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COLCHICINE TABLETS BP 500MCG

Active substance(s): COLCHICINE

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(Colchicine)

Patient Information Leaflet: COLCHICINE TABLETS BP 500 micrograms

What you need to know about Colchicine Tablets
Please read this leaflet carefully before you start to take
your tablets. It contains important information. If you are
not sure about anything, or you want to know more, ask
your doctor or a pharmacist. Keep this leaflet safe, as you
may want to read it again.
Your tablets are called Colchicine Tablets BP and they are
part of a group of drugs known as anti-mitotics. The
medicine acts by stopping the movement of granulocytes (a
type of white blood cell) into a damaged area which is
swollen, red and painful (inflamed). This medicine has been
prescribed for you. Never give it to someone else. It may
not be the right medicine for them even if their symptoms
seem to be the same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

What is in this leaflet:
1. What Colchicine is and what it is 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 active ingredient in Colchicine Tablets is Colchicine.
In adults, Colchicine Tablets are used in the short term
treatment of gout and to prevent attacks of gout from
happening.
Uric acid is one of the body’s waste products. In gout,
crystals of uric acid are deposited in joints causing pain and
inflammation.
Other medicines which are used to treat gout (like
allopurinol or uricosuric drugs), take a long time to work
and so colchicine can be used together with these drugs at
the start of treatment.
In children, Cochicine Tablets are used in the treatment of
Familial Mediterranean Fever for relief during attacks and
to prevent a build up of proteins happening.
Familial Mediterranean Fever, is an inherited disease
causing pain and swelling in the joints and body organs.

2. Before you take Colchicine Tablets
Do not take Colchicine Tablets if you:
• Think you may be allergic to Colchicine or to any of the
other ingredients of Colchicine Tablets. (These are listed
in section 6.);
• You have a problem with your blood, e.g. leukaemia;
• You have any problems with your liver;
• You have any problems with your kidneys;
• You have any problems with your heart;
• You have any problems with your digestive system;
• You are pregnant, may become pregnant or are breast
feeding.
Please tell your doctor before you start to take Colchicine
Tablets if you:
• Have ever had an adverse reaction to Colchicine or to
any of the other ingredients of Colchicine Tablets. (These
are listed in section 6.);
• Are pregnant, may become pregnant or are breastfeeding;
• Have ever had any problems with your liver or kidneys;
• Are older than 40 years of age;
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your
doctor if you are elderly or debilitated. Tell your doctor if
you are taking any of the following:
• You are receiving vitamin B12 injections for anaemia.
Colchicine may prevent the absorption of vitamin B12;

• You are taking sympathomimetic drugs (e.g. to treat
asthma or a blocked nose);
• You are taking drugs which depress the nervous system
(e.g. some drugs used to treat anxiety and sleeping problems);
• You are taking cyclosporin (a drug used to reduce the body’s
resistance to infection by suppressing the immune system.
• You are taking the antibiotic erythromycin or
clarithromycin. These antibiotics can increase the risk of
side effects from colchicine.
These tablets contain Lactose. If you have been told by
your doctor that you have an intolerance to some sugars
contact your doctor before taking these tablets.
If you need blood or urine tests, tell the doctor that you are
taking Colchicine Tablets, as your tablets may affect the
results. Colchicine may decrease the absorption of fat,
sodium, potassium, nitrogen, xylose, and also sugars from
the stomach and intestine.
Use in children: These tablets are not suitable for children.
If you see another doctor or visit a hospital, remember to
tell them what medicines you are already taking.

3. How to take Colchicine Tablets
Colchicine is potentially toxic so it is important not to exceed
the dose prescribed by your doctor.
You must take your tablets exactly as your doctor has told you
to. The dose will be on the pharmacist’s label. Check the label
carefully. It should tell you how many tablets to take and how
often. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole with water.

The following doses are intended as a guide:
ADULTS:
Treating acute gout: The most common dose for the
treatment of gout in adults is 1mg (2 tablets) to start then
500mcg (1 tablet) every 4 hours until the pain is better or
you feel sick or diarrhoea occurs. Up to 6mg (12 tablets)
can be taken altogether. You should not take treatment
again until at least 3 days have passed.
To help prevent attacks of gout: 500mcg (1 tablet) each week
may be enough, or 500mcg (1 tablet) 2 - 3 times a day.
To prevent gout happening again or to prevent gout at the
start of treatment with other medicines (eg. Allopurinol):
Take 500mcg (1 tablet) 2-3 times a day.
If you are elderly, or have kidney problems, you may need a
lower dose.
CHILDREN:
In children with Familial Mediterranean fever the
recommended dose is based on age. The following daily
doses may be given as a single dose or divided dose twice
daily (for doses over 1mg/day);
• Children less than 5 years of age; 0.5 mg/day
• Children 5 to 10 years of age: 1 mg/day
• Children more than 10 years of age: 1.5 mg/day
Colchicine dosage should be increased in a stepwise fashion
(0.25 mg/step) up to a maximum of 2 mg/day. Any increase
of the dose should be monitored closely for adverse effects.
If you forget to take a dose at the right time, take it as soon
as you remember. Do not take two doses together.

If you take more colchicine tablets than you should; If you
take more colchicine tablets than you are supposed to (or if
you think a child has swallowed any), contact your doctor
or nearest hospital accident and emergency department
immediately. Take this leaflet and any colchicine tablets you
have left with you.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Allergic reactions may
occur and could include breathlessness and collapse.
Colchicine may have an effect on the sperm count in men.
Stop taking these tablets and tell your doctor immediately if
you get any of the following:





A fever;
A sore throat;
Rashes or ulcers in your mouth and throat;
Skin colourations;

as this could be a sign that you are not making any white
blood cells to fight off infection. If this happens your
treatment should be stopped. However this is a rare side
effect and occurs most commonly within the first two
months of treatment and in patients over the age of 40 who
are taking larger doses.
Other side effects are:
• Loss of hair;
• Skin rashes;









Inflammation of nerves;
Muscle weakness;
Numbness especially in the hands and feet;
No urine production;
Blood in the urine and bruising;
Blood changes and kidney damage may occur;
Bone marrow may become depressed (no blood cells or
clot forming cells being made).
If you feel unwell in any other way, tell your doctor as soon
as you can.
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
Yellow Card Scheme on the MHRA website
(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 Tablets
Store the tablets in their original pack away from direct
light. You should store these tablets below 25ºC and
protected from light. Keep the container tightly closed.

6. Further Information
There is one strength of Colchicine Tablets 500 micrograms
(mcg). Colchicine Tablets are white and come in packs of
100.
Colchicine Tablets contain the active ingredient Colchicine.
Each tablet contains Colchicine 500 micrograms (mcg)
(active ingredient); and lactose, starch maize and
magnesium stearate (inactive ingredients).
Marketing Authorisation Holder:
RPH Pharmaceuticals AB, Lagervägen 7,
136 50 Jordbro, Sweden.
Manufacturer:
Recipharm Limited, Vale of Bardsley,
Ashton-under-Lyne, Lancashire, OL7 9RR, UK.
Colchicine Tablets are distributed by:
Focus Pharmaceuticals Ltd, Unit 5, Faraday Court,
First Avenue, Burton-upon-Trent, DE14 2WX, UK.
This leaflet was last amended in March 2015.
SIN 6229P

Keep all medicines out of the reach and sight of children.
Do not take the tablets after the expiry date which is
printed on the carton and label.
You should take any tablets that are out of date or which
you no longer need back to your pharmacist.
11001244

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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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