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HYDROCORTISONE ACETATE 10% W/W RECTAL FOAM

Active substance(s): HYDROCORTISONE ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COLIFOAM® / HYDROCORTISONE ACETATE 10% W/W
RECTAL FOAM
(hydrocortisone acetate)

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.

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 pharmacist
 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/ Hydrocortisone Acetate 10% W/W
Rectal Foam is called Colifoam.
Important:
 Colifoam is a steroid medicine, prescribed for many different
conditions, including serious illnesses
 You need to use 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.

How to use Colifoam

Always use Colifoam exactly as your doctor has told you.

Remember:
 You need to use your medicine regularly to get the maximum benefit.
 Do not use for long periods in children or pregnant women.
 Treatment should be given carefully in cases of severe ulcerative
disease.
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.
For rectal use only.
Do not swallow
1. Shake the canister vigorously for 30 seconds
before each use.

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
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.

Before you use Colifoam

Do not use Colifoam:

 If you are allergic to hydrocortisone acetate or to any other ingredient in

3. Hold the applicator upright and insert the
canister top into the applicator tip. Make sure
you hold the plunger and applicator 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 applicator body. Only a short press is
needed to do this.

anastomosis or extensive fistulae.

 If you are suffering from fungal or viral infection, tuberculosis or

Check with your doctor first:
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
Tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.

CAUTION: The can is under pressure so do not leave it in the sun or very
hot places (above 50°C). It contains a flammable propellant. Do not
spray on a naked flame or any incandescent material. Keep away from
sources of ignition - No Smoking. Do not pierce or burn, even when
empty.
 Do not put in the fridge or freezer. Store up to 25°C.
 Do not use the product after the expiry date on the canister.
 REMEMBER - KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
 If your doctor tells you to stop using this medicine, please take it back to
the pharmacist for safe disposal. Only keep your medicine if your doctor
tells you to.
 If the foam becomes discoloured or the product shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
6. Further information
What Colifoam contains:
The canister contains 10% w/w of the active ingredient hydrocortisone
acetate in the form of a rectal foam.
The product also contains propylene glycol, stearyl alcohol ethoxylate,
polyoxyethylene-10-stearyl ether, cetyl alcohol, methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216), triethanolamine, purified water
and isobutane and propane as the propellant.
Colifoam does not contain CFCs.
Colifoam contains cetyl alcohol and stearyl alcohol ethoxylate which may
cause local skin reactions (e.g. contact dermatitis).
Colifoam contains propylene glycol which may cause skin irritation.
Colifoam contains methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).
What Colifoam looks like and the contents of the pack
Colifoam is available in packs of 20.8g rectal foam contained in a white
aerosol canister with white plastic cap. The pack also contains a clear plastic
applicator with a blue plunger.
The canister contains white odourless foam which gives approximately 14
doses.

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.

Manufacturer
Colifoam is manufactured by: Pharmasol Ltd, North Way, Walworth
Industrial Estate, Andover, SP10 5AZ, UK and is procured from within the
EU by the Product Licence holder: G. Pharma Ltd., Salford M50 2PU.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

PL 16369/1328

4. Possible side effects

Colifoam (see section 6)

 If you have ever had severe depression or manicdepression (bipolar

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 taking 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.

 If you have bowel obstruction, abscess, perforation, recent intestinal
peritonitis.
If any of the above applies to you talk to your doctor or pharmacist.

After using the applicator
 Always take the applicator apart and wash it thoroughly after use
 The canister top should also be removed and washed
 Replace the canister top with care. Make sure it is placed vertically on
top of the canister, and not at an angle.

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.

Colifoam is used to treat inflammation of the colon and rectum.
2.

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

If you use more Colifoam than you should
If you use too much go to your doctor as soon as possible.

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

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:
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 Colifoam

Important:
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.

In this leaflet:
1. What Colifoam is for
2. Before you use Colifoam
3. How to use Colifoam
4. Possible side effects
5. How to store Colifoam
6. Further information
1. What Colifoam is for

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

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.

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.

POM
04/03/2014

Colifoam is a registered trademark of Meda AB.

