Budesonide rectal foam and enemas

Budesonide rectal foam and enemas are used to treat ulcerative colitis. These medicines are inserted into your bottom (rectum).

Ulcerative colitis is a long-term condition where you get swelling (inflammation), and sometimes ulcers, in the lining of your bowel. The most common symptoms are stomach (abdominal) pain and diarrhoea with blood in it.

Budesonide is a type of medicine known as a steroid or corticosteroid.

Budesonide rectal foam and enemas do not cure ulcerative colitis. However, they can help symptoms by reducing the inflammation in your bowel.

This medicine is only available on prescription.

Budesonide also comes as:

• budesonide inhalers – for asthma and chronic obstructive pulmonary disease (COPD)
• budesonide nasal spray – for allergic rhinitis, hay fever and nasal polyps
• budesonide tablets, capsules and granules – for inflammatory conditions such as Crohn's disease and ulcerative colitis, and autoimmune hepatitis

Most adults aged 18 years old and over can use budesonide rectal foam and enemas.

Budesonide rectal foam and enemas are not suitable for some people. To make sure it's safe for you, tell your doctor or pharmacist before starting to use this medicine if you:

• have ever had an allergic reaction to budesonide or any other medicine
• have recently been in contact with someone with chickenpox, shingles or measles
• currently have an infection, or have had one recently
• have any other problems with your bowel or rectum
• have ever had a stomach ulcer or ulcer in your intestines (duodenal ulcer)
• have had mental health problems, such as depression or psychosis
• have high blood pressure (hypertension)
• have diabetes
• have liver problems
• have osteoporosis
• have ever had tuberculosis (TB)
• have glaucoma or a cataract
• have recently had a vaccination, or are due to have a vaccination
• are pregnant, trying to get pregnant or breastfeeding

The usual dose of budesonide rectal foam or budesonide enema is 2mg, used once a day for up to 8 weeks.

Budesonide rectal foam comes in a can with single-use plastic tubes (applicators) that you use to insert the foam.

Each application gives a 2mg dose of budesonide.

Try to use it at about the same time of day, either in the morning or in the evening before bed.

Use the rectal foam after doing a poo. This is because the medicine works best when your bowels are empty.

After you use the foam, try not to poo again for at least a few hours. For the medicine to work properly it needs to stay inside your bowel as long as possible.

How to use it

1. Read the instruction leaflet. The pictures show you exactly how to use the foam.
2. If you're using it for the first time, remove the plastic flap (or safety lock) from underneath the dome-shaped pump at the top of the can.
3. Wash your hands before and after using the foam.
4. Push a new applicator onto the nozzle. This nozzle sticks out beneath the dome at the top of the can.
5. Shake the can for about 15 seconds.
6. Twist the rounded dome at the bottom.
7. Put your index finger on top of the dome and turn the can upside down. It's important to keep the can as straight (vertical) as possible.
8. Stand with one leg raised on a chair – or lie down on your side if you prefer. Gently put the applicator into your bottom as far as possible.
9. Push the dome down fully once.
10. Then release the dome slowly. The foam comes out of the spray can when you do this.
11. Wait 10 to 15 seconds before removing the applicator from your bottom. This is important to make sure you get the full dose and to stop any foam spilling out.
12. Twist the dome at the base and remove the applicator from the nozzle. This stops any foam coming out when you're not using it. Put the applicator in the plastic bag provided and throw the bag away.

This medicine comes as liquid and tablets that you mix together. Once made up, it contains a 2mg dose of budesonide.

It's best to use budesonide enemas at night, just before going to bed.

It's best to go to the toilet before using the enema. This is because it's more comfortable if you empty your bowels and bladder before using it.

You may want to sleep on a towel or similar covering. This is to protect your bedding from stains.

How to use a budesonide enema

You should have 1 bottle of liquid, 1 nozzle and enema tablets.

1. Check the instruction leaflet first. The pictures show you exactly how to prepare and use the enema.
2. Take a bottle of the liquid and unscrew the cap.
3. Remove 1 tablet from the foil strip and drop it into the bottle of liquid.
4. Replace the cap and screw firmly back onto the bottle.
5. Shake the bottle well for at least 15 seconds, or until the tablet has dissolved in the liquid.
6. Remove the cap and screw the nozzle tightly onto the top of the bottle.
7. The enema is now ready and should be used immediately.
8. Wash your hands before and after using the enema.
9. Lie on your side, with your bottom slightly higher than the rest of your body. You can use a pillow to lift your bottom up. You may want to lie on a towel.
10. Put one of the disposable plastic bags provided over your hand (like a glove) and pick up the bottle.
11. Shake the bottle and remove only the protective cap that covers the nozzle (do not unscrew the nozzle itself).
12. Gently push the nozzle into your bottom as far as is comfortable. You can use a lubricant if you find this uncomfortable.
13. Squeeze the bottle to push the liquid into your bottom. It's normal for some liquid to be left in the bottle afterwards.
14. Remove the nozzle from your bottom.
15. Put the bottle into the disposable plastic bag by rolling the bag off your hand and over the bottle, ready to throw away.
16. Roll onto your front and wait for 5 minutes. This will stop any liquid coming out of your bottom.
17. For sleeping, find a comfortable position that keeps the liquid in your bottom for as long as possible. The longer it stays there, the better it will work.

Your doctor will tell you how long to use budesonide rectal foam or enemas for. This will usually be for no longer than 8 weeks. Do not use budesonide rectal foam or enemas for more than 8 weeks without speaking to a doctor.

