Budesonide rectal

Budesonide is a steroid that reduces inflammation in the body.

Budesonide rectal is used to treat ulcerative colitis.

Budesonide rectal may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to budesonide.

To make sure budesonide is safe for you, tell your doctor if you have:

• tuberculosis (now or in the past);

• a serious bacterial, viral, or fungal infection;

• herpes infection of the eyes;

• cirrhosis or other liver disease;

• diabetes;

• high blood pressure;

• osteoporosis;

• a stomach ulcer;

• glaucoma;

• a weak immune system (caused by disease or by using certain medicines); or

• if you plan to have surgery.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Budesonide can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Budesonide rectal is not approved for use by anyone younger than 18 years old.

Other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by budesonide.

If your condition does not improve or if it become worse, check with your doctor.

Using too much of budesonide or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using budesonide: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are taking another steroid medicine and will switch to Uceris®, check first with your doctor. This may increase your chance of having steroid withdrawal side effects, such as headache, loss of appetite, blurred vision, change in the ability to see colors (especially blue or yellow), or vomiting.

You may get infections more easily while using budesonide. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

Make sure any doctor or dentist who treats you knows that you are using budesonide. You may need to stop using budesonide several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

This medication is used to treat symptoms of a certain bowel disease (ulcerative colitis). It works by reducing swelling (inflammation). Budesonide belongs to a class of drugs known as corticosteroids. Budesonide does not cure ulcerative colitis, but it may help relieve symptoms such as abdominal pain, diarrhea, and bloody stools. Using this medication as a foam allows it to work directly on the bowel and rectum.

How to use Budesonide Foam

Read the Patient Information Leaflet if available from your pharmacist before you start using budesonide and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Use this medication as a foam in the rectum as directed by your doctor, usually in the morning and evening for the first 2 weeks, then once a day in the evening for the next 4 weeks. It is best to use this medication just before bedtime in the evening.

This medication is flammable. Avoid smoking when applying this medication and immediately afterward. Do not use or store it near heat or open flame.

It is best to use this medication after a bowel movement. You may apply this medication while standing, lying down, or sitting. Do not insert any part of the canister into the anus. Use the enclosed applicator to apply this drug. Follow the instructions for attaching the applicator to the canister. Warm the canister in your hands and shake the canister well for 10 to 15 seconds before use. Hold the canister upside down and gently insert the applicator tip into the anus. Push down on the pump and hold it in that position for 2 seconds to apply the foam. Afterward, release your finger from the pump and continue to hold the applicator in place for 10 to 15 seconds. Then, remove the applicator and throw it away. Wash your hands after use. Keep the medication in your rectum for as long as possible, for example overnight.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. You may also have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication when you are using budesonide. Ask your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition persists or worsens.

Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.