How does it work?

Entocort enema contains 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 inflammatory bowel diseases.

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 a particular area, inflammation is reduced.

Entocort enema is administered into the rectum to reduce inflammation associated with ulcerative colitis affecting the lower end of the bowel and rectum. The budesonide acts locally to reduce inflammation in this area and helps relieve the symptoms of flare-ups of ulcerative colitis.One enema is administered into the rectum at night for four weeks. The full effect is usually seen within two to four weeks of treatment. If the inflammation in the bowel is not controlled after four weeks, it may be used for a further four weeks.

What is it used for?

• Ulcerative colitis affecting the lower bowel and rectum.

Warning!

• This medicine is for rectal use only.
• Corticosteroids can 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 with this medicine.
• If you have never had chickenpox you should avoid close personal contact with people who have chickenpox or shingles (herpes zoster) during treatment with this medicine. 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 stop you getting the diseases.
• If you go into hospital, or visit a dentist or another doctor while using this medicine, you should tell them you are using this medicine.

Use with caution in

• Decreased liver function.
• Peptic ulcer.
• High blood pressure (hypertension).
• Diabetes, or a family history of diabetes.
• Glaucoma, or a family history of glaucoma.
• History of cataracts.
• Osteoporosis.
• Women who have passed the menopause.
• People with infections.
• People with a history of tuberculosis (TB).

Not to be used in

• 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 using 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.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Excess gas in the stomach and intestines (flatulence).
• Nausea.
• Diarrhoea.
• Skin reactions such as rashes or hives.
• Difficulty sleeping (insomnia).
• Agitation.
• On rare occasions this medicine may be absorbed into the bloodstream in sufficient amounts to cause some of the side effects associated with corticosteroids taken by mouth. See the factsheets linked at the end of this page for more information.

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 using, 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 using this one, to ensure that the combination is safe.

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

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

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.

Budesonide that has been absorbed into the bloodstream may decrease the body's immune response. This means that vaccines may be less effective if given during treatment, because the body does not produce sufficient antibodies. Live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, chickenpox, oral polio, oral typhoid and yellow fever. Tell your doctor that you are using this medicine if you are due to have any vaccines.

Other medicines containing the same active ingredient