Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Astellas Pharma Co. Ltd
M02AA15
DICLOFENAC SODIUM
1 %w/w
Gel
Product subject to prescription which may be renewed (B)
Antiinflammatory preparations, non-steroids for topical use
Authorised
2006-06-13
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What DIFENE 1% w/w GEL is and what it is used for 2. What you need to know before you use DIFENE 1% w/w GEL 3. How to use DIFENE 1% w/w GEL 4. Possible side effects 5. How to store DIFENE 1% w/w GEL 6. Contents of the pack and other information 1. WHAT DIFENE 1% W/W GEL IS AND WHAT IT IS USED FOR DIFENE 1% w/w GEL contains the active substance diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). DIFENE 1% w/w GEL is used to relieve the acute pain and swelling affecting small or medium-sized joints and surrounding tissues due to sprains, strains and bruising. It can also be used for the treatment of soft tissue rheumatism. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFENE 1% W/W GEL DO NOT USE DIFENE 1% W/W GEL • If you are allergic (hypersensitive) to diclofenac sodium or any other ingredient of DIFENE 1% w/w GEL. Please refer to section 6 of this leaflet for the ingredients of Difene. • If you have ever had an allergic reaction (skin rash, difficulty in breathing or runny nose) to aspirin (acetylsalicylic acid) or any other NSAIDs such as ibuprofen. • In the last three months of pregnancy - please see section on ‘Pregnancy and breastfeeding’. • If you have a stomach ulcer. • If you have ever had an allergic reaction to propylene glycol or isopropyl alcohol. • Use in children and adolescents is not recommended. If any of these apply to you, tell you Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difene 1% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diclofenac sodium 1 %w/w Excipients with known effect: propylene glycol (250mg/g of gel) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gel. A slightly turbid, colourless gel with the odour of isopropyl alcohol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For local symptomatic relief of pain and inflammation in 1. Trauma of the tendons, ligaments, muscles and joints e.g. due to sprains, strains and bruises. 2. Localised forms of soft tissue rheumatism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical administration. Adults: Diclofenac Gel should be rubbed gently into the skin. Depending on the size of the site to be treated, 2 to 4 g (a circular shaped mass approximately 2 to 2.5 cm in diameter) should be applied 2 to 4 times daily. After the application the hands should be washed unless they are the site being treated. It is recommended that the treatment be reviewed after 14 days. These indications should not warrant treatment for more than 6 weeks. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. Children and adolescents below 14 years: Not recommend. There are insufficient data on efficacy and safety available for children and adolescents below 14 years of age (see also contraindications section 4.3). 4.3 CONTRAINDICATIONS Hypersensitivity to diclofenac or any of the excipients. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or ether non- steroidal anti-inf1ammatory drugs (NSAIDs). Third trimester of pregnancy Lees het volledige document