COLCHICINE Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Colchicine 500 microgram Tablets.
Qualitative and quantitative composition
Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500 micrograms on a dry weight basis). Excipient with known effect: One tablet contains 56.6mg of lactose. For the full list of excipients, see ...
Pharmaceutical form
Tablet oral use.
Therapeutic indications
Adults Treatment of acute gout. Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs.
Posology and method of administration
Posology Adults Treatment of acute gout attack 1 mg (2 tablets) to start followed by 500 micrograms (1 tablet) after 1 hour. No further tablets should be taken for 12 hours. After 12 hours, treatment can ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with blood dyscrasias. Pregnancy. Breastfeeding. Women of childbearing potential unless using effective ...
Special warnings and precautions for use
Colchicine is potentially toxic so it is important not to exceed the dose prescribed by a physician with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The administration ...
Interaction with other medicinal products and other forms of interaction
Colchicine is a substrate for both CYP3A4 and the transport protein P-gp. In the presence of CYP3A4 or P-gp inhibitors, the concentrations of colchicine in the blood increase. Toxicity, including fatal ...
Fertility, pregnancy and lactation
Fertility Colchicine administration in animals induces significant reductions in fertility. Pregnancy Colchicine is genotoxic in vitro and in vivo, and is teratogenic in animal studies (see section 5.3). ...
Effects on ability to drive and use machines
No details are available regarding the influence of colchicine on the ability to drive and use machines. However, the possibility of drowsiness and dizziness should be taken into account.
Undesirable effects
The following adverse reactions have been observed. The frequencies are listed under one of the following classifications: Very common >1/10 Common >1/100 and <1/10 Uncommon >1/1000 and <1/100 Rare >1/10 ...
Overdose
Colchicine has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastro-intestinal or cardiac disease and ...
Pharmacodynamic properties
Pharmacotherapeutic group: drugs for gout, with no effect on uric acid metabolism ATC code: M04AC01 In the AGREE (Acute Gout Flare Receiving Colchicine Evaluation) study low- and high-dose colchicine were ...
Pharmacokinetic properties
Colchicine is rapidly and almost completely absorbed after oral administration. Maximum plasma concentrations are met usually after 30 to 120 minutes. The terminal half-life is 3 to 10 hours. Plasma protein ...
Preclinical safety data
Genotoxicity In one study, a bacterial test indicated that colchicine has a slight mutagenic effect. However, two other bacterial tests and a test in Drosophila melanogaster found that colchicine was not ...
List of excipients
Lactose monohydrate Microcrystalline cellulose Pregelatinised starch Sodium starch glycolate Magnesium stearate
Incompatibilities
None known.
Shelf life
Three years in polypropylene or polyethylene tablet containers. Two years in strip packs of opaque white or clear PVC film and 20µ aluminium foil of 10 or 14 tablets.
Special precautions for storage
Do not store above 25°C Store in the original container.
Nature and contents of container
Polypropylene or polyethylene containers containing 100 or 500 tablets. Strip packs of opaque white or clear PVC film and 20µ aluminium foil of 10 or 14 tablets. The tablets will be packed in multiple ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom
Marketing authorization number(s)
PL 29831/0055
Date of first authorization / renewal of the authorization
12/08/1982
Date of revision of the text
02/08/2019
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