Budesonide is used to treat ulcerative colitis (inflammation in the lower part of the large intestine and the rectum).
Use Budesonide exactly as directed by your doctor or according to the instructions on the label. Do not use more or less than instructed by your doctor.
This medicine is available as a rectal suspension or foam enema.
Budesonide suspension and foam enema may only be used by inserting it into the rectum (back passage). Do not take it by mouth or use it in any other way. Try to go to the toilet before using the enema.
Suspension enema consists of two components, a dispersible tablet and a vehicle. If you are using the suspension enema, follow these steps:
- Prepare the suspension enema by dissolving 1 tablet in 1 bottle of solution provided. Shake the bottle well (at least 15 seconds) until the tablet is completely dissolved. Use a freshly prepared suspension enema immediately every administration.
- Shake the bottle well again before using and remove the protective cap from the nozzle.
- Hold the bottle by the neck. You may wish to hold it using a plastic bag to cover your hand.
- Lie down on your side (choose whichever side is comfortable) with your bottom slightly higher than the rest of your body. You may raise your bottom by placing 1 or 2 pillows under it.
- Insert the nozzle gently into your rectum.
- When you are sure that the nozzle is safely in your rectum, squeeze the bottle slowly to release most of the medicine into your rectum. You will not be able to empty the bottle since it has been designed to keep some liquid after use.
- Slowly withdraw the nozzle from your rectum after administration. If you used a protective plastic bag, remove it from your hand leaving the bottle inside the bag to be disposed of.
- Roll over onto your stomach and stay in this position for at least 5 minutes to prevent the liquid from coming out of your rectum.
- Find a comfortable position to sleep in order to keep the suspension enema in your rectum for as long as possible.
If you are using the foam enema, follow these steps:
- Wash your hands thoroughly.
- Shake the can well before using. Rest it for a few seconds then shake again.
- Push the applicator firmly onto the spout of the spray can.
- Before your first use, remove the safety tag (plastic flap) from under the pump dome.
- Twist the dome on top of the spray can until the semi-circular gap underneath is aligned with the applicator.
- Hold the can in the palm of your hand and place your index finger on the top of the pump dome. Turn the can upside-down.
- Stand with one foot raised on a stool or chair, or you may lie down on your side with your lower leg stretched out while the other bent forward.
- Gently insert the applicator into your rectum as far as you are comfortable.
- Push the pump dome fully once then slowly release it. The foam only comes out of the spray can when you release the dome. To administer your second spray, push the pump dome again then release slowly.
- Keep the applicator in place for at least 10-15 seconds before pulling it out to ensure that you delivered your full dose without spilling.
- When you have removed the applicator, place it in the plastic bag provided for disposal. Use a new applicator for your next administration.
- Wash your hands after. Try not to empty your bowel until the next morning.
Budesonide enema may cause staining of direct contact surfaces such as fabrics and beddings, if possible, cover your beddings with a plastic sheet to protect it in case of any liquid spillage.
The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on your condition.
Budesonide must be used regularly for it to be effective. Continue using this medicine even when you feel better. Do not stop using it suddenly as this may worsen your condition.
Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.
DO NOT double a dose under any circumstances.
If you often forget to use your medicine, let your doctor and pharmacist know.
Alert your doctor if you have severe liver disease known as cirrhosis, as Budesonide may not be suitable for you.
Inform your doctor if you have the following conditions:
- with or a family history of diabetes
- heart disease
- high blood pressure
- stomach problems e.g. stomach ulcer
- myasthenia gravis (muscle weakness disorder)
- eye disease e.g. glaucoma (increased pressure in the eye), cataract (clouding of the lens of the eye)
- active or a history of TB (infection known as tuberculosis)
- active, recurring or untreated infections caused by fungi, bacteria, virus, or parasites
- conditions which increase the risk of bone weakness e.g. with or history of osteoporosis (thinning and weakening of bones), being immobile for a long time, menopausal women, smoking, poor nutritional intake
- mood disorders or mental health problems
- thyroid disease
- liver disease
Let your doctor know if you are pregnant or breastfeeding.
Avoid exposure to anyone who is infected with chickenpox or measles. If you are exposed to these infections, inform your doctor immediately.
Inform your doctor if you have been recently vaccinated. Do not receive any vaccinations without first asking your doctor.
If you are going to undergo a laboratory test (e.g. ACTH stimulation test), or an operation, including minor surgery or dental work, inform your doctor or dentist that you are using Budesonide.
Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.
- You may need to have routine tests (e.g. blood sugar and electrolyte levels, liver function) while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
- Monitoring for signs and symptoms of changes in your adrenal glands and infection may also be needed.
Budesonide may cause any of the following side effects: nausea, stomach wind, diarrhoea, indigestion, muscle or joint pain, muscle weakness or twitching, skin rash or irritation, and pain or burning sensation in the rectum.
Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:
- rashes, breathlessness, swollen face, eyes, tongue or throat
- rounding of the face, acne, swelling in the ankles or feet, weight gain, irregular menstruation (in women), bruising easily, stretch marks on the skin
- blurring of your vision or other visual disturbances
- unusual changes in mood or behaviour (being too depressed, anxious, irritable, or aggressive)
- signs of infection e.g. fever, chills, unusual tiredness or weakness
Inform your doctor if any of these side effects do not go away or are severe, or if you experience any other side effects.
Inform your doctor and pharmacist if you are taking any of these medicines:
- medicines for HIV infection e.g. ritonavir, indinavir, nelfinavir, saquinavir, cobicistat
- medicines to treat fungal infection e.g. ketoconazole, itraconazole
- certain antibiotics e.g. clarithromycin
- medicine for epilepsy (fits or seizures) e.g. carbamazepine
- medicine for TB (infection known as tuberculosis) e.g. rifampicin
This list does not include all medicines that may interact with Budesonide.
Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements and medicines that you buy without a prescription.
Avoid alcohol.
Avoid excessive consumption of grapefruit or grapefruit juice.
Store in a cool, dry place away from the reach of children.
Keep the foam enema below 25°C. Do not refrigerate or freeze. Protect from heat, direct sunlight, open flame or while smoking.
Medicines must not be used past the expiry date.
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