PACKAGE LEAFLET: INFORMATION FOR THE USER
COLIFOAM® / HYDROCORTISONE ACETATE 10% W/W
RECTAL FOAM
(hydrocortisone acetate)

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.

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 pharmacist
 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/ Hydrocortisone Acetate 10% W/W
Rectal Foam is called Colifoam.
Important:
 Colifoam is a steroid medicine, prescribed for many different
conditions, including serious illnesses
 You need to use 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.

How to use Colifoam

Always use Colifoam exactly as your doctor has told you.

Remember:
 You need to use your medicine regularly to get the maximum benefit.
 Do not use for long periods in children or pregnant women.
 Treatment should be given carefully in cases of severe ulcerative
disease.
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.
For rectal use only.
Do not swallow
1. Shake the canister vigorously for 30 seconds
before each use.

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
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.

Before you use Colifoam

Do not use Colifoam:

 If you are allergic to hydrocortisone acetate or to any other ingredient in

3. Hold the applicator upright and insert the
canister top into the applicator tip. Make sure
you hold the plunger and applicator 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 applicator body. Only a short press is
needed to do this.

anastomosis or extensive fistulae.

 If you are suffering from fungal or viral infection, tuberculosis or

Check with your doctor first:
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
Tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.

CAUTION: The can is under pressure so do not leave it in the sun or very
hot places (above 50°C). It contains a flammable propellant. Do not
spray on a naked flame or any incandescent material. Keep away from
sources of ignition - No Smoking. Do not pierce or burn, even when
empty.
 Do not put in the fridge or freezer. Store up to 25°C.
 Do not use the product after the expiry date on the canister.
 REMEMBER - KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
 If your doctor tells you to stop using this medicine, please take it back to
the pharmacist for safe disposal. Only keep your medicine if your doctor
tells you to.
 If the foam becomes discoloured or the product shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
6. Further information
What Colifoam contains:
The canister contains 10% w/w of the active ingredient hydrocortisone
acetate in the form of a rectal foam.
The product also contains propylene glycol, stearyl alcohol ethoxylate,
polyoxyethylene-10-stearyl ether, cetyl alcohol, methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216), triethanolamine, purified water
and isobutane and propane as the propellant.
Colifoam does not contain CFCs.
Colifoam contains cetyl alcohol and stearyl alcohol ethoxylate which may
cause local skin reactions (e.g. contact dermatitis).
Colifoam contains propylene glycol which may cause skin irritation.
Colifoam contains methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).
What Colifoam looks like and the contents of the pack
Colifoam is available in packs of 20.8g rectal foam contained in a white
aerosol canister with white plastic cap. The pack also contains a clear plastic
applicator with a blue plunger.
The canister contains white odourless foam which gives approximately 14
doses.

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.

Manufacturer
Colifoam is manufactured by: Pharmasol Ltd, North Way, Walworth
Industrial Estate, Andover, SP10 5AZ, UK and is procured from within the
EU by the Product Licence holder: G. Pharma Ltd., Salford M50 2PU.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

PL 16369/1328

4. Possible side effects

Colifoam (see section 6)

 If you have ever had severe depression or manicdepression (bipolar

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 taking 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.

 If you have bowel obstruction, abscess, perforation, recent intestinal
peritonitis.
If any of the above applies to you talk to your doctor or pharmacist.

After using the applicator
 Always take the applicator apart and wash it thoroughly after use
 The canister top should also be removed and washed
 Replace the canister top with care. Make sure it is placed vertically on
top of the canister, and not at an angle.

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.

Colifoam is used to treat inflammation of the colon and rectum.
2.

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

If you use more Colifoam than you should
If you use too much go to your doctor as soon as possible.

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

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:
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 Colifoam

Important:
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.

In this leaflet:
1. What Colifoam is for
2. Before you use Colifoam
3. How to use Colifoam
4. Possible side effects
5. How to store Colifoam
6. Further information
1. What Colifoam is for

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

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.

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.

POM
04/03/2014

Colifoam is a registered trademark of Meda AB.

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.

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