Active substance: BUDESONIDE

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Entocort® Enema
budesonide 0.02 mg/ml

Read all of this leaflet carefully before you start using
this medicine.
•  eep this leaflet. You may need to read it again.
• f you have any further questions, ask your doctor or
•  his 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.
• f any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Entocort Enema is and what it is used for
2. Before you use Entocort Enema
3. How to use Entocort Enema
4. Possible side effects
5. How to store Entocort Enema
6. Further information
1. What Entocort Enema is and what it is used for
Entocort Enema contains a medicine called budesonide.
This belongs to a group of medicines called ‘corticosteroids’.
These are used to reduce inflammation.
•  n enema is a liquid that is inserted into the back
passage (rectum).
•  ntocort Enema is used to treat inflammation and ulcers
in the large intestine (colon) and rectum. This is known as
ulcerative colitis.
2. Before you use Entocort Enema
Do not use Entocort Enema if:
You are allergic (hypersensitive) to budesonide or any of
the other ingredients of Entocort Enema (listed in Section 6:
Further information).
Take special care with Entocort Enema
Check with your doctor or pharmacist before using
Entocort Enema if:
•  ou have recently had a bowel infection.
•  ou have ever had liver problems.
•  ou or a member of your family has ever had mental
health problems.
Taking other medicines
Please tell your doctor or pharmacist before using
Entocort Enema if you are taking, or have recently taken,
any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because
Entocort Enema can affect the way some medicines work
and some medicines can have an effect on Entocort Enema.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
•  teroid medicines, such as prednisolone or dexamethasone.
•  etoconazole or itraconazole, used to treat infections
caused by a fungus.
•  edicines that contain oestrogen, such as hormone
replacement therapy (HRT) and some oral contraceptives.
•  IV protease inhibitors (such as ritonavir and nelfinavir).
•  arbamazepine (used to treat epilepsy and fits).
Pregnancy and breast-feeding
Talk to your doctor before using Entocort Enema if you are
pregnant, may become pregnant or are breast-feeding.
Driving and using tools and machines
Entocort Enema is not likely to affect you being able to drive
or use any tools or machines.
Important information about some of the ingredients
Entocort Enema contains propyl parahydroxybenzoate (E216)
and methyl parahydroxybenzoate (E218), these may cause
allergic reactions (possibly delayed).

Entocort Enema also contains lactose, a type of sugar, which
some people may be intolerant to. If you have been told by
your doctor that you have an intolerance to some sugars,
please talk to your doctor before using this medicine.
3. How to use Entocort Enema
Always use Entocort Enema exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure.
Entocort Enema should only be used in your back passage
(rectum), as directed by your doctor.
Entocort Enema is not recommended for use by children.
When to use Entocort Enema and how long to use it for
• t is important to use each enema at the right time.
•  sually this will be once a day, just before bedtime.
•  ormally, your treatment will last for 4 weeks. However,
your doctor may decide that you need to use
Entocort Enema for longer.
Protective Cap
Parts of the bottle
To prepare your enema for use,
you need to be familiar with the
following parts of the plastic bottle:
Preparing Entocort Enema for use
To prepare one enema, dissolve
one tablet in one bottle of liquid.
To do this, follow the instructions below:
1. Take one of the plastic bottles containing
a liquid. Unscrew the complete nozzle
section and protective cap in one piece.
2. Take one of the tablets from its foil strip.
Then drop it into the bottle.


3. Put the nozzle and protective cap back
onto the bottle. Then screw them up until
they are tight.


4. Shake the bottle well for at least
15 seconds, or until you cannot see the
tablet in the liquid any more.


5. The enema is now ready. Use it straight away.
•  ou will find it more comfortable to use Entocort Enema if
you empty your bowels and bladder before using it.
•  ntocort Enema can stain your bedclothes. It is best to
protect your bedclothes with a plastic sheet in case any
liquid is spilled.
Inserting the enema into your back passage
To insert the enema into your back passage, follow the
instructions below:
1.  hake the bottle again. Then only take off the protective
cap. This will reveal the nozzle.
 . Undress from the waist down, then lie down on your side.
Choose whichever side is most comfortable.
Try to lie down so that your bottom is slightly higher than
the rest of your body. For example, you can raise the
bottom of the bed onto blocks or place one or two pillows
under your bottom. This will help to keep the liquid in your
back passage.

