Страна: Мальта
Язык: английский
Источник: Medicines Authority
ETOFENAMATE
MEDA Manufacturing GmBH
M02AA06
ETOFENAMATE
GEL
ETOFENAMATE 100 milligram(s)/gram
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Authorised
2008-01-18
Package leaflet – Traumon Gel 10% 1 Translation from the German Language PACKAGE LEAFLET: INFORMATION FOR THE USER _TRAUMON_ _®_ _ GEL 10%_ _ _ _Traumon® Gel 10%_, 1 g of gel contains 100 mg of etofenamate. Active substance: Etofenamate For use in adults. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL NEED TO USE _TRAUMON GEL 10%_ CAREFULLY TO GET THE BEST RESULTS FROM IT. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. 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 You must contact a doctor if your symptoms worsen or do not improve after two weeks (blunt injuries) and/or after 3-4 weeks in case of rheumatic disorders. What is in this leaflet: 1. What _Traumon Gel 10%_ is and what it is used for 2. What you need to know before you use _Traumon Gel 10%_ 3. How to use _Traumon Gel 10%_ 4. Possible side effects 5. How to store _Traumon Gel 10% _ 6. Contents of the pack and other information. 1. WHAT _TRAUMON GEL 10%_ IS AND WHAT IT IS USED FOR _Traumon Gel 10% _is a medicinal product for external, local application. Etofenamate, the active substance in _Traumon Gel 10%_, belongs to the group of the non-steroidal (cortisone-free) anti-rheumatics (rheumatism cure) and has anti-inflammatory (antiphlogistic) and pain-relieving (analgesic) properties . Package leaflet – Traumon Gel 10% 2 USES ▫ For the external supportive symptomatic treatment of pain: ▫ caused by acute strains, sprains or bruises in the limbs after blunt injuries such as sports injuries; ▫ in soft tissue near a joint (e.g. bursa, tendon, cord and joint capsule) in cases of arthrosis of the knee. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE _TRAUMON GEL 10%_ DO NOT USE_ TRAUMON GEL 10%_, – if you are allergic (hypersensitive) to etofenamate, flufenamic acid, other non-steroidal a Прочитать полный документ
SPC – EN - Traumon Gel 10% 1 01 November 2017 Translation from the German Language _TRAUMON_ _®_ _ GEL 10% _ EXPERT INFORMATION (German Summary of Product Characteristics (SmPC)) 1. NAME OF THE MEDICINAL PRODUCTS _Traumon Gel 10% _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of gel contains 100 mg of etofenamate Excipient with known effect Propylene glycol (E1520): 1g Traumon Gel 10% contains 30mg propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORMS Clear to slightly opalescent, colourless to slightly yellowish gel 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the external supportive symptomatic treatment of pain: ▫ caused by acute strains, sprains or bruises in the extremities after blunt trauma such as sports injuries; ▫ in soft tissue near a joint (e.g. bursa, tendon, cord and joint capsule) in cases of gonarthrosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply an about 10 cm long ribbon of _ Traumon Gel 10%_ (equivalent to about 3.3 g per administration) three times a day in a thin layer on the affected parts of the body and gently rub into the skin. For topical use only. Do not ingest. Before applying a dressing, _Traumon Gel 10%_ should be left for a few minutes to dry on the skin. The application of an occlusive dressing is not recommended. SPC – EN - Traumon Gel 10% 2 01 November 2017 In case of blunt injury (e.g. sports injury) usually treatment for one week is sufficient. Therapeutic benefit of a longer use has not been verified. For rheumatic disorders therapy lasting 3-4 weeks is sufficient in most cases. If symptoms persist a doctor should be consulted to determine whether further treatment is required. 4.3 CONTRAINDICATIONS _Traumon Gel 10%_ must not be used in the following cases: - Hypersensitivity to the active substance etofenamate, the main metabolite flufenamic acid or to any other of the excipients listed in section 6.1; - History of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) occ Прочитать полный документ