País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
diclofenac sodium, Quantity: 50 mg
Apotex Pty Ltd
Diclofenac sodium
Tablet, enteric coated
Excipient Ingredients: lactose monohydrate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; maize starch; sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; methacrylic acid copolymer; triethyl citrate; purified talc; titanium dioxide; iron oxide yellow
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: Brown yellow film coated tablet, biconvex with facet on both sides, intact surface and uniform colour.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2009-05-06
APO-DICLOFENAC 1 APO-DICLOFENAC _Diclofenac sodium _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR APO-Diclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and reduce inflammation (swelling and redness). APO-Diclofenac is used to treat: • 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) It can relieve the symptoms of pain and inflammation but it will not cure your condition. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. It is not addictive. There is not enough information to recommend the use of this medicine for children. BEFORE YOU USE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT USE THIS MEDICINE IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • diclofenac • or any of the other ingredients listed at the end of this leaflet • aspirin • ibuprofen • any other NSAID • lactose, or are lactose intolerant - these tablets contain a small amount of l Leer el documento completo
1 AUSTRALIAN PRODUCT INFORMATION APO-DICLOFENAC ENTERIC COATED TABLETS (DICLOFENAC SODIUM) 1 NAME OF THE MEDICINE Diclofenac sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg or 50 mg of diclofenac sodium as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 25 MG TABLETS (AUST R 160729) Brown yellow film-coated tablet, biconvex with an intact surface and uniform colour. 50 MG TABLETS (AUST R 160730) Brown yellow film-coated tablet, biconvex with facet on both sides, intact surface and uniform colour. 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 APO- Diclofenac enteric coated tablets are intended for oral administration. Pregnancy: see section 4.3 CONTRAINDICATIONS and section 4.6 FERTILITY, PREGNANCY AND LACTATION. 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 minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see 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. The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed. Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100 mg daily is usually sufficient. 2 The daily dose should generally be prescribed in two or three 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 Leer el documento completo