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Details for: PMS-URSODIOL C

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02273497PMS-URSODIOL CURSODIOