BUDECOL CR 3MG CAPSULES
Active substance(s): BUDESONIDE
Entocort CR 3mg Capsules / Budecol CR 3mg Capsules
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
* 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
What Entocort Capsules are and what they are used
Entocort Capsules contain the active substance budesonide. This belongs to
a group of medicines called ‘corticosteroids’. These are used to reduce
Crohn’s disease: Entocort Capsules are used to treat an inflammation of the
small bowel and the first part of the large bowel.
Microscopic colitis: Entocort Capsules are used to treat acute episodes of
microscopic colitis (a disease with chronic inflammation of the large bowel
which is typically with chronic watery diarrhoea).
In particular, tell your doctor or pharmacist if you are taking any of the
medicines, such as prednisolone or dexamethasone.
used to reduce cholesterol levels or reduce itching caused
by liver problems.
or itraconazole, used to treat infections caused by a fungus.
Medicines that contain oestrogen, such as hormone replacement therapy
* (HRT) and some oral contraceptives.
protease inhibitors (such as ritonavir, cobicistat and nelfinivir).
Carbamazepine (used to treat epilepsy and fits).
medicines may increase the effects of Entocort capsules and your
doctor may wish to monitor you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir, cobicistat).
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
Driving and using machines
Entocort Capsules are not likely to affect you being able to drive or use any
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.
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.
What you need to know before you take Entocort
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.
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.
Contact your doctor if you experience blurred vision or other visual
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.
Your doctor will tell you how many capsules to take and when to take them.
Swallow the capsules whole with a glass of water.
Crohn’s disease: 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.
Microscopic colitis: Take 3 capsules once daily in the morning. When
treatment is to be discontinued, the dose should normally be reduced for the
last 2 to 4 weeks of therapy.
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.
Entocort CR 3mg Capsules / Budecol CR 3mg Capsules
Patient Information Leaflet (continued)
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
* 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.
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
The following side effects may happen with this medicine:
Common (may affect up to 1 in 10 people)
* Muscle cramps.
* Pounding heart beat (palpitations).
* 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, mood
swings and depression.
Uncommon (may affect up to 1 in 100 people)
* Unintentional movements or extreme restlessness possibly accompanied
by muscle spasms or twitching.
Rare (may affect up to 1 in 1000 people)
* 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)
* Blurred vision
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 or pharmacist. This includes
any possible side effects not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the
safety of this medicine.
How to store Entocort Capsules
Do not use this medicine after the expiry date shown on the carton label or
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.
not store above 30°C.
in the original container.
* Replace cap firmly after use.
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.
Entocort CR 3mg Capsules/
Budecol CR 3mg Capsules
Entocort and Budecol are a registered trademark of AstraZeneca AB.
Revision date: 07/12/17
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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.