ketoprofen and higher doses are not recommended (see also section 4.4). _Elderly _ The dose should be carefully prescribed by the doctor who should consider সম্পূর্ণ নথি পড়ুন