Consumer Information for: URSODIOL C

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


PATIENT MEDICATION INFORMATION

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PrURSODIOL C

Ursodiol Tablets

Read this carefully before you start taking URSODIOL C and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about URSODIOL C.

What is URSODIOL C used for:

URSODIOL C is used to manage cholestatic liver disease.

How does URSODIOL C work?

URSODIOL C contains ursodiol (ER-so-DYE-all), which is a naturally occurring bile acid found in small quantities in normal human bile.

Cholestatic liver disease is caused when the release and flow of bile through the bile ducts from your liver are reduced. By taking URSODIOL C 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.

What are the ingredients in URSODIOL C?

Medicinal ingredients: Ursodiol

Non-medicinal ingredients: URSODIOL C contains the following excipients: Magnesium Stearate, Microcrystalline Cellulose, Opadry Clear (contains Hydroxypropyl Methylcellulose and Polyethylene Glycol), Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, and Sodium Starch Glycolate.

URSODIOL C comes in the following dosage forms:

Tablets: 250 mg and 500 mg

Do not use URSODIOL C if you:

 

  • have an allergy to ursodiol or to any ingredient in the formulation.

  • have a blockage of bile flow due to widespread liver disease.

  • have a complete blockage of bile flow due to disease outside of the liver.

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

  • have taken URSODIOL C before and it was not well-tolerated or caused an allergy.

  • have liver problems, or are in need of a liver transplant.

  • have a partial blockage of bile flow due to disease outside of the liver.

  • have variceal bleeding (bleeding from swollen veins, arteries, or lymph vessels).

  • have ascites (swelling in the abdomen).

  • are pregnant, plan to become pregnant, are breast-feeding or plan to breast-feed.

  • need other medical treatment by another healthcare professional, let him or her know that you are taking URSODIOL C.

Other warnings you should know about:

Laboratory tests: Your healthcare professional may do certain tests during your treatment. These include liver function tests and bilirubin levels every month for three months after start of treatment, and every six months thereafter.

Bezoars in Patients with a Risk for Blockage in the Gut (intestine): A bezoar is where material builds up in the stomach or gut, causing a blockage. This can cause symptoms such as nausea, vomiting, and pain in the belly area. Bezoars may cause a blockage that requires surgery. This very rare side effect happened in patients who were taking ursodiol and had medical conditions that caused stomach or gut blockage (such as previous gut surgery or Crohn’s disease).

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 URSODIOL C:

  • Medicines that reduce the amount of bile acids such as cholestyramine or colestipol

  • Antacids that contain aluminum

  • Cyclosporine

  • Dapsone

  • Nitrendipine

How to take URSODIOL C:

Take URSODIOL C for the full duration of treatment, even if you begin to feel better.

This medication should only be used as instructed by your healthcare professional. Follow your healthcare professional’s instructions. Do not change the dose or stop the treatment without your healthcare professional‘s advice.

Usual dose:

Your healthcare professional would have prescribed the amount of URSODIOL C you should take each day for your medical condition. URSODIOL C 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.

Overdose:

The most severe symptom of overdosage would likely be diarrhea.

If you think you, or a person you are caring for, have taken too much URSODIOL C, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no 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.

What are possible side effects from using URSODIOL C?

These are not all the possible side effects you may have when taking URSODIOL C. If you experience any side effects not listed here, tell your healthcare professional. Side effects include:

  • Dizziness

  • Headache

  • Indigestion

  • Itchiness

  • Swelling of the extremities

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

Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness

  

✓

  

Blood glucose increased

  

✓

  

RARE

Intestinal blockage or obstruction (blockage that stops or impairs passage of contents of intestines): cramping pain in abdomen that may begin suddenly, bloating, loss of appetite, pain that comes and goes but will then last, nausea and vomiting, constipation or diarrhea

    

✓

UNKNOWN

Swelling beneath the skin and Swelling of the throat

    

✓

Palpitations: fast-beating, fluttering or pounding heart

✓

    

Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing.

  

✓

  

Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat.

    

✓

Neutropenia (decreased number of certain white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms

  

✓

  

Interstitial lung disease: shortness of breath at rest, dry cough

    

✓

Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness

  

✓

  

Skin Reactions: Severe inflammation and peeling of the skin, skin redness and papular skin lesions (small solid bumps on skin), or sensitivity to Light

    

✓

New or worsening Jaundice: yellow appearance of the skin and white portion of the eyes

    

✓

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:

  • Visiting the Web page on Adverse Reaction Reporting

(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

  • Calling toll-free at 1-866-234-2345.

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:

URSODIOL C Tablets should be stored between 15°C and 30°C in a closed container.

Keep out of reach and sight of children.

If you want more information about URSODIOL C:

This leaflet was prepared by

Sanis Health Inc.

1 President's Choice Circle

Brampton, Ontario

L6Y 5S5

Last revised: NOV 21, 2023

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