PREDNISOLONE 20 MG/DOSE RECTAL FOAM

Active substance: PREDNISOLONE METASULPHOBENZOATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PREDFOAM
Prednisolone
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:

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.
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.

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 gently insert the nozzle tip into
and discard the small plastic safety
firmly and release. Only press the
your rectum.
tag from under the button.
button once otherwise you will
It may help if you smear the nozzle with
3. Carefully push an applicator nozzle
exceed the recommended dose.
lubricating jelly before insertion.
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.
foam
canister
canister nozzle
Foam is expelled when the button is
applicator nozzle
released.
safety tag
Dispose of the used nozzle in the
semi-circular
plastic bag provided - the nozzles
cut-out
dose button
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. 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

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 31.4mg of the active
ingredient (equivalent to 20.0mg of prednisolone).
The other ingredients are non-ionic emulsifying wax, cetostearyl alcohol, oleyl alcohol, technical white oil,
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
Manufactured on behalf of Chemidex Pharma Ltd by:
Pharmaserve (North West) Limited
Astmoor Industrial Estate
Runcorn, Cheshire WA7 1NU.
This leaflet was last approved in: 03/2011

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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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