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COLOMYCIN INJECTION 1 MILLION INTERNATIONAL UNITS. POWDER FOR SOLN FOR INJ INFUSION OR INHALATION

Active substance(s): COLISTIMETHATE SODIUM

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• If you suffer from myasthenia gravis
• If you suffer from porphyria
• If you suffer from asthma

PACKAGE LEAFLET:
INFORMATION FOR THE USER
COLOMYCIN INJECTION
1 million or 2 million International Units
Powder for solution for injection,
infusion or inhalation
Colistimethate Sodium

Some people may experience a feeling of
tightness in the chest due to narrowing of the
airways when inhaling Colomycin. Your
doctor may prescribe other medicines for
inhalation directly before or after using
Colomycin; in order to prevent or treat this.
In premature and new-born babies, special
care should be taken when using Colomycin
as the kidneys are not yet fully developed.
Other medicines and Colomycin
Tell your doctor if you are taking, have
recently taken or might take any other
medicines.
If you are taking any of the following
medicines, you may or may not be able to
take Colomycin. Sometimes the other
medicines must be stopped (if only for a
while) or you may need a lower dose of
Colomycin or you may need to be monitored
while you are taking Colomycin. In some
cases, the level of Colomycin in your blood
may have to be measured from time to time
to make sure that you are having the right
dose.

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.
• 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. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Colomycin is and what it is used for
2. What you need to know before you use
Colomycin
3. How to use Colomycin
4. Possible side effects
5. How to store Colomycin
6. Contents of the pack and other
information

1. WHAT COLOMYCIN IS AND WHAT IT
IS USED FOR
Colomycin contains the active substance
colistimethate sodium. Colistimethate sodium
is an antibiotic. It belongs to a group of
antibiotics that are called polymyxins.
Colomycin is given by injection to treat some
types of serious infections caused by certain
bacteria. Colomycin is used when other
antibiotics are not suitable.
Colomycin is given as an inhalation to treat
chronic chest infections in patients with cystic
fibrosis. Colomycin is used when these
infections are caused by specific bacteria
called Pseudomonas aeruginosa.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE COLOMYCIN
Do not use Colomycin:
• If you are allergic (hypersensitive) to
colistimethate sodium, colistin or to other
polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Colomycin
• If you have or have had kidney problems.

• medicines like antibiotics called
aminoglycosides (which include gentamicin,
tobramycin, amikacin and netilmicin) and
cephalosporins which can affect how your
kidneys function. Taking such medicines at
the same time as Colomycin can increase
the risk of damage to the kidneys (see
section 4 of this leaflet).
• medicines like antibiotics called
aminoglycosides (which include gentamicin,
tobramycin, amikacin and netilmicin) which
can affect your nervous system. Taking such
medicines at the same time as Colomycin
can increase the risk of side effects in the
ears and other parts of your nervous system
(see section 4 of this leaflet).
• medicines called muscle relaxants, often
used during general anaesthesia. Colomycin
can increase the effects of these medicines.
If you have a general anaesthetic, let your
anaesthetist know that you are having
Colomycin.
If you suffer from myasthenia gravis and are
also taking other antibiotics called macrolides
(such as azithromycin, clarithromycin or
erythromycin) or antibiotics called
fluoroquinolones (such as ofloxacin,
norfloxacin and ciprofloxacin), taking
Colomycin further increases the risk of muscle
weakness and breathing difficulties.
Having Colomycin as an infusion at the same
time as receiving Colomycin as an inhalation
can increase your risk of side effects.
Pregnancy and breast-feeding
Colomycin is not known to harm the unborn
child but, like all medicines, it will only be
given to a pregnant woman if it is really
needed. If you are pregnant, think you may
be pregnant or are planning to have a baby
ask your doctor for advice before taking this
medicine.
Are you breast-feeding? Small amounts of
Colomycin enter the milk. If you cannot stop
breast-feeding while you take Colomycin, you
should watch your baby carefully for any
signs of illness and tell your doctor if you
notice anything wrong.
Driving and using machines
When Colomycin is given into a vein there
may be side effects such as dizziness,
confusion or problems with vision. If these
occur, you should not drive or operate
machinery.

