COLCHICINE

Israel - English - Ministry of Health

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Active ingredient:
COLCHICINE
Available from:
RAFA LABORATORIES LTD
ATC code:
M04AC01
Pharmaceutical form:
TABLETS
Composition:
COLCHICINE 500 MCG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
RAFA LABORATORIES LTD, JERUSALEM
Therapeutic group:
COLCHICINE
Therapeutic area:
COLCHICINE
Therapeutic indications:
Prevention and treatment of gout and FMF (familial mediterranean fever).
Authorization number:
016 73 24811 00
Authorization date:
2011-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

23-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

םיחקורה תונקתיפלןכרצלןולע ( םירישכת ) משתה " ו – 1986

אפורםשרמבתבייחוזהפורת

הפורתבשמתשתםרטבופוסדעןולעהתאןויעבארק

ןיציכלוק

תוילבט

בכרה :

ביכרמה ליעפה

הליכמהילבטלכ : Colchicine 0.5mg

םיליעפ יתלבםיביכרמ

Lactose,corn starch,povidone,magnesiumstearate.

הליכמהילבטלכ 80 מ " זוטקלג .

תיטיופרתהצובק : דיאולקלא

פ תיאופרתוליע :

םיתחדקלשענומלופיטוןודגישלשםיפירחםיפקתהבלופיטלתדעוימהפורתה - תיתחפשמתינוכית ( FMF ) .

רישכתבשמתשהלןיאיתמ ?

ויביכרממדחאלתושיגרהעודיםארישכתבשמתשהלןיא .

ןוירהבךניהםארישכתבשמתשהלןי .

שמתשהלןיא רישכתב תלבסואלבוסךניהםא רבעב הילכהדוקפתברומחיוקילמ וא ךניהםא לפוטמ

הזילאיד .

לופיטהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא םיאבהםירקמב :

הקינמךניהםא .

דוקפתביוקלמרבעבתלבסואלבוסךניהםא : ובלה / םדילכוא , דבכה , הילכה / ןתשהתכרעמ , לוכיעהתכרעמ

סוקלואןוגכ ) , םדהתכרעמ ( ןוגכ תוערפה השירק , blood dyscrasias .)

ךלשםוי םויהייחלעהפורתהעיפשתךיא ?

תונייתותשלןיא הפורתבלופיטהתפוקתבםיפירחתואקשמוא וז .

תורהזא :

שיגרךניהםא לואוהשלכןוזמל יהשלכהפורת , לעעידוהלךילע - הפורתהתליטנינפלאפורלךכ .

מןיציכלוק ליכ זוטקל . זוטקללשיגרךניהםא וזהפורתתליטנינפלאפורהתאעדילשי .

םדתוקידבךורעלשיוזהפורתבךשוממלופיטב .

ידוקפתביוקילמםילבוסהםילוחוםישישק ה ודבכ / וא ה רתויםישיגרתויהלםילולעהילכ ןכלווזהפורתל

ויאופרבקעמתחת תויהלםהילע / לבוקמהמךומנןונימלוטילוא .

תויתפורתןיבתובוגת :

לטונךניהםא פורת תו פסונ ו ת , הנוזת יפסותוםשרמאללתורכמנהתופורת ללוכ , םאוא תמייס לופיט התעהז

תרחאהפורתב , יאואםינוכיסעונמלידכלפטמהאפורלחוודלךילע - ליעי ןיבתובוגתמםיעבונהתו - תויתפורת ,

תואבהתוצובקהמתופורתיבגלדחוימב : םצעהחמתאתואכדמהתופורת ( ןוגכ היפרתומיכ ) , ןירופסולקיצ ,

לורטסלוכתדרוהלםיטרביפהואםיניטטסה תחפשממתופורת , ןיצימורתירלק , ןיצימורתירא , ןימטיו B12 .

ענמיהלשי תליכאמ ואתוילוכשא ץימתייתשמ בתוילוכשא ןמז לופיטה .

יאוולתועפות :

הפורתהלשהיוצרהתוליעפלףסונב , יאוולתועפותעיפוהלתולולעהבשומישה ןמזב .

תודירטמןהשואתופלוחןניאיאוולהתועפותםא , אפורה םעץעייתהלשי .

תדחוימתוסחייתהתובייחמהתועפות :

עיפוהב רועבהחירפ ואיוריג , לושלש , תואקהואהליחב , לקשמבהדירי , ןטביבאכ – קספה לופיטה הנפו

דימאפורל !

ךשוממשומישב : עיפוהב םוח , ןורגבאכ , השלוח , ןתשבואהאוצבםד , םירירשתשלוח , םדהתנומתבםייוניש

רידנ ) – קספה לופיטה הנפו דימאפורל !

