Uceris rectal

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take budesonide rectal by mouth. It is for use only in your rectum.

Budesonide rectal is usually given once in the morning and once in the evening for 2 weeks. Then you will use the medicine only once per day (at bedtime) for 4 more weeks. Follow your doctor's dosing instructions very carefully.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the rectal foam.

Wash your hands before and after using this medicine.

Warm the medicine canister in your hands and shake it for 10 to 15 minutes before each use.

After using budesonide rectal at bedtime, avoid using the bathroom until the next morning.

Budesonide rectal foam is flammable. Do not use near high heat or open flame, or while smoking.

If you plan to have a colonoscopy, tell your doctor ahead of time. You may need to stop using budesonide rectal while you are using laxative medicine to prepare for the colonoscopy. Follow your doctor's instructions about when to start using budesonide rectal foam again.

If you also use another steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.

Store at room temperature away from moisture and heat.

Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty rectal foam canister.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Darkening of the skin
• diarrhea
• dizziness
• fainting
• loss of appetite
• mental depression
• nausea
• skin rash
• unusual tiredness or weakness
• vomiting

• Blistering, burning, crusting, dryness, or flaking of the skin
• blurred vision
• cough or hoarseness
• difficulty swallowing
• fever or chills
• headache
• hives or itching
• itching, scaling, severe redness, soreness, or swelling of the skin
• lower back or side pain
• painful or difficult urination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow or fast heartbeat
• tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blemishes on the skin
• pimples
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 Uceris Aerosol, Foam With Applicator

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.

Before using budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high blood pressure, personal or family history of diabetes, bone loss (osteoporosis), stomach/intestinal ulcer, a certain bowel disease (diverticulitis), mental/mood disorders (such as depression, psychosis), personal or family history of high pressure in the eye (glaucoma), cataracts, current/past infections (such as tuberculosis, ocular herpes simplex, fungal), thyroid problems.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Budesonide may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Budesonide may cause vaccines not to work as well. Therefore, do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.