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as 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 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:
•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.
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.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a
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)
Pregnancy and breast-feeding
Ask your doctor for advice before using Predfoam if you are pregnant or breast-feeding.
3. How to use Predfoam
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.

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.
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.
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:
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 reach and sight of children.
Do not use Predfoam after the expiry date stated on the carton and canister after ‘Use By End’. 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 25˚C.
Protect from sunlight and do not expose to temperatures above 50˚C. Do not pierce or burn even after use. Do not spray
on naked flame or any incandescent material. Do not store in a refrigerator.
Discard after 14 doses have been used.
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. Each metered dose contains 31.4 mg of the active
ingredient (equivalent to 20.0 mg of prednisolone).
The other ingredients are non-ionic emulsifying wax, cetostearyl alcohol, oleyl alcohol, light liquid paraffin,
phenoxyethanol, sorbic acid, polysorbate 20, disodium edetate, sodium hydroxide and purified water. The propellant in
Predfoam is Butane 48.
What Predfoam looks like and contents of the pack
Predfoam is supplied in a canister. Each canister contains enough product for 14 doses and comes supplied with
disposable applicators and disposal bags.
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House
Egham Business Village, Crabtree Road,
Egham, Surrey TW20 8RB, UK
Manufactured on behalf of Chemidex Pharma Ltd by:
Pharmaserve (North West) Limited
Astmoor Industrial Estate
Runcorn, Cheshire WA7 1NU, UK
This leaflet was last revised in:
October 2017

5. Important: Holding the canister
4. The easiest way to use Predfoam is to
1. Shake before use.
with the dose button pointing down,
2. When using for the first time remove stand with one foot raised on a chair
press the button on the canister
and discard the small plastic safety
firmly and release. Only press the
your rectum. It may help if you smear
tag from under the button.
button once otherwise you will
the nozzle with lubricating jelly before
3. Carefully push an applicator nozzle
exceed the recommended dose.
onto the side arm of the canister.
Note: the canister will only work
Line up semi-circular cut-out on cap
when held with the dose button
with nozzle.
pointing down.
canister nozzle
Foam is expelled when the button is
applicator nozzle
safety tag
Dispose of the used nozzle in the
plastic bag provided - the nozzles
dose button
will not flush down toilets.

‘Chemidex’ and Chemidex logo are registered trademarks of Chemidex Pharma Ltd


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Further information

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