What Entocort Capsules is used for and how to use it
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Entocort Capsules - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Crohn's Disease, Maintenance, Crohn's Disease, Acute, Crohn's Disease, Inflammatory Bowel Disease
Class: Glucocorticoids
Form: Capsules
Ingredients: budesonide, acetyltributyl citrate, dimethicone (Antifoam M), ethylcellulose, gelatin, iron oxide, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulphate, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethylcitrate

About this Medication

What the medication is used for:

ENTOCORT Capsules are used to treat Crohn’s disease, an inflammatory bowel disease, in the small bowel and the first part of the large bowel. ENTOCORT Capsules reduce the inflammation and related symptoms of this disease, such as stomach pain and diarrhea.

What it does:

ENTOCORT is an anti-inflammatory drug which belongs to the steroid family of drugs. ENTOCORT Capsules have been shown to help reduce the production of substances and interfere with the processes responsible for the inflammatory response, thereby reducing the inflammation and improving related symptoms.

When it should not be used:

Do not use ENTOCORT Capsules (budesonide) if you:

  • have any infection(s) in the rest of the body
  • have tuberculosis
  • are allergic to any of the ingredients in ENTOCORT Capsules (see What the medicinal ingredient is and What the nonmedicinal ingredients are).

What the medicinal ingredient is:

budesonide

What the nonmedicinal ingredients are:

The nonmedicinal ingredients are: acetyltributyl citrate, dimethicone (Antifoam M), ethylcellulose, gelatin, iron oxide, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulphate, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethylcitrate.

What dosage forms it comes in:

Capsules 3 mg Each capsule is filled with a large number of small grains. When swallowed, the medicine passes through the stomach intact, and is gradually released in the small bowel.

Warnings and Precautions

BEFORE you use ENTOCORT Capsules, talk to your doctor or pharmacist if:

  • you have any health problems such as liver disease, brittle bones (osteoporosis), stomach ulcer, high blood pressure, cataracts or any other eye diseases, diabetes or a family history of diabetes or glaucoma
  • you are about to have or plan to have any operation
  • 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 Capsules (budesonide) is excreted in human breast milk. Talk to your doctor.

Avoid exposure to chicken pox and measles.

Regular ingestion of grapefruit or its juice should be avoided during treatment with ENTOCORT Capsules, since intake of grapefruit can increase the amount of budesonide that is absorbed from the gut (other fruits such as orange or apple do not influence the uptake of budesonide).

Do not stop using ENTOCORT Capsules until your doctor tells you to.

Tell your doctor if your symptoms become worse while you are using ENTOCORT Capsules.

ENTOCORT Capsules have 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.

Interactions with this Medication

Tell your doctor about all the medications you are taking, including ones you can buy without a prescription.

Drugs that may interact with ENTOCORT Capsules include:

  • estrogens and oral contraceptives
  • ketoconazole, fluconazole, itraconazole, miconazole
  • cyclosporin
  • erythromycin, troleandomycin

Proper use of this Medication

Take all doses of ENTOCORT Capsules, as recommended by your doctor, even if you feel better. The full effect of ENTOCORT Capsules is usually achieved within 2-4 weeks.

ENTOCORT Capsules should be swallowed whole with water. It is important that the contents of the capsules are not crushed or chewed. ENTOCORT Capsules should be taken before meals.

Usual adult dose:

Acute Treatment

The usual dose for treatment of acute symptoms is 9 mg per day, for up to 8 weeks. The dose can be given once daily as three 3 mg capsules in the morning.

Long Term Treatment

The usual starting dose for long-term treatment is 6 mg per day. Take two 3 mg capsules in the morning, before breakfast. Your doctor may want to change the dose, depending on the activity of your disease.

Do not stop taking ENTOCORT Capsules on your own. Your doctor may want to slowly reduce your dose, especially if you have been using ENTOCORT Capsules for a long time.

Note: If your medication has been changed from “cortisone” tablets (such as prednisone, prednisolone or methylprednisolone) to ENTOCORT Capsules 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.

Missed Dose:

If you miss a dose, just take the next dose on time. Never take a double dose of ENTOCORT capsules to make up for missed doses.

Overdose:

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.

Side Effects and what to do about them

ENTOCORT Capsules, like any medication, may cause side effects in some people.

Side effects that do occur are usually mild to moderate. However, be sure to tell your doctor if any of the following side effects bother you: swelling of the face; indigestion; menstrual problems; behavioural changes such as insomnia, mood swings and nervousness; muscle cramps; trembling; rapid or irregular heartbeats; blurred vision, itching and skin rash. Low potassium levels in the blood may also occur.

Although rare, symptoms of steroid withdrawal i.e. fatigue, muscle or joint aches may occur if ENTOCORT Capsules are stopped too quickly.

Serious Side Effects, how often they Happen and what to do about them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Very raresevere 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 Capsules, contact your doctor or pharmacist.

How to Store it

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

Store ENTOCORT Capsules at room temperature (15-30°C) and in a dry place. Do not keep them in the bathroom medicine cabinet or other warm, moist places. Do not use ENTOCORT Capsules after the expiry date marked on the package.

Remember to keep ENTOCORT Capsules well out of the reach and sight 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
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

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.

More Information

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

The most current information, the Consumer Information Leaflet, plus the full Product Monograph, prepared for health professionals can be found at: www.astrazeneca.ca or by contacting the sponsor, AstraZeneca Canada Inc., at: Customer Inquiries – 1 (800) 668-6000, Renseignements 1-800-461-3787.