Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
diclofenac sodium, Quantity: 50 mg
Novartis Pharmaceuticals Australia Pty Ltd
Suppository, moulded
Excipient Ingredients: hydrogenated coco-glycerides; Hard fat
Rectal
10 suppositories
(S4) Prescription Only Medicine
Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis. Short term (up to three days) treatment of post-operative pain in children.
Visual Identification: White to yellowish torpedo-shaped with smooth surfaces; Container Type: Blister Pack; Container Material: PVC/PE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-05-25
VOLTAREN ® TABLETS & SUPPOSITORIES _diclofenac sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Voltaren tablets and suppositories. 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 using 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 IS USED FOR Voltaren belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs), which are used to treat pain and reduce inflammation (swelling and redness). Voltaren is used to treat: • 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 (e.g. tennis elbow) • menstrual cramps (period pain) • relieve pain in children after they have had an operation. 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 purpose. Voltaren is only available with a doctor's prescription. It is not addictive. Voltaren suppositories should not be used in children under 12 months of age. Because of their strength, Voltaren Διαβάστε το πλήρες έγγραφο
1 AUSTRALIAN PI – VOLTAREN ® (DICLOFENAC SODIUM) TABLETS AND SUPPOSITORIES 1 NAME OF THE MEDICINE Active ingredient: Diclofenac sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Voltaren Tablets are enteric coated and contain either 25 mg or 50 mg of diclofenac sodium. List of excipients with known effect: lactose monohydrate For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. Voltaren Suppositories contain either 12.5 mg, 25 mg, 50 mg or 100 mg diclofenac sodium in a triglyceride base. 3 PHARMACEUTICAL FORM Enteric coated tablets 25 MG: yellow, round, slightly biconvex tablets with bevelled edges. Debossed with BZ on one side and CG on reverse side’.50 MG: light brown, round, slightly convex, coated tablets. Imprinted with CG on one side and GT on the other’. Suppositories 12.5 MG, 25 MG AND 50 MG: white to yellowish torpedo-shaped with smooth surfaces’ 100 MG: yellowish white "torpedo shaped" suppository, rounded one end, flat at other, being 30 mm long 12 mm diameter at widest part tapering to 9 mm small end’ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Tablets: • 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. Suppositories: • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis. • Short term (up to three days) treatment of post-operative pain in children. 2 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 FOR USE’). Patients on long term treatment Διαβάστε το πλήρες έγγραφο