Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Rowex Ltd
M02AA; M02AA15
Diclofenac sodium
1 percent weight/weight
Gel
Product not subject to medical prescription
Antiinflammatory preparations, non-steroids for topical use; diclofenac
Marketed
2004-07-30
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLAC RELIEF 1% W/W GEL diclofenac sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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 or nurse. 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 Diclac Relief Gel is and what it is used for 2. What you need to know before you use Diclac Relief Gel 3. How to use Diclac Relief Gel 4. Possible side effects 5. How to store Diclac Relief Gel 6. Contents of the pack and other information. 1. WHAT DICLAC RELIEF GEL IS AND WHAT IT IS USED FOR DICLAC belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammation. Diclac Relief Gel can be used topically in adults, the elderly and adolescents aged 14 years and over to relieve pain and reduce swelling in a number of painful conditions affecting the joints and muscles e.g. sprains, strains and bruises. It is also used to relieve the pain of muscular rheumatism. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DICLAC RELIEF GEL DO NOT USE DICLAC RELIEF GEL IF: - you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) - you are an asthmatic - you have ever had an allergic reaction after taking medicines to treat inflammation or pain (e.g. acetylsalicylic acid/aspirin, diclofenac or ibuprofen). Reactions may include asthma, runny nose, skin rash, face swelling. If you think you may be allergic, ask your doctor for advice. - you have broken or denuded skin - you are pregnant or breast feeding - Przeczytaj cały dokument
Health Products Regulatory Authority 09 January 2024 CRN00DHGZ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac Relief 1% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of Diclac Relief 1% w/w Gel contains Diclofenac Sodium 10 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel A slight yellow emulsion, cutaneous gel with an alcoholic smell. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the local symptomatic relief of pain and inflammation in: - trauma of the tendons, ligaments, muscles and joints, - e.g. due to sprains, strains and bruises. - localised forms of soft tissue rheumatism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children 14 years or over:_ Diclac Relief Gel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3-4 times a day. After application, the hands should be washed unless they are the site being treated. Fire, flame and smoking must be avoided until Diclac Relief has dried. It is recommended that treatment be limited to 7 days. In children aged 14 years and over, if this product is required for more than 7 days for pain relief, or if the symptoms worsen, the patient/ parents of the adolescent is/are advised to consult a doctor. _Children and adolescents below 14 years:_ There are insufficient data on efficacy and safety available for children and adolescents below 14 years of age (see also contraindications section 4.3). _Use in the elderly:_ The usual adult dosage may be used. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Przeczytaj cały dokument