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HYDROCORTISONE ACETATE 10%W/W FOAM

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S707 LEAFLET Colifoam 20150305

Patient Information Leaflet

COLIFOAM 10%w/w
(hydrocortisone acetate)

Check with your doctor first:


If you have ever had severe depression or manic- depression
(bipolar disorder). This includes having had depression before
while using steroid medicines like Colifoam.



If any of your close family has had these illnesses

Read all of this leaflet carefully before you start using this
medicine.



If you have diseases of the bowel (rectum).



Keep this leaflet. You may need to read it again



If any of these applies to you, talk to your doctor before using
Colifoam.

If you have any further questions, ask your doctor or pharmacist



Taking other medicines

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

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

 Throughout this leaflet Colifoam 10%w/w is called Colifoam.
Important:

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.



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

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.
Remember:



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)



You need to use your medicine regularly to get the maximum
benefit.





Do not use for long periods in children or pregnant women.

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.

3. HOW TO USE COLIFOAM
Always use Colifoam exactly as your doctor has told you.
Important:

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.

Now read the rest of this leaflet.

Do not swallow

It includes other important information on the safe and effective use
of this medicine that might be especially important for you.

1. Shake the canister vigorously

In this leaflet:

for 30 seconds before each
use.

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

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

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

3. Hold the applicator upright and
insert the canister top into
the applicator tip. Make sure you
hold the plunger and applicator

2. BEFORE YOU USE COLIFOAM

body FIRMLY with your fingers.

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.

4. Press down gently on the
canister top with your fingers,
so that the foam fills about 1/4
of the applicator body. Only
a short press is needed to do
this.


5. Wait for a few seconds until the
foam stops expanding.

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.

DO NOT fill the applicator in
one go. Always release the
canister top after a short press.

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

6. Repeat steps 4 & 5 above until



Irregular periods

the foam expands to just reach



Hair starts to grow on your body (women)

the 'Fill' line. This normally



Dusky complexion with purple patches

takes 2 to 4 short press/wait.



Itching.

Reporting of side effects

7. Stand with one leg raised on
a chair, or lie down on your

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.

side. Hold the applicator as
shown. Insert gently into the

5. HOW TO STORE COLIFOAM

plunger fully into the applicator.

After using the applicator


Always take the applicator apart and wash it thoroughly after
use



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Pressurised container containing flammable propellant. Protect
from sunlight and do not expose to temperatures above 50°C.



back passage and push the

Do not store above 25°C. Do not refrigerate.



Do not spray on naked flame or any incandescent material.



Keep away from sources of ignition - no smoking.



Do not pierce or burn even after use.

The canister top should also be removed and washed



Do not use after the expiry date printed on canister.



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 your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

If you use too much go to your doctor as soon as possible.



If the medicine becomes discoloured or sho ws any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

6. FURTHER INFORMAT ION
What Colifoam contains


Colifoam contains 10%w/w of the active ingredient,
hydrocortisone acetate, as aerosol foam in a pressurised
canister with an applicator.



Colifoam also contain the following inactive ingredients: cetyl
alcohol, methyl hydroxybenzoate, propyl hydroxybenzoate,
polyoxyethylene-10-stearyl ether, propylene glycol,
triethanolamine, purified water, propellant HP 70 and
emulsifying wax. Colifoam does not contain CFCs.

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.

What Colifoam looks like and contents of the pack
Colifoam is available in an aerosol canister containing 20.8g of
foam. The pack contains approximately 14 doses.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Pharmasol Ltd, Northway,
Walworth Industrial Estate, Andover, Hampshire, SP 10 5AZ, UK.

POM

PL No. 19488/0707

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.

Leaflet revision date: 05 March 2015
Colifoam is a registered trade mark of Meda AB, Sweden.
S707 LEAFLET Colifoam 20150305

S707 LEAFLET Hydrocortisone 20150305

Patient Information Leaflet

Check with your doctor first:


If you have ever had severe depression or manic- depression
(bipolar disorder). This includes having had depression before
while using steroid medicines like Hydrocortisone acetate
Foam.



If any of your close family has had these illnesses

HYDROCORTISONE ACETATE 10%w/w FOAM
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 Hydrocortisone acetate 10%w/w Foam is
called Hydrocortisone acetate Foam.

Important:


Hydrocortisone acetate Foam is a steroid medicine,
prescribed for many different conditions, including serious
illnesses



Don't stop using this medicine without talking to your doctor
- you may need to reduce the dose gradually

Taking other medicines
Tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding
ask your doctor or pharmacist for advice before using
Hydrocortisone acetate Foam.

