Patient Information Leaflet

Entocort® CR 3 mg Capsules

budesonide

Please read this leaflet carefully before you take these capsules. If you have any queries or are unsure about anything to do with Entocort CR 3 mg Capsules, ask your doctor or pharmacist (chemist).

Remember this medicine is only for you. Never give your Entocort CR 3 mg Capsules to anyone else.

What is in your medicine?

Entocort CR 3 mg Capsules contain 3 mg of an active ingredient called budesonide.

They also contain ethyl cellulose, tributyl acetylcitrate, methacrylic acid copolymer, triethylcitrate, Antifoam M, polysorbate 80, talc, sucrose, maize starch, gelatine, titanium dioxide (E 171) and iron oxide (E 172).

100 pink and grey capsules are provided in a white plastic container fitted with a cap containing a desiccant.

Budesonide is a type of steroid which reduces inflammation.

What is your medicine used for?

Entocort CR 3 mg Capsules are used to treat an inflammation of the small bowel and first part of the large bowel, called Crohn’s disease.

Before taking your medicine

Please make sure that you have told your doctor about any other medicines that you are taking, including any you have bought without a prescription.

If you can answer yes to any of these questions, please discuss it with your doctor or pharmacist before taking Entocort CR 3 mg Capsules.

• Do you have any infections?
• Have you ever had an unpleasant reaction to budesonide or any of the other ingredients of Entocort CR 3 mg Capsules?
• Are you already taking steroids?
• Do you have, or have you ever had, tuberculosis, high blood pressure, diabetes, brittle bones, stomach ulcers, glaucoma, cataracts or liver problems?
• Has anyone in your family ever had diabetes or glaucoma?
• Are you pregnant, think you might be pregnant or considering becoming pregnant?
• Are you breast-feeding?
• Are you taking colestyramine, ketoconazole, itraconazole, oestrogens or oral contraceptives?

You should avoid eating grapefruit or drinking grapefruit juice while you are taking Entocort CR 3mg Capsules as this can increase the amount of budesonide absorbed from the gut. Other fruits such as orange and apple do not affect the uptake of budesonide.

 

Please try to avoid people who have chicken pox or measles whilst you are taking Entocort CR 3 mg Capsules. If you are worried that you may have caught chicken pox or measles, speak to your doctor.

Taking your medicine

Your doctor will tell you how many capsules to take and when to take them. You should swallow the capsules whole with half a glass of water.

If you are having an attack of Crohn’s disease, you will normally be told to take three Entocort CR 3 mg Capsules in the morning. You will normally take this number of capsules for up to eight weeks, and then gradually reduce the dose.

Full effect is usually achieved in 2–4 weeks. You should continue to take Entocort CR 3 mg Capsules, as your doctor has told you, even if you start feeling better.

Do not suddenly stop taking your capsules without speaking to your doctor first, as this may make you ill.

After taking your medicine

All medicines may cause side effects in some people.

Entocort CR 3 mg Capsules do not usually cause serious side effects. They may cause a roundness of your face, acne and a reduced rate of growth.

They may also rarely cause heartburn, cramps, shakiness, a fluttering feeling in the chest, blurred eyesight, rash, itchy skin, heavy or irregular periods in women, reduced levels of potassium in the blood, nervousness, sleeplessness and mood swings.

If you are worried by these or any other side effects you think you may have, do not stop taking your capsules but go and see your doctor.

Storing your medicine

• Do not use your Entocort CR 3 mg Capsules after the date indicated on the bottle.
• Keep your capsules at room temperature (not above 30°C) and out of the reach and sight of children.
• Replace cap firmly after use.