Entocort Enema: Uses, Side Effects and Dosage

What is ENTOCORT ENEMA used for?

ENTOCORT ENEMA is used to treat inflammation and ulcers in the

• large intestine (colon) and
• rectum

ENTOCORT ENEMA is not for use in children under the age of 18.

How does ENTOCORT ENEMA work?

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

ENTOCORT ENEMA acts to

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

What are the ingredients in ENTOCORT ENEMA?

Dispersible Tablets:

Medicinal ingredient: budesonide

Non-medicinal ingredients: crospovidone, lactose, lactose anhydrous, magnesium stearate, riboflavin-5-phosphate sodium, silicon dioxide

Vehicle (Solution):

Non-medicinal ingredients: methylparaben, propylparaben, sodium chloride, water purified

ENTOCORT ENEMA comes in the following dosage form:

Dispersible Tablet 2.3 mg and Solution 115 mL.

Enema contains 0.02 mg/mL budesonide, when reconstituted (mixed).

Do not use ENTOCORT ENEMA if:

• you have the following bowel problems

  • holes in bowel
  • blockage of bowel
  • recent surgical procedure to repair bowel separation
  • twisted and /or tubular bowel sections (fistulas)
  • wounds, abscesses or infections in the bowel
• you have any infection(s) in the rest of the body
• you have tuberculosis
• you are allergic to budesonide or any of the ingredients in ENTOCORT ENEMA

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ENTOCORT ENEMA. 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 ENEMA.
  • 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 ENEMA can harm your unborn baby. Your doctor will decide whether giving you ENTOCORT ENEMA outweighs the potential risk to the unborn baby.

• are breastfeeding or planning to breastfeed. ENTOCORT ENEMA 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 ENEMA 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 ENEMA may worsen your glaucoma by increasing the pressure in your eyes.
• have diabetes. ENTOCORT ENEMA 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 ENEMA can increase your risk of certain side effects, including:

• Eye problems: ENTOCORT ENEMA 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 ENEMA 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 ENEMA:

• ENTOCORT ENEMA may cause allergies (red itchy skin, runny and congested nose) that were previously controlled when using other steroid drugs.
• Taking ENTOCORT ENEMA 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 ENEMA 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 ENEMA. 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 ENEMA. This is because it can change how ENTOCORT ENEMA 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 ENEMA:

• 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 ENEMA:

• Do not stop using ENTOCORT ENEMA even if you feel better. Your doctor will tell you when to stop taking ENTOCORT ENEMA.
• ENTOCORT ENEMA has been specifically prescribed for your current condition. Do not use it for other problems unless your doctor tells you to do so.
• Never give your medicine to someone else.
• Before using this, or any other enema with rigid tubing, colostomy and ileostomy patients should consult with their doctor.
• Follow your doctor’s directions carefully. They may differ from the information in this leaflet.
• ENTOCORT ENEMA is a ‘retention enema’. This means that the solution is meant to be held in the rectum for as long as possible. The longer it is kept there the more time it has to work and the better the results should be.

Usual Adult Dose:

• Administer once a day in the evening before going to bed.
• Normally, your treatment will last for 4 weeks. Your doctor may extend the treatment to 8 weeks.

The contents of the ENTOCORT ENEMA kit include (Figure 1):

Figure 1

• 7 dispersible tablets wrapped in foil, inside a small box
• 7 plastic bottles containing 115 mL solution
• 7 nozzles (applicator enema)
• 7 plastic bags to be used when giving the enema

How To Prepare ENTOCORT ENEMA for use

1. 1. Unscrew the cap of one of the plastic bottles.
2. 2. Take one of the dispersible tablets from its foil strip. Drop the dispersible tablet into one bottle as shown below (Figure 2).

Figure 2

1. 3. Place the cap back onto the bottle. Screw the cap tightly by turning the cap clockwise as shown below (Figure 3).

Figure 3

1. 4. Shake the bottle well for at least 15 seconds as shown below (Figure 4), or until you cannot see the tablet in the solution any more. Solution should turn slightly yellowish.

Figure 4

1. 5. Unscrew the cap and remove the cap from the bottle.
2. 6. Unpack one nozzle from the pouch labelled ‘Applicator Enema’. Screw the nozzle on the bottle tightly by turning the nozzle clockwise as shown below (Figure 5).

Figure 5

1. 7. The enema is now ready and should be used immediately.

Inserting the enema into your rectum

Important Information:

• The nozzle can be lubricated with petroleum jelly if use is uncomfortable.
• You will find it more comfortable to use ENTOCORT ENEMA if you empty your bowels and bladder before using it.
• ENTOCORT ENEMA can stain your bedding. It is best to protect your bedding with a plastic sheet in case any of the solution is spilled.

To insert the enema into your rectum, follow the instructions below:

1. 1. Undress from the waist down, then lie down on your side. Choose whichever side is most comfortable. Try to lie down so that your bottom is slightly higher than the rest of your body. For example, you can raise the bottom of the bed onto blocks or place one or two pillows under your bottom. This will help to keep the solution in your rectum.
2. 2. If you wish, hold the bottle using one of the plastic bags as shown below (Figure 6). This use of the plastic bag is optional.

Figure 6

1. 3. Shake the bottle again.
2. 4. Gently ease the nozzle into your rectum as far as is comfortable.
3. 5. Squeeze the bottle, this will push most of the solution into your rectum. However, you will not be able to empty the whole bottle. It has been designed to keep some solution after being used.
4. 6. Then remove the nozzle from your rectum.
5. 7. If you used a plastic bag, remove it from your hand by pulling it forward over the bottle. This will leave the bottle inside the bag, ready to be disposed of as shown below (Figure 7).

Figure 7

1. 8. Roll over onto your stomach. Stay like this for 5 minutes to stop any solution coming out of your rectum.
2. 9. Find a comfortable position to sleep in that helps you to keep the solution in your rectum for as long as possible. The longer it is kept there the more time it has to work and the better the results should be.

Overdose:

Do not use ENTOCORT ENEMA more often or over a longer period than your doctor has prescribed. If by accident you take more ENTOCORT ENEMA than prescribed on a single occasion no harmful effects should occur. If too much ENTOCORT ENEMA is used over a longer period (months or more) it is possible that side effects may arise, see “Serious side effects and what to do about them”. If you think that this may have happened to you, contact your doctor immediately.

Missed Dose:

If you missed a dose of ENTOCORT ENEMA, 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 ENEMA?

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

The most common side effects of ENTOCORT ENEMA are:

• upset stomach or gut

  • gas in stomach or bowels
  • nausea
  • diarrhea

Other possible side effects of ENTOCORT ENEMA are:

• agitation
• insomnia or sleepiness

• skin discolouration

  • 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:

Store the tablets and the solution at room temperature (15-30°C). Do not prepare and use ENTOCORT ENEMA after the expiry date marked on the outer carton.

Always keep ENTOCORT ENEMA, including the plastic bags, in a safe place out of sight and reach of children.

If you want more information about ENTOCORT ENEMA:

• 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-31-2023