Ireland - English - HPRA (Health Products Regulatory Authority)

tiofarma b.v. - colchicine ph. eur. - tablet - 1000 microgram(s) - preparations with no effect on uric acid metabolism; colchicine

United Kingdom - English - myHealthbox

actavis group ptc ehf - colchicine - tablets - 500micrograms - drugs for gout, with no effect on uric acid metabolism - treatment of acute gout. prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - colchiceine (unii: hj30158l57) (colchiceine - unii:hj30158l57) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares: colchicine tablets are indicated for prophylaxis of gout flares. -   treatment of gout flares: colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine cro

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colchicine, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, behcet’s disease, or familial mediterranean fever (fmf) treated with colchicine at therapeutic doses during pregnancy. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. risk summary colchicine is present in human milk (see data) . adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. there are no data on the effects of colchicine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for colchicine and any potential adverse effects on the breastfed child from colchicine or from the underlying maternal condition. data limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. a systematic review of literature reported no adverse effects in 149 breastfed children. in a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants. infertility case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. a case report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility. however, since the progression of fmf without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see nonclinical toxicology (13.1)] . the safety and efficacy of colchicine in children of all ages with fmf has been evaluated in uncontrolled studies. there does not appear to be an adverse effect on growth in children with fmf treated long-term with colchicine. safety and effectiveness of colchicine in pediatric patients with gout has not been established. clinical studies with colchicine for treatment of fmf did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see dosage and administration (2.4), clinical pharmacology (12.3)]. colchicine is significantly excreted in urine in healthy subjects. clearance of colchicine is decreased in patients with impaired renal function. total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis. fmf although, pharmacokinetics of colchicine in patients with mild (clcr 50 to 80 ml/min) and moderate (clcr 30 to 50 ml/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. dose reduction may be necessary. in patients with severe renal failure (clcr less than 30 ml/min) and end-stage renal disease requiring dialysis, colchicine tablets may be started at the dose of 0.3 mg/day. any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine tablets [see clinical pharmacology (12.3), dosage and administration (2.5)] . the clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment compared to healthy subjects [see clinical pharmacology (12.3)]. fmf in patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see clinical pharmacology (12.3), dosage and administration (2.6)]. tolerance, abuse or dependence with colchicine has not been reported.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

mayoly benelux s.p.r.l.-b.v.b.a. - colchicine 1 mg - tablet - 1 mg - colchicine 1 mg - colchicine derivatives

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

tiofarma b.v. - colchicine 0,54 mg - tablet - 0,5 mg - colchicine 0.5 mg - colchicine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

tiofarma b.v. - colchicine 1,08 mg - tablet - 1 mg - colchicine 1 mg - colchicine

Canada - English - Health Canada

jamp pharma corporation - colchicine - tablet - 0.6mg - colchicine 0.6mg - antigout agents

Canada - English - Health Canada

odan laboratories ltd - colchicine - tablet - 0.6mg - colchicine 0.6mg - antigout agents

New Zealand - English - Medsafe (Medicines Safety Authority)

miro healthcare limited - colchicine 0.5mg - tablet - 0.5 mg - active: colchicine 0.5mg excipient: pregelatinised starch lactose monohydrate magnesium stearate povidone - treatment of acute gout. colchicine should not be used unless nsaids are contraindicated, or have been used and found to lack efficacy or to have unacceptable side effects in the individual patient.