Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
diclofenac potassium, Quantity: 50 mg
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, sugar coated
Excipient Ingredients: colloidal anhydrous silica; calcium phosphate; magnesium stearate; maize starch; povidone; sodium starch glycollate; microcrystalline cellulose; iron oxide red; macrogol 8000; sucrose; purified talc; titanium dioxide
Oral
4,5,6,10,20 and 30 tablets
(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: Reddish brown, round, biconvex, sugar coated tablets, diameter approx.8.8mm, thickness approx.5.2mm.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1993-05-27
VOLTAREN ® RAPID _diclofenac potassium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Voltaren Rapid. 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. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VOLTAREN RAPID IS USED FOR Voltaren Rapid belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAID). It relieves pain and reduces inflammation (swelling and redness). It is used for short-term treatment of the following conditions: • migraine headaches and it may also relieve the accompanying symptoms, such as nausea and vomiting, which you sometimes experience when you have a migraine • relief of menstrual cramps (period pain). • short-term treatment (up to 1 week) of other painful conditions where swelling is a problem such as back or joint pain, dental pain, muscle strains or sprains and tendonitis (e.g. tennis elbow). Voltaren Rapid 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 purpose. Voltaren Rapid is only available with a doctor's prescription. It is not addictive. There is not eno Izlasiet visu dokumentu
1 AUSTRALIAN PI – VOLTAREN ® RAPID (DICLOFENAC POTASSIUM) TABLETS 1 NAME OF THE MEDICINE Active ingredient: Diclofenac Potassium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Voltaren Rapid tablets contain 50 mg of diclofenac potassium. Diclofenac potassium is a white or slightly yellowish, crystalline powder, slightly hygroscopic, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, slightly soluble in acetone. EXCIPIENTS: Each diclofenac potassium 50 mg tablet contains 5.8 mg of potassium. For the full list of excipients, see section 6.1 ‘LIST OF EXCIPIENTS’. 3 PHARMACEUTICAL FORM Tablets (reddish-brown, round, biconvex sugar-coated tablets). 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • As short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component. • Treatment of acute migraine attacks (with or without aura) • Symptomatic treatment of primary dysmenorrhoea. 4.2 D OSE AND METHOD OF 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 minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 ‘SPECIAL WARNINGS AND PRECAUTIONS’). 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 DOSE Adults ACUTE PAIN STATES WITH AN INFLAMMATORY COMPONENT As a rule, the initial daily dosage for adults is 100 to 150 mg. In milder cases, as well as for children over 14 years of age, 75 to 100 mg daily is usually sufficient. The total daily dosage should generally be prescribed in 2 or 3 fractional doses. Treatment is to continue for a maximum of 7 days. If th Izlasiet visu dokumentu