How does it work?

Entocort CR capsules contain the active ingredient budesonide, which is a type of medicine known as a corticosteroid. Corticosteroids are hormones that are produced naturally by the adrenal glands. They have many important functions in the body, including control of inflammatory responses. Corticosteroid medicines are man-made derivatives of the natural hormones. They are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.

Budesonide is a synthetic steroid that has an anti-inflammatory effect. It is used to reduce inflammation associated with the inflammatory bowel disease, Crohn's disease.

Budesonide decreases inflammation by acting within cells to prevent the release of certain chemicals that are important in the immune system. These chemicals are normally involved in producing immune and allergic responses. By decreasing the release of these chemicals in the gut, inflammation is reduced.

Entocort CR capsules are controlled release capsules that are taken by mouth to treat Crohn's disease. The capsules contain granules of budesonide with a special coating that allows the budesonide to pass through the stomach and be released at the end of the small intestine and start of the large intestine (colon). This allows the budesonide to act locally to reduce inflammation in this particular area of the gut. It helps relieve the symptoms of flare-ups of Crohn's disease. The capsules must be swallowed whole and not broken, crushed, or chewed, as this would stop the controlled release action from working.

The capsules are usually taken once daily in the morning, for up to eight weeks. The full effect is usually seen within two to four weeks of treatment.Once the inflammation in the bowel is stable and under control your doctor will tell you to stop using the medicine. Your dose should normally be reduced for the last two to four weeks of therapy.

Although Entocort CR capsules act locally in the gut, the budesonide is also absorbed into the bloodstream, which means it can cause side effects on other parts of the body. However, it produces less of these types of side effect than other corticosteroids taken by mouth, for example prednisolone.

What is it used for?

• Mild to moderate Crohn's disease affecting the end of the small intestine (ileum) and/or the start of the large intestine (ascending colon).

Warning!

• Entocort CR capsules should be taken in the morning. They should be swallowed whole and not broken, crushed or chewed.
• Entocort CR capsules should be stored in the original container, because this contains a dessicant to stop the capsules absorbing moisture. Replace the cap firmly after use.
• The manufacturer recommends that you should avoid eating grapefruit or drinking grapefruit juice while taking this medicine, because it may increase the amount of budesonide in your blood.
• You should not stop taking this medicine suddenly unless directed by your doctor, because long-term use of corticosteroids can suppress the natural production of corticosteroids by the adrenal glands. This means that the body may become temporarily reliant on the medicine. When it is time to stop treatment with this medicine, the dose should normally be reduced over the last two to four weeks of treatment. Follow the instructions given by your doctor or pharmacist.
• You will be given a steroid card with this medicine that you should carry with you at all times. Show it to anyone who treats you (eg doctor, nurse, pharmacist, dentist, anaesthetist).The card contains details of your prescriber, type of steroid, dose taken and the duration of treatment. It's purpose is to act as a reminder that your medicine should not be stopped suddenly, and to provide information of your treatment to other people treating you. This is important because the effects that corticosteroids have on the body may affect other medical treatment you may be given.If you have an accident the card contains information that could save your life. You should also show your steroid card to anyone who treats you for three months after you stop treatment with steroids.
• During times of physical stress, for example illnesses, trauma or surgery, your adrenal glands would normally produce more steroid hormones to cope. However, during long-term treatment with this medicine the action of your adrenal glands will be suppressed, so this increase in hormones won't happen naturally. As a result your steroid dose will normally need to be increased temporarily during these kind of events. Discuss this with your doctor.
• Corticosteroids decrease the body's natural immune and inflammatory responses. They may increase your susceptibility to infections and can also mask the symptoms of infections, making you think they are less serious than they are. For this reason, it is important to consult your doctor if you get any signs of infection during treatment.
• If you have never had chickenpox you could be at risk of severe chickenpox while having treatment with this medicine and should avoid close personal contact with people who have chickenpox or shingles (herpes zoster). You should also avoid contact with people who have measles. If you are exposed to people with these diseases either during treatment, or in the three months after stopping treatment, you should consult your doctor urgently, as you may need an injection of immunoglobulin to help you stop getting the diseases. This is very important as these diseases can be life-threatening in people treated with long-term corticosteroids.
• Corticosteroid treatment, especially with high doses, can alter mood and behaviour early in treatment. People may experience confusion, irritability, nightmares, difficulty sleeping, mood changes and depression, and suffer from delusions and suicidal thoughts. In a few cases these effects have also occured when corticosteroid treatment is being withdrawn. For this reason, it is important to let your doctor know if you notice any change in your mood or behaviour during treatment or when stopping treatment, particularly if you begin to feel depressed, or have any disturbing thoughts or feelings. Most of these problems go away if the dose is lowered or the medicine is stopped. However if problems do happen they might need treatment.

Use with caution in

• Elderly people.
• People with infections.
• Decreased kidney function.
• Decreased liver function.
• Liver cirrhosis.
• Peptic ulcer.
• Inflammation of the bowel and back passage (ulcerative colitis).
• Painful inflammation of small sacs or pouches in the wall of the gut (diverticulitis).
• People who have recently had a surgical procedure called intestinal anastomosis, which involves the joining together of ends of the intestine after a section has been removed.
• People at risk of blood clots in the blood vessels (thromboembolism).
• Heart failure.
• People who have recently had a heart attack.
• High blood pressure (hypertension).
• Diabetes, or a family history of diabetes.
• Underactive thyroid gland (hypothyroidism).
• Epilepsy.
• Glaucoma, or a family history of glaucoma.
• History of cataracts.
• Current severe psychiatric illness, or a personal or family history of psychiatric illness, including depression, manic depression or schizophrenia.
• History of psychiatric illness caused by the use of a corticosteroid.
• Osteoporosis.
• Women who have passed the menopause.
• Abnormal muscle weakness (myasthenia gravis).
• People who have previously experienced muscle disorders (myopathy) caused by steroids.
• People with a history of tuberculosis (TB).
• Herpes simplex virus infection of the eye.

