Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
diclofenac sodium
Sandoz Pty Ltd
Registered
DICLOFENAC SANDOZ ® 1 DICLOFENAC SANDOZ ® _diclofenac sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Diclofenac Sandoz. 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.sandoz.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 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 DICLOFENAC SANDOZ IS USED FOR This medicine is used to treat: • inflammatory and degenerative forms of rheumatism, rheumatoid arthritis and osteoarthritis • relief of acute or chronic pain states in which there is an inflammatory component • symptoms of menstrual pain (period pain). It contains the active ingredient diclofenac sodium. Diclofenac sodium belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). It works by reducing pain and inflammation (swelling and redness). 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. There is no evidence that this medicine is addictive. There is not enough information to recommend the use of Diclofenac Sandoz tablets in children. BEFORE YOU TAKE DICLOFENAC SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE Read the complete document
191209-diclofenac-sandoz-pi Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION DICLOFENAC SANDOZ ® (DICLOFENAC SODIUM) 1 NAME OF THE MEDICINE Diclofenac sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Diclofenac Sandoz ® 25 mg film-coated tablets contains 25 mg diclofenac sodium. Each Diclofenac Sandoz ® 50 mg film-coated tablets contains 50 mg diclofenac sodium. Diclofenac sodium is an odourless, yellowish-white, crystalline powder sparingly soluble in water. _List of excipients with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Diclofenac Sandoz 25 mg enteric coated tablet: Brown yellow film coated tablet, biconvex with an intact surface and uniform colour. Diclofenac Sandoz 50 mg enteric coated tablet: Brown yellow film coated tablet, biconvex with facet on both sides, intact surface and uniform colour. _Not all strengths may be marketed in Australia. _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • 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. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE 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. Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100 mg daily is usually sufficient. 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 dos Read the complete document