Skip to Content

ENTOCORT ENEMA

Active substance(s): BUDESONIDE / BUDESONIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

6148018-03

Entocort® Enema
budesonide 0.02 mg/ml
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Preparing Entocort Enema for use
To prepare one enema, dissolve one tablet in one bottle of liquid. To do
this, follow the instructions below:

What is in this leaflet
1. What Entocort Enema is and what it is used for
2. What you need to know before you use Entocort Enema
3. How to use Entocort Enema
4. Possible side effects
5. How to store Entocort Enema
6. Contents of the pack and other information

2. Take one of the tablets from its foil strip. Then drop it into the bottle.

1. Take one of the plastic bottles containing a liquid. Unscrew the
complete nozzle section and protective cap in one piece.

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

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.
• An enema is a liquid that is inserted into the back passage (rectum).
• Entocort Enema is used to treat inflammation and ulcers in the large
intestine (colon) and rectum. This is known as ulcerative colitis.

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

2. What you need to know before you use Entocort Enema

Pregnancy, breast-feeding and fertility

5. Squeeze 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. Then 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.

If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Entocort Enema is not likely to affect you being able to drive or use any
tools or machines.
Entocort Enema contains propyl parahydroxybenzoate (E216),
methyl parahydroxybenzoate (E218) and lactose
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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
3. How to use Entocort Enema
Always use this medicine exactly as your doctor has told you. 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.
Use in children
Entocort Enema is not recommended for use by children.
When to use Entocort Enema and how long to use it for
• It is important to use each enema at the right time.
• Usually this will be once a day, just before bedtime.
• Normally, your treatment will last for 4 weeks. However, your doctor
may decide that you need to use Entocort Enema for longer.
Parts of the bottle
To prepare your enema for use, you need to be familiar with the
following parts of the plastic bottle:
Protective Cap
Nozzle
Tablet
Bottle

6148018-03.indd 1

8. Now, roll over onto your stomach. Stay like this for 5 minutes to stop
any liquid coming out of your back passage.
9. Then, 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
• If 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.
• Do not use a double dose (two doses at the same time) to make up
for a forgotten dose.
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
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.
Other possible side effects:
Common: may affect up to 1 in 10 people
• Depression.
• Upset stomach or gut such as stomach pains, wind, diarrhoea,
heartburn and feeling sick.
• Skin reactions such as lumpy rash and skin rash.
Uncommon: may affect up to 1 in 100 people
• Feeling agitated.
• Difficulty sleeping.
• Anxiety.

31.05.17 08:35

31.05.2017 SBU

Kontur
Guides
n/a

240 x 500 mm

n/a

4. Gently ease the nozzle into your back passage as far as is
comfortable.

9,5 pt

Diagnostic tests for pituitary glands activity may show false low values
due to suppression of the adrenal function.

3. If you wish, hold the bottle using one of the plastic bags.

NimbusSanLOT Bold, Regular; Tahoma Regular

Some medicines may increase the effects of Entocort Enema and
your doctor may wish to monitor you carefully if you are taking
these medicines (including some medicines for HIV: ritonavir,
cobicistat).

2. 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.

6148018-03

In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
• Steroid medicines, such as prednisolone or dexamethasone.
• Ketoconazole or itraconazole, used to treat infections caused by a
fungus.
• Medicines that contain oestrogen, such as hormone replacement
therapy (HRT) and some oral contraceptives.
• HIV protease inhibitors (such as ritonavir, cobicistat and nelfinavir).
• Carbamazepine (used to treat epilepsy and fits).

1. Shake the bottle again. Then only take off the protective cap. This will
reveal the nozzle.

TAK

Other medicines and Entocort Enema
Tell your doctor or pharmacist if you are taking, have recently taken or
might take 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.

Inserting the enema into your back passage
To insert the enema into your back passage, follow the instructions
below:

PIL Entocort 2 mg 115 mL
Enema GB

Contact your doctor if you experience blurred vision or other visual
disturbances.

• You will find it more comfortable to use Entocort Enema if you empty
your bowels and bladder before using it.
• Entocort Enema can stain your bedclothes. It is best to protect your
bedclothes with a plastic sheet in case any liquid is spilled.

Black

Warnings and precautions
Talk to your doctor or pharmacist before using Entocort Enema:
• If you have recently had a bowel infection.
• If you have ever had liver problems.
• If you or a member of your family has ever had mental health
problems.

5. The enema is now ready. Use it straight away.

Tillotts Pharma AG

Do not use Entocort Enema:
If you are allergic to budesonide or any of the other ingredients of this
medicine (listed in section 6).

• Unintentional movements or extreme restlessness possibly
accompanied by muscle spasms or twitching.
• Ulcers in the stomach or duodenum.
Rare: may affect up to 1 in 1,000 people
• An effect on the adrenal gland (a small gland near the kidney).
• Glaucoma (increased pressure in the eye).
• Blurred vision
• Aggression.
• Clouding of the eye’s natural lens including the back of the lens.
• Inflamed pancreas (associated with pain in upper abdomen and back
and feeling sick).
• Skin discoloration resulting from bleeding beneath the skin.
• Death of bone tissue caused by loss of blood supply to the bone.
Very rare: may affect up to 1 in 10,000 people
• A severe allergic reaction (called anaphylaxis) which may cause
difficulty in breathing or shock.
Medicines like Entocort Enema (corticosteroids) can affect the normal
production of steroid hormones in your body. The effects include:
• Changes in bone mineral density (thinning of the bones).
• Glaucoma (increased pressure in the eye).
• A slowing of the rate of growth of children and adolescents.
• An effect on the adrenal gland (a small gland near the kidney).
Most of the side effects mentioned in this list can also be expected with
other glucocorticoids treatment.
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

31.05.2017 SBU

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
• Keep this medicine out of the sight and reach of children.
• Do not store this medicine above 30°C.
• Do not use this medicine after the expiry date which is stated on the
bottle or foil after EXP. The expiry date relates to the last day of that
month.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

• 7 tablets wrapped in foil, inside a small box.
• 7 plastic bottles containing solution.
• 7 plastic bags to be used when giving the enema.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Entocort Enema is held by Tillotts
Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany
Entocort Enema is manufactured by Takeda Pharma Sp. z o.o., ul.
Księstwa Łowickiego 12, 99-420 Łyszkowice, Poland.
For any information about this medicine, please contact the
local representative of the Marketing Authorisation Holder:
Tillotts Pharma UK Ltd., The Stables, Wellingore Hall, Wellingore,
Lincoln, UK LN5 0HX Tel: +44 1522 813500 e-mail: ukinfo@tillotts.com

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
information:
Product name
Entocort Enema
Reference number
45329/0004
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in May 2017.

6148018-03.indd 2

31.05.17 08:35

240 x 500 mm

n/a

6148018-03

n/a

9,5 pt

Entocort Enema comes in a box containing the following:

NimbusSanLOT Bold, Regular; Tahoma Regular

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

TAK

Tillotts Pharma AG

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.

PIL Entocort 2 mg 115 mL
Enema GB

Black

What Entocort Enema contains
The active substance 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.

Kontur
Guides

6. Contents of the pack and other information

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