3. HOW TO USE COLOMYCIN
Depending on the reason (see section 1 of
this leaflet), Colomycin may be given by fast
injection (over 5 minutes into a special kind
of tube in a vein) or slow injection (infusion
over about 30 to 60 minutes) into a vein.
Colomycin may occasionally be given by
injection into the heart or the spine.
Colomycin can also be breathed into the
lungs as a fine spray made using a machine
called a nebuliser. The droplets of the spray
produced by the nebuliser are small enough
to enter the lungs so that Colomycin can
reach the site of the bacterial infection.
Always use Colomycin exactly as your doctor
has told you. Check with your doctor if you
are not sure.
For use by infusion or injection:
Colomycin is given to you by your doctor as
an infusion into a vein over 30 – 60 minutes.
The usual daily dose in adults is 9 million
units, divided into two or three doses. If you
are quite unwell, you will be given a higher
dose of 9 million units once at the start of
treatment.
In some cases, your doctor may decide to
give a higher daily dose of up to 12 million
units.
The usual daily dose in children weighing up
to 40 kg is 75,000 to 150,000 units per
kilogram body weight, divided into three
doses.
Higher doses have occasionally been given in
cystic fibrosis.
Children and adults with kidney problems,
including those on dialysis, are usually given
lower doses.
Your doctor will monitor your kidney function
regularly while you receive Colomycin.
Method of administration
Colomycin is given by injection mainly in
hospitals. If you are to treat yourself at home,
your doctor or nurse will show you how to
dissolve the powder and inject the right dose
of solution.
Duration of treatment
Your doctor will decide how long your
treatment should last depending of the
severity of the infection. When treating
bacterial infections it is important to
complete the full course of treatment so as to
prevent worsening of the existing infection.
For use in a nebuliser:
The usual dose for adults, adolescents and
children aged 2 years or older is 1-2 million
units two to three times per day (maximum 6
million units per day).
The usual dose for children less than 2 years
old is 0.5-1 million units twice daily
(maximum 2 million units per day).
Your doctor may decide to adjust the dose
depending on your circumstances. If you also
take other inhaled medicines, your doctor
will tell you which order to taken them in.
Method of administration
If you are treating yourself at home, your
doctor or nurse will show you how to use
Colomycin in your nebuliser when you first
start the treatment. The following are general
instructions.

The plastic cap is flipped open and the foil
seal carefully ripped from around the top of
the vial to remove it completely. The rubber
bung is taken out carefully and sterile water
or sterile salt water (saline) is added to each
vial to dissolve the powder as follows:

If you experience any difficulty
breathing you should seek urgent
medical attention.
Other possible side effects include numbness
or tingling (especially around the face),
dizziness or loss of balance, rapid changes in
blood pressure or blood flow (including
faintness and flushing), slurred speech,
problems with vision, confusion and mental
problems (including loss of sense of reality).
There can be reactions at the site of the
injection, such as irritation.

1 million unit vial: 2ml sterile water / saline
2 million unit vial: 4ml sterile water / saline
The solution is then poured into the nebuliser.
IMPORTANT: Do not mix Colomycin with any
other product for nebulisation at the same
time.

Kidney problems may also occur. These are
especially likely in people who already have
poor kidneys, or who are given Colomycin at
the same time as other medicines that can
cause side effects in the kidneys or who are
given a dose that is too high. These
problems will normally get better if
treatment is stopped or the dose of
Colomycin is reduced.

Duration of treatment
For nebulised use your doctor will advise on
the course of the treatment.
If you use more Colomycin than you
should
If you think that you have given yourself too
much Colomycin, you should contact your
doctor or nurse immediately for advice or, if
they are not available, contact or go to your
nearest hospital accident and emergency
department. If too much Colomycin is
accidentally given, the side effects can be
serious and can include kidney problems,
muscle weakness and difficulty (or even
stopping) breathing.

If you get any side effects, talk to your
doctor. This includes any possible side effects
not listed in this leaflet.
Side effects associated with inhaling
Colomycin (nebulisation)
The risk of side effects is usually much less
when it is given by inhalation because very
little Colomycin usually reaches the
bloodstream when it is given this way.

