Pendo-Ursodiol C: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

pendo-URSODIOL C has been prescribed for you by your physician for the management of cholestatic liver disease.

pendo-URSODIOL C is only available by prescription.

What it does:

Ursodiol 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 pendo-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.

When it should not be used:

If you are allergic (hypersensitive) to ursodiol or to any of the non medicinal ingredients (see what the nonmedicinal ingredients are)

What the medicinal ingredient is:

Ursodiol

What the non-medicinal ingredients are:

hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate.

What dosage forms it comes in:

Tablets: 250 mg and 500 mg

WARNINGS AND PRECAUTIONS

BEFORE you use pendo-URSODIOL C tell your doctor if:

• You have taken pendo-URSODIOL C before and if it was not well-

  tolerated or caused an allergy.

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

• 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 pendo-URSODIOL C.

pendo-URSODIOL C is not recommended for use in children.

You should discuss with your doctor the benefits and risks of taking pendo-URSODIOL C 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 pendo-URSODIOL C 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 pendo-URSODIOL C you should take each day for your medical condition. pendo-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.

Take pendo-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 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.

In case of drug overdose, contact a health care practitioner, 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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

HOW TO STORE IT

pendo-URSODIOL C Tablets should be stored between 15EC and 30EC 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 MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Pendopharm, a division of Pharmascience Inc. at, 1-888-550-6060.

Pendopharm, a division of Pharmascience Inc.

Montreal Quebec

H4P 2T4

Last revised: July 30, 2014