Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
ETOFENAMATE
Viatris Healthcare GmbH Lutticher Strasse 5 53842 Troisdorf, Germany
M02AA06
ETOFENAMATE 100 mg/g
GEL
ETOFENAMATE 100 mg/g
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Authorised
2008-01-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAUMON GEL 10% Etofenamate For use by adults CAREFULLY READ THROUGH THE ENTIRE PACKAGE INSERT BEFORE YOU USE THIS MEDICINE. THE PACKAGE INSERT CONTAINS IMPORTANT INFORMATION. Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. • Retain this package leaflet. You might want to read it again. • Ask your pharmacist if you need more information or advice. • If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified in this leaflet. See section 4. • If you do not feel better or your condition deteriorates after 2 weeks (for blunt injuries) or after 3-4 weeks (for rheumatic diseases), contact your doctor. WHAT IS IN THIS LEAFLET: 1. What is _Traumon Gel 10%_ , and what is it used for? 2. What should you watch out for before using _Traumon Gel 10%_ ? 3. How to use _Traumon Gel 10%_ 4. What are the possible side effects? 5. How to store _Traumon Gel 10%_ 6. Contents of the package and other information. 1. WHAT IS _TRAUMON GEL 10%_ AND WHAT IS IT USED FOR? _Traumon Gel 10%_ is a medicine for external, topical use. The active ingredient etofenamate belongs to the group of non-steroidal (cortisone-free) anti- inflammatory drugs (rheumatic agents) and has anti-inflammatory and analgesic properties. SCOPE OF USE For the external symptomatic treatment of pain; • in cases of acute strains, sprains or bruises in the limbs due to blunt traumas, e.g. sports injuries; • soft tissues close to joints (e.g. bursas, tendons, ligaments and joint capsules), for osteoarthritis of the knee joint. _ _ If you do not feel better or your condition deteriorates after 2 weeks (for blunt injuries) or after 3-4 weeks (for rheumatic diseases), contact your doctor. 2. WHAT SHOULD YOU BEAR IN MIND BEFORE USING _TRAUMON GEL 10%_? 2 _TRAUMON GEL 10%_ MUST NOT BE USED, – if you are allergic to etofenamate, the main metabolite flufenamic acid, or any of the other ingredients Leggi il documento completo
Page 1 of 7 1. NAME OF THE MEDICATION _Traumon Gel 10% _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Traumon Gel 10% _ 1 g of gel contains 100 mg Etofenamate. Other components with known effects Propylene glycol (E1520): 1 g of Traumon Gel 10% contains 30 mg Propylene glycol. For a complete list of other components, see section 6.1. 3. DOSAGE FORMS _Traumon Gel 10%: _ Gel _ _ Clear to slightly opalescent, colourless to slightly yellowish gel 4. CLINICAL INFORMATION 4.1. SCOPE OF USE For the external symptomatic treatment of pain; ▫ in cases of acute strains, sprains or bruises in the limbs due to blunt traumas, e.g. sports injuries; ▫ soft tissues close to joints (e.g. bursas, tendons, ligaments and joint capsules), for osteoarthritis of the knee joint. 4.2. DOSAGE AND APPLICATION _Traumon Gel 10% _ Three times daily, thinly apply a 10 cm long line of _Traumon Gel 10%_ (approx. 3.3 g per application) to the affected parts of the body and lightly rub it. 4.3. CONTRAINDICATIONS Do not use the _Traumon Gel 10% _ Page 2 of 7 - if you are hypersensitive to the active substance etofenamate, the main metabolite flufenamic acid or any of the other ingredients listed in section 6.1; - if you have a history of hypersensitivity reactions (e.g. asthma, bronchospasms, rhinitis, angioedema or urticaria) after taking acetylsalicylic acid or other non-steroidal anti- inflammatory drugs/anti-inflammatory drugs (NSAIDs); - on open injuries, inflammation or skin infections, as well as on eczema; - on eyes, lips or mucous membranes; - in the last trimester of pregnancy; - for children and adolescents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Traumon Gel 10% _ may only be used under certain precautionary measures and under direct medical supervision if: - Patients suffering from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive respiratory diseases or chronic respiratory infections (especially coupled with hay fever-like symptoms). When using _Traumon Gel 10% / _ these patients Leggi il documento completo