Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
diclofenac sodium, Quantity: 50 mg
Sandoz Pty Ltd
Diclofenac sodium
Tablet, enteric coated
Excipient Ingredients: maize starch; methacrylic acid copolymer; colloidal anhydrous silica; magnesium stearate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; purified talc; triethyl citrate; iron oxide yellow; titanium dioxide; lactose monohydrate; sodium starch glycollate
Oral
50 tablets
(S4) Prescription Only Medicine
Inflammatory and degenerative forms of rheumatism; rheumatoid arthritis; osteoarthritis. Relief of acute or chronic pain states in which there is an inflammatory component. Symptomatic treatment of primary dysmenorrhoea.
Visual Identification: round brown tablet; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2010-01-11
FENAC _contains the active ingredient diclofenac sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FENAC. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking FENAC against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT FENAC IS USED FOR FENAC belongs to a group of medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation (swelling and redness). FENAC is used to treat the symptoms of: • different types of arthritis including rheumatoid arthritis and osteoarthritis • other painful conditions where swelling is a problem, such as back pain, rheumatism, muscle strains, sprains and tendonitis (e.g. tennis elbow) • menstrual cramps (period pain). Although FENAC can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor may have prescribed FENAC for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FENAC HAS BEEN PRESCRIBED FOR YOU. FENAC is not recommended for use in children as its safety and effectiveness in children has not been established. There is no evidence that FENAC is addictive. FENAC is available only with a doctor's prescription. BEFORE YOU TAKE FENAC _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE FENAC IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • diclofenac (the active ingredient in this medicine) any of the other ingredients listed at the end of this leaflet other medicines containing diclofenac (e.g Voltaren Rapid tablets, Voltaren Emulgel) • aspirin • ibuprofen • any other NSAID IF YOU ARE NOT SURE IF YOU ARE TAKING ANY OF THE ABOVE MEDICINES, ASK YOUR DOCTOR OR PHARMACIST. Symptoms of an allergic reaction to Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION FENAC _Diclofenac sodium enteric coated tablets _ 1 NAME OF THE MEDICINE Diclofenac sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FENAC tablets are enteric coated and contain either 25 mg or 50 mg of diclofenac sodium. Excipients with known effect: Contains sugars as lactose and trace amounts of sulfites. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM FENAC 25 mg is available as a round brown coloured enteric-coated tablet. FENAC 50 mg is available as a round brown coloured enteric-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis. • Relief of acute or chronic pain states in which there is an inflammatory component. • Symptomatic treatment of primary dysmenorrhoea. 4.2 DOSE AND METHOD OF ADMINISTRATION After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Patients on long term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. DOSE Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100 mg daily is usually sufficient. The daily dosage should generally be prescribed in 2 or 3 divided doses. In primary dysmenorrhoea the daily dosage, which should be individually adapted, is generally 50 to 150 mg. Initially a dose of 50 to 100 mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started upon appearance of the first symptoms and, depending on the symptomatology, continued for a few days. METHOD OF ADMINISTRATION The tablets should be swallowed whole with liquid, preferably before meals, and must not b Прочитајте комплетан документ