3. If you wish, hold the bottle
using one of the plastic bags.
4. Gently ease the nozzle into
your back passage as far as is
5 S
 .  queeze the bottle, this will push most of the liquid into
your back passage. However, you will not be able to
empty the whole bottle. It has been designed to keep
some liquid after being used.
6 T
 .  hen remove the nozzle from your back passage.
7 If
 .  you used a plastic bag, remove it from
your hand by pulling it forward over the
bottle. This will leave the bottle inside the
bag, ready to be disposed of.
8 N
 .  ow, roll over onto your stomach. Stay
like this for 5 minutes to stop any liquid
coming out of your back passage.
9 T
 .  hen, find a comfortable position to sleep in that helps
you to keep the liquid in your back passage for as long
as possible.
Entocort Enema is a ‘retention enema’. This means that the
liquid is meant to be held in the back passage for as long as
possible. The longer it is kept there the more time it has to
work and the better the results should be.
If you use more Entocort Enema than you should
If you use more enemas than prescribed by your doctor, talk
to a doctor or pharmacist straight away.
If you forget to use Entocort Enema
• f you forget a dose of Entocort Enema, use it as soon as
you remember. However, if it is nearly time for the next
dose, skip the missed dose.
•  o not use a double dose (two doses at the same time)
to make up for a forgotten dose.

Mental health problems can happen while taking steroids like
Entocort Enema. Talk to a doctor if you (or someone taking
this medicine), show any signs of mental health problems.
This is particularly important if you are depressed, or might
be thinking about suicide. Very rarely mental health problems
have happened when high doses have been taken for a
long time.
Do not be concerned by this list of possible side effects.
You may not get any of them. If any of the side effects get
serious, or if you notice any side effects not listed in this
leaflet, please tell 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. Website: 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 Entocort Enema
•  o not use your enemas after the expiry date shown on
the bottle or foil.
•  eep your medicine in a safe place where children cannot
reach or see it.
•  o not store this medicine above 30°C.
•  edicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help to protect the
6. Further information

4. Possible side effects

What Entocort Enema contains
The active ingredient is budesonide. Each bottle provides a
dose of approximately 2 mg of budesonide at a concentration
of 0.02 mg of budesonide per ml of solution.
The other ingredients are lactose anhydrous, polyvidone,
riboflavine sodium phosphate, lactose monohydrate,
magnesium stearate, colloidal anhydrous silica,
sodium chloride, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216) and water purified.

Like all medicines, Entocort Enema can cause side effects,
although not everybody gets them.

What Entocort Enema looks like and contents of the pack
Entocort Enema, once prepared, is a whitish yellow liquid.

If you have an allergic reaction, see a doctor straight
away. The signs may include raised lumps on your skin
(weals), or swelling of your face, lips, mouth, tongue or
throat. This may make it difficult to breathe.

Entocort Enema comes in a box containing the following:
•   tablets wrapped in foil, inside a small box.
•   plastic bottles containing solution.
•   plastic bags to be used when giving the enema.

Other possible side effects:
Common (affects less than 1 in 10 people)
•  pset stomach or gut such as stomach pains, wind,
diarrhoea, heartburn and feeling sick.
•  kin reactions such as lumpy rash and skin rash.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Entocort Enema is held by
AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.
Entocort Enema is manufactured by Takeda Nycomed AS,
Solbaervegen 5, NO-2409 Elverum, Norway.

Uncommon (affects less than 1 in 100 people)
• Feeling agitated.
• Difficulty sleeping.

To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following
Product name
Entocort Enema
Reference number 17901/0123
This is a service provided by the Royal
National Institute of Blind People.

If you stop using Entocort Enema
Do not stop using Entocort Enema without talking to your
doctor first. If you stop using your enema suddenly it may
make you ill.

Rare (affects less than 1 in 1,000 people)
•  n effect on the adrenal gland (a small gland near the
Very rare (affects less than 1 in 10,000 people)
•  severe allergic reaction (called anaphylaxis) which may
cause difficulty in breathing or shock.
Other side effects may include:
•  laucoma (increased pressure in the eye).
Medicines like Entocort Enema (corticosteroids) can affect
the normal production of steroid hormones in your body. The
effects include:
•  hanges in bone mineral density (thinning of the bones).
•  laucoma (increased pressure in the eye).
•  slowing of the rate of growth of children and
•  n effect on the adrenal gland (a small gland near the

Leaflet prepared: February 2014
© AstraZeneca 2014
Entocort is a trade mark of the AstraZeneca group of
GI 14 0001

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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.