You need to take it regularly to get the maximum benefit



 If you have diseases of the bowel (rectum).
If any of these applies to you, talk to your doctor before using
Hydrocortisone acetate Foam.









Hydrocortisone acetate Foam 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

3. HOW TO USE HYDROCORTISONE ACETATE FOAM
Always use Hydrocortisone acetate Foam exactly as your doctor
has told you.
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.

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)

Remember:


You need to use your medicine regularly to get the maximum
benefit.

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.



Do not use for long periods in children or pregnant women.



Treatment should be given carefully in cases of severe
ulcerative disease.

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.

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.

Now read the rest of this leaflet.

For rectal use only.

It includes other important information on the safe and effective use
of this medicine that might be especially important for you.
In this leaflet:

Do not swallow

1. What Hydrocortisone acetate Foam is for

1. Shake the canister vigorously
for 30 seconds before each
use.

2. Before you use Hydrocortisone acetate Foam
3.

How to use Hydrocortisone acetate Foam

4. Possible side effects
5. How to store Hydrocortisone acetate Foam
6. Further information

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

1. WHAT HYDROCORTISONE ACETATE FOAM IS FOR
Hydrocortisone acetate Foam - benefit information
Hydrocortisone acetate Foam 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 Hydrocortisone acetate Foam) is an effective way to treat
various illnesses involving inflammation in the body. Hydrocortisone
acetate Foam reduces this inflammation, which could otherwise go
on making your condition worse. You must take this medicine
regularly to get maximum benefit from it.
Hydrocortisone acetate Foam is used to treat inflammation of the
colon and rectum.

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.

2. BEFORE YOU USE HYDROCORTISONE ACETATE FOAM
Do not use Hydrocortisone acetate Foam:


If you are allergic to Hydrocortisone acetate Foam or to any
other ingredient in Hydrocortisone acetate Foam (see section 6)



If you have bowel obstruction, abscess, perforation, recent
intestinal anastomosis or extensive fistulae.

canister top with your fingers,



If you are suffering from fungal or viral infection, tuberculosis or
peritonitis.

of the applicator body. Only

If any of the above applies to you talk to your doctor or pharmacist.

4. Press down gently on the
so that the foam fills about 1/4
a short press is needed to do
this.

5. Wait for a few seconds until the
foam stops expanding.



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.

DO NOT fill the applicator in
one go. Always release the
canister top after a short press.

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

6. Repeat steps 4 & 5 above until



Irregular periods

the foam expands to just reach



Hair starts to grow on your body (women)

the 'Fill' line. This normally



Dusky complexion with purple patches

takes 2 to 4 short press/wait.



Itching.

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

By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE HYDROCORTISONE ACETATE FOAM

plunger fully into the applicator.

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



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



Pressurised container containing flammable propellant. Protect
from sunlight and do not expose to temperatures above 50°C.



back passage and push the

Do not store above 25°C. Do not refrigerate.



Do not spray on naked flame or any incandescent material.



Keep away from sources of ignition - no smoking.



Do not pierce or burn even after use.



Do not use after the expiry date printed on canister.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you forget to use Hydrocortisone acetate Foam
Do not use double the dose to make up for a missed dose. Simply
take your next dose as planned.
If you stop using Hydrocortisone acetate Foam
Do not stop using Hydrocortisone acetate Foam without talking to
your doctor. Your doctor may reduce your dose gradually.

6. FURTHER INFORMAT ION
What Hydrocortisone acetate Foam contains


Hydrocortisone acetate Foam contains 10%w/w of the active
ingredient, hydrocortisone acetate, as aerosol foam in a
pressurised canister with an applicator.



Hydrocortisone acetate Foam also contains the following
inactive ingredients: cetyl alcohol, methyl hydroxybenzoate,
propyl hydroxybenzoate, polyoxyethylene-10-stearyl ether,
propylene glycol, triethanolamine, purified water, propellant HP
70 and emulsifying wax. Hydrocortisone acetate Foam does not
contain CFCs.

Mental problems while using Hydrocortisone acetate Foam
Mental health problems can happen while using steroids like
Hydrocortisone acetate Foam (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.

What Hydrocortisone acetate Foam looks like and contents of
the pack
Hydrocortisone acetate Foam is available in an aerosol canister
containing 20.8g of foam. The pack contains approximately 14
doses.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

4. POSSIBLE SIDE EFFECTS
Like all medicines, Hydrocortisone acetate Foam 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

This product is manufactured by Pharmasol Ltd, Northway,
Walworth Industrial Estate, Andover, Hampshire, SP 10 5AZ, UK.
POM

PL No. 19488/0707

Leaflet revision date: 05 Mrach 2015
S707 LEAFLET Hydrocortisone 20150305

Expand Transcript

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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