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

Manufacture: Actavis
Country: Canada
Condition: Biliary Cirrhosis, Gallbladder Disease
Class: Gallstone solubilizing agents
Form: Tablets
Ingredients: ursodiol, 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

About this medication

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 nonmedicinal 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 forms 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.

If you take more medication than you have been told to take, you should contact your doctor, hospital emergency department, or nearest poison control center immediately, even if you do not feel sick or you have no other symptoms.

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

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect Talk with your doctor or pharmacist Stop taking
drug and
call your
doctor or
pharmacist
Only
if
severe
In all
cases
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 Swellingof 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 it

URSO and URSO DS tablets should be stored at room temperature at 15oC to 30oC in a closed container.

Keep this and all other medication out of the reach 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 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