PREDNISOLONE 20MG/100ML RECTAL SOLUTION

Active substance: PREDNISOLONE METASULPHOBENZOATE SODIUM

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PATIENT INFORMATION LEAFLET
PREDENEMA
(Prednisolone)

102/LBG/1

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 alternativley 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., Chemidex House, 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.
How to administer Predenema
Predenema 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 bag with the tube upwards, squeeze
base of tube where it joins the bag. Remove cap and lubricate the
nozzle. 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
March 2008
102/LBG/1

102/LBGEG/1

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 alternativley 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
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.
How to administer Predenema
Predenema 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 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
March 2008
102/LBGEG/1

PATIENT INFORMATION LEAFLET
PREDENEMA
(Prednisolone)

102/LBT7/1

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.

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.
How to administer Predenema
Predenema 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 bottle hygienically. Lie face downwards
for a few minutes in order to retain the fluid before going to sleep in your
usual position.

Long tube Predenema is available in packs of 7 bottles with 7 screw-on
applicators.

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.

The Marketing Authorisation holder is
Chemidex Pharma Ltd., Chemidex House, Egham Business Village,
Crabtree Road, Egham, Surrey TW20 8RB.
and the manufacturer is:Forest Laboratories UK Ltd.,Bexley DA5 1NX.

After using your medicine
There are not normally problems after using Predenema but if any
unwanted effects are noticed tell your doctor or pharmacist.

What is Predenema used for?
Predenema is used to treat ulcerative colitis (inflammation of the
bowels).

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.

If you are not sure why you have been given Predenema ask your
doctor or pharmacist (chemist).

Date of last review of leaflet
March 2008

102LBT7/1

102/LBT7EG/1

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 disodium
edetate, parahydroxybenzoates (E214, E216, E218), 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.
How to administer Predenema
Predenema 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 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
March 2008
102LBT7EG/1

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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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