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ENTOCORT CR 3MG CAPSULES

Active substance(s): BUDESONIDE / BUDESONIDE MICRONISED

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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.

Package leaflet: Information for the user

P039645

Entocort® CR 3 mg Capsules
budesonide

5. How to store Entocort Capsules
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the bottle.
The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Replace the cap firmly after use.
• 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.

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.

6. Contents of the pack and other information
What Entocort Capsules contain
The active ingredient is budesonide. Each capsule contains 3 mg of budesonide.
The other ingredients are ethyl cellulose, tributyl acetylcitrate, methacrylic acid
copolymer, triethylcitrate, Antifoam M, polysorbate 80, talc, sucrose (see section 2),
maize starch, gelatine, titanium dioxide (E 171) and iron oxide (E 172).
What Entocort Capsules look like and contents of the pack
Entocort Capsules are pink and grey. They come in a white plastic container fitted
with a cap containing a desiccant. There are 100 capsules in each container.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Entocort CR 3 mg Capsules is held by
AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.

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 CR 3 mg Capsules are manufactured by AstraZeneca UK Ltd,
Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.

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.

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)

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.
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.

Please be ready to give the following information:
Product name
Entocort CR 3 mg Capsules
Reference number 17901/0122

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

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in December 2014
© AstraZeneca 2014
Entocort is a trade mark of the AstraZeneca group of companies.
GI 14 0035

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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

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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.
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.

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.
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.

3. How to take Entocort Capsules

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.

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

Uncommon (may affect up to 1 in 100 people)
• Shaking.

• 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.

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.

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.

Use in children
Entocort Capsules are not recommended for children.
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 take more Entocort Capsules than you should
If you take more Entocort Capsules than you should, talk to a doctor or pharmacist
straight away.
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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).
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.
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.
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Other side effects may include:
• Glaucoma (increased pressure in the eye).

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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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