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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: 1451/060318/1/F

prednisolone (as prednisolone metasulphobenzoate sodium)
Patient Information Leaflet
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.

• If you suffer from severe ulcerative colitis this

Your medicine is called Predfoam 20 mg/dose
Rectal Foam and will be referred to as Predfoam
throughout the leaflet.

Using other medicines
You can use Predfoam whilst 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
Predfoam and your doctor may wish to monitor
you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir,
cobicistat)

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. This medicine 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 this medicine:
• 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.

medicine 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 difficult but your doctor should be
aware of this.
This medicine 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.

Pregnancy and breast-feeding
Ask your doctor for advice before using this
medicine 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.
This medicine 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

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.

Take special care with Predfoam:
• Talk to your doctor before taking Predfoam, if you
have scleroderma (also known as systemic
sclerosis, an autoimmune disorder) because daily
doses of 15 mg or more may increase the risk of a
serious complication called scleroderma renal
crisis. Signs of scleroderma renal crisis include
increased blood pressure and decreased urine
production. The doctor may advise that you have
your blood pressure and urine regularly checked.
4. The easiest way to use Predfoam foam 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.

5

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.

How to store Predfoam

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.
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.

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.
This medicine 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.
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 it 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.
Side effects where the frequency is not known:
Scleroderma renal crisis in patients already
suffering from scleroderma (an autoimmune
disorder). Signs of scleroderma renal crisis include
increased blood pressure and decreased urine
production.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed on this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play
or Apple App Store. By reporting side effects,
you can help provide more information on the
safety of this medicine.

6

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: 06/03/18

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

Ref: 1451/060318/1/B

Prednisolone 20 mg/dose Rectal Fom

Ref: 1451/060318/2/F

prednisolone (as prednisolone metasulphobenzoate sodium)
Patient Information Leaflet
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.

• If you suffer from severe ulcerative colitis this

Your medicine is called Prednisolone 20 mg/dose
Rectal Foam and will be referred to as Prednisolone
throughout the leaflet.

Using other medicines
You can use Prednisolone whilst 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
Prednisolone and your doctor may wish to monitor
you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir,
cobicistat)

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 Predfoam 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. This medicine 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 this medicine:
• 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.

medicine 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 difficult but your doctor should be
aware of this.
This medicine 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.

Pregnancy and breast-feeding
Ask your doctor for advice before using this
medicine 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.
This medicine 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

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.

Take special care with Prednisolone:
• Talk to your doctor before taking Prednisolone, if
you have scleroderma (also known as systemic
sclerosis, an autoimmune disorder) because daily
doses of 15 mg or more may increase the risk of a
serious complication called scleroderma renal
crisis. Signs of scleroderma renal crisis include
increased blood pressure and decreased urine
production. The doctor may advise that you have
your blood pressure and urine regularly checked.
4. The easiest way to use Prednisolone foam 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.

5

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.

How to store Predfoam

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.
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.

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.
This medicine 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.
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 it 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.

4

Possible side effects

Normally, there are no side effects associated with
the use of Prednisolone.
Side effects where the frequency is not known:
Scleroderma renal crisis in patients already
suffering from scleroderma (an autoimmune
disorder). Signs of scleroderma renal crisis include
increased blood pressure and decreased urine
production.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed on this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play
or Apple App Store. By reporting side effects,
you can help provide more information on the
safety of this medicine.

6

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: 06/03/18

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

Ref: 1451/060318/1/B

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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