Ulcerative colitis, proctosigmoiditis and granular proctitis.
What is Colifoam used for?
- Inflammatory disease of the large intestine (ulcerative colitis).
- Inflammation of the rectum (proctitis).
- Inflammation of the rectum and lower bowel (proctosigmoiditis).
How does Colifoam work?
- Colifoam contains the active ingredient hydrocortisone, 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.
Important information about Colifoam
- This medicine is for rectal use only.
- Although administered locally into the rectum, the hydrocortisone in this medicine could be absorbed into the bloodstream, particularly when the bowel is inflamed. Continuous long-term use is not recommended, because this can result in significant amounts of the medicine being absorbed, and increases the chance of side effects on the rest of the body.
- 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 could be at risk of severe chickenpox if your immune system becomes less active while having treatment with this medicine. As a result you 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 whose immune system is underactive due to long-term treatment with corticosteroids.
- Corticosteroid treatment that is absorbed into the bloodstream, 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.
- You must not stop using this medicine suddenly if you have been using it for long periods of time, because long-term use of corticosteroids that have been absorbed into the bloodstream can suppress the natural production of corticosteroids by the adrenal glands. This means that the body could become temporarily reliant on the medicine. When stopping treatment after long periods of time the dose of this medicine may need to be tapered down gradually, to allow the adrenal glands to start producing adequate amounts of natural steroids again. Follow the instructions given by your doctor or pharmacist when stopping treatment.
Colifoam should be used with caution in
- Elderly people.
- Decreased kidney function.
- Liver failure.
- Peptic ulcer.
- Severe ulcerative colitis.
- Painful inflammation of small sacs or pouches in the wall of the gut (diverticulitis).
- 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).
- Glaucoma, or a family history of glaucoma.
- 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.
- 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).
Colifoam should not be used in
- People with widespread infection, or infection in the bowel, unless this is being treated with specific anti-infectives.
- People with a blockage (obstruction) in the intestines.
- People with an abnormal hole in the bowel (perforation).
- People with extensive abnormal openings from the intestines into the abdomen (fistulas).
- 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.
- 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.
- When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of slowed growth in the developing baby. As a result, 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. Seek further medical advice from your doctor.
- This medicine may pass into breast milk, although doses of up to 160mg of hydrocortisone daily in the mother are unlikely to have any effect on a nursing infant. Seek medical advice from your doctor if you are breastfeeding.
Possible side effects of Colifoam
Medicines and their possible side effects can affect individual people in different ways. The main side effect associated with hydrocortisone used in the rectum is local irritation.
Although administered locally into the rectum, the hydrocortisone in this medicine could also be absorbed into the bloodstream, particularly when the bowel is inflamed. Continuous long-term use is not recommended, because this can result in significant amounts of the medicine being absorbed, and increases the chance of side effects on other areas of the body.
The following are some of the side effects that are known to be associated with corticosteroids that have been 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.
- 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.
- Effects on the eyes, such as raised pressure inside the eye (glaucoma), cataracts.
- Slowed growth in children and adolescents.
- Blood clots in the blood vessels (thromboembolism).
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.
If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.
How can Colifoam affect other medicines?
As this medicine could be absorbed into the bloodstream 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. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe. If absorbed into the bloodstream in sufficient amounts hydrocortisone can have the effects on other medicines listed below.
Hydrocortisone 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.
- Hydrocortisone 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.
There may be an increased chance of the level of potassium in the blood falling too low (hypokalaemia) if hydrocortisone is used in combination with any of the following medicines, which can also lower the amount of potassium in the blood:
- beta agonists, eg salbutamol, salmeterol, terbutaline
- potassium-losing diuretics, eg furosemide, bendroflumethiazide
If the level of potassium in your blood falls during treatment, this can increase the risk of side effects on the heart caused by a medicine called digoxin.
Hydrocortisone may enhance the anti-blood-clotting effect of anticoagulant medicines such as warfarin. People taking anticoagulant medicines in combination with hydrocortisone should have their blood clotting time (INR) regularly monitored, particularly after starting or stopping treatment with hydrocortisone and after any dose changes.
If hydrocortisone 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.
Hydrocortisone may decrease the blood levels of salicylates such as aspirin. When hydrocortisone is stopped, this may result in excessive levels of the salicylate, unless the dose is readjusted.
The following medicines may increase the removal of hydrocortisone from the body, thus reducing its effects:
- barbituates, eg amobarbital, phenobarbital
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 hydrocortisone from the body and so may increase its effects or side effects:
- ciclosporin (hydrocortisone may also increase the blood level and risk of side effects of ciclosporin)
- macrolide-type antibiotics, eg erythromycin
- protease inhibitors such as ritonavir.
Hydrocortisone 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.