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COLCHICINE 500 MICROGRAM TABLETS

Active substance(s): COLCHICINE

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Package leaflet: Information for the user
Colchicine 500 microgram Tablets
Colchicine
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.
What is in this leaflet:
1. What Colchicine Tablets are and what they are
used for
2. What 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. Contents of the pack and other information
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 prevent flare-ups of
gout in adults when treatment is started with other
drugs such as allopurinol, probenecid and
sulfinpyrazone.
In children, Colchicine Tablets are indicated in
Familial Mediterranean Fever for relief during
attacks and to prevent a build up of proteins
happening.
2. What you need to know before you take
Colchicine Tablets
Do not take Colchicine 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 breast feeding.
• 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 :
• have problems with your heart, liver or

kidneys or digestive system
• are elderly and weak
• have 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 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:
• Certain antibiotics such as clarithromycin,
erythromycin and telithromycin
(used to treat infections)
• Anti-viral drugs such as ritonavir, atazanavir
and indinavir (used to treat HIV infection)
• Ciclosporin (used to prevent organ rejection
after a transplant, psoriasis and
rheumatoid arthritis)
• Anti-fungal medicines such as ketoconazole,
itraconazole and voriconazole
• Certain heart medicines such as verapamil
and diltiazem
• Disulfram (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.
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.
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.
Colchicine passes into breast milk. If you are
breast-feeding, do not take this medicine.
Driving and using machines
The possibility of drowsiness and dizziness should
be taken into account. If affected, do not drive or
operate machinery.
Colchicine Tablets contain lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking Colchicine Tablets.
3. 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.
Colchicine Tablets should be swallowed whole with
a glass of water. For adults and children who have
difficulty swallowing (especially small children),
the tablet can be dissolved in a glass of water and
drunk immediately.
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
Continued over page

completion of a course of Colchicine Tablets, you
should not start another course for at least three days.
Dose to prevent flare-ups of gout when treatment is
started with other drugs:
• The recommended dose is 1 Colchicine
Tablet twice daily.
Your doctor will tell you how long your treatment
with Colchicine Tablets will last.
If you have kidney or liver problems
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.
Use in children and Adolescents
In children with Familial Mediterranean fever the
recommended posology is based on age. The
following daily doses may be given as a single or
divided dose twice daily (for doses over 1mg/day);
- For children under 5 years of age the
recommended dose is one tablet a day as a
single dose.
- For children aged 5 years to 10 years, the usual
dose is two tablets a day, as a single or divided
dose.
- For children over 10 years of age, the usual
dose is three tablets a day, as a single or
divided dose.
The doctor may gradually adjust the dose, depending
upon the reaction of the child, to a maximum of four
tablets a day.
This medicine is not suitable for children who
require a dose of less than 1 tablet a day.
Route and method of administration
Oral use
If you take more Colchicine Tablets than you
should
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.
If you forget to take Colchicine Tablets
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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. 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:

Do not take Colchicine Tablets if you notice that
they are showing signs of deterioration such as
discolouration.

• 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).

This medicinal product does not require any special
temperature storage conditions. Store at or below
25°C after first opening the bottle and use within 50
days.
Store in the original package.

Symptoms 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:
• Inflammation of the nerves which can cause
pain, weakness, tingling or numbness
• Nerve damage
• Gastrointestinal bleeding
• Liver damage
• Hair loss
• Rash
• Pain or weakness in muscles
• Abnormal muscle breakdown which can lead to
kidney problems (rhabdomyolysis)
• Kidney damage
• Absence of menstrual periods
• Painful periods
• Reduced ability to produce sperm (low or zero
sperm count)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or Apple
App Store
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie
E-mail: medsafety@hpra.ie.
5. How to store Colchicine Tablets
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton and label 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 to protect the environment.
6. Contents of the pack and other information
What Colchicine Tablets contain
The active substance is colchicine. Each tablet
contains 500 micrograms of colchicine.
The other ingredients are lactose monohydrate,
maize starch, magnesium stearate and starch,
pre-gelatinized.
What Colchicine Tablets looks like and contents
of the pack
Colchicine Tablets are 5.5 mm, white, round,
shallow biconvex tablets, plain on both sides.
Colchicine Tablets are available in HDPE containers
of 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Renata (UK) Limited
Greenway Business Centre,
Harlow Business Park, Harlow,
CM19 5QE
United Kingdom
Distributed by:
Flynn Pharma Ltd
Hertlands House, Primett Road
Stevenage, Hertfordshire
SG1 3EE
United Kingdom
Manufacturer:
ALTERNO AD d.o.o., PE
Brnčičeva ulica 29,
Ljubljana-Črnuče, 1231
Slovenia
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Ireland - Colchicine 500 microgram Tablets
United Kingdom - Colchicine 500 microgram
Tablets
This leaflet was last revised in November 2017

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