If you are being treated in hospital or at home
by a doctor or nurse and think that you may
have missed a dose or been given too much
Colomycin, please ask your doctor, nurse or
pharmacist about this.

Possible side effects include coughing, a
feeling of tightness in the chest due to
narrowing of the airways, sore mouth or
throat and thrush (Candida) infections of the
mouth or throat.

If you forget to use Colomycin
If you are treating yourself and have missed
any doses, you should give the missed dose as
soon as you remember and then give the next
dose 8 hours later if using Colomycin three
times a day, or 12 hours later if using
Colomycin twice a day. Carry on from there as
instructed. Do not take a double dose to
make up forgotten dose.

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

If you stop using Colomycin
Do not stop your treatment early unless your
doctor says you can. Your doctor will decide
how long your treatment should last. If you
have any further questions on the use of this
medicine, ask your doctor.

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

4.POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/
adrportal

Allergic reactions
Whether Colomycin is given into a vein or by
inhalation, an allergic reaction is possible.
Serious allergic reactions can happen even
with the very first dose and can include rapid
development of rashes, swelling of the face,
tongue and neck, inability to breathe due to
narrowing of the airways and loss of
consciousness.
If you experience signs of an allergic
reaction you should seek urgent medical
attention.

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

5. HOW TO STORE COLOMYCIN
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 vial label after EXP. The
expiry date refers to the last date of that
month.
Do not store the vials above 25°C.
Keep the vials in the outer carton in order to
protect from light.
Colomycin solutions for injection and for
inhalation should be used immediately after
preparation.
If this is not possible, talk first to your doctor
or pharmacist as the solutions may be stored
in a refrigerator for no longer than 24 hours.
Any remaining solution should be discarded.
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 Colomycin contains
Each vial contains the active substance
colistimethate sodium (also called colistin) as
an amount of powder equivalent to one
million or two million units. There are no
other ingredients. This medicinal product
contains less than 1mmol sodium (23mg) per
vial, i.e. essentially ‘sodium free’.
What Colomycin looks like and contents
of the pack
Colomycin, a powder for solution for
injection, infusion or inhalation, is supplied as
a creamy white powder in single dose vials of
either:
• 1 million units of colistimethate sodium per
vial: red cap (1.0 MIU)
• 2 million units of colistimethate sodium per
vial: lilac cap (2.0 MIU)
Each box contains ten vials.
Marketing Authorisation Holder
Forest Laboratories UK Limited
Whiddon Valley,
Barnstaple
North Devon
EX32 8NS
United Kingdom
Manufacturer and site of batch release
Penn Pharmaceutical Services
Tredegar
Gwent
NP22 3AA
UK
This leaflet was last revised in September
2015

Other sources of information:

Less severe allergic reactions include skin
rashes that appear later during treatment.

Other formats:
To listen to or to request a copy of this leaflet in Braille, large print or audio please call
free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:

Side effects associated with injecting
Colomycin into a vein
Side effects that affect the nervous system are
more likely to occur when the dose of
Colomycin is too high, in people who have
poor kidneys or in those who are also taking
muscle relaxants or other medicines with a
similar effect on how the nerves work.
The most serious of these possible side effects
in the nervous system is inability to breathe
because of paralysis of the chest muscles.

Product Name

Reference Number

Colomycin Injection 1 million International Units

0108/5006

Colomycin Injection 2 million International Units
0108/0122
This is a service provided by the Royal National Institute of Blind People.
Patients in Ireland should telephone Forest Laboratories UK Ltd. on +44 (0) 1322 421800
AAAI2941

Colistimethate sodium 1 and 2 million Powder for solution for injection,
Infusion or Inhalation PIL Forest UK/IE/MT
item no: AAAI2941

dimensions: 280 x 230

print proof no: 3

pharmacode:

origination date: 10.09.15

min pt size: 6

originated by: S.Anson
approved for print/date

colours/plates
1. black
2. pms 2592
3.
4.
5.
6.

revision date: 22.09.15

Technical Approval

revised by: S.Anson

date sent: 10.09.15

supplier: Penn Pharmaceuticals

technically app. date: 10.09.15

Non Printing Colours
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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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