Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
diclofenac sodium, Quantity: 25 mg
Arrotex Pharmaceuticals Pty Ltd
Diclofenac sodium
Tablet, enteric coated
Excipient Ingredients: sodium starch glycollate type A; iron oxide yellow; povidone; methacrylic acid - ethyl acrylate copolymer (1:1); maize starch; microcrystalline cellulose; titanium dioxide; purified talc; magnesium stearate; hypromellose; lactose monohydrate; triethyl citrate; PEG-40 hydrogenated castor oil; colloidal anhydrous silica
Oral
20, 50
(S4) Prescription Only Medicine
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.
Visual Identification: Round, pale yellow, enteric coated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-04-04
CLONAC – Consumer Medicine Information Page 1 of 5 CLONAC _diclofenac sodium _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CLONAC. It does not contain all 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 CLONAC against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT CLONAC IS USED FOR CLONAC belongs to a family of medicines called non-steroidal anti- inflammatory drugs (NSAIDs), which are used to treat pain and reduce inflammation (swelling and redness) that may occur in the following: • 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 (eg. tennis elbow) • menstrual cramps (period pain). These medicines can relieve the symptoms of pain and inflammation, but they will not cure your condition. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. CLONAC is available only with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE CLONAC IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • DICLOFENAC (THE ACTIVE INGREDIENT IN CLONAC) OF ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET • OTHER MEDICINES CONTAINING DICLOFENAC • ASPIRIN • IBUPROFEN • ANY OTHER NSAID. IF YOU ARE NOT SURE IF YOU ARE TAKING ANY OF THE ABOVE MEDICINES, ASK YOUR DOCTOR OR PHARMACIST. Some of the symptoms of an allergic reaction may include • shortness of breath • wheezing or difficulty brea Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – CLONAC (DICLOFENAC SODIUM) TABLETS 1 NAME OF THE MEDICINE Diclofenac sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CLONAC tablets are enteric coated and contain either 25 mg or 50 mg of diclofenac sodium. 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: Pale yellow, round, enteric coated tablets plain on both sides. 50 mg Tablets: Pale brown, round, enteric coated tablets plain on both sides 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE 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. The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed. 2 ADULTS: 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. 4.3 C ONTRAINDICATIONS • Gastri Přečtěte si celý dokument