Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
diclofenac potassium, Quantity: 25 mg
Haleon Australia Pty Ltd
Tablet, sugar coated
Excipient Ingredients: macrogol 8000; iron oxide red; sucrose; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; purified talc; maize starch; povidone; calcium phosphate; microcrystalline cellulose; titanium dioxide
Oral
4,5,6,10,20 and 30 tablets
(S3) Pharmacist Only Medicine
As short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component. Symptomatic treatment of primary dysmenorrhoea. INDICATIONS AS AT 16 NOVEMBER 1998: 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.
Visual Identification: Pale red, round, biconvex, sugar coated tablets.; Container Type: Blister Pack; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius
Registered
1993-05-27
1 AUSTRALIAN PRODUCT INFORMATION VOLTAREN RAPID 25 (DICLOFENAC POTASSIUM) TABLET 1 NAME OF THE MEDICINE Diclofenac potassium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: diclofenac potassium 25 mg/tablet. Each Voltaren Rapid 25 tablet contains 2.9 mg of potassium. Also contains sugars. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Light red, round, biconvex sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • As short-term treatment 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 After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest duration should be used. Adverse effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4 ‘Special warnings and precautions for use’). The tablets should be swallowed whole with water and must not be divided or chewed. It is preferable to take the tablets before meals (see section 5.2 Pharmacokinetic Properties – Absorption). ADULTS AND CHILDREN AGED 14 YEARS AND OVER: Voltaren Rapid 25 should not be used for more than a few days at a time unless on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. 2 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 daily dosage should generally be taken in 2 or 3 fractional doses. In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. If the pain is not relieved within 2 hours of this initial dose, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at interva Belgenin tamamını okuyun