Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
colchicine, Quantity: 500 microgram
Pharmacor Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; sodium starch glycollate; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch
Oral
30 tablets
(S4) Prescription Only Medicine
Relief of pain in acute gout. Colchicine should not be used unless NSAIDS are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. Colchicine is not an analgesic and does not provide relief from other types of pain.
Visual Identification: Round, off white coloured biconvex, uncoated tablets embossed "C5" on one upper side and plain on the bottom face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 31 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-03-22
PHARMACOR COLCHICINE Page 1 PHARMACOR COLCHICINE COLCHICINE _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PHARMACOR COLCHICINE. 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 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 PHARMACOR COLCHICINE IS USED FOR PHARMACOR COLCHICINE contains colchicine as the active ingredient. PHARMACOR COLCHICINE is used for the relief of pain in acute attacks of gout. It is not an analgesic and does not provide relief from other types of pain. PHARMACOR COLCHICINE has a preventative effect that helps to reduce the incidence of acute attacks. It will not reduce the amount of uric acid in the body. PHARMACOR COLCHICINE belongs to a group of medicines called antigout drugs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHARMACOR COLCHICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. There is no evidence that it is addictive. _HOW PHARMACOR _ _COLCHICINE WORKS _ • Colchicine decreases leucocyte chemo taxis and phagocytosis and thereby inhibits the formation and release of a chemotactic glycoprotein that is produced during the phagocytosis of urate crystals. • Colchicine also inhibits urate crystal deposition, which is enhanced by a low pH in the tissues, probably by inhibiting oxidation of glucose and subsequent, lactic acid production in leucocytes. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHARMACOR COLCHICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. There Read the complete document
PHARMACOR COLCHICINE Page 1 AUSTRALIAN PRODUCT INFORMATION PHARMACOR COLCHICINE (COLCHICINE) TABLETS 1. NAME OF THE MEDICINE Colchicine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACOR COLCHICINE - Each uncoated tablet contains 500 microgram of Colchicine Excipient with known effect – contains lactose For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM Uncoated Tablets PHARMACOR COLCHICINE - Round, off white coloured biconvex, uncoated tablets embossed “C5” on one upper side and plain on the bottom face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of pain in acute gout. Colchicine should not be used unless NSAIDS are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. Colchicine is not an analgesic and does not provide relief from other types of pain. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS 1mg (2 tablets) at the first sign of the flare followed by 0.5mg (1 tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.5 mg over a one hour period. Do not repeat the course within 3 days. If gastrointestinal side effects occur, discontinue immediately. Colchicine may be taken with or without food. PHARMACOR COLCHICINE Page 2 CHILDREN: The safety and effectiveness in this age group have not been established. See SECTION 4.3 CONTRAINDICATIONS . ELDERLY: The elderly, even those with normal renal and hepatic function, may be more susceptible to cumulative toxicity with colchicine. As the elderly are more likely to have age related renal function impairment, caution and careful attention to dosage is recommended. In those elderly patients who are small and slight (less than 50kg) and those with renal or hepatic impairment, other treatments should be considered. If colchicine is used in these patients a maximum cumulative dose of 1.5mg over three days should be observed. REDUCED HEPATIC AND Read the complete document