Details for: CORTIMENT
Company: FERRING INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02455889 | CORTIMENT | BUDESONIDE | 9 MG | TABLET (DELAYED AND EXTENDED RELEASE) | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is 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.
What it does
CORTIMENT is believed to reduce substances which inflame body tissues. This helps decrease symptoms of ulcerative colitis such as pain and diarrhea.
When it should not be used
- 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.
What the medicinal ingredient is
The medicinal ingredient is budesonide. Each tablet contains 9 mg budesonide.
What the non-medicinal ingredients are
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.
What dosage form it comes in
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.
Warnings and precautions
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 liver or kidney problems.
- are about to have an operation.
- have chicken pox or measles or have recently have been near anyone with chicken pox.
- have an infection.
- have or had history of diabetes.
- have or had cataracts or increased pressure in the eye (glaucoma).
- have or had tuberculosis .
- have high blood pressure .
- have brittle bone.
- have 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.
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.
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.
- No drug interaction studies have been done for CORTIMENT.
Interactions with this medication
- 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.
Proper use of this medication
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.
Side effects and what to do about them
Like all medicine, this medicine can cause side effects although not everybody gets them.
This medication usually has fewer side effects than other corticosteroid because CORTIMENT works in the gut and only small amount are absorbed into the body.
If you have an allergic reaction, see a doctor right away. Signs may include hives, swelling of the face, lips, mouth, tongue and throat. This can make it difficult to breathe.
The following side effects may happen with this medicine. Common side effects that may affect up to 1 in 10 people include:
- feeling sick.
- abdominal pain.
- bloated stomach.
- dry mouth,
- headache.
- feeling tired.
- Insomnia.
- muscle pain.
- upset stomach.
Other side effects include: dizziness, back pain, and muscle cramps.
If these side effects become bothersome, contact your doctor.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.
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).
- 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.
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.
If you take other steroid medicines for allergies, switching to CORTIMENT may cause these allergies to come back. Contact your doctor if any allergies get worse.
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| COMMON | |||
| Reduced blood cortisol | ✔ | ||
| UNCOMMON | |||
| Dizziness | ✔ | ||
| Influenza | ✔ | ||
| Swelling in your legs | ✔ | ||
| Elevated white blood cell count | ✔ | ||
| Excessive stomach or intestinal gas | ✔ | ||
| Change in behavior, such as nervousness or mood swings | ✔ | ||
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.
How to store
Store at controlled room temperature 15-30°C.
Keep out of reach and sight of children.
Reporting 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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
- 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.
This leaflet was prepared by Ferring Inc.
Last Revised June 17, 2016