Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about ENTOCORT. It does not contain all the information that is known about ENTOCORT.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefit. Your doctor will have weighed the risks of you taking ENTOCORT against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What ENTOCORT is for
ENTOCORT capsules are used to treat Crohn's disease. It can be used to treat acute attacks.
Crohn's disease is an inflammatory disease of the bowel. It mainly affects the small bowel and the first part of the large bowel and causes symptoms such as stomach pain, diarrhoea and fever.
ENTOCORT belongs to the family of corticosteroids, which are used to reduce inflammation in many parts of the body.
ENTOCORT capsules are designed to release their contents in the small bowel and the first part of the large bowel.
Your doctor will have explained why you are being treated with ENTOCORT and told you what dose to take.
Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
There is no evidence to show that ENTOCORT is addictive.
Before you take ENTOCORT
When you must not use it
Do not take ENTOCORT if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved. There is very limited experience with ENTOCORT capsules in pregnant or breastfeeding women.
Do not give ENTOCORT to children. There is no information available on its use in children.
Do not take ENTOCORT after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.
Do not take ENTOCORT if the packaging is torn or shows signs of tampering.
Do not use it to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else.
Before you start to take it
You must tell your doctor if:
1. you have any allergies to:
any ingredients listed at the end of this leaflet
any steroid preparation (inhaled, oral or cream)
any other substance
If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.
2. you have any of these medical conditions
any recent infection, or tuberculosis
brittle bones (osteoporosis)
high blood pressure
glaucoma or cataracts
It may not be safe for you to take ENTOCORT if you have any of these conditions.
3. if you have NOT had chicken pox or measles.
These may be much worse than normal if you catch them while taking ENTOCORT. Your doctor may want to vaccinate you for them before you start on ENTOCORT.
Taking other Medicines
Tell your doctor if you are taking any other medicines, including
any medicines you buy at the chemist, supermarket or health food shop
These medicines may affect the way ENTOCORT works.
Your doctor or pharmacist can tell you what to do if you are taking any other medicines.
If you have not told your doctor about any of these things, tell them before you take any ENTOCORT.
How to take it
Swallow ENTOCORT capsules whole with a glass of water. Do not crush or chew the capsules. If the granules are chewed or crushed they won't work properly.
Always eat some food after you take ENTOCORT.
The usual dose of ENTOCORT when your Crohn's disease is active is 9mg per day. This is usually taken as a single dose in the morning. This dose usually continues for up to 8 weeks.
Treatment with ENTOCORT must not be stopped suddenly. The dose is to be reduced over the last 2-4 weeks.
It may take 2-4 weeks to get the full effect from ENTOCORT. Do not forget to take doses even if you feel better.
Follow your doctor's directions carefully. They may differ from the information contained in this leaflet.
If you forget to take it
If you forget to take an occasional dose of ENTOCORT capsules it is not necessary to make up for the dose you missed. Just take the next dose as usual.
Don't double the dose.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Telephone your doctor, the Poisons Information centre (13 11 26) or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much ENTOCORT even if there are no signs of discomfort or poisoning.
While you are taking it
Things you must not do
Do not take ENTOCORT with grapefruit or grapefruit juice. Grapefruit juice, but not other fruit juices, may increase the effect of ENTOCORT.
Do not stop taking ENTOCORT unless your doctor tells you to. You need to reduce the dose gradually before stopping.
Tell your doctor if you have an infection while you are taking ENTOCORT. It may not be safe for you to continue taking ENTOCORT if you have an infection.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ENTOCORT. ENTOCORT helps most people with Crohn's disease, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
swelling of the face
unexplained bruising, muscle cramps
headache or dizziness
shaking or tremors
unusually fast or irregular heartbeats
skin rash or itchiness
These are usually mild side effects of ENTOCORT.
If your medicine has been changed from 'cortisone' tablets (eg. prednisone, prednisolone or methylprednisolone) to ENTOCORT capsules you may notice some symptoms that bothered you earlier, eg. rash, or pain in muscles and joints.
If this happens or you get headaches, nausea (feel sick) or vomiting, or feel tired please contact your doctor.
Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while taking ENTOCORT.
After using it
Keep your ENTOCORT capsules in the bottle until it is time to take them. Replace the cap firmly after use. If you take ENTOCORT out of the bottle it will not keep well.
Keep it in a cool dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Do not leave it in the car on hot days.
Ask your pharmacist what to do with any capsules you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.
What ENTOCORT looks like
ENTOCORT is a hard gelatine capsule, with an opaque, light grey body and an opaque, pink cap, in bottles of 50 or 90. It is printed with CIR 3mg. Ingredients
Each ENTOCORT capsule contains micronised budesonide as the active ingredient, plus;
Methacrylic acid copolymer
Each capsule is made from gelatine (E441), with colouring agents titanium dioxide (E171) and iron oxide (E172).
AstraZeneca Pty Ltd
ACN 009 682 311
NORTH RYDE NSW 2113
Tel: 1 800 805 342
This leaflet was prepared in November 2002.
Australian Registration Number
ENTOCORT 3mg: 62812