Not to be used in

• People with widespread infections, unless this is being treated with specific anti-infectives.
• This medicine is not recommended for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the developing baby. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of slowed growth in the developing baby. They may also cause the baby to make less of itsown steroid hormones after birth, though this usually resolves on its own and rarely causes any problems. Seek further medical advice from your doctor.
• This medicine may pass into breast milk. It should be used with caution in mothers who are breastfeeding and only if the benefits to the mother outweigh any risks to the nursing infant. Usual doses taken by the mother are unlikely to significantly affect the baby, but if the mother is taking higher doses for long periods of time, the medicine could cause the baby's adrenal glands to make less of their own steroid hormones. Seek medical advice from your doctor.

Label warnings

• Follow the printed instructions you have been given with this medication.
• This medication is to be swallowed whole, not chewed.
• Do not take indigestion remedies at the same time of day as this medication.

Side effects

Medicines and their possible side effects can affect individual people in different ways. Entocort CR capsules cause fewer side effects than equivalent doses of prednisolone taken by mouth, but can still cause some of the typical side effects associated with corticosteroids that are absorbed into the bloodstream.

The following are some of the side effects that are known to be associated with corticosteroids that are absorbed into the bloodstream. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Raised blood sugar level.
• Increased appetite and weight gain.
• Increased susceptibility to infections and increased severity of infections (see warnings above).
• Effects on the gut, such as indigestion or abdominal bloating, nausea, ulceration in the stomach or intestine, inflammation of the pancreas (pancreatitis).
• Ulceration or thrush infection in the throat.
• Muscle weakness or wasting.
• Thinning of the bones (osteoporosis) and increased risk of breaking a bone.
• Effects on the skin, such as skin thinning, impaired healing, acne, bruising, stretch marks, increased sweating, change in pigmentation, increased hair growth (hirsutism).
• Psychiatric reactions, such as mood changes (including irritability, depression and suicidal thoughts), psychotic reactions (including mania, delusions and hallucinations), anxiety, confusion, memory loss, sleep disturbances (see warning above).
• Cushing's syndrome, characterised by a moon-shaped face.
• Menstrual disturbances.
• Sodium and water retention.
• Increase in blood pressure (hypertension).
• Decrease in the level of potassium in the blood.
• Decrease in the production of natural steroids by the adrenal glands (adrenal suppression - see warning above).
• Effects on the eyes, such as raised pressure inside the eye (glaucoma), cataracts.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Entocort CR capsules contain granules of budesonide with a special coating that allows the budesonide to pass through the stomach and be released at the end of the small intestine and start of the large intestine (colon). Antacids (indigestion remedies) should not be taken at the same time of day as these capsules, because they allow this special coat to dissolve too quickly.

Budesonide can cause fluid and salt retention and so may oppose the effects of the following medicines:

• antihypertensive medicines used to treat high blood pressure
• diuretics, eg furosemide.

There may be an increased chance of the level of potassium in the blood falling too low (hypokalaemia) if budesonide is used in combination with any of the following medicines, which can also lower the amount of potassium in the blood:

• acetazolamide
• amphotericin
• beta agonists, eg salbutamol, salmeterol, terbutaline
• carbenoxolone
• potassium-losing diuretics, eg furosemide, bendroflumethiazide
• theophylline.

Budesonide may increase blood sugar levels and so may oppose the blood sugar lowering effects of antidiabetic medicines. People with diabetes may need an increase in their dose of insulin or antidiabetic tablets.

Budesonide may enhance the anti-blood-clotting effect of anticoagulant medicines such as warfarin. People taking anticoagulant medicines in combination with prednisolone should have their blood clotting time (INR) regularly monitored, particularly after starting or stopping treatment with budesonide and after any dose changes.

If budesonide is used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) eg ibuprofen, there may be an increased risk of side effects on the gut, such as stomach ulceration and bleeding.

Budesonide may decrease the blood levels of salicylates such as aspirin. When budesonide is stopped in people taking regular salicylates, the blood level of the salicylate may subsequently rise excessively, unless the dose is readjusted.

The following medicines may increase the removal of budesonide from the body, thus reducing its effects. You may need a larger dose of budesonide if you are also taking any of these medicines:

• barbituates, eg amobarbital,phenobarbital
• carbamazepine
• phenytoin
• primidone
• rifabutin
• rifampicin.

The effect of corticosteroids may be reduced in the three to four days following use of mifepristone.

The following medicines may reduce the removal of budesonide from the body and so may increase its effects or side effects:

• ciclosporin
• itraconazole
• ketoconazole
• protease inhibitors, eg ritonavir.

Budesonide may decrease the body's immune response. Thismeans that vaccines may be less effective if given during treatment, becausethe body does not produce sufficient antibodies. Live vaccines may causeserious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, chickenpox, oralpolio, oral typhoid and yellow fever. These should not be given to peoplewhose immune system is underactive due to treatment with this medicine.

Other medicines containing the same active ingredient