Skip to Content

ENTOCORT CR 3MG CAPSULES

Active substance(s): BUDESONIDE / BUDESONIDE MICRONISED / BUDESONIDE / BUDESONIDE MICRONISED / BUDESONIDE / BUDESONIDE MICRONISED

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
®

Entocort CR 3 mg Capsules
budesonide

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.
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).
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.

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.
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).
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.
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.
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.
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.
124022_LFT_Mock Up CR_3mg UK_2_p01.indd 1

20.09.16 14:29

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.
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,

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 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.
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.

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 Tillotts Pharma GmbH, Warmbacher Strasse 80,
79618 Rheinfelden, Germany.
Entocort CR 3 mg Capsules are manufactured by AstraZeneca AB,
Gärtunavägen, 151 85 Södertälje, Sweden.
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 CR 3 mg
Capsules
Reference number 45329/0003
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 2016
GI 14 0035

124022_LFT_Mock Up CR_3mg UK_2_p01.indd 2

20.09.16 14:29

Expand Transcript

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