Skip to Content

PREDNISOLONE 20MG/100ML RECTAL SOLUTION

Active substance(s): PREDNISOLONE METASULPHOBENZOATE SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET
Predenema
(prednisolone)
Please read this leaflet carefully. It gives you a summary of the information about your medicine. If there is
anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.
What is in Predenema?
Predenema is a single dose retention enema for application into the rectum. Each single dose, disposable
enema contains a rectal solution of 20mg prednisolone, as prednisolone sodium metasulphobenzoate, in
100ml.
Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.
As well as the active ingredient, your medicine also contains disodium edetate, parahydroxybenzoates (E214,
E216, E218), and purified water.
Predenema is supplied as a plastic bag containing the enema solution with an applicator nozzle and cap or
alternatively with an extension tube attached to the nozzle (long-tube version) to enable easier selfadministration.
The standard version is available in packs of 10 and the long tube version is available in packs of 7.
The Marketing Authorisation holder is
Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham
Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
and the manufacturer is Forest Laboratories UK Ltd.,Bexley DA5 1NX.
What is Predenema used for?
Predenema is used to treat ulcerative colitis (inflammation of the bowels).
If you are not sure why you have been given Predenema ask your doctor or pharmacist (chemist).
Before Administering Predenema
This medicine is suitable for adults and children over 12 years of age.
Do not administer to younger children. Do not use but tell your doctor if you are pregnant or breast feeding
or suffering from peritonitis (inflammation of the walls of the abdominal cavity), anal sinus infection,
fistulae (an unnatural connection between the bowel and other body organ or to outside the body), intestinal
obstruction or perforation of the bowel.
Parahydroxybenzoates may cause allergic type reactions in sensitive patients. If this applies to you contact
your doctor before using Predenema.
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.
How to administer Predenema
Predenema is for rectal use only. The normal dose is one enema nightly for two to four weeks.

102/LBG/3
1

Predenema may be administered at room temperature, or warmed in warm water before use. Holding the bag
with the tube upwards, squeeze base of tube where it joins the bag. Remove cap and lubricate the nozzle. Lie
in bed on your side with knees drawn up. Insert into rectum as far as the flange on the nozzle. Squeeze
container gently until empty and discard bottle hygienically. Lie face downwards for a few minutes in order
to retain the fluid before going to sleep in your usual position.
What if I miss a dose?
Do not worry if you miss your dose of Predenema, if possible administer your Predenema as soon as you
remember. Use your next dose at the usual time. Only use one dose per day.
After using your medicine
There are not normally problems after using Predenema but if any unwanted effects are noticed tell your
doctor or pharmacist.
Storing your medicine
Predenema should be stored below 25°C and protected from light.
Do not use after the expiry date.
Date of last review of leaflet
June 2015

102/LBG/3
2

PATIENT INFORMATION LEAFLET
Predenema
(Prednisolone)
Please read this leaflet carefully. It gives you a summary of the information about your medicine. If there is
anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.
What is in Predenema?
Predenema is a single dose retention enema for application into the rectum. Each enema bottle contains a
rectal solution of 20mg prednisolone, as prednisolone sodium metasulphobenzoate, in 100ml.
Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.
As well as the active ingredient, your medicine also contains parahydroxybenzoates, disodium edetate and
purified water.
Predenema is supplied in a disposable plastic bottle. This ‘long tube’ version is supplied with a separate
applicator which is screwed onto the bottle before use. This version may enable easier self-administration.
Long tube Predenema is available in packs of 7 bottles with 7 screw-on applicators.
The Marketing Authorisation holder is
Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham
Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
and the manufacturer is Forest Laboratories UK Ltd.,Bexley DA5 1NX.
What is Predenema used for?
Predenema is used to treat ulcerative colitis (inflammation of the bowels).
If you are not sure why you have been given Predenema ask your doctor or pharmacist (chemist).
Before Administering Predenema
Predenema is suitable for adults and children over 12 years of age.
Do not administer to younger children. Do not use but tell your doctor if you are pregnant or breast feeding
or suffering from peritonitis (inflammation of the walls of the abdominal cavity), anal sinus infection,
fistulae (an unnatural connection between the bowel and other body organ or to outside the body), intestinal
obstruction or perforation of the bowel.
Parahydroxybenzoates may cause allergic type reactions in sensitive patients. If this applies to you contact
your doctor before using Predenema.
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.
How to administer Predenema
This medicine is for rectal use only. The normal dose is one enema nightly for two to four weeks.
Predenema may be administered at room temperature, or warmed in warm water before use. Holding the
bottle upright, remove the cap and screw on the applicator nozzle firmly. Lubricate the nozzle. Lie in bed on
your side with knees drawn up. Insert nozzle into rectum and squeeze the bottle gently until empty. Discard

102/LBT7/3
3

bottle hygienically. Lie face downwards for a few minutes in order to retain the fluid before going to sleep in
your usual position.
What if I miss a dose?
Do not worry if you miss your dose of Predenema, if possible administer your Predenema as soon as you
remember. Use your next dose at the usual time. Only use one dose per day.
After using your medicine
There are not normally problems after using Predenema but if any unwanted effects are noticed tell your
doctor or pharmacist.
Storing your medicine
Do not store above 25°C. In order to protect from light store the bottles in the carton. Do not use after the
expiry date printed on the bottle and carton.
Date of last review of leaflet
June 2015

102/LBT7/3
4

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