Land: Malta
Taal: Engels
Bron: Malta Medicines Authority
IBUPROFEN
Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom
M02AA13
IBUPROFEN 5 % (W/W)
GEL
IBUPROFEN 5 % (W/W)
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Withdrawn
2006-03-20
pharmacode read direction READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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 recommended for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Fenbid Gel and what it is used for 2. Before you use Fenbid Gel 3. How to use Fenbid Gel 4. Possible side effects 5. How to store Fenbid Gel 6. Further information 1. WHAT IS FENBID GEL AND WHAT IT IS USED FOR Fenbid Gel contains ibuprofen and belongs to a group of medicines called non-steroid anti- inflammatory drugs (NSAID’s). These medicines reduce pain and inflammation, and bring down a high temperature. Fenbid Gel is used to treat a number of painful conditions affecting the joints and muscles, such as backache, rheumatic and muscular pain, sprains, strains and sports injuries. It is also used to treat pain from non-serious arthritic conditions and nerve pain (neuralgia). 2. BEFORE YOU USE FENBID GEL DO NOT USE FENBID GEL: • If you are allergic to ibuprofen, aspirin or similar medicines (e.g NSAIDs) or any of the other ingredients in this gel (listed at the end of this leaflet) • If you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) • On broken, damaged, infected or diseased skin. TAKE SPECIAL CARE WITH FENBID GEL: • Protect treated areas from direct sunlight to avoid any sensitivity reaction, e.g. a rash • If you suffer from bronchial asthma or any allergic disease • If you have had an ulcer or some other problem affecting your stomach or intestines in the past • If you have asthma or wheezing attacks (or if you have had asthma in the past) • If you have any kidney problems • If you develop a rash after using the gel stop using it any furthe Lees het volledige document
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fenbid gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5% w/w Ibuprofen Phur. 3 PHARMACEUTICAL FORM Gel for topical application. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Pharmacy Only Indications_:_ _ Topical analgesic and anti-inflammatory for backache, pain of non-serious arthritic conditions, muscular pain, sprains, strains, sports injuries and neuralgia. _General Sales List Indications_:_ _ Topical analgesic and anti-inflammatory for backache, rheumatic and muscular pain, sprains, strains and sports injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Strength 5% maximum METHOD OF ADMINISTRATION For topical application to the skin. DOSAGE _Adults, the elderly and children over 12_ years:_ _ Squeeze 50 to 125mg (4 to 10cm) of the gel from the tube and lightly rub into the affected area until absorbed. The dose should not be repeated more frequently than every four hours and no more than 4 times in any 24 hour period. Wash hands after each application. Do not exceed the stated dose. Review treatment after 2 weeks, especially if the symptoms worsen or persist. Page 2 of 6 _ _ _Children under _12 _years:_ Do not use on children under 12 years of age except on the advice of a doctor. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the constituents. Hypersensitivity to aspirin, or other non-steroidal anti-inflammatory drugs, asthma, rhinitis or urticaria. Not to be used on broken or damaged skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin. Discontinue if rash develops. Hands should be washed immediately after use. Not for use with occlusive dressings. The label will state: Do not exceed stated dose Keep out of reach of children For external use only. If symptoms persist consult your doctor or pharmacist Do not use if you are allergic to Ibuprofen or any of the ingredients, aspirin, or any other painkillers. Consult your docto Lees het volledige document