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PREDFOAM 20 MG/DOSE RECTAL FOAM

Active substance(s): PREDNISOLONE

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Predfoam ® 20 mg/dose Rectal Foam

Ref: 1451/300414/1/F

prednisolone (as prednisolone metasulphobenzoate sodium)
Patient Information Leaflet
Please 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
• 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.
• If you notice any side effects please tell your
doctor.
Your medicine is called Predfoam 20 mg/dose
Rectal Foam and will be referred to as Predfoam
throughout the leaflet.

In this leaflet:
1 What Predfoam is and what it is used
for
2 Before you use Predfoam
3 How to use Predfoam
4 Possible side effects
5 How to store Predfoam
6 Further information

1

What Predfoam is and what it is
used for

Predfoam is a foam enema which is inserted into the
rectum. Predfoam belongs to a group of medicines
called corticosteroids which are used to reduce
inflammation.
Predfoam is used to treat ulcerative colitis
(inflammation of the bowels) and may be used to
treat proctitis (inflammation of the rectum).

2

Before you use Predfoam

Do not use Predfoam:
• If you are allergic (hypersensitive) to prednisolone
or any of the other ingredients of Predfoam (see
Section 6 for full list of ingredients).
• If you suffer from peritonitis (inflammation of the
peritoneum – (abdominal lining))
• If you suffer from bowel problems such as
obstruction, perforation or rectal/colonic fistulae
(abnormal connection between internal organs) or
if you have a possible infection.
If you think this may apply to you speak to your
doctor.

Take special care with Predfoam:
• If you suffer from severe ulcerative colitis
Predfoam may not be suitable for you and you
should talk to your doctor before using it.
• The use of Predfoam may make diagnosing an
infection more diffi cult but your doctor should be
aware of this.
Predfoam is for application in the rectum only.
It is not advisable to use Predfoam for a long period
of time, but your doctor will be aware of this.
Using other medicines
You can use Predfoam whilst taking other
medicines.
Pregnancy and breast-feeding
Ask your doctor for advice before using Predfoam if
you are pregnant or breast-feeding.

3

How to use Predfoam

Dosage
Always use Predfoam exactly as your doctor has
told you. You should check with your doctor if you
are not sure. Predfoam is not recommended for use
in children (i.e. those under 18 years old).
One metered-dose of Predfoam should be inserted
rectally, using one of the applicator nozzles
provided, once or twice daily for 2 weeks.
Your doctor may decide to extend the treatment for
a further 2 weeks.
Administration
Predfoam has been designed for your maximum
comfort and ease of use. Read these instructions
carefully before using Predfoam for the first time.
If you find it difficult to use Predfoam in a standing
position an alternative is to administer while lying on
your side with both legs bent up.

1. Shake before use.
2. When using for the first time remove
and discard the small plastic safety tag from
under the button.
3. Carefully push an applicator nozzle onto the
side arm of the canister. Line up semi-circular
cut-out on cap with nozzle.

4. The easiest way to use Predfoam is to stand
with one foot raised on a chair and gently insert
the nozzle tip into your rectum. It may help if you
smear the nozzle with lubricating jelly before
insertion.

Keep pressurised container away from heat and
light. Do not pierce or burn even after use. Do not
spray on naked flame or any incandescent material.
Discard after 14 doses have been used.
Do not use after the expiry date which is stated on
the canister label and on the carton. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6
5. Important: Holding the canister with the dose
button pointing down, press the button on the
canister firmly and release. Only press the
button once otherwise you will exceed the
recommended dose.
Note: the canister will only work when held with
the dose button pointing down. Foam is expelled
when the button is released.
Dispose of the used nozzle in the plastic bag
provided - the nozzles will not flush down toilets.
Disposal
The used nozzles should be disposed of in the
plastic bag provided.
If you forget to use Predfoam
Do not worry if you miss a dose of Predfoam.
Administer Predfoam as soon as you remember and
then use your next dose at the usual time. Do not
use more than 2 doses in one day.
If you use more Predfoam than you should
Overdosage by this route is unlikely, but if someone
else takes your medicine or it is used incorrectly
take the canister to your doctor and ask for advice.
If you have any further questions on the use of this
product, ask your doctor.

4

Possible side effects

Normally, there are no side effects associated with
the use of Predfoam. However, if you think that
Predfoam is causing you any unusual discomfort or
problems, please contact your doctor or pharmacist.

5

How to store Predfoam

Further Information

What Predfoam contains
The active substance is prednisolone
metasulphobenzoate sodium. Each metered dose
contains 31.4mg of the active ingredient (equivalent
to 20.0mg of prednisolone).
The other ingredients are cetomacrogol emulsifying
wax, cetostearyl alcohol, oleyl alcohol, technical
white oil, phenoxyethanol, sorbic acid, polysorbate
20, disodium edetate, sodium hydroxide, purified
water and butane 48.
What Predfoam looks like and contents of the
pack
Predfoam is an areosol foam supplied in a canister.
Each canister contains enough product for 14 doses
and comes supplied with disposable applicators and
disposal bags.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmaserve
(North West) Limited, Astmoor Industrial Estate,
Runcorn, Cheshire WA7 1NU, United Kingdom and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1451

Predfoam is a registered trademark of Chemidex
Generics Limited.
Leaflet revision date: 30/04/2014

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Keep out of the sight and reach of children.
Predfoam is supplied in a pressurised container
containing a flammable propellant.
Do not store above 25˚C. Do not refrigerate.
Ref: 1451/300414/1/B

Prednisolone 20 mg/dose Rectal Foam

Ref: 1451/300414/2/F

prednisolone (as prednisolone metasulphobenzoate sodium)
Patient Information Leaflet
Please 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
• 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.
• If you notice any side effects please tell your
doctor.
Your medicine is called Prednisolone 20 mg/dose
Rectal Foam and will be referred to as Prednisolone
throughout the leaflet.

