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ENTOCORT CR 3 MG CAPSULES

Active substance(s): BUDESONIDE / BUDESONIDE MICRONISED

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Entocort® CR
3 mg Capsules
(budesonide)
PATIENT INFORMATION LEAFLET
This medicine is called Entocort CR 3 mg Capsules
but will be referred to as Entocort Capsules
throughout this leaflet.
Read all of this leaflet carefully before you start
taking 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.
What is in this leaflet
1.
What Entocort Capsules are and what they
are used for
2.
What you need to know before you take
Entocort Capsules
3.
How to take Entocort Capsules
4.
Possible side effects
5.
How to store Entocort Capsules
6.
Contents of the pack and other information

1. What Entocort Capsules are and what
they are used for
Entocort Capsules contain the active substance
budesonide. This belongs to a group of medicines
called 'corticosteroids'. These are used to reduce
inflammation.
Entocort Capsules are used to treat an
inflammation of the small bowel and the first part of
the large bowel. This is known as Crohn's disease.

2. What you need to know before you take
Entocort Capsules
Do not take Entocort Capsules:

If you are allergic to budesonide or any of the
other ingredients of this medicine (listed in
section 6).

If you have an infection.

In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:

Steroid medicines, such as prednisolone or
dexamethasone.

Colestyramine, used to reduce cholesterol
levels or reduce itching caused by liver
problems.

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 and
nelfinivir).

Carbamazepine (used to treat epilepsy and
fits).
Entocort Capsules with food and drink
Do not drink grapefruit juice while you are taking
Entocort Capsules. It can affect the way the
medicine works.
Pregnancy, breast-feeding and fertility
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 Capsules are not likely to affect you being
able to drive or use any machines.
Entocort Capsules contain sucrose
Entocort Capsules contain sucrose which is a type
of sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3. How to take Entocort Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.






Your doctor will tell you how many capsules
to take and when to take them.
Swallow the capsules whole with a glass of
water.
The recommended dose for an attack of
Crohn's disease is 3 capsules in the morning
before breakfast.
Normally, you will take this number of
capsules for up to 8 weeks. Your doctor will
then gradually reduce the dose.
The medicine will usually have its full effect
within 2 to 4 weeks. Continue to take
Entocort Capsules as your doctor has told
you, even if you start feeling better.

Do not take Entocort Capsules if any of the above
apply to you. If you are not sure, talk to your doctor
or pharmacist before taking Entocort Capsules.

Use in children
Entocort Capsules are not recommended for
children.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Entocort Capsules if:

You have ever had tuberculosis (TB).

You have ever had high blood pressure.

You have diabetes.

You have ever had brittle bones.

You have ever had stomach ulcers.

You have ever had glaucoma (increased
pressure in the eye) or cataracts.

A member of your family has ever had
diabetes or glaucoma.

You have ever had liver problems.

You or a member of your family has ever had
mental health problems.

Additional information about taking Entocort
Capsules

If you are about to have an operation or
during times of stress, please tell the doctor
that you take Entocort Capsules. The doctor
may ask you to take steroid tablets as well,
particularly if you have been taking a high
dose of Entocort Capsules, or a similar
medicine, for a long time.

Try to avoid people who have chicken pox or
measles while you are taking Entocort
Capsules. Talk to your doctor if you think you
may have caught chicken pox or measles
while taking this medicine.

If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Entocort Capsules.
Other medicines and Entocort Capsules
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 Capsules can affect the way
some medicines work and some medicines can
have an effect on Entocort Capsules.

If you take more Entocort Capsules than you
should
If you take more Entocort Capsules than you
should, talk to a doctor or pharmacist straight away.
If you forget to take Entocort Capsules

If you forget to take a dose of Entocort
Capsules, take it as soon as you remember.
However, if it is nearly time for the next dose,
skip the missed dose.

Do not take a double dose to make up for a
forgotten dose.

If you stop taking Entocort Capsules
Do not stop taking Entocort Capsules without
talking to your doctor first. If you stop taking your
capsules suddenly it may make you ill.

5. How to store Entocort Capsules

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






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.
The following side effects may happen with this
medicine:
Common (may affect up to 1 in 10 people)

Heartburn.

Muscle cramps.

Pounding heart beat (palpitations).

Blurred eyesight.

Rash or itchy skin.

Heavy or irregular periods in women.

Low levels of potassium in the blood which
may cause muscle weakness, thirst or 'pins
and needles'.

Cushingoid features such as a rounded face,
acne, weight gain and bruising more easily.

Behavioural changes such as feeling
nervous, difficulty sleeping and mood swings.
Uncommon (may affect up to 1 in 100 people)

Shaking.






Keep out of the sight and reach of children.
Do not use your capsules after the expiry date
stated on the bottle and carton. The expiry
date refers to the last day of that month.
Do not store above 30°C.
Keep container tightly closed.
Store in the original container.
Medicines 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
environment.
If your capsules show any signs of
discolouration or deterioration return them to
your pharmacist.

6. Contents of the pack and other
information
What Entocort CR 3 mg Capsules contain
Each modified release capsule contains 3 mg of
budesonide as the active ingredient.
They also contain ethylcellulose, tributyl
acetylcitrate, methacrylic acid copolymer type C,
triethyl citrate, antifoam, polysorbate 80, talc, sugar
spheres (contains sucrose and maize starch),
gelatin, sodium lauryl sulfate, edible oil, colloidal
silicon dioxide, red iron oxide (E172), black iron
oxide (E172), yellow iron oxide (E172), titanium
dioxide (E171). The composition of the ink
inscription on the capsule contains: shellac, black
iron oxide (E172), soya lecithin, silicon, potassium
hydroxide, ammonium hydroxide.

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.

A slowing of the rate of growth in children and
adolescents.

What Entocort CR 3 mg Capsules look like and
contents of the pack
Entocort CR 3 mg Capsules are hard gelatine
capsules with a light grey plain body and an
opaque pink cap. The caps are marked ‘CIR 3mg’
in black radial print. The capsules are supplied in a
white plastic bottle with a tamper proof screw cap.
There are 100 capsules in each container.

Other side effects may include:

Glaucoma (increased pressure in the eye).

The product is manufactured by
AstraZeneca AB, S-151 85, Sodertalje, Sweden.

Medicines like Entocort Capsules (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).

They are procured from within the EU and
repackaged by Mediwin Limited, PL Holder:
Mediport Limited, 13 Martello Enterprise Centre,
Courtwick Lane, Littlehampton, West Sussex,
BN17 7PA.

Mental health problems can happen while taking
steroids like Entocort Capsules. 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.

Date of Leaflet Preparation: 21/03/2016

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 or
pharmacist. 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.

POM

PL: 18980/0850

ENTOCORT® IS A REGISTERED TRADEMARK
OF ASTRAZENECA AB.

PIL-0850-S0005

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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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