Pajjiż: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Diclofenac sodium 100mg; ;
Novartis New Zealand Ltd
Diclofenac sodium 100 mg
100 mg
Modified release tablet
Active: Diclofenac sodium 100mg Excipient: Cetyl alcohol Colloidal silicon dioxide Hypromellose Iron oxide red Magnesium stearate Opacode black S-1-17823 Polysorbate 80 Povidone Purified talc Sucrose Titanium dioxide
Blister pack, 30 tablets
Prescription
Prescription
Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)
· Treatment of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism.
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 60 months from date of manufacture, no storage statement needed
1983-09-29
__________________________________________________________________________________________________ VOLTAREN Page 1 of 6 VOLTAREN 50MG TABLETS (DICLOFENAC SODIUM) 75MG SR TABLETS (DICLOFENAC SODIUM) 50MG DISPERSIBLE TABLETS (DICLOFENAC FREE ACID) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Voltaren . It does not contain all the available information . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking it 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 VOLTAREN IS USED FOR Voltaren relieves pain and reduces 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) Voltaren belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines can relieve the symptoms of pain and inflammation but they will not cure your condition. Your doctor may prescribe Voltaren for another purpose. Ask your doctor if you have any questions about why it has been prescribed for you. Voltaren is only available with a doctor's prescription. It is not addictive. BEFORE YOU TAKE VOLTAREN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE VOLTAREN IF YOU HAVE AN ALLERGY TO: diclofenac (the active ingredient in Voltaren) or any of the other ingredients listed at the end of this leaflet other medicines containing diclofenac (eg. Voltaren Emulgel) aspirin/ acetylsalicylic acid any other NSAID medicine Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure Aqra d-dokument sħiħ
NEW ZEALAND DATA SHEET Page 1 of 14 1 PRODUCT NAME VOLTAREN® SR 75 mg Modified release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release tablet contains 75 mg of diclofenac sodium. For the full list of excipients, see section 6.1 This product is not able to deliver all approved dose regimens. 3 PHARMACEUTICAL FORM Modified release tablets. Pale pink, triangular, prolonged‐release, film‐coated tablet containing 75mg diclofenac sodium. Dimensions: height: 8.5mm, width: 9.00mm. Branding: CG on one side and ID on the other side in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non‐ articular rheumatism. Post‐traumatic and post‐operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis. 4.2 DOSE AND METHOD OF ADMINISTRATION This product is not able to deliver all approved dose regimens. Voltaren SR should only be prescribed when the benefits are considered to outweigh the potential risks. 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). Dosage GENERAL POPULATION The recommended initial daily dose is 100 to 150 mg, in 1 or 2 divided doses. In milder cases, as well as for long‐term therapy, 75 to 100 mg daily is usually sufficient. Where the symptoms are most pronounced during the night or in the morning, Voltaren SR 75 mg should preferably be taken in the evening. SPECIAL POPULATIONS _PAEDIATRIC POPULATION _ Because of their dosage strength, Voltaren SR tablets 75 mg are not suitable for children and adolescents. Aqra d-dokument sħiħ