Entocort CR capsules (budesonide)

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 its own 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. 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. These should not be given to people whose immune system is underactive due to treatment with this medicine.

References:

http://www.medicines.ie/medicine/867/SPC/Entocort+CR+3mg+Capsules/

http://www.netdoctor.co.uk/medicines/digestive-health/a6661/entocort-cr-capsules-budesonide/

https://www.medicines.org.uk/emc/medicine/172

http://www.rxlist.com/entocort-drug.htm

https://www.drugs.com/pro/entocort-ec.html