Entocort Enema - Consumer Medicine Information
|Form:||Liquid solution, Rectal, Tablets|
|Ingredients:||budesonide, colloidal silicon dioxide, lactose, magnesium stearate, methyl paraben, polyvidone, propyl paraben, riboflavin-5 phosphate sodium, water|
About this Medication
What the medication is used for
ENTOCORT Enema is used to treat ulcerative colitis (inflammation of the bowel wall) localised in the rectum and the lower large bowel.
What it does
ENTOCORT is an anti-inflammatory drug which belongs to the steroid family of drugs. ENTOCORT Enema has been shown to help reduce the production of substances and interfere with the processes responsible for the inflammatory response, thereby reducing the inflammation.
When it should not be used
Do not use ENTOCORT Enema (budesonide) if you:
- have holes in your bowel (perforations) , bowel obstructions, twisted and /or tubular bowel sections (fistulas), wounds, abscesses or infections in the bowel
- have any infection(s) in the rest of the body
- have tuberculosis
- are allergic to any of the ingredients in ENTOCORT Enema (see What the medicinal ingredient is and What the nonmedicinal ingredients are).
What the medicinal ingredient is
What the nonmedicinal ingredients are
The nonmedicinal ingredients of the final solution are: colloidal silicon dioxide, lactose, magnesium stearate, methyl paraben, polyvidone, propyl paraben, riboflavin-5 phosphate sodium, water.
What dosage form it comes in
Dispersible Tablet 2.3 mg and Solution 115 mL. Enema 0.02 mg/mL budesonide, when reconstituted.
Warnings and Precautions
BEFORE you use ENTOCORT Enema, talk to your doctor or pharmacist if:
- you have any health problems such as liver disease, diabetes, stomach ulcers, brittle bones (osteoporosis) or glaucoma
- you are taking or have taken steroid medicines within the past several months
- you are pregnant or plan to become pregnant
- you are breastfeeding or planning to breastfeed. ENTOCORT Enema (budesonide) is excreted in human breast milk. Talk to your doctor.
Do not stop using ENTOCORT Enema until your doctor tells you to.
If your symptoms become worse during treatment contact your doctor.
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.
There is limited information available about the use of ENTOCORT Enema in children.
Interactions with this Medication
Tell your doctor about all the medications you are taking, including ones you have bought without a prescription.
Drugs that may interact with ENTOCORT Enema include:
- estrogens and oral contraceptives
- ketoconazole, fluconazole, itraconazole, miconazole
- erythromycin, troleandomycin
Proper Use of this Medication
Usual Adult Dose
The dosage is individual. Follow your doctor’s directions carefully. They may differ from the information in this leaflet.
Before using this, or any other enema with rigid tubing, colostomy and ileostomy patients should consult with their doctor.
The budesonide enema should be administered in the evening before going to bed.
Note: If your medication has been changed from “cortisone” tablets (such as prednisone, prednisolone or methylprednisolone) to ENTOCORT Enema, you may temporarily experience symptoms, that may have bothered you when you first started taking “cortisone”, e.g. 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.
Do not forget to take ENTOCORT Enema even if you start feeling better.
The budesonide enema (0.02 mg/mL) consists of a dispersible tablet (1) and solution (2)
- 1 dispersible tablet contains: Budesonide 2.3 mg, lactose, colour (riboflavin-5-phosphate sodium), and constituents.
- 1 bottle (115 mL) of solution contains: Sodium chloride, preservatives (methylparaben and propylparaben) and purified water.
How To Prepare The Enema
|1. Remove the nozzle, with the protective cap on, from the bottle.|
|2. Take a tablet from the aluminum foil pack and put it into the bottle. DO NOT SWALLOW THE TABLET.|
|3. Put the nozzle back on the bottle and make sure that the protective cap is firmly on. Shake the bottle vigorously for at least 10 seconds or until the tablet has dissolved and a slightly yellowish liquid has been formed. The final volume is about 115 mL.|
|4. A plastic bag has been enclosed which you may use to protect your hand when you administer the enema. |
Put your hand inside the plastic bag and grip the bottle.
|5. Lie down on your left side. Shake the bottle again before removing the protective cap. Gently insert the nozzle into your rectum and empty the contents of the bottle.|
|6. Take the nozzle out of your rectum. After use, remove the plastic bag from your hand by pulling it over the bottle.|
|7. Roll over on your stomach. Stay in this position for 5 minutes.|
|8. Choose a suitable position to sleep in. Try to retain the enema as long as possible, preferably for the whole night.|
NB: After preparation, the budesonide enema is intended for immediate use.
If you forget to take an occasional dose of ENTOCORT Enema it is not necessary to make up the missed dose. Just continue with the next dose as prescribed.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Do not use ENTOCORT Enema more often or over a longer period than your doctor has prescribed. If by accident you take more ENTOCORT than prescribed on a single occasion no harmful effects should occur. If too much ENTOCORT is used over a longer period (months or more) it is possible that side effects may arise, see “Side Effects and What To Do About Them”. If you think that this may have happened to you, please discuss it with your doctor.
Side Effects and what to do about them
Side effects that you may get while you are using ENTOCORT Enema are usually mild. However, be sure to tell your doctor if any of the following side effects bother you.
Common side effects that may occur are indigestion (e.g. gas in stomach or bowels), nausea, diarrhea, skin rash and/or itching.
Uncommon side effects that may occur are agitation and sleeplessness.
Serious Side Effects, how often they Happen and what to do about them
|Symptom / Effect||Talk with your|
drug and call
your doctor or
|Very rare||severe allergic reactions with symptoms such as rash, swelling of tissues, and/or difficulties in breathing.||✓|
This is not a complete list of side effects. For any unexpected effects while taking ENTOCORT Enema, contact your doctor or pharmacist.
How to Store it
Store the tablets and the liquid 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.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.
For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at:
or by contacting the sponsor, AstraZeneca Canada Inc. at:
Customer Inquiries – 1 (800) 668-6000,
Renseignements – 1 (800) 461-3787.