עפותשיגרמךניהובשהרקמלכב הזןולעבוניוצאלשיאוולתו , ךילעתיללכהךתשגרהביונישלחםאוא

דימאפורהםעץעייתהל !

ןונימ : דבלבאפורהתוארוהיפלןונימ . תצלמומההנמהלערובעלןיא .

לפטמהאפורה ידילעעבקנשיפכםיבוצקםינמזבוזהפורתבשמתשהלשי .

לוטילשיבוצקןמזבוזהפורתלוטילתחכשםא תרכזנשכ דימהנמ , דחיבתונמיתשלוטילןיאןפואםושבךא !

שומישהןפוא :

סועללןיא , הילבטהתאקסרלואשותכל !

היצחוקןיאורחאמהילבטהתאתוצחלןיא .

םימסוכםעהפורתהתאעולבלשי .

לופיטהתחלצהלעייסללכותדציכ ?

אפורהידילעץלמוהשלופיטהתאםילשהלךיילע .

גישב ןוד , רבועבאכהםאהפורתהתליטנקיספהלשי .

הלערהענמ !

וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת / ענמת ךכידילעותוקונית וא

הלערה . הפורתהןמדליעלבתועטבםעוארתיתנמתלטנםא , םילוחתיבלשןוימרדחלדימהנפ , אבהו

אהפורתהתזירא ךתי .

האקהלםורגתלא אפורמתשרופמהארוהאלל !

ךתלחמבלופיטלהמשרנוזהפורת ; קיזהלהלולעאיהרחאהלוחב . ךיבורקלוזהפורתןתית לא , ואךינכש

ךירכמ .

ךשוחבתופורת לוטילןיא ! הנמהותיוותהקודב םעפ לכב הפורתלטונךניהש .

םהלקוקזךניהםאםייפקשמבכרה .

הנסחא :

לשי לתחתמןסחא C- ° 25 .

הזיראה יאנתיפלםג / םיצלמומההנסחא , דבלבתלבגומהפוקתלתורמשנתופורת . ךיראתלבלםישלאנ

רישכתהלשהגופתה ! קפסלשהרקמלכב , קפיסשחקורבץעוויהלךילע ךל הפורתהתא .

הזיראהתואבתונושתופורת ןסחאלןיא .

סמ ' הפורתהםושיר : 167324811

פרתודבעמ עבא " מ , ת . ד . 405 , םילשורי 91003

ע עבקנהזןולעטמרופ " ודילערשואוקדבנונכותותואירבהדרשמ י ב ראוני 2011 .

Product Information

Colchicine Tablets

Composition

Active ingredients: 0.5 mg Colchicine

List of excipients: starch corn, lactose, povidone K25, magnesium stearate

Indication

Prevention and treatment of gout and FMF (familial mediterranean fever).

Dosage and administration

Gout:

The patient should be instructed to always have colchicines at hand, so that therapy can be

started at the first sign of an impending attack. Initiation of colchicines therapy in the later

stages of an attack may not completely abate the condition.

The initial dose to relieve an attack is 1 or 2 tablets, followed by 1 tablet each hour or 2 tablets

every 2 hours, until the pain is relieved, or nausea, vomiting or diarrhea develops. The total

amount of colchicines usually required is variable. A course of therapy may range from 3-6

mg. as intermittent treatment,

A total dose of 6mg should not be exceeded. The course should not be repeated within three

days.

Familial Mediterranean Fever

The recommended dosage of COLCHICINE for FMF in adults is 1 mg to 2 mg daily.

COLCHICINE should be increased as needed to control disease and as tolerated in

increments of 0.25 mg/day to maximum recommended daily dose. If intolerable side effects

develop, the dose should be decreased in increments of 0.25 mg/day. The total daily

COLCHICINE dose may be administered in one to two divided doses.

Renal Impairment:

For mild/moderate renal impairment (creatinine clearance 10-50 ml/minute), reduce dose or

increase interval between doses (see section Contraindications).

Elderly:

To be given with great care.

Children:

FMF: The recommended dosage of colchicine for FMF in pediatric patients 4 years of age

and older is based on age. The following daily doses may be given as a single or divided

dose twice daily:

Children 4 – 6 years: 0.25 mg to 1.5 mg daily

Children 6 – 12 years: 1 mg to 1.5 mg daily

Contraindications

The use of colchicine is contraindicated in patients with hypersensitivity to colchicines. 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 not be used in patients with severe renal impairment (creatinine clearance

less than 10ml/minute).

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 or blood problems, hepatic,

gastrointestinal disease or if patients are breast-feeding.

Reduce dose in patients with mild to moderate renal impairment (see Method of

Administration and Contraindications).

