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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLCHICINE 500 MICROGRAM TABLETS
COLCHICINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Colchicine Tablets are and what they are used for
2.
Before you take Colchicine Tablets
3.
How to take Colchicine Tablets
4.
Possible side effects
5.
How to store Colchicine Tablets
6.
Further information
1.
WHAT COLCHICINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Colchicine Tablets.
The active ingredient, colchicine, in Colchicine Tablets is an
anti-gout agent.
Colchicine Tablets are used to treat gout attacks. They are also used
to prevent flare-ups of gout when
treatment is started with other drugs such as allopurinol, probenecid
and sulfinpyrazone.
2.
BEFORE YOU TAKE COLCHICINE TABLETS
DO NOT TAKE COLCHICINE TABLETS IF YOU ARE:
allergic to colchicine or any of the other ingredients of Colchicine
Tablets (see list under ‘What
Colchicine Tablets contain’)
pregnant
under 12 years of age
undergoing haemodialysis
suffering from severe kidney impairment
suffering from any severity of kidney or liver impairment and taking
the following drugs:
-
clarithromycin, erythromycin or telithromycin (used to treat
infections)
-
ritonavir, atazanavir or indinavir (anti-viral drugs, used to treat
HIV infection)
-
ciclosporin (used to prevent organ rejection after a transplant,
psoriasis and rheumatoid
arthritis)
-
ketoconazole or itraconazole (used to treat fungal infections)
-
verapamil (used to treat high blood pressure or angina)
-
quinidine (used to treat abnormal heart rhythms).
TAKE SPECIAL
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製品の特徴
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Colchicine 500 micrograms Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500
micrograms on
a dry weight basis).
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet - oral use.
4
CLINICAL PARTICULARS
4.1
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.
4.2
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 should not be repeated within three days.
_Renal Impairment: _
For mild/moderate renal impairment (creatinine clearance 10-50
ml/minute),
reduce dose or increase interval between doses (see section 4.3
Contraindications).
_ _
_For use with allopurinol or uricosuric drugs:_
500 micrograms two to three times daily.
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Elderly:
To be given with great care.
Children:
Not recommended.
4.3
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 not be used in patients with severe renal impairment
(creatinine clearance less than 10ml/minute).
Colchicine is contraindicated in patients with renal or hepatic
impairment who
are taking a P-glycoprotein or a strong CYP3A4 inhibitor (see section
4.5,
Interaction with other medicinal products and other forms of
interaction).
4.4
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
disease or if patients are breast-feeding.
Colchicine should be avoid
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