Budesonide - Rectal

Budesonide is used to treat ulcerative colitis (a disease that causes inflammation and sores in the lining of the large intestine and 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 suppository, suspension enema, or foam enema.

Budesonide suppository, suspension and foam enema are to be inserted into the rectum. Do not take it by mouth or use it in any other way. Try to go to the toilet before using these preparations.

If you are using the suppository, follow these steps:

1. Wash your hands thoroughly.
2. Remove the suppository from the foil wrapper.
3. If you are right-handed, lie on your left side and pull your right knee up towards your chest.
4. Gently insert the suppository with the pointed end first into your rectum. Gently push the suppository as far as it will go.
5. Remain lying in this position for 10-15 minutes to allow the suppository to melt. If you feel that the suppository is slipping out, press your buttocks together. The suppository must remain in the rectum so that the medicine can be absorbed.

If you are using the suspension enema, follow these steps:

1. The suspension enema is used just before going to bed and it consists of two components, a dispersible tablet and a vehicle solution. Prepare the suspension enema by dissolving 1 tablet in 1 bottle of the vehicle solution provided. Replace the cap onto the bottle and shake it well for at least 15 seconds until the tablet is completely dissolved. Use a freshly prepared suspension enema for each administration.
2. Remove the protective cap and screw the provided applicator nozzle onto the bottle.
3. Shake the bottle well again and hold the bottle by the neck. You may wish to hold it using a plastic bag provided to cover your hand.
4. 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.
5. Insert the nozzle gently into your rectum as far as you are comfortable.
6. When you are sure that the nozzle is safely inserted in your rectum, squeeze the bottle slowly to release most of the medicine. You will not be able to empty the bottle since it has been designed to keep some liquid after use.
7. Slowly withdraw the nozzle from your rectum after administration. If you used a protective plastic bag, remove it from your hand by pulling the end forward over the bottle. This leaves the bottle inside the bag ready for disposal.
8. 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.
9. Do not get up from the bed. Find a comfortable position to sleep to keep the suspension enema in your rectum for as long as possible while sleeping.

If you are using the foam enema, follow these steps:

1. Wash your hands thoroughly.
2. Shake the can well before using. Rest it for a few seconds then shake again.
3. Push the applicator firmly onto the spout of the spray can.
4. Before your first use, remove the safety tag (plastic flap) from under the pump dome.
5. Twist the dome on top of the spray can until the semi-circular gap underneath is aligned with the applicator.
6. 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.
7. 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 is bent forward.
8. Gently insert the applicator into your rectum as far as you are comfortable.
9. Push the pump dome fully once then slowly release it. The foam only comes out of the spray can when you release the dome.
10. 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.
11. When you have removed the applicator, place it in the plastic bag provided for disposal. Use a new applicator for your next administration.
12. 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 them 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.

Inform your doctor if you have the following conditions:

• heart disease e.g. heart failure (weakness and inability of the heart to pump blood), recent heart attack
• high blood pressure
• current or family history of diabetes
• stomach or bowel problems e.g. peptic ulcer (open sores in the lining of the stomach, small intestine, or lower food pipe)
• myasthenia gravis (muscle weakness disorder)
• osteoporosis (thinning and weakening of bones)
• eye problems e.g. glaucoma (increased pressure in the eye), cataract (clouding of the lens of the eye)
• thyroid disease e.g. overactive or underactive thyroid gland
• mental health problems
• history of epilepsy (fits or seizures)
• active or a history of TB (a lung infection known as tuberculosis)
• untreated bacterial, fungal, viral or parasitic infections
• liver disease

Let your doctor know if you are pregnant or breastfeeding.

Be sure to check with your doctor or pharmacist before giving this medicine to the elderly. Elderly people may be more sensitive to the side effects.

Avoid exposure to anyone who is infected with chickenpox, shingles, or measles. If you are exposed to these infections, contact your doctor immediately.

If you are going to have certain laboratory tests (e.g. test to detect a problem in the pituitary gland), inform your doctor that you are using Budesonide.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Routine tests (e.g. blood sugar and electrolyte levels, liver function) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Your blood pressure may rise to unsafe levels without you noticing it. Monitor your blood pressure regularly.
• Regular monitoring for signs of infection or changes in vision may also be needed.

Budesonide may cause any of the following side effects: headache, nausea, indigestion, stomach wind, diarrhoea, muscle or joint pain, 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, swelling of the face, eyes, mouth or throat
• rounding of the face, swelling in the ankles or feet, weight gain, severe headache, wound that heals slowly, hair growth, pimples, stretch marks on the skin
• eye pain, blurred vision or other changes in eyesight
• fever, chills, sore throat, cough, unusual tiredness or weakness
• unusual changes in mood or behaviour (being too depressed, agitated, or having compulsive and impulsive behaviour)

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 to treat fungal infection e.g. ketoconazole, itraconazole
• certain antibiotics e.g. erythromycin, clarithromycin
• medicines for HIV infection e.g. ritonavir, indinavir, saquinavir, cobicistat
• ciclosporin (medicine used in organ transplants or certain immune disorders)
• carbamazepine (medicine for epilepsy [fits or seizures])
• rifampicin (medicine to treat TB [lung infection known as tuberculosis])

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 (more than 1 litre a day).

Store in a cool, dry place away from the reach of children.

Do not refrigerate or freeze.

Protect from direct sunlight and heat.

The rectal foam is flammable. Avoid exposure of this medicine to fire and open flames.

Medicines must not be used past the expiry date.