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COLCHICINE 500MICROGRAM TABLETS

Active substance(s): COLCHICINE

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• S ymptoms such as fever, inflammation
of the mouth, sore throat, prolonged
bleeding, bruising or skin problems.
These could be signs that you have
a serious blood problem as a result
of bone marrow depression (see also
section 2 ‘Warnings and Precautions’).
The frequency of these side effects is
not known (cannot be estimated from
the available data).
Other side effects that have been seen
(with unknown frequency) are:
• I nflammation of the nerves which
can cause pain, weakness, tingling or
numbness
•N
 erve damage
•G
 astrointestinal bleeding
• L iver damage
•H
 air loss
•R
 ash
•P
 ain or weakness in muscles
•A
 bnormal muscle breakdown
which can lead to kidney problems
(rhabdomyolysis)
•K
 idney damage
•A
 bsence of menstrual periods
•P
 ainful periods
•R
 educed ability to produce sperm (low
or zero sperm count)

Do not use this medicine after the expiry
date which is stated on the carton and
blister after EXP. The expiry date refers to
the last day of that month.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6

Reporting of side effects

Colchicine 500microgram tablets
are white to off-white, round, 6mm
diameter, flat tablets marked with “0.5”
on one side.

This leaflet was last revised in
April 2016.

By reporting side effects you can help
provide more information on the safety
of this medicine.

How to store Colchicine Tablets
Keep this medicine out of the sight and
reach of children.
Store in the original package in order to
protect from light.

If you would like a
leaflet with larger text,
please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

50896212 AAAI9217

JDE No.:

What Colchicine Tablets looks like
and contents of the pack

Manufacturer
Actavis
Barnstaple
EX32 8NS
UK

Malta
You can also report side effects
directly to ADR Reporting Website:
www.medicinesauthority.gov.mt/
adrportal

Colchicine Tablets
500mcg x 100’s (UK)

• The active substance is colchicine.
Each tablet contains 500micrograms of
colchicine.
• The other ingredients are lactose
monohydrate, microcrystalline
cellulose, pregelatinised starch, sodium
starch glycolate, magnesium stearate.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

What Colchicine Tablets contain

Blister packs of 100 tablets.

If you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via:

5

Contents of the pack and other
information

Package leaflet: Information for the patient

Colchicine 500microgram Tablets
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
•  Keep this leaflet. You may need to
read it again.
•  If you have any further questions,
ask your doctor or pharmacist.
•  This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as
yours.
•  If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section
4.
•  The full name of this medicine is
Colchicine 500microgram Tablets
but within the leaflet it will be
referred to as Colchicine Tablets.

1

What Colchicine Tablets are
and what they are used for
The active ingredient in Colchicine
Tablets is colchicine.
Colchicine is an anti-gout agent.
Colchicine Tablets are used to treat gout
attacks in adults. They are also used to

page 4

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

 hat you need to know before
W
you take Colchicine Tablets
Do not take Colchicine Tablets
tablets:

• if you are allergic to colchicine or any of
the other ingredients of this medicine
(listed in section 6)
• if you have a severe blood disorder
• if you are pregnant
• if you are breastfeeding
• if you are a woman of childbearing
age, unless you are using effective
contraception
• if you have severe kidney or liver
problems
• if you are undergoing haemodialysis
• if you have kidney or liver problems
and you are taking certain medicines
(see ‘Other medicines and Colchicine
Tablets’)
If you are not sure whether any of the
above apply to you, talk to your doctor
or pharmacist before taking Colchicine
Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Colchicine Tablets if you
•h
 ave problems with your heart,
kidneys, liver or digestive system
• a re elderly and weak
•h
 ave a blood disorder
Colchicine Tablets can be toxic so it is
important that you do not exceed the
dose prescribed by your doctor.
There is only a slight difference between
an effective dose of Colchicine Tablets

page 1

Colchicine All Strengths, PIL (Blister Carton), UK Malta

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
30/03/16
Technologist: R.Wrey

2

What is in this leaflet
1 W
 hat Colchicine Tablets are
and what they are used for
2 W
 hat you need to know before
you take Colchicine Tablets
3 How to take Colchicine Tablets
4 Possible side effects
5 How to store Colchicine Tablets
6 C
 ontents of the pack and other
information

50896212

Pharmacode: 4204

prevent flare-ups of gout in adults when
treatment is started with other drugs
such as allopurinol, probenecid and
sulfinpyrazone.

item no: AAAI9217

dimensions: 148 x 210

print proof no: 1

pharmacode:

origination date: 07/04/16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: MB
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Safe Area
2.
3.

and an overdose. Therefore, if you get
symptoms such as nausea (feeling sick),
vomiting (being sick), stomach pain and
diarrhoea, stop taking Colchicine Tablets
and immediately contact your doctor
(see also section 4 ‘Possible side effects’).
Colchicine Tablets can cause a serious
decrease in bone marrow function
leading to a decrease in certain white
blood cells (agranulocytosis), a decrease
in red blood cells and pigment (aplastic
anaemia) and/or a low blood platelet
count (thrombocytopenia). You should
have regular blood tests to monitor any
changes.
If you develop symptoms such as fever,
inflammation of the mouth, sore throat,
prolonged bleeding, bruising or skin
problems, stop taking this medicine and
contact your doctor immediately. These
could be signs that you have a serious
blood problem and your doctor may
want you to have blood tests straight
away (see also section 4 ‘Possible side
effects’).

