Држава: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Diclofenac sodium 50mg;
Sandoz New Zealand Limited
Diclofenac sodium 50 mg
50 mg
Enteric coated tablet
Active: Diclofenac sodium 50mg Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Methacrylic acid copolymer Microcrystalline cellulose Purified talc Sodium starch glycolate Titanium dioxide Triethyl citrate
Blister pack, PVDC/PVC aluminium foil blister containing, 50 tablets
Prescription
Prescription
Amoli Organics Limited
Treatment of: inflammatory and degenerative forms of rheumatism - rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism; acute attacks of gout; 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; as an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Package - Contents - Shelf Life: Blister pack, Polypropylene/Aluminium or PVDC/PVC Aluminium - 50 tablets - 18 months from date of manufacture stored at or below 25°C
2009-06-08
DICLOFENAC SANDOZ ® 1 DICLOFENAC SANDOZ ® _diclofenac sodium enteric-coated tablets _ 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 Прочитајте комплетан документ
NEW ZEALAND DATA SHEET Page 1 of 19 1 PRODUCT NAME DICLOFENAC SANDOZ 25 mg enteric coated tablet 50 mg enteric coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Diclofenac Sandoz 25 mg tablet contains Diclofenac Sodium 25 mg Each Diclofenac Sandoz 50 mg tablet contains Diclofenac Sodium 50 mg _Excipients with known effect:_ lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 25 MG Brown-yellow gastro-resistant film coated tablets, round, biconvex faced with a plain rim. Approximate tablet dimensions: diameter 6.1 to 6.3 mm; thickness 2.9 to 3.2 mm. Each tablet contains Diclofenac Sodium Ph Eur 25 mg. 50 MG Brown-yellow gastro-resistant film coated tablets, round, biconvex faced with a banded rim. Approximate tablet dimensions: diameter 8.0 to 8.3 mm; thickness 3.5 to 3.8 mm. Each tablet contains Diclofenac Sodium Ph Eur 50 mg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: • Inflammatory and degenerative forms of rheumatism - rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism; • Acute attacks of gout; • 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; NEW ZEALAND DATA SHEET Page 2 of 19 • As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. 4.2 DOSE AND METHOD OF ADMINISTRATION _DOSAGE _ Diclofenac Sandoz 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 po Прочитајте комплетан документ