For the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.
What is Budenofalk rectal foam used for?
- Ulcerative colitis affecting the lower bowel and rectum.
How does Budenofalk rectal foam work?
- Budenofalk rectal foam contains the active ingredient budesonide, 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. They are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.
- Budesonide is a synthetic steroid that has an anti-inflammatory effect.
Budenofalk rectal foam should be used with caution in
- Decreased liver function.
- Peptic ulcer.
- High blood pressure (hypertension).
- Diabetes, or a family history of diabetes.
- Glaucoma, or a family history of glaucoma.
- History of cataracts.
- Osteoporosis.
- Women who have passed the menopause.
- People with infections.
- People with a history of tuberculosis (TB).
- Budenofalk rectal foam should not be used in
- 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 using 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.
Possible side effects of Budenofalk rectal foam
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
- Pain or burning sensation in the rectum.
- Headache.
- Nausea.
- Excess gas in the stomach and intestines (flatulence).
- Abdominal pain.
- Indigestion.
- Anal fissure.
- Haemorrhoids (piles).
- Rectal bleeding.
- Frequent urge to defecate.
- Difficulty sleeping (insomnia).
On rare occasions this medicine may be absorbed into the bloodstream in sufficient amounts to cause some of the side effects associated with corticosteroids taken by mouth.
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 or pharmacist. If they think it's necessary they'll report it for you.
How can Budenofalk rectal foam affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already using, 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 using this one, to ensure that the combination is safe.
The following medicines may reduce the removal of budesonide from the body and so may increase the risk of its side effects:
- ciclosporin
- itraconazole
- ketoconazole
- protease inhibitors, eg ritonavir.
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.
Budesonide that has been absorbed into the bloodstream 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. Tell your doctor that you are using this medicine if you are due to have any vaccines.
References:
http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con2024076.pdf
https://www.medicines.org.uk/emc/product/237/smpc
https://www.hpra.ie/img/uploaded/swedocuments/2183017.PA0573_002_002.e2cc55a7-156e-445d-8726-f637fb69baac.000001PIL.170526.pdf
https://www.netdoctor.co.uk/medicines/digestion/a6671/budenofalk-rectal-foam-budesonide/
https://www.imt.ie/news/budenofalk-rectal-foam-01-06-2010/
https://www.mims.co.uk/budenofalk-rectal-foam-ulcerative-colitis/article/891991
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