If you forget to use your budesonide rectal foam or enema, use it as soon as you remember unless it's nearly time for the next dose. In this case, skip the missed dose and take the next one at the usual time.

Never use 2 doses to make up for a missed dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to use this medicine.

Using too much budesonide is unlikely to harm you.

If you're worried, talk to your doctor or a pharmacist.

These common side effects of budesonide rectal foam and enemas happen in more than 1 in 100 people. There are things you can do to cope with them:

Drink lots of fluids, such as water or squash, to avoid dehydration. Signs of dehydration include peeing less than usual or having dark strong-smelling pee.

Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.

If you take the combined contraceptive pill or progestogen-only pill and you have severe diarrhoea for more than 24 hours, your contraception may not protect you from pregnancy. Check the pill packet for advice.

It may help if you stick to plain food, do not eat rich or spicy food and try eating smaller meals and more often.

Tell your doctor if this problem does not go away. They may be able to prescribe an extra medicine to protect your stomach.

If you need something to ease the indigestion or trapped wind, try taking an antacid. If it gets very uncomfortable, speak to your doctor.

This is usually mild and only lasts a few days. Ask a pharmacist to recommend a cream if it bothers you. Tell your doctor if this does not go away.

Speak to a doctor or pharmacist if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

It's rare to get serious side effects with budesonide rectal foam or enemas.

This is because they're applied directly into the bowel and the medicine gets to where it's needed without affecting the rest of your body.

Sometimes budesonide can get through the lining of your bowel into your blood, meaning you're at higher risk of side effects. However, this is more likely to happen if you use it for a long time.

Speak to your doctor if you get "moon face" (a puffy, rounded face), weight gain in the upper back or belly. This happens gradually and can be a sign of Cushing's syndrome.

Tell a doctor or call 111 straight away if you get:

• a high temperature, chills, a very sore throat, ear or sinus pain, a cough, coughing up more mucus (phlegm) or a change in colour of your mucus, pain when you pee, mouth sores or a wound that is not healing – these can be signs of an infection
• a very upset stomach or you're being sick (vomiting), feeling very dizzy or passing out, muscle weakness, feeling very tired, mood changes, loss of appetite and weight loss – these can be signs of adrenal insufficiency
• changes in your eyesight, such as blurred vision or a cloudy lens in the eye – these can be signs of increased pressure in your eyes (glaucoma), a cataract or a retinal condition called CSCR (central serous chorioretinopathy)
• depressed, have mood swings (highs or lows), feel anxious, are seeing or hearing things that are not there or having strange or frightening thoughts – these can be signs of mental health problems
• severe stomach pain, severe back pain, a very upset stomach or you're being sick (vomiting) – these can be signs of pancreas problems

• you have thoughts of harming yourself

Do not drive to A&E. Ask someone to drive you or call 999 and ask for an ambulance.

Bring all the medicines you take with you.

It's possible to have a serious allergic reaction (anaphylaxis) to budesonide rectal foam and enemas.

Call 999 now if:

• your lips, mouth, throat or tongue suddenly become swollen
• you're breathing very fast or struggling to breathe (you may become very wheezy or feel like you're choking or gasping for air)
• your throat feels tight or you're struggling to swallow
• your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
• you suddenly become very confused, drowsy or dizzy
• someone faints and cannot be woken up
• a child is limp, floppy or not responding like they normally do (their head may fall to the side, backwards or forwards, or they may find it difficult to lift their head or focus on your face)

You or the person who's unwell may also have a rash that's swollen, raised, itchy, blistered or peeling.

These can be signs of a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of budesonide rectal foam and enemas. For a full list see the leaflet inside your medicines packet.

Budesonide rectal foam and enemas can be used in pregnancy. Your doctor is likely to recommend that you continue to use them if you need to.

Active inflammatory bowel disease can affect your baby's growth and if it's not controlled well, it may lead to premature birth. It's recommended that you continue to use budesonide rectal foam and enemas to keep you and your baby well.

You may be offered extra scans to check the baby's growth later on in your pregnancy.

If your doctor or health visitor says your baby is healthy, it's generally OK to use budesonide rectal foam and enemas while breastfeeding. However, always check with your doctor first.

It's not known how much budesonide gets into breast milk, but it's likely to be a small amount that is unlikely to cause side effects in your baby. However, your baby may need extra monitoring if you use higher doses or if you're using it for a long time.

If you notice that your baby is not feeding as well as usual, or if you have any other concerns about your baby, talk to your health visitor, midwife or doctor as soon as possible.

There's no evidence to suggest that using budesonide reduces fertility in either men or women.

Speak to a pharmacist or your doctor if you're trying to get pregnant.

Tell your doctor if you're:

• trying to get pregnant
• pregnant
• breastfeeding

Some medicines can affect the way budesonide rectal foam and enemas work and increase your chance of getting side effects.

Speak to a doctor or a pharmacist before starting to use budesonide rectal foam or enemas if you take any of these:

• medicines used to treat HIV, such as ritonavir or cobicistat
• antifungal medicines, such as itraconazole
• other medicines that contain steroids, such as eczema creams, steroid tablets, injections, inhalers, nasal sprays, or eye or nose drops

There's not enough information to say whether complementary medicines, herbal remedies and supplements are safe to take with budesonide rectal foam and enemas. They're not tested in the same way as pharmacy and prescription medicines. They're generally not tested for the effect they have on other medicines.

Tell your doctor or pharmacist if you're taking any other medicines, including herbal remedies, vitamins or supplements.