Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Glucosamine
Laboratoires Expanscience
M01AX; M01AX05
Glucosamine
625 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine
Not marketed
2007-10-05
PACKAGE LEAFLET: INFORMATION FOR THE USER FLEXOVE 625 MG TABLETS Glucosamine 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 further questions, please 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. IN THIS LEAFLET : 1. What Flexove is and what it is used for 2. What you need to know before you take Flexove 3. How to take Flexove 4. Possible side effects 5. How to store Flexove 6. Contents of the pack and other information 1. WHAT FLEXOVE IS AND WHAT IT IS USED FOR Flexove belongs to the group of medicines called anti-inflammatory and anti-rheumatic agents, non-steroids. Flexove is used for the relief of symptoms in mild to moderate osteoarthritis of the knee. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLEXOVE DO NOT TAKE FLEXOVE IF YOU: are ALLERGIC to GLUCOSAMINE or to ANY OF THE OTHER INGREDIENTS of Flexovethis medicine (listed in section 6). are ALLERGIC (hypersensitive) to SHELLFISH , since glucosamine is manufactured from shellfish. WARNINGS AND PRECAUTIONS. Glucosamine is not indicated for the treatment of acute painful symptoms. TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING FLEXOVE suffer from IMPAIRED GLUCOSE TOLERANCE . More frequent controls of your blood glucose levels may be necessary when starting treatment with Flexove. have a KNOWN RISK FACTOR FOR CARDIOVASCULAR (HEART) DISEASE , since an abnormally high level of cholesterol in the blood has been observed in a few patients treated with Flexove. suffer from ASTHMA . When starting on Flexove, you should be aware of potential worsening of symptoms. CHILDREN AND ADOLESCENTS - Flexove should not be used in c Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flexove 625 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg of glucosamine hydrochloride equivalent to 625 mg of glucosamine For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to light beige, oval tablet of 10 mm x 18.75 mm marked with “G” on one side and a score line on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flexove is indicated in adults for the relief of symptoms in mild to moderate osteoarthritis of the knee. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1250 mg glucosamine once daily for relief of symptoms. Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated. Additional information on special populations. _Paediatric population_ Flexove should not be used in children and adolescents below the age of 18 (see 4.4). _Elderly_ No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients. _Impaired renal and/or liver function_ In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed. _Method of administration_ Tablets can be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Flexove must not be given to patients who are allergic to shellfish as the active substance is obtained from shellfish. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Przeczytaj cały dokument