Cortiment: Uses, Side Effects and Dosage

What is CORTIMENT used for?

CORTIMENT is used in adults for the treatment of mild to moderate ulcerative colitis, an inflammation of the large intestine (colon) and the rectum.

How does CORTIMENT work?

CORTIMENT is believed to reduce substances which inflame body tissues. This helps decrease symptoms of ulcerative colitis such as pain and diarrhea.

What are the ingredients in CORTIMENT?

Medicinal ingredients: The medicinal ingredient is budesonide. Each tablet contains 9 mg budesonide.

Non-medicinal ingredients: The non-medicinal ingredients are: stearic acid, lecithin (derived from soya oil), microcrystalline cellulose, hydroxypropylcellulose, lactose monohydrate, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethylcitrate, and titanium dioxide.

CORTIMENT comes in the following dosage forms:

CORTIMENT, 9 mg tablets are white to off white, round, double convex tablets with a film coating and “MX9” engraved on one side of the tablet. They come in blister packs with aluminium press-through foil in a cardboard carton.

Do not use CORTIMENT if:

• you are allergic to budesonide or any of the ingredients in CORTIMENT.
• you are allergic to peanut or soya. CORTIMENT contains lecithin which is a derivate from soya oil.
• you have an infection.
• you have tuberculosis.

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

• have ever had liver or kidney problems.
• are about to have an operation.
• have chicken pox or measles or are at risk for chicken pox or measles.
• have an infection.
• or a family member has have or ever had history of diabetes.
• have or had tuberculosis .
• have ever had high blood pressure .
• have brittle bones.
• have ever had stomach ulcers.
• have any other medical condition.

• are pregnant or plan to become pregnant. It is not known if CORTIMENT tablets can harm your unborn baby.

• are breastfeeding or plan to beast-feed. CORTIMENT can pass into breast milk and may harm your baby. You and your healthcare provider should decide if you will take CORTIMENT or breastfeed. You do not do both.
• are on other steroid therapy.
• or a family member has a history of mental health problems

CORTIMENT is not recommended for use in children.

Other warnings you should know about:

Do not eat grapefruit or drink grapefruit juice while taking CORTIMENT. These can increase the levels of CORTIMENT in your blood and affect the way the medicine works.

CORTIMENT may affect certain medical test results. Tell your doctor that you are taking CORTIMENT when receiving a test for adrenal insufficiency.

Talk to your doctor if you develop problems with your vision. CORTIMENT may cause clouding of the lens of your eye (cataracts) or increase pressure in the eye (glaucoma).

CORTIMENT contains lactose monohydrate, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

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

It is particularly important that you tell your doctor if you are taking, have recently taken or might take one of the following medicines:

• ketoconazole or itraconazole, which are substances used to treat fungal infections;
• medicines used for HIV treatment (e.g. ritonavir, nelfinavir, cobicistat-containing products);
• carbamazepine, which is used for treatment of epilepsy;
• cardiac glycosides and diuretics;
• medicines that contain oestrogens, such as hormone replacement therapy (HRT) and some oral contraceptives;

• cholestyramine, which is used to lower cholesterol levels or treat itching caused by liver problems, or antacids which are used to neutralize the acid made by your stomach.

  • No drug interaction studies have been done for CORTIMENT.

The following may interact with CORTIMENT:

• steroids, such as prednisolone or dexamethasone.
• cholestyramine, used to lower cholesterol levels or reduce itching caused by liver problems, antacids. Therefore these drugs should be taken two hours before or after CORTIMENT.
• ketoconazole or itraconazole, used to treat fungal infections.
• medicines that contain estrogens, such as hormone replacement therapy (HRT) and some oral contraceptives.
• cardiac glycosides and diuretics.
• HIV protease inhibitors such as ritonavir and nelfinavir.
• carbamazepine, used to treat epilepsy.
• erythromycin, which is an antibiotic.

How to take CORTIMENT:

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

• The recommended dose is one tablet in the morning preferably after breakfast.
• Swallow the tablet whole with a glass of water. The tablet must not be broken, crushed or chewed.
• Usually you will take this medicine daily for a maximum of eight weeks.
• Keep taking CORTIMENT tablets as your doctor has told you, even if you start feeling better.

Usual adult dose:

One 9 mg tablet once daily in the morning preferably after breakfast, for up to eight weeks.

Overdose:

If you take more CORTIMENT tablets than you should, inform your doctor immediately.

Missed Dose:

If you forget to take CORTIMENT tablet, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double dose to make up for the forgotten tablet.

What are possible side effects from using CORTIMENT?

These are not all the possible side effects you may feel when taking CORTIMENT. If you experience any side effects not listed here, contact your healthcare professional.

The following side effects may happen with this medicine:

• feeling sick.
• abdominal pain.
• bloated stomach.
• dry mouth,
• headache.
• Insomnia.
• muscle pain or cramps.
• upset stomach
• Cushing-like symptoms, such as a round face, acne, weight gain and a tendency to bruise easily
• Low potassium levels in the blood, which can cause muscle weakness or fatigue, thirst or a tingling sensation
• Depression
• Pounding heart beats (palpitations)
• Indigestion (dyspepsia)
• Skin rash or itchiness
• Heavy or irregular menstruation in women
• Back pain

Medicines like CORTIMENT (corticosteroids) may affect the normal production of steroid hormones in your body. The effects include:

• changes to bone mineral density (thinning of the bones).
• glaucoma (increase pressure in the eye pressure).out
• effects on the adrenal gland (small gland near the kidney).

CORTIMENT may lower your ability to fight infections and you should:

• avoid contact with people who have chicken pox or measles.

• contact your doctor if you have signs of infection such as:

  • fever.
  • pain.
  • ache, chills, feeling tired.
  • nausea, vomiting.

Using corticosteroid for a long time reduces your ability to handle stress. Before having an operation or emergency, contact your doctor if you are under stress and have symptoms such as:

• tiredness, weakness, feeling faint.
• Nausea, vomiting.

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Using a corticosteroid may cause you to have too much steroid in your blood (hypercorticism). Talk to your doctor if you have symptoms of too much medicine such as:

• rounded face (moon face).
• fatty pad between your shoulders (buffalo hump).
• acne, bruise easily, ankle swelling.
• more or thicker hair on the body and face.

Mental health problems may occur when taking steroids like CORTIMENT. This happens rarely when high doses are taken for a long time. Talk to a doctor if you or someone you know develops mental problems, especially depression or thoughts of self-harm (suicide) when taking CORTIMENT.

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at controlled room temperature 15-30°C.

Keep out of reach and sight of children.

If you want more information about CORTIMENT

• 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; or by calling the manufacturer phone number 1- 866 – 384-1314.

Last Revised May 23, 2018