Details for: URSO
Company: APTALIS PHARMA CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02238984 | URSO | URSODIOL | 250 MG | TABLET | ORAL |
| 02245894 | URSO DS | URSODIOL | 500 MG | TABLET | ORAL |
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
URSO® or URSO DS® has been prescribed for you by your physician for the management of cholestatic liver disease.
URSO® and URSO DS® are only available by prescription.
What it does
URSO® and URSO DS® contain ursodiol (ER-so-DYE-all), which is a naturally occurring bile acid found in small quantities in normal human bile.
In patients with cholestatic liver disease the release and flow of bile through the bile ducts are reduced. By taking URSO® or URSO DS® the amount of ursodiol in the bile increases, changing the make-up of the bile and causing an increase in bile flow. Ursodiol also works by replacing toxic bile acids that can destroy liver tissue.
When it should not be used
Do not take URSO® or URSO DS® if you:
- have an allergy to ursodiol or to any ingredient in the formulation.
- have blockage of bile flow due to widespread liver disease.
- have complete blockage of bile flow due to disease outside of the liver.
What the medicinal ingredient is
ursodiol
What the non-medicinal ingredients are
URSO® and URSO DS® contain the following excipients: carnauba wax, dibutyl sebacate, ethylcellulose aqueous (cetyl alcohol, ethylcellulose, hydrogen peroxide, sodium lauryl sulfate), hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and sodium starch glycolate.
What dosage form it comes in
250 mg tablet
URSO® (ursodiol) is available as 250 mg white, elliptical, biconvex, film-coated tablets, engraved with “URS785". Each bottle contains 100 tablets.
500 mg tablet
URSO DS® (ursodiol) is available as 500 mg white, elliptical, biconvex, scored, film-coated tablets, engraved with “URS790". Each bottle contains 100 tablets.
Warnings and precautions
Before you take URSO® or URSO DS®, tell your doctor if:
- You have taken URSO® or URSO DS® before and it was not well-tolerated or caused an allergy.
- You have liver problems, or are in need of a liver transplant.
- You have a partial blockage of bile flow due to disease outside of the liver.
- You have variceal bleeding (bleeding from swollen veins, arteries, or lymph vessels).
- You have ascites (swelling in the abdomen).
- You are taking other prescription or non-prescription medicines.
- You are using any new medicine (prescription or non-prescription) such as bile reduction medicines (cholestyramine or colestipol), aluminum based antacids (Rolaids, Maalox, Mylanta, and many others), and cyclosporine, nitrendipine, or dapsone.
- You develop any new medical problem while using this medicine.
- You have severe stomach pain.
- You are pregnant, plan to become pregnant, are breast-feeding or plan to breast-feed.
- You need other medical treatment by another doctor, let him or her know that you are taking URSO® or URSO DS®.
URSO® and URSO DS® are not recommended for use in children.
You should discuss with your doctor the benefits and risks of taking URSO® and URSO DS® for your medical condition.
This medication is prescribed for a particular health problem and for your personal use only. Do not give it to another person.
Keep this and all other medicines out of the reach of children.
Interactions with this medication
The following medicines may decrease the amount of ursodiol that is absorbed into your body:
- Medicines that reduce the amount of bile acids such as cholestyramine or colestipol
- Antacids that contain aluminum such as Rolaids, Maalox, Mylanta, and many others.
The absorption and metabolism of the following medicines may be affected by taking ursodiol:
- Cyclosporine
- Dapsone
- Nitrendipine
Use of these medicines with URSO® or URSO DS® may require patients to be closely monitored and the dose of their medicines adjusted.
Proper use of this medication
Usual Adult Dose
Your doctor would have prescribed the amount of URSO® or URSO DS® you should take each day for your medical condition. URSO® and URSO DS® should be taken in 2 to 4 divided doses with food. It is easier to remember to take your medication if it is taken at the same time each day. Setting up a routine to take your medication helps this activity become a normal part of your day.
Take URSO® and URSO DS® for the full duration of treatment, even if you begin to feel better.
To break URSO DS® scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be swallowed unchewed, with water.
To prevent leakage of the active medicinal ingredient (ursodiol) from the cut tablets onto the surface of whole tablets and spreading the bitter taste, it is recommended that cut tablets be stored separately from whole tablets.
This medication should only be used as instructed by your doctor. Follow your doctor’s instructions. Do not change the dose or stop the treatment without your doctor’s advice.
Your doctor will ask you to have regular medical checkups, and will likely require liver tests. It is important to respect the dates proposed.
Overdose
The most severe symptom of overdosage would likely be diarrhea.
Missed Dose
If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take your next regularly scheduled dose. Do not take a double dose.
Side effects and what to do about them
| 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 talk with your doctor or pharmacist |
|---|---|---|---|
| Common >1% and <10% | |||
| Anemia | ✔ | ||
| Dizziness | ✔ | ||
| Reduced white blood cells in the blood | ✔ | ||
| Headache | ✔ | ||
| Diarrhea | ✔ | ||
| Swelling of the extremities | ✔ | ||
| Blood glucose increased | ✔ | ||
| Abdominal pain | ✔ | ||
| Unknown | |||
| Swelling beneath the skin and Swelling of the throat | ✔ | ||
| Palpitation | ✔ | ||
| Cough | ✔ | ||
| Increase in eosinophils in the blood | ✔ | ||
| Drug hypersensitivity to include facial edema | ✔ | ||
| Decreased blood neutrophils | ✔ | ||
| Interstitial lung disease | ✔ | ||
| Decreased blood platelets | ✔ | ||
| Severe inflammation and peeling of the skin | ✔ | ||
| Constipation | ✔ | ||
| Skin redness and Papular skin lesion | ✔ | ||
| Fever | ✔ | ||
| Photosensitivity reaction | ✔ | ||
| Aggravation or occurrence of Jaundice | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking URSO® or URSO DS ®, contact your doctor or pharmacist.
How to store
URSO® and URSO DS® tablets should be stored at room temperature at 15°C to 30°C in a closed container.
Keep this and all other medication out of the reach 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 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 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
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.aptalispharma.com, or by contacting the sponsor, Aptalis Pharma Canada Inc. at:
1-800-565-3255
This leaflet was prepared by Aptalis Pharma Canada Inc.
URSO® and URSO DS® are registered trademarks of Aptalis Pharma Canada Inc.
Last revised: August 18, 2014