COLCHICINA (2010)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Wockhardt UK Ltd |
|---|---|
| Διεύθυνση | Ash Road North, Wrexham, LL13 9UF, United Kingdom |
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Name of the medicinal product
Colchicine 500 micrograms Tablets.
Qualitative and quantitative composition
Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500 micrograms on a dry weight basis). For excipients, see 6.1.
Pharmaceutical form
Tablet oral use.
Therapeutic indications
Colchicine tablets may be used for the treatment of acute gout and for short term prophylaxis during initial therapy with allopurinol and uricosuric drugs.
Posology and method of administration
Adults only: Gout: 1mg initially, followed by 500 micrograms every two to three hours until relief of pain is obtained or vomiting or diarrhoea occurs. A total dose of 6mg should not be exceeded. The course ...
Contraindications
The use of Colchicine is contraindicated in pregnancy. Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion. Colchicine should ...
Special warnings and precautions for use
Colchicine should be given with care to elderly and debilitated patients as there is a greater risk of cumulative toxicity. Care should also be exercised in those with cardiac, hepatic, gastrointestinal ...
Interaction with other medicinal products and other forms of interaction
Antibacterials: increased risk of Colchicine toxicity when given with clarithromycin or erythromycin, particularly in patients with pre-existing renal impairment. Rare reports of fatalities (see section ...
Pregnancy and lactation
Do not use in pregnancy as there is a risk of foetal chromosome damage. Colchicine is distributed into breast milk. Colchicine may be used with caution during breast-feeding.
Effects on ability to drive and use machines
None known.
Undesirable effects
Colchicine frequently causes nausea, vomiting and abdominal pain. Larger doses may cause profuse diarrhoea, gastrointestinal haemorrhage, skin rashes and renal and hepatic damage. Rarely peripheral neuritis, ...
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, gastrointestinal or cardiac disease, and ...
Pharmacodynamic properties
The anti-inflammatory effect of Colchicine in acute gouty arthritis is selective for this disorder. Although its mode of action is not clearly understood, it is thought that Colchicine causes the inhibition ...
Pharmacokinetic properties
Colchicine is readily absorbed from the gastrointestinal tract and peak concentrations occur in plasma by half an hour to two hours. The kidney, liver and the spleen also contain high concentrations of ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.
List of excipients
Lactose Pregelatinised Maize Starch Stearic Acid Purified Talc Purified Water Ethanol 96%
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 MA 154/00301
Date of first authorization / renewal of the authorization
23/10/2007
Date of revision of the text
11 June 2010
Σχετικά φαρμακευτικά σκευάσματα
| Κωδικός | Όνομα | Κ | Ν.Τ. | Χ.Τ. | Λ.Τ. | Κάτοχος άδειας |
|---|---|---|---|---|---|---|
| 31055.01.01 | COLCHICINA/MED LINE TAB 1MG/TAB BTx30 (1x30) tabs (Αδιαφανές PVC/ALU Blister) | 3,29 | 3,78 | 5,20 | Med Line Μ.Ε.Π.Ε. |