Država: Tanzanija
Jezik: angleščina
Source: Tanzania Medicinces & Medical Devices Authority
Meloxicam
Remedica LTD, CYPRUS
Anti-Inflammatory And Antirheumatic Products/ Non-
Meloxicam
15
Tablets
Remedica Limited, CYPRUS
Physical description: Light yellow, round, flat tablets, score on one side; Local technical representative: Stanley Tanzania Limited (4885)
Registered/Compliant
2024-01-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MELOREM 7.5 MG TABLETS MELOREM 15 MG TABLETS Meloxicam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE 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 your 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 Melorem is and what it is used for 2. What you need to know before you take Melorem 3. How to take Melorem 4. Possible side effects 5. How to store Melorem 6. Contents of the pack and other information 1. WHAT MELOREM IS AND WHAT IT IS USED FOR Melorem contains the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which are used to reduce inflammation and pain in joints and muscles. Melorem is used for the: short-term treatment of flare-ups of osteoarthritis. long-term treatment of: rheumatoid arthritis. ankylosing spondylitis (also known as Bechterew’s Disease). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELOREM DO NOT TAKE MELOREM if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6). cy-pl-melorem-tabs-a0 page 1 of 11 if you are allergic (hypersensitivity) to aspirin or other anti-inflammatory medicines (NSAIDs). during the last three months of pregnancy. children and adolescents under 16 years of age. any of the following signs after taking aspirin or other NSAIDs: wheezing, chest tightness, breathlessness (asthma). nasal blockage due to swellings in the lining in your nose (nasal polyps). skin rashes/nettle rash (urticaria). sudden skin or mucosal swelling, such as swe Preberite celoten dokument
cy-spc-melorem-tabs-v02-r00-a0 page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Melorem 7.5 mg tablets Melorem 15 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Melorem 7.5 mg tablets: Each tablet contains 7.5 mg meloxicam. Melorem 15 mg tablets: Each tablet contains 15 mg meloxicam. Excipient(s) with known effect Melorem 7.5 mg tablets: This product contains 43 mg lactose. Melorem 15 mg tablets: This product contains 86 mg lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. Melorem 7.5 mg tablets Light yellow, round, flat tablets, scored on one side. The score line is only to facilitate breaking for ease of swallowing. Melorem 15 mg tablets Light yellow, round, flat tablets, scored on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - short-term symptomatic treatment of exacerbations of osteoarthrosis. - long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis. - exacerbations of osteoarthrosis: 7.5 mg/day. cy-spc-melorem-tabs-v02-r00-a0 page 2 of 15 If necessary, in the absence of improvement, the dose may be increased to 15 mg/day. - rheumatoid arthritis, ankylosing spondylitis: 15 mg/day. (see also section ‘Special populations’ below). According to the therapeutic response, the dose may be reduced to 7.5 mg/day. DO NOT EXCEED THE DOSE OF 15 mg/day. Method of administration Oral administration. The total daily amount should be taken as a single dose, with water or another liquid, during a meal. Special populations _Elderly patients and patients with increased risks of adverse reaction (see section 5.2): _ The Preberite celoten dokument