מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Astellas Pharma Co. Ltd
M01AB05
DICLOFENAC SODIUM
100 Milligram
Suppositories
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances
Authorised
2006-06-13
51734239 1. 2. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPOR- TANT INFORMATION FOR YOU. • 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 signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side ef- fects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Difene is and what it is used for 2. What you need to know before you use Difene 3. How to use Difene 4. Possible side effects 5. How to store Difene 6. Contents of the pack and other information 1. WHAT DIFENE IS AND WHAT IT IS USED FOR Difene contains diclofenac sodium as the active in- gredient, which is a non-steroidal anti-inflammatory drug (NSAID). This means that it is a painkilling medicine which reduces inflammation and swelling, but it does not contain any steroid medicine. Difene suppositories are used rectally in the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis, osteoarthritis, ankylosing spondylitis, psoriatic arthropathy, low back pain and acute musculoskeletal disorders including peri-arthritis, tendonitis, tenosynovitis, bursitis, sprains, strains, dislocations and in acute gout. It can also be used to treat pain and inflammation after orthopaedic, dental or other minor surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFENE SUPPOSITORIES DO NOT TAKE DIFENE IF YOU: • are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6). • have ever had an allergic reaction (difficulty in breathing, skin rash and runny nose) to aspirin (acetylsalicylic acid) or any other NSAID such as ibuprofen. • have had any gastrointestinal problems after taking any other NSAID, e.g. vomiting blood or passing black, tarry stools. • ha קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difene 100mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains diclofenac sodium 100mg. Each suppository contains 100mg of diclofenac sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository. White torpedo-shaped rectal suppositories consisting of a waxy base weighing approximately 2 g. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Difene can be used in the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis, osteoarthritis, ankylosing spondylitis, psoriatic arthropathy, low back pain and acute musculoskeletal disorders including peri-arthritis, tendinitis, tenosynovitis, bursitis, sprains, strains, dislocations and in acute gout. It can also be of use in the management of post operative pain and inflammation in orthopaedic, dental and other minor surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For rectal use only. Adults: The usual dosage is 100 mg inserted into the rectum in the evening. 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 (see section 4.4, Special warnings and precautions for use). Children: Use in children or adolescents is not recommended. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. See also section 4.4, Special warnings and precautions for use. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Active gastric or i קרא את המסמך השלם