In this leaflet:
1 What Prednisolone is and what it is used
for
2 Before you use Prednisolone
3 How to use Prednisolone
4 Possible side effects
5 How to store Prednisolone
6 Further information

1

What Prednisolone is and what it is
used for

Prednisolone is a foam enema which is inserted into
the rectum. Prednisolone belongs to a group of
medicines called corticosteroids which are used to
reduce inflammation.
Prednisolone is used to treat ulcerative colitis
(inflammation of the bowels) and may be used to
treat proctitis (inflammation of the rectum).

2

Before you use Prednisolone

Do not use Prednisolone:
• If you are allergic (hypersensitive) to prednisolone
or any of the other ingredients of Prednisolone
(see Section 6 for full list of ingredients).
• If you suffer from peritonitis (inflammation of the
peritoneum – (abdominal lining))
• If you suffer from bowel problems such as
obstruction, perforation or rectal/colonic fistulae
(abnormal connection between internal organs) or
if you have a possible infection.
If you think this may apply to you speak to your
doctor.

Take special care with Prednisolone:
• If you suffer from severe ulcerative colitis
Prednisolone may not be suitable for you and you
should talk to your doctor before using it.
• The use of Prednisolone may make diagnosing an
infection more diffi cult but your doctor should be
aware of this.
Prednisolone is for application in the rectum only.
It is not advisable to use Prednisolone for a long
period of time, but your doctor will be aware of this.
Using other medicines
You can use Prednisolone whilst taking other
medicines.
Pregnancy and breast-feeding
Ask your doctor for advice before using
Prednisolone if you are pregnant or breast-feeding.

3

How to use Prednisolone

Dosage
Always use Prednisolone exactly as your doctor has
told you. You should check with your doctor if you
are not sure. Prednisolone is not recommended for
use in children (i.e. those under 18 years old).
One metered-dose of Prednisolone should be
inserted rectally, using one of the applicator nozzles
provided, once or twice daily for 2 weeks.
Your doctor may decide to extend the treatment for
a further 2 weeks.
Administration
Prednisolone has been designed for your maximum
comfort and ease of use. Read these instructions
carefully before using Prednisolone for the first time.
If you find it difficult to use Prednisolone in a
standing position an alternative is to administer
while lying on your side with both legs bent up.

1. Shake before use.
2. When using for the first time remove
and discard the small plastic safety tag from
under the button.
3. Carefully push an applicator nozzle onto the
side arm of the canister. Line up semi-circular
cut-out on cap with nozzle.

4. The easiest way to use Prednisolone is to
stand with one foot raised on a chair and gently
insert the nozzle tip into your rectum. It may help
if you smear the nozzle with lubricating jelly
before insertion.

Keep pressurised container away from heat and
light. Do not pierce or burn even after use. Do not
spray on naked flame or any incandescent material.
Discard after 14 doses have been used.
Do not use after the expiry date which is stated on
the canister label and on the carton. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6
5. Important: Holding the canister with the dose
button pointing down, press the button on the
canister firmly and release. Only press the
button once otherwise you will exceed the
recommended dose.
Note: the canister will only work when held with
the dose button pointing down. Foam is expelled
when the button is released.
Dispose of the used nozzle in the plastic bag
provided - the nozzles will not flush down toilets.
Disposal
The used nozzles should be disposed of in the
plastic bag provided.
If you forget to use Prednisolone
Do not worry if you miss a dose of Prednisolone.
Administer Prednisolone as soon as you remember
and then use your next dose at the usual time. Do
not use more than 2 doses in one day.
If you use more Prednisolone than you should
Overdosage by this route is unlikely, but if someone
else takes your medicine or it is used incorrectly
take the canister to your doctor and ask for advice.
If you have any further questions on the use of this
product, ask your doctor.

Further Information

What Prednisolone contains
The active substance is prednisolone
metasulphobenzoate sodium. Each metered dose
contains 31.4mg of the active ingredient (equivalent
to 20.0mg of prednisolone).
The other ingredients are cetomacrogol emulsifying
wax, cetostearyl alcohol, oleyl alcohol, technical
white oil, phenoxyethanol, sorbic acid, polysorbate
20, disodium edetate, sodium hydroxide, purified
water and butane 48.
What Prednisolone looks like and contents of
the pack
Prednisolone is an areosol foam supplied in a
canister. Each canister contains enough product for
14 doses and comes supplied with disposable
applicators and disposal bags.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmaserve
(North West) Limited, Astmoor Industrial Estate,
Runcorn, Cheshire WA7 1NU, United Kingdom and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1451

Leaflet revision date: 30/04/2014
4

Possible side effects

Normally, there are no side effects associated with
the use of Prednisolone. However, if you think that
Prednisolone is causing you any unusual discomfort
or problems, please contact your doctor or
pharmacist.

5

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

How to store Prednisolone

Keep out of the sight and reach of children.
Prednisolone is supplied in a pressurised container
containing a flammable propellant.
Do not store above 25˚C. Do not refrigerate.
Ref: 1451/300414/2/B

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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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