Skip to Content

COLCHICINE 500 MICROGRAM TABLETS

Active substance(s): COLCHICINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Colchicine

500microgram Tablets

Colchicine

Read all of this leaflet carefully before you start
using 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 500 microgram
Tablets, but it will be called Colchicine in this leaflet.
What is in this leaflet
1. What Colchicine is and what it is used for
2. What you need to know before you take Colchicine
3. How to take Colchicine
4. Possible side effects
5. How to store Colchicine
6. Contents of the pack and other information
1. What Colchicine is and what it is used for
The name of your medicine is Colchicine Tablets.
Colchicine is an anti-gout agent. In adults, colchicine is
used to treat gout attacks. They are also used to prevent
gout flare-ups when treatment with other medicinal
products is used, such as allopurinol, probenecid,
and sulfinpyrazone.
In children, colchicine may be used to treat an inherited
disorder called Familial Mediterranean Fever. This leads
to intermittent attacks of high temperature, pain, and other
factors. Treatment for this is under specialised medical care.
2. What you need to know before you take Colchicine
Do not take Colchicine:
- if you are allergic to colchicine or any of the other
ingredients of this medicine (listed in section 6).
- if you have 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’).
- if you are under 12 years of age (unless under
specialised treatment for Familial Mediterranean Fever).
If you are not sure whether any of the above apply to you,
talk to your doctor or pharmacist before taking Colchicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Colchicine
if you
- are elderly and weak.
- have problems with your heart, kidneys, liver or digestive
system.
- have a blood disorder.
Colchicine 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 and an overdose. Therefore, if you get
symptoms such as nausea (feeling sick), vomiting (being
sick), stomach pain and diarrhoea, stop taking Colchicine
and immediately contact your doctor (see also section 4
‘Possible side effects’).
Colchicine 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’).
Children and adolescents
Only children diagnosed with Familial Mediterranean Fever,
and under specialised medical care should take Colchicine
tablets.
Other medicines and Colchicine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including
medicines obtained without a prescription. Using another
medicine while using Colchicine can affect how colchicine
or the other medicine works.
When Colchicine is 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 antiobiotics 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 or temporarily
stop your treatment with Colchicine. If you have liver or
kidney problems and you are taking any of the above
medicines, you should not take Colchicine.
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 together
with ciclosporin or ‘statins’ also increases your risk of
developing this disesase.
Talk to your doctor before taking Colchicine 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 may reduce the amount of vitamin B12 that your
body can absorb through your gut.
Colchicine with food, drink and alcohol
Grapefruit juice may increase the amount of colchicine in
your blood. Therefore, you should not drink grapefruit juice
whilst you are taking Colchicine.
Pregnancy, breast-feeding and fertility
You should not take Colchicine if you are pregnant - talk to
your doctor first.
Colchicine passes into the breast milk. Do not take
Colchicine if you are breast-feeding without talking to your
doctor first.
In men, use of Colchicine may reduce the ability to
produce sperm; if you are trying to make your partner
pregnant, you should discuss this with your doctor.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine or any
other 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 contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
using this medicinal product.

3. How to take Colchicine
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 Colchicne tablets to
take, and for how long you should take them.
Colchicine tablets should be swallowed whole with a glass
of water.
Adults
Dose to treat gout attack:
• The recommended dose is two (2) Colchicine tablets to
start followed by one (1) Colchicine tablet after one (1) hour.
No further tablets should then be taken for twelve (12) hours.
If necessary, treatment with Colchicine tablets can then
resume with a maximum dose of one (1) tablet three
times daily until symptoms are relieved.
The course of treatment should end when symptoms
are relieved or when a total of tweleve (12) Colchicine
tablets have been taken. You should not take more than
tweleve (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.
Dose to prevent flare-ups of gout when treatment is started
with other drugs:
• The recommended dose is one (1) Colchicine tablet
twice daily.
Your doctor will tell you how long your treatment with
Colchicine will last.
Elderly patients, or patients with other problems:
Eldelry patients, or patients with other problems, especially
with kidney problems, will need to take lower or less
frequent doses.

(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).
Additional side effects in children and adolescents
Side effects may be more frequent in this patient group.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Colchicine
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special
temperature storage conditions. Store in the original
package in order to protect from light.

Use in children and adolescents:
The only use in children and adolescents is for the
treatment of Familial Mediterranean Fever, while under
close medical supervision.
For children aged under 5 years, the usual 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 aged over 10 years, 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.

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.

If you take more Colchicine than you should
If you take more Colchicine than you should, immediately
contact your doctor or nearest hospital accident and
emergency department. Take this leaflet and the tablets
you have left with you.

- The active substance is Colchicine. Each tablet
contains 500 micrograms of colchicine (as colchicine
sesquihydrate).
- The other ingredients (excipients) are lactose
monohydrate, pregelatinised starch, purified talc (E 553b)
and stearic acid (E 570).

At too high a dose Colchicine 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
If you forget to take Colchicine, take it 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 dose.
If you stop taking Colochicine
Do not stop taking Colchicine without talking to your doctor
first.
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 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).
• 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

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. Contents of the pack and other information
What Colchicine contains

What Colchicine looks like and contents of the pack
Colchicine tablets are white to off-white coloured, circular
biconvex uncoated tablet with “C5” embossed on one side
and plain on the other side with diameter of 5.5 mm.
Blisters of either aluminium-aluminium, or white opaque
PVC-aluminium containing either 10 or 14 tablets are
available. Packs containing 10 tablets, 14 tablets,
20 tablets, 28 tablets, 30 tablets, 40 tablets, 56 tablets,
60 tablets, 84 tablets, 90 tablets, 100 tablets, or 112 tablets
are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Morningside Healthcare Ltd
115, Narborough Road, Leicester, LE3 0PA,
United Kingdom
Manufacturer:
Morningside Pharmaceuticals Ltd
5, Pavilion Way, Loughborough, LE11 5GW,
United Kingdom
This leaflet was last revised in December 2015.

M0262LAMUKNAS-001

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.

Hide