Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Rowex Ltd
M02AA; M02AA15
Diclofenac sodium
1 percent weight/weight
Gel
Product subject to prescription which may be renewed (B)
Antiinflammatory preparations, non-steroids for topical use; diclofenac
Marketed
1999-08-23
1 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 to treat pain and inflammation in: Localised forms of soft tissue rheumatism Trauma of tendons, ligaments, muscle and joints e.g. due to sprains, strains and bruises. 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 - you are a child or adolescent younger than 14 years of age If any of these apply t Прочитајте комплетан документ
Health Products Regulatory Authority 15 November 2019 CRN009C71 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac 1% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100g of Diclac 1% w/w Gel contains Diclofenac Sodium 1g. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel. A slightly yellow emulsion, cutaneous gel with an alcoholic smell. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS -Post-traumatic inflammation of the tendons, ligaments, muscles, and joints, e.g. due to sprains, strains and bruises -Localised forms of soft-tissue rheumatism It is recommended that treatment should be reviewed after 14 days in these indications. These indications should not warrant treatment for more than 6 weeks. -For the symptomatic treatment of osteoarthritis of superficial joints such as the knee Therapy should be reviewed after 4 weeks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical. RECOMMENDED DOSAGE SCHEDULE: Adults and children 14 years and over: Diclofenac gel is applied locally to the skin 3 or 4 times daily and rubbed in gently. The amount needed depends on the size of the painful site. For example, 2 to 4 g Diclofenac gel (a quantity ranging from the size of a cherry to the size of a walnut) is sufficient to treat an area of about 400 to 800 cm 2 . After application, the hands should be washed, unless they are the site being treated. The duration of treatment depends on the indication and the response obtained. It is recommended that treatment be reviewed after 2 weeks. These indications should not warrant treatment for more than 6 weeks. 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). Elderly Ther Прочитајте комплетан документ