What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 36633/0006.

Entocort CR 3mg Capsules

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 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.

Contact your doctor if you experience blurred vision or other visual disturbances.

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.

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:

For treatment of active disease: 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.

For the maintenance of remission: Take 2 capsules once daily in the morning (or the lowest effective dose).

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).
  • 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)
  • 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 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. They are available in pack sizes of 50 or 100 capsules..

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Entocort CR 3 mg Capsules is held by

Tillotts Pharma UK Ltd.
Wellingore Hall
Wellingore
Lincolnshire
LN5 0HX
UK
Tel: +44 1522 813500
e-mail: [email protected]

Entocort CR 3 mg Capsules are manufactured by

AstraZeneca AB
Gärtunavägen
151 85 Södertälje
Sweden

Recipharm Fontaine SAS
Rue des Prés Potets
21121 Fontaine-les-Dijon
France

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 36633/0006

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in October 2019.

GI 14 0035