Patient Medication Information: uses, side effects, how to take - Budesonide
What is BUDESONIDE used for?
BUDESONIDE is used to treat:
- A condition called Crohn’s disease. It is used to treat mild to moderate Crohn’s disease that involves the small bowel and the first part of the large bowel.
How does BUDESONIDE work?
BUDESONIDE is an anti-inflammatory drug which belongs to the steroid family of drugs. BUDESONIDE has been shown to help reduce local inflammation.
BUDESONIDE acts to
- block the production of substances that cause inflammation
- restricts the processes that cause inflammation
What are the ingredients in BUDESONIDE?
Medicinal ingredients: budesonide
Non-medicinal ingredients: acetyltributyl citrate, ethyl cellulose, gelatin, iron oxide, methacrylic acid copolymer, polysorbate 80, silicon dioxide, simethicone (Antifoam M), sodium lauryl sulphate, sugar spheres (sucrose and maize starch), talc, titanium dioxide and triethyl citrate.
BUDESONIDE comes in the following dosage form:
As capsules containing 3 mg budesonide.
Do not use BUDESONIDE if:
- you have any infection(s) in the rest of the body
- you have tuberculosis
- you are allergic to any of the ingredients in BUDESONIDE (see What are the ingredients in BUDESONIDE?)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BUDESONIDE. 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 BUDESONIDE.
- 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 BUDESONIDE can harm your unborn baby. Your doctor will decide whether giving you BUDESONIDE outweighs the potential risk to the unborn baby.
- are breastfeeding or planning to breastfeed. BUDESONIDE 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. BUDESONIDE 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. BUDESONIDE may worsen your glaucoma by increasing the pressure in your eyes.
- have diabetes. BUDESONIDE 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 BUDESONIDE can increase your risk of certain side effects, including:
- Eye problems: BUDESONIDE 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: BUDESONIDE 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 BUDESONIDE:
- BUDESONIDE may cause allergies (red itchy skin, runny and congested nose) that were previously controlled when using other steroid drugs.
- Taking BUDESONIDE 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 BUDESONIDE 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 BUDESONIDE. 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 BUDESONIDE. This is because it can change how BUDESONIDE 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 BUDESONIDE:
- 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 BUDESONIDE:
- Take BUDESONIDE exactly as your doctor has told you to.
- Swallow capsules whole with water. Do not crush or chew the capsules.
Take BUDESONIDE before a meal.
- Never stop taking BUDESONIDE on your own. Your doctor may want to slowly reduce your dose, especially if you have been using BUDESONIDE for a long time. Your doctor will tell you when to stop taking BUDESONIDE.
Usual Adult Dose:
Acute Treatment
- Three capsules once a day, in the morning.
- This treatment will last for up to 8 weeks.
Long Term Treatment
- Two capsules once a day, in the morning.
- This treatment will last for up to 3 months.
- Your doctor may want to change the dose, depending on the activity of your disease.
Overdose:
| If you think you, or a person you are caring for, have taken too much BUDESONIDE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you missed a dose of BUDESONIDE, 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 BUDESONIDE?
These are not all the possible side effects you may have when taking BUDESONIDE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- muscle cramps
- rapid or irregular heartbeat
- upset stomach or gut or heartburn
- blood in stools
- body and joint ache and fatigue
- headache
- dizziness
- respiratory infection
- swelling in hands and legs
- shaking
- hyperactivity
- insomnia (trouble sleeping)
- skin discolouration resulting from bleeding under the skin
- rash
- red spots which burn, itch or sting
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Psychiatric and behavioural changes: feeling depressed, anxiety, mood swings and feelings of unease | ✓ | ||
Effects caused by steroids: heavy or irregular menstrual periods; Cushingoid features such as a rounded face, acne, weight gain and bruising more easily; low levels of potassium in the blood which may cause muscle weakness, thirst or ‘pins and needles’ feeling; slowing of the rate of growth in children and adolescents; changes in bone mineral density (thinning of the bones); glaucoma (eye disorder) | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Viral infections (such as chicken pox or measles): aches and pains, chills, fever, feeling tired, headache, nausea or vomiting, sore throat, rash, runny nose | ✓ | ||
| UNCOMMON | |||
| Unintentional movements or extreme restlessness possibly accompanied by muscle spasms or twitching | ✓ | ||
| Clouding of the eye’s natural lens including the back of the lens: blurred vision or other visual problems | ✓ | ||
| VERY RARE | |||
| Severe allergic reactions: rash, swelling of the face, lips, tongue or throat, difficulties in breathing | ✓ | ||
| UNKNOWN | |||
| Hypersensitivity reaction: allergic reaction which can cause swelling of the face, particularly eyelids, lips, tongue or throat (angioedema) | ✓ | ||
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
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
BUDESONIDE comes in a container with a drying agent fitted in the cap. Always keep BUDESONIDE capsules in the container. If you don’t, moisture from the air may damage the capsules.
Store BUDESONIDE at room temperature (15-30⁰C) and in a dry place. Keep the bottle closed tightly.
Keep out of sight and reach of children.
If you want more information about BUDESONIDE:
- 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