Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
MELOXICAM
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
M01AC06
MELOXICAM 7.5 mg
TABLET
MELOXICAM 7.5 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2007-03-27
Meloxicam 7,5mg, 15mg, PIL, Malta dimensions: pharmacode: date sent: TECHNICAL APPROVAL min pt size: awstudio@actavis.co.uk print proof no: origination date: originated by: revision date: supplier: technically app. date*: * Please note the technical approval is provided by the supplier and is valid on the date indicated. Any technical changes made by the supplier after approval are not the responsibility of the Artwork Studio. Non Printing Colours colours/plates revised by: approved for print/date 1. 2. 3. 4. 5. 6. black 3 8,5pt 190x345 08.10.2014 13.10.2014 08.10.2014 KM KM Malta Zejtun Item No: AAAH3259 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 Melocid is and what it is used for 2. What you need to know before you take Melocid 3. How to take Melocid 4. Possible side effects 5. How to store Melocid 6. Contents of the pack and other information 1. WHAT MELOCID IS AND WHAT IT IS USED FOR Melocid Tablets are for the short-term treatment of the symptoms associated with osteoarthritis when this condition flares up. They are also used for the long-term treatment of the symptoms associated with rheumatoid arthritis and ankylosing spondylitis (a type of arthritis that causes pain and stiffness around the spine). Meloxicam is one of a group of medicines called non-steroidal anti- inflammatory drugs and it works by reducing inflammation and pain in the joints and muscles. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELOCID DO NOT TAKE MELOCID: • if you are Lue koko asiakirja
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Melocid 7.5 mg Tablets Melocid 15 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Meloxicam 7.5 mg and 15 mg Excipients with known effect: Each 7.5mg tablet contains 23.5mg Lactose monohydrate. Each 15mg tablet contains 20.0mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 7.5 mg: Pale yellow round tablets with “>” on one side and “ML 7.5” on the other. 15 mg: Pale yellow round tablets with “>” on one side and “ML breakline 15” on the other. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Short-term symptomatic treatment of exacerbation of osteoarthrosis. - Long-term symptomatic treatment of rheumatoid arthritis or of ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use Exacerbation of osteoarthrosis: 7.5 mg once daily (one 7.5 mg tablet or half a 15 mg tablet). In the absence of an effect, the dose may be increased to 15 mg once daily (two 7.5 mg tablets or one 15 mg tablet). Rheumatoid arthritis, ankylosing spondylitis: 15 mg once daily (two 7.5 mg tablets or one 15 mg tablet). (See also "Special populations").Page 1 of 15 Page 2 of 15 Depending on the therapeutic effect, the dose may be reduced to 7.5 mg once daily (one 7.5 mg tablet or half a 15 mg tablet). DO NOT EXCEED A DAILY DOSE OF 15 MG. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The dose should be taken as a single dose with water or other liquid in conjunction with a meal. SPECIAL POPULATIONS _Elderly patients and patients with an increased risk of undesirable effects (see section _ _5.2): _ For elderly patients the recommended dose for long-term treatment of rheumatoid arthrit Lue koko asiakirja