PREDNISOLONE 20MG RECTAL FOAM

Active substance: PREDNISOLONE

View full screen / Print PDF » Download PDF ⇩

Transcript
3.

Prednisolone 20mg Rectal Foam
(prednisolone (as prednisolone metasulphobenzoate sodium))

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).

PATIENT INFORMATION LEAFLET

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.

You medicine is available using the name Prednisolone 20mg Rectal Foam but will be referred to as
Prednisolone throughout this leaflet.

Administration

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
1.
2.
3.
4.
5.
6.
1.

HOW TO USE PREDNISOLONE

Dosage

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.
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.

5.

this leaflet:
What this medicine is and what it is used for
Before you use Prednisolone
How to use Prednisolone
Possible side effects
How to store Prednisolone
Further information

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.

WHAT THIS MEDICINE 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.

Take special care with Prednisolone:


If you suffer from severe ulcerative colitis this 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.

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.

canister nozzle
applicator nozzle

Using other medicines

You can use Prednisolone whilst taking other medicines.

foam
canister
safety tag
semi-circular
cut-out
dose button

Pregnancy and breast-feeding

Ask your doctor for advice before using this medicine if you are pregnant or breast-feeding.

Disposal

The used nozzles should be disposed of in the plastic bag provided.

Page 1 of 2

If you forget to use Prednisolone

Manufacturer

If you use more Prednisolone than you should

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

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.

Manufactured by: Pharmaserve (North West) Limited, Astmoor Industrial Estate, Runcorn, Cheshire,
WA7 1NU.

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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

If you have any further questions on the use of this product, ask your doctor.

PL No: 21828/0506

4. SIDE EFFECTS

POM

Latest revision date: 29.11.13

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

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PREDNISOLONE
Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and canister after ‘Exp’.
The expiry date refers to the last day of that month.
Prednisolone 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 store in a refrigerator.
Discard after 14 doses have been used.
If your medicine appears to be discoloured or shows any other signs of deterioration, please return it
to your pharmacist who will advise you further.
If your doctor decides to stop your treatment, return any unused medicine 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 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 and
purified water. The propellant in Prednisolone is Butane 48 mixture.

What Prednisolone looks like and contents of the pack

Prednisolone is a white to pale cream coloured, metered-dose rectal foam supplied in a canister.
Each canister contains enough product for 14 doses.
Each pack contains one canister, 14 disposable applicators and 14 disposable plastic bags.

Page 2 of 2

Expand view ⇕

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.

Hide
(web3)