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Patient Information Leaflet

Colifoam 10% w/w Rectal Foam
(Hydrocortisone acetate)
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours
• Throughout this leaflet Colifoam 10% w/w Rectal
Foam is called Colifoam.
• Colifoam is a steroid medicine, prescribed for
many different conditions, including serious illnesses
• You need to take it regularly to get the
maximum benefit
• Don’t stop using this medicine without talking to
your doctor - you may need to reduce the dose gradually
• Colifoam can cause side effects in some
people (read section 4 below). Some problems
such as mood changes (feeling depressed, or ‘high’),
or stomach problems can happen straight away. If
you feel unwell in any way, keep using your medicine,
but see your doctor straight away
• Some side effects only happen after weeks
or months. These include weakness of arms and
legs, or developing a rounder face (read section 4
for more information)
• If you use it for more than 3 weeks, you will
get a blue ‘steroid card’: always keep it with you
and show it to any doctor or nurse treating you.
• Keep away from people who have chickenpox or shingles, if you have never had them. They
could affect you severely. If you do come into
contact with chicken pox or shingles, see your
doctor straight away.
Now read the rest of this leaflet.
It includes other important information on the safe and
effective use of this medicine that might be especially
important for you.
In this leaflet:
What Colifoam is for
Before you use Colifoam
How to use Colifoam
Possible side effects
How to store Colifoam
Further information
1. What Colifoam is for
Colifoam – benefit information
Colifoam belongs to a group of medicines called
steroids. Their full name is corticosteroids. These
corticosteroids occur naturally in the body, and help to
maintain health and well-being. Boosting your body
with extra corticosteroid (such as Colifoam) is an
effective way to treat various illnesses involving

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inflammation in the body. Colifoam reduces this
inflammation, which could otherwise go on making
your condition worse. You must take this medicine
regularly to get maximum benefit from it.

The usual dose for adults including children and the
elderly is one applicator of foam once or twice per
day for two to three weeks and every second day
thereafter, applied into the rectum.

Colifoam is used to treat inflammation of the colon
and rectum.

For rectal use only.
Do not swallow

2. Before you use Colifoam
Do not use Colifoam:
• If you are allergic to hydrocortisone acetate or to
any other ingredient in Colifoam (see section 6)
• If you have bowel obstruction, abscess, perforation,
recent intestinal anastomosis or extensive fistulae.
• If you are suffering from fungal or viral infection,
tuberculosis or peritonitis.
If any of the above applies to you talk to your doctor
or pharmacist.

1. Shake the canister vigorously
for 30 seconds before each

2. Withdraw the plunger until it
stops at the catch Iine.


Warnings and precautions:
• Contact your doctor if you experience blurred vision
or other visual disturbances.
Check with your doctor first:
• If you have ever had severe depression or manicdepression (bipolar disorder). This includes having
had depression before while using steroid
medicines like Colifoam.
• If any of your close family has had these illnesses
• If you have diseases of the bowel (rectum).
If any of these applies to you, talk to your doctor
before using Colifoam.
Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines may increase the effects of Colifoam
and your doctor may wish to monitor you carefully
if you are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or
breast-feeding ask your doctor or pharmacist for
advice before using Colifoam.

3. Hold the applicater upright
and insert the canister top into
the opplicater tip. Make sure
you hold the plunger and
applicater body FIRMLY with
your fingers.

4. Press down gently on the
canister top with your fingers,
so that the foam fills about ¼
of the opplicater body. Only
a short press is needed to do





5. Wait for a few seconds until the
foam stops expanding.
DO NOT fill the applicator in
one go. Always release the
canister top after a short press.

3. How to use Colifoam
Always use Colifoam exactly as your doctor has
told you.
Your doctor will choose the dose that is right
for you. Your dose will be shown clearly on
the label that your pharmacist puts on your
medicine. If it is not, or you are not sure, ask
your doctor or pharmacist.
• You need to use your medicine regularly to get the
maximum benefit.
• Do not use for long periods in children or pregnant
• Treatment should be given carefully in cases of
severe ulcerative disease.

6. Repeat steps 4 & 5 above until
the foam expands to just reach
the ‘Fill’ Iine. This normally
takes 2 to 4 short press/wait.



7. Stand with one leg raised on
a chair, or lie down on your
side. Hold the applicater as
shown. lnsert gently into the
back passage and push the
plunger fully into the applicator.

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After using the applicator
• Always take the applicator apart and wash it
thoroughly after use
• The canister top should also be removed and
• Replace the canister top with care. Make sure it is
placed vertically on top of the canister, and not at
an angle.
If you use more Colifoam than you should
If you use too much go to your doctor as soon as
If you forget to use Colifoam
Do not use double the dose to make up for a missed
dose. Simply take your next dose as planned.
If you stop using Colifoam
Do not stop using Colifoam without talking to your
doctor. Your doctor may reduce your dose gradually.
Mental problems while using Colifoam
Mental health problems can happen while using
steroids like Colifoam (see also section 4 Possible
Side Effects).
• These illnesses can be serious
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However, if
problems do happen they might need treatment.
Talk to a doctor if you (or someone using this
medicine), show any signs of mental problems. This
is particularly important if you are depressed, or might
be thinking about suicide. In a few cases, mental
problems have happened when doses are being
lowered or stopped.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Colifoam can cause side effects,
although not everybody gets them.
Serious effects: tell your doctor straight away
Steroids can cause serious mental health problems.
These are common in both adults and children. They
can affect about 5 in every 100 people taking
medicines that contain steroids.
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up and down
• Feeling anxious, having problems sleeping, difficulty
in thinking or being confused and losing your memory
• Feeling, seeing or hearing things which do not exist.
Having strange and frightening thoughts, changing
how you act or having feelings of being alone.
If you notice any of these problems talk to a doctor
straight away.

Other side effects
If you get any of the following, keep using the medicine but tell your doctor:
• Unexpected fattening of the face, neck and body
• Irregular periods
• Hair starts to grow on your body (women)
• Dusky complexion with purple patches
• Itching
• Blurred vision (frequency not known).
Reporting of side effects
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 the Yellow Card Scheme at:

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact:
Meda Pharmaceuticals Ltd,
Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford, CM22

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

How to store Colifoam

Keep out of the reach and sight of children.
Do not use Colifoam after the expiry date which is
stated on the canister and carton. The expiry date
refers to the last day of that month.
• Do not expose to temperatures above 50°C.
• Store in the original packaging to protect from
• Store below 25°C.
• Do not refrigerate.
• Keep away from sources of ignition - No smoking.
• Do not spray on a naked flame or anything hot.
• Do not pierce or burn the container even after use.
Medicines should not be disposed of via wastewater
or household waste. Return any medicine you no
longer need to your pharmacist.
6. Further information
What Colifoam contains:
The active substance in Colifoam is hydrocortisone
acetate (10% w/w).
The other ingredients are cetyl alcohol, emulsifying
wax (contains cetostearyl alcohol), methyl
parahydroxybenzoate (E218), polyoxyl (10); stearyl
ether, propylene glycol, propyl parahydroxybenzoate
(E216), trolamine, purified water and propellant
HP-70 consisting of isobutane and propane.
What Colifoam looks like
Colifoam is a white rectal foam contained in a
pressurised canister.
Contents of the pack
Each pack contains a canister and an applicator.
Each canister contains approximately 14 doses.
Marketing Authorisation Holder in the UK:
Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.
Pharmasol Limited, North Way, Walworth Industrial
Estate, Andover, SP10 5AZ, UK.

Colifoam is a registered trademark of Meda AB.

This leaflet was last approved in February 2017

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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.