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ENTOCORT CR 3 MG CAPSULES

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

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Package Leaflet: Information for the User
®

Entocort CR 3mg Capsules
(budesonide)
This medicine is called Entocort CR 3 mg Capsules but will be referred to
as Entocort Capsules in 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.
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, cobicistat and nelfinivir).
• Carbamazepine (used to treat epilepsy and fits).

Some 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 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.
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.
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 your capsules 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.
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 contain 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 (contain sucrose and maize
starch), gelatin, sodium lauryl sulphate, edible oil, colloidal silicon
dioxide, red iron oxide (E172), black iron oxide (E172), yellow iron
oxide (E172), titanium dioxide (E 171). The composition of the ink
inscription on the capsule contains: shellac, black iron oxide (E 172),
soya lecithin, silicon, potassium hydroxide, ammonium hydroxide.

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. Pack contains 100 capsules.
There are 50 capsules in each container.
Manufacturer
AstraZeneca AB, S-151 85, Sodertalje, Sweden.
Procured from within the EU and repackaged by Mediwin Limited,
Product Licence Holder: Mediport Limited, 13 Martello Enterprise Centre,
Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, United
Kingdom.
POM

PL: 18980/0850
®

Entocort is a Registered Trademark of Tillots Pharma AG.
Date of leaflet preparation: 09/06/2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0330 684 1100 to obtain the
leaflet in a format suitable for you.
PIL-0850-S0009

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.

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