Entocort: Uses, Side Effects and Dosage

What is ENTOCORT used for?

ENTOCORT is used to treat:

• A condition called Crohn’s disease. It is used to treat mild to moderate Crohn’s disease that involves the small bowel and the first part of the large bowel.

How does ENTOCORT work?

ENTOCORT is an anti-inflammatory drug which belongs to the steroid family of drugs. ENTOCORT has been shown to help reduce local inflammation.

ENTOCORT acts to

• block the production of substances that cause inflammation
• restricts the processes that cause inflammation

What are the ingredients in ENTOCORT?

Medicinal ingredients: budesonide

Non-medicinal ingredients: acetyltributyl citrate, ethyl cellulose, gelatin, iron oxide, methacrylic acid copolymer, polysorbate 80, silicon dioxide, simethicone (Antifoam M), sodium lauryl sulphate, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate.

ENTOCORT comes in the following dosage form:

As capsules containing 3 mg budesonide.

Do not use ENTOCORT if:

• you have any infection(s) in the rest of the body
• you have tuberculosis
• you are allergic to any of the ingredients in ENTOCORT (see What are the ingredients in ENTOCORT)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ENTOCORT. Talk about any health conditions or problems you may have, including if you:

• are taking, have recently taken or might take any of the following medicines:

  • steroid medicines
  • CYP3A inhibitor medicines. This includes antifungal agents (ketoconazole, itraconazole, fluconazole, miconazole). These medicines may increase the effects of ENTOCORT.
  • acetylsalicylic acid (Aspirin®). Speak to your doctor if you have a blood disorder that prevents your blood from clotting properly.
• are about to have or plan to have any operation

• are pregnant or plan to become pregnant. It is not known if ENTOCORT can harm your unborn baby. Your doctor will decide whether giving you ENTOCORT outweighs the potential risk to the unborn baby.

• are breastfeeding or planning to breastfeed. ENTOCORT is excreted in human breast milk.
• have a condition that causes inflammation of the filters found in the kidneys
• have liver disease
• have diverticulitis (a condition that causes inflammation of certain parts of the intestines)
• have brittle bones. ENTOCORT can cause the thinning of bones that lead to osteoporosis.
• have muscle weakness
• have thrombophlebitis (a condition that causes inflammation of a vein due to a blood clot)
• have glaucoma. ENTOCORT may worsen your glaucoma by increasing the pressure in your eyes.
• have diabetes. ENTOCORT may worsen your diabetes.
• have high blood pressure
• have an overactive thyroid gland
• have had mental health problems
• have skin allergies or reactions (rash)
• have ulcers in your stomach or intestines or presence of obstruction in the intestine

• have a heart condition such as

  • the heart’s ability to pump blood is reduced
  • the blood supply to the heart becomes damaged

Other warnings you should know about:

Treatment with ENTOCORT can increase your risk of certain side effects, including:

• Eye problems: ENTOCORT can cause serious eye problems such as cataracts (cloud vision), glaucoma (increased pressure in eye) or rare diseases that cause a build-up of fluid in your eyes. Tell your doctor right away if you get blurred vision, loss of vision or other vision changes.
• Infections: ENTOCORT can cause new infections that may be difficult to detect. Contact your doctor if you think you have been exposed to chicken pox or measles.

Transfer from other steroid drugs to ENTOCORT:

• ENTOCORT may cause allergies (red itchy skin, runny and congested nose) that were previously controlled when using other steroid drugs.
• Taking ENTOCORT after using other steroid drugs may reduce the function of the adrenal glands, responsible for producing cortisol. This can lead to a decrease in your own body’s hormone production.
• Taking ENTOCORT after using “cortisone” tablets may cause temporary symptoms that you experienced when you first started taking “cortisone” tablets (rash, pain in muscles and joints). If any of these symptoms bothers you, or symptoms such as headache, tiredness, nausea or vomiting occur, please contact your doctor.

Ending treatment

You may experience certain side effects when stopping treatment. Speak to your doctor before you stop taking ENTOCORT. You may experience the following symptoms when you suddenly stop treatment:

• pain in muscles and joints
• tiredness
• headache
• nausea
• vomiting

You should not eat grapefruits or drink grapefruit juice while you are taking ENTOCORT. This is because it can change how ENTOCORT works.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ENTOCORT:

• estrogens and oral contraceptives
• medicines used to treat fungal infections such as ketoconazole, fluconazole, itraconazole and miconazole
• medicines used to treat HIV such as ritonavir, cobicistat
• cyclosporine, used to suppress the immune system
• erythromycin, troleandomycin, used to treat bacterial infections

How to take ENTOCORT:

• Take ENTOCORT exactly as your doctor has told you to.
• Swallow capsules whole with water. Do not crush or chew the capsules.

• Take ENTOCORT before a meal.

• Never stop taking ENTOCORT on your own. Your doctor may want to slowly reduce your dose, especially if you have been using ENTOCORT for a long time. Your doctor will tell you when to stop taking ENTOCORT.

Usual Adult Dose:

Acute Treatment

• Three capsules once a day, in the morning.
• This treatment will last for up to 8 weeks.

Long Term Treatment

• Two capsules once a day, in the morning.
• This treatment will last for up to 3 months.
• Your doctor may want to change the dose, depending on the activity of your disease.

Overdose:

Missed Dose:

If you missed a dose of ENTOCORT, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using ENTOCORT?

These are not all the possible side effects you may have when taking ENTOCORT. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• muscle cramps
• rapid or irregular heartbeat
• upset stomach or gut or heartburn
• blood in stools
• body and joint ache and fatigue
• headache
• dizziness
• respiratory infection
• swelling in hands and legs
• shaking
• hyperactivity
• insomnia (trouble sleeping)
• skin discolouration resulting from bleeding under the skin
• rash
• red spots which burn, itch or sting

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

ENTOCORT comes in a container with a drying agent fitted in the cap. Always keep ENTOCORT capsules in the container. If you don’t, moisture from the air may damage the capsules.

Store ENTOCORT at room temperature (15-30⁰C) and in a dry place. Keep the bottle closed tightly.

Keep out of sight and reach of children.

If you want more information about ENTOCORT:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1-855-831-5420.

Importer/Distributor:

C.R.I.

Burlington, ON, L7N 3G2

Last Revised MAR-09-2023