For patients on long-term therapy, compete blood counts are mandatory at periodic intervals.

Reduction in dosage is indicated if weakness, anorexia, nausea, vomiting or diarrhea appear.

Colchicine-induced myoneuropathy in patients with altered renal functions is not infrequent.

Colchicines withdrawal resulted in a spontaneous remission of symptoms within 4-6 weeks.

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp

lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Drug interactions

Co-administration with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases

the risk of colchicines-induced toxic effects. If treatment with a P-gp or strong CYP3A4

inhibitor is required in patients with normal renal and hepatic function, the patient's dose of

colchicines may need to be reduced or interrupted. Use of colchicine with P-gp or strong

CYP3A4 inhibitors is contraindicated in patients with renal or hepatic impairment. (Strong

CYP3A4 inhibitors:atazanavir, clarithromycin,indinavir, itraconazole,

ketoconazole,nefazodone, nelfinavir, ritonavir,saquinavir,telithromycin). (Moderate CYP3A4

inhibitors: amprenavir, aprepitant, diltiazem, erythromycin, fluconazole,fosamprenavir,

grapefruit juice, verapamil). (P-gp inhibitors: cyclosporine, ranolazine).

Vitamins: the absorption of Vitamin B

may be impaired by chronic administration or high

doses of colchicine; requirement may be increased.

Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with

chronic treatment in therapeutic doses. Patients with renal dysfunction and elderly patients,

even those with normal renal and hepatic function, are at increased risk. Concomitant use of

atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid, or

benzafibrate or cyclosporine may potentiate the development of myopathy. Once colchicine is

stopped, the symptoms generally resolve within 1 week to several months.

Concurrent use of alcohol with orally administered colchicines increases the risk of

gastrointestinal toxicity, especially in alcoholics; also, alcohol increases blood uric acid

concentrations and may decrease the efficacy of prophylactic gout therapy.

Additive bone marrow depression may occur; dosage reductions may be required when 2 or

more bone marrow depressants, including radiation, are used concurrently or consecutively.

Pregnancy and lactation

Do not use in pregnancy as there is a risk of foetal chromosome damage. Colchicines may be

used with caution during breast-feeding.

Adverse Reactions

Colchicine frequently causes nausea, vomiting and abdominal pain. Larger doses may cause

profuse diarrhea, gastrointestinal hemorrhage, skin rashes and renal and hepatic damage.

Rarely peripheral neuritis, myopathy, rhabdomyolysis, alopecia, inhibition of spermatogenesis

and, with prolonged treatment, bone marrow suppression with agranulocytosis,

thrombocytopenia and aplastic anaemia occur. Peripheral neuritis and depilation have also

been reported. Dermatoses and hypersensitivity reactions occur infrequently.

Pharyngolaryngeal pain was seen in 3% of patients treated for gout flares.

Overdose

a) Symptoms

Symptoms of acute overdosage with oral colchicine may not appear for 2 to 72 hours. The

first signs of toxicity may be a feeling of burning and rawness in the mouth and throat and

difficulty in swallowing. These are followed by nausea, vomiting and diarrhoea. The diarrhoea

may be severe and haemorrhagic and accompanied by colic and tenesmus. These

symptoms, coupled with vascular damage, may lead to dehydration, hypotension and shock.

Multiple organ failure may occur and may be manifest as CNS toxicity, bone marrow

depression, hepatocellular damage, muscle damage, respiratory distress, myocardial injury

and renal damage. Death may be due to respiratory depression, cardiovascular collapse or

sepsis.

In surviving patients, alopecia, rebound leucocytosis and stomatitis may occur about 10 days

after the acute overdose.

b) Treatment

Patients should be carefully monitored for some time after overdosage or acute poisoning

with colchicine to allow for the delayed onset of symptoms.

In acute poisoning multiple doses of activated charcoal should be administered. Respiration

may need assistance. Because of the high degree of tissue binding, colchicine is not

dialysable. Circulation should be maintained and fluid and electrolyte imbalance corrected.

Morphine sulphate 10mg, intramuscularly, may be given to relieve severe abdominal cramps.

Pharmacodynamics

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 of the migration of granulocytes into the inflamed area. This reduces the release of

lactic acid and pro-inflammatory enzymes that occurs during phagocytosis and breaks the

cycle that leads to the inflammatory response.

Pharmacokinetics

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 colchicine, but it is apparently largely excluded from the heart, skeletal

muscle and brain. It is partially deacetylated in the liver. Colchicine and its metabolites are

excreted in the urine and faeces.

he page

Storage: Store below 25

Packaging: 30 tablets

Manufacturer: Rafa Laboratories Ltd. POB 405 Jerusalem 91003.

The format and content of this document have been approved by the Ministry of Health in

January 2011

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