Other medicines and Colchicine
Tablets

Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines. Taking
another medicine whilst you are taking
Colchicine Tablets can affect how they or
the other medicine works.
When Colchicine Tablets are taken
together with any of the following
medicines, side effects due to colchicine
toxicity are more likely and these can be
serious and life-threatening:
•C
 ertain antiobiotics such as
clarithromycin, erythromycin and
telithromycin (used to treat infections)
•A
 nti-viral drugs such as ritonavir,
atazanavir and indinavir (used to treat
HIV infection)
•C
 iclosporin (used to prevent organ
rejection after a transplant, psoriasis
and rheumatoid arthritis)
•A
 nti-fungal medicines such as
ketoconazole, itraconazole and
voriconazole
•C
 ertain heart medicines such as
verapamil and diltiazem

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Colchicine Tablets
500mcg x 100’s (UK)
JDE No.:

Colchicine passes into breast milk. If
you are breast-feeding, do not take this
medicine.

It is also important to tell your doctor or
pharmacist if you are taking any of the
following medicines:
• Cimetidine (used to reduce stomach
acid), as it may increase the amount of
colchicine in your blood
• Tolbutamide (used to control blood
sugar), as it may increase the amount of
colchicine in your blood
• Digoxin (used to treat certain heart
conditions) and ‘fibrates’ (medicines
used to lower cholesterol), as they
may increase your risk of a muscle
disease known as ‘rhabdomyolysis’.
Taking Colchicine Tablets together with
ciclosporin or ‘statins’ also increases
your risk of developing this disease.

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking
Colchicine Tablets.

Talk to your doctor before taking
Colchicine Tablets if you are taking any
medicines that may possibly damage
your kidneys, liver or blood. Check with
your doctor if you are not sure.
Colchicine Tablets may reduce the
amount of vitamin B12 that your body
can absorb through your gut.

Colchicine Tablets with food and
drink
Grapefruit juice may increase the
amount of colchicine in your blood.
Therefore, you should not drink
grapefruit juice whilst you are taking
Colchicine Tablets .

Pregnancy and breast-feeding

If you are pregnant, think you may be
pregnant or are planning to have a baby,
do not take this medicine.
If you are a woman of childbearing
potential, do not take this medicine
unless you are using effective
contraception.

The possibility of drowsiness and
dizziness should be taken into account.
If affected, do not drive or operate
machinery.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

If you take more Colchicine
Tablets than you should

Colchicine Tablets contain lactose

3

If you take more Colchicine Tablets
than you are supposed to, contact
your doctor or nearest hospital
accident and emergency department
immediately. Take this leaflet and any
Colchicine Tablets you have left with
you.
At too high a dose Colchicine Tablets
can be seriously toxic, even fatal. Early
symptoms of overdose (which appear
on average after 3 hours but can take
longer) may include nausea, vomiting,
stomach pain, bloody diarrhoea and low
blood pressure.

How to take Colchicine Tablets
Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
Your doctor will tell you how many
Colchicine Tablets to take and for how
long you should take them.

If you forget to take Colchicine
Tablets

Colchicine Tablets should be swallowed
whole with a glass of water.

If you forget to take a dose, take another
as soon as you remember. If it is almost
time for your next dose, do not take the
missed dose at all. Do not take a double
dose to make up for a forgotten tablet.
Do not take Colchicine Tablets with a
shorter interval than prescribed by your
doctor.

Use in adults

Dose to treat gout attack:
• The recommended dose is 2 Colchicine
Tablets to start followed by 1 Colchicine
Tablet after 1 hour. No further tablets
should then be taken for 12 hours. If
necessary, treatment with Colchicine
Tablets can then resume with a
maximum dose of 1 tablet three times
daily until symptoms are relieved.
The course of treatment should end
when symptoms are relieved or when
a total of 12 Colchicine Tablets have
been taken. You should not take more
than 12 Colchicine Tablets as a course
of treatment.
After completion of a course of
Colchicine Tablets, you should not start
another course for at least three days.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4

Dose to prevent flare-ups of gout when
treatment is started with other drugs:
• The recommended dose is one
Colchicine Tablet twice daily.
Your doctor will tell you how long your
treatment with Colchicine Tablets will
last.

page 2

Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
If you notice any of the following side
effects, stop taking Colchicine Tablets
and immediately contact a doctor
or the nearest hospital accident and
emergency department:
• Nausea (feeling sick), vomiting (being
sick), stomach pain and diarrhoea
(see also section 2 ‘Warnings and
Precautions’). These side effects are
common (may affect up to 1 in 10
people).

page 3

Colchicine All Strengths, PIL (Blister Carton), UK Malta

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
30/03/16
Technologist: R.Wrey

Your doctor may reduce your dose of
Colchicine Tablets, and you should be
carefully monitored for side effects.
Do not take Colchicine Tablets if you
have severe kidney or liver problems.

Driving and using machines

50896212

Pharmacode: 4204

If you have kidney or liver
problems

•D
 isulfram (used to help treat
alcoholism)
If you are taking any of the above
medicines, your doctor may want to
adjust your dose of Colchicine Tablets
or temporarily stop your treatment with
Colchicine Tablets. If you have liver or
kidney problems and you are taking any
of the above medicines, you should not
take Colchicine Tablets.

item no: AAAI9217

dimensions: 148 x 210

print proof no: 1

pharmacode:

origination date: 07/04/16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: MB
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Safe Area
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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