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PREDFOAM 20MG RECTAL FOAM

Active substance(s): PREDNISOLONE METASULPHOBENZOATE SODIUM

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Package Leaflet: Information for the user

PREDFOAM® 20 mg Rectal Foam
(prednisolone metasulphobenzoate sodium)
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.
 The name of this medicine is PREDFOAM® 20 mg Rectal Foam but
will be referred to as Predfoam throughout the remainder of 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.

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
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.

If you think this may apply to you speak to your doctor.
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.
 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 difficult
but your doctor should be aware of this.

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.

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.

Note: the canister will only work
when held with the dose button
pointing down.

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).

Foam is expelled when the button
is released.

Pregnancy and breast-feeding
Ask your doctor for advice before using Predfoam if you are pregnant or
breast-feeding.

Dispose of the used nozzle in the
plastic bag provided - the nozzles
will not flush down toilets.

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.
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.

PL: 33532/0548

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.

PREDFOAM® is a registered trademark of Chemidex Generics Ltd.

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, 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 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.
5. How to store Predfoam
 Keep out of the sight and reach of children.
 Do not use Predfoam after the expiry date stated on the carton and
canister after ‘EXP’. The expiry date refers to the last day of that
month.
 Predfoam is supplied in a pressurised container containing a
flammable propellant.
 Do not store above 25oC.
 Protect from sunlight and do not expose to temperatures above 50oC.
 Do not pierce or burn even after use.
 Do not spray on naked flame or any incandescent material.
 Do not refrigerate.
 Discard after 14 doses have been used.
 If your medicine becomes discoloured or shows any signs of
deterioration, return them to your pharmacist.
 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. Further information
What Predfoam contains
The active substance is prednisolone metasulphobenzoate sodium
31.4 mg, equivalent to prednisolone 20.0 mg.
Also contains: cetomacrogol emulsifying wax, cetostearyl alcohol, oleyl
alcohol, sodium hydroxide, technical white oil, phenoxyethanol, sorbic
acid, polysorbate 20, disodium edetate, purified water and butane 48.
What Predfoam looks like and contents of the pack
Aluminium aerosol with a metering valve containing a white to pale
cream coloured foam. Aerosol contained in a printed carton, together
with 14 disposable applicators and 14 disposable plastic bags.
Manufactured by
Pharmaserve (North West) Limited, Astmoor Industrial Estate,
Runcorn, Cheshire, WA7 1NU, UK.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.

Leaflet dated 13th November 2017
Leaflet coded XXXXXXXXXX

POM

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Package Leaflet: Information for the user

Prednisolone 20 mg/dose Rectal Foam
(prednisolone metasulphobenzoate sodium)
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.
In this leaflet:
1. What Prednisolone 20 mg/dose Rectal Foam is and what it is used for
2. Before you use Prednisolone 20 mg/dose Rectal Foam
3. How to use Prednisolone 20 mg/dose Rectal Foam
4. Possible side effects
5. How to store Prednisolone 20 mg/dose Rectal Foam
6. Further information
1. What Prednisolone 20 mg/dose Rectal Foam is and what it is
used for
Prednisolone 20 mg/dose Rectal Foam is a foam enema which is
inserted into the rectum. Prednisolone 20 mg/dose Rectal Foam belongs
to a group of medicines called corticosteroids which are used to reduce
inflammation.
Prednisolone 20 mg/dose Rectal Foam 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 20 mg/dose Rectal Foam
Do not use Prednisolone 20 mg/dose Rectal Foam:
 If you are allergic (hypersensitive) to prednisolone or any of the other
ingredients of Prednisolone 20 mg/dose Rectal Foam (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.

3. How to use Prednisolone 20 mg/dose Rectal Foam
Dosage
Always use Prednisolone 20 mg/dose Rectal Foam exactly as your
doctor has told you. You should check with your doctor if you are not
sure.
Prednisolone 20 mg/dose Rectal Foam is not recommended for use in
children (i.e. those under 18 years old).
One metered-dose of Prednisolone 20 mg/dose Rectal Foam 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.
4. The easiest way to use
Prednisolone 20 mg/dose Rectal
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.

If you think this may apply to you speak to your doctor.
Take special care with Prednisolone 20 mg/dose Rectal Foam:
 Talk to your doctor before taking Prednisolone 20 mg/dose Rectal
Foam, 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.
 If you suffer from severe ulcerative colitis Prednisolone 20 mg/dose
Rectal Foam may not be suitable for you and you should talk to your
doctor before using it.
 The use of Prednisolone 20 mg/dose Rectal Foam may make
diagnosing an infection more difficult but your doctor should be aware
of this.
Prednisolone 20 mg/dose Rectal Foam is for application in the rectum
only.
It is not advisable to use Prednisolone 20 mg/dose Rectal Foam for a
long period of time, but your doctor will be aware of this.
Using other medicines
You can use Prednisolone 20 mg/dose Rectal Foam 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 20 mg/dose
Rectal Foam 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
Ask your doctor for advice before using Prednisolone 20 mg/dose Rectal
Foam if you are pregnant or breast-feeding.

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.

Prednisolone 20 mg/dose Rectal Foam has been designed for your
maximum comfort and ease of use. Read these instructions carefully
before using Prednisolone 20 mg/dose Rectal Foam for the first time.
If you find it difficult to use Prednisolone 20 mg/dose Rectal Foam 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 20 mg/dose Rectal Foam
Do not worry if you miss a dose of Prednisolone 20 mg/dose Rectal
Foam. Administer Prednisolone 20 mg/dose Rectal Foam 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 20 mg/dose Rectal Foam 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 20 mg/dose Rectal Foam.
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, 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 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.
5. How to store Prednisolone 20 mg/dose Rectal Foam
 Keep out of the sight and reach of children.
 Do not use Prednisolone 20 mg/dose Rectal Foam after the expiry
date stated on the carton and canister after ‘EXP’. The expiry date
refers to the last day of that month.
 Prednisolone 20 mg/dose Rectal Foam is supplied in a pressurised
container containing a flammable propellant.
 Do not store above 25oC.
 Protect from sunlight and do not expose to temperatures above 50oC.
 Do not pierce or burn even after use.
 Do not spray on naked flame or any incandescent material.
 Do not refrigerate.
 Discard after 14 doses have been used.
 If your medicine becomes discoloured or shows any signs of
deterioration, return them to your pharmacist.
 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. Further information
What Prednisolone 20 mg/dose Rectal Foam contains
The active substance is prednisolone metasulphobenzoate sodium
31.4 mg, equivalent to prednisolone 20.0 mg.
Also contains: cetomacrogol emulsifying wax, cetostearyl alcohol, oleyl
alcohol, sodium hydroxide, technical white oil, phenoxyethanol, sorbic
acid, polysorbate 20, disodium edetate, purified water and butane 48.
What Prednisolone 20 mg/dose Rectal Foam looks like and contents
of the pack
Aluminium aerosol with a metering valve containing a white to pale
cream coloured foam. Aerosol contained in a printed carton, together
with 14 disposable applicators and 14 disposable plastic bags.
Manufactured by
Pharmaserve (North West) Limited, Astmoor Industrial Estate,
Runcorn, Cheshire, WA7 1NU, UK.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.

PL: 33532/0548
Leaflet dated 13th November 2017
Leaflet coded XXXXXXXXXX

POM

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

+ 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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