দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
ETOFENAMATE
Chiesi Espana S.A. c/Berlin 38-48. 7 Planta 08029. Barcelona, Spain
M02AA06
ETOFENAMATE 50 mg/ml
CUTANEOUS SPRAY, SOLUTION
ETOFENAMATE 50 mg/ml
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Authorised
2006-11-03
PACKAGE LEAFLET: INFORMATION FOR THE USER FLOGOPROFEN SOLUTION Etofenamate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - 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 talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET: 1. What Flogoprofen is and what it is used for 2. What you need to know before you use Flogoprofen 3. How to use Flogoprofen 4. Possible side effects 5. How to store Flogoprofen 6. Contents of the pack and other information 1. WHAT FLOGOPROFEN IS AND WHAT IT IS USED FOR Flogoprofen is an anti-inflammatory with analgesic properties used for the topical treatment of painful and inflammatory processes. Flogoprofen is indicated in adults and adolescents (over 12 years) for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, strains, torticollis or other contractures, low back pain and mild sprains by a twist. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLOGOPROFEN DO NOT USE FLOGOPROFEN: - If you are allergic to etofenamate or any other of the ingredients of this medicine (listed in section 6). - If the area to which the solution is to be applied is irritated or has a wound or any skin disease. - In the mucous membranes or the eyes. - If you have suffered any allergic reaction caused by acetylsalicylic acid or other anti-inflammatory medicine. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Flogoprofen. - Use only on intact skin. Do not apply to open wounds, mucous membranes or irritated skin. - Avoid contact with the eyes. In the event of contact with the eyes, wash thoroughly সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flogoprofen 50 mg/ml Cutaneous spray solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Cutaneous spray solution contains 50 mg of etofenamate EXCIPIENTS WITH KNOWN EFFECT: Each ml of solution contains 100 mg of dimethyl sulfoxide and 100 mg of propyl ene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Flogoprofen 50 mg/ml Cutaneous spray solution: Clear slightly yellowish solution with an aroma of turpentine oil. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated in adults and adolescents (over 12 years) for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, strains, torticollis or other contractures , low back pain and mild sprains caused by a twist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cutaneous use. Adults and adolescents (over 12 years): Apply a thin layer of gel or solution 3 or 4 times a day on the affected area and massage gently until absorbed. Wash hands after each application. Do not apply for more than 7 consecutive days. Children (younger than 12 years): Do not administer to children because of the lack of safety and efficacy datari_nttJt\i.Sr_po.pllll joJ - . I I Adults over 65 years: No dose modification is required for this group of patients. 4.3 Contraindications Hypersensitivity to etofenamate or to any of the medicine's excipierits. It should not be applied to mucous membranes, wounds, irritated areas or areas of sunburn or dermatosis. Do not administer to patients with previous allergic reactions (rhinitis, asthma, pruritus, angioedema, urticaria, shock or other), caused by acetylsalicylic acid or other NSAIDs, due to the possibility of cross hypersensitivity. 4.4 Special warnings and precautions for use Use only on intact skin. Do not apply to open wounds, mucous membranes or eczematous skin. Avoid contact with the eyes and mucous membranes. In the event of contact with the eyes or mucous membranes, wash সম্পূর্ণ নথি পড়ুন