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BUDECOL CR 3MG CAPSULES

Active substance(s): BUDESONIDE

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Ref: 0682/230816/1/F

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Entocort CR 3mg Capsules / Budecol CR 3mg Capsules
(budesonide)
Patient Information Leaflet
Your medicine is called Entocort CR 3mg Capsules/Budecol CR 3mg
Capsules, but will be referred to as Entocort Capsules.
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 of the 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

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

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.
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.
Warning 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
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
effect the way some medicines work and some medicines can have an effect
on Entocort Capsules.

Driving and using machines
Entocort Capsules are not likely to affect you being able to drive or use any
machines.
Entocort Capsules contains 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.
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.
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.

Ref: 0682/230816/1/B

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Entocort CR 3mg Capsules / Budecol CR 3mg Capsules
(budesonide)
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone 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 as a rounded face, acne, weight gain and bruising
more easily.
* Behavioural changes such as feeling nervous, difficulty sleeping, mood
swings and depression.
Uncommon (may affect up to 1 in 100 people)
* Shaking.
* Unintentional movements or extreme restlessness possibly accompanied
by muscle spasms or twitching.
* Anxiety.
Rare (may affect up to 1 in 1000 people)

* Aggression.
* Clouding of the eye's natural lens including the back of the lens.
* Skin discoloration resulting from bleeding beneath the skin.
* Glaucoma (increased pressure in the eye)
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.
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).
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
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.
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 Capsules

Expiry Date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicines no longer required. This
will help to protect the environment.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing Your Medicine
OUT OF THE SIGHT AND REACH OF CHILDREN.
* KEEP
not store above 30°C.
* Do
in the original container.
* Store
Replace
cap firmly after use.
*

6

Contents of the pack and other information

What Entocort Capsules contains:
Each capsule contains 3mg of budesonide in a modified release formulation.
Your medicine also contains the following inactive ingredients:
ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer,
triethylcitrate, antifoam M, polysorbate 80, talc, sucrose, maize starch,
gelatin, titanium dioxide (E171), iron oxide (E172), black printing ink.
What Entocort Capsules looks like and contents of the pack
The capsules are orange one side and light grey the other side, on the
orange end markings of CIR 3mg in black radial print.
Entocort Capsules are supplied in white plastic bottles fitted with a cap
containing a desiccant.
The capsules are available in 50’s or 100’s.
Manufacturer and Licence Holder
The capsules are manufactured by AstraZeneca AB, S - 151 85 Sodertalje,
Sweden and are procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0682

Entocort CR 3mg Capsules/
Budecol CR 3mg Capsules

Entocort and Budecol are a registered trademark of AstraZeneca AB.
Revision date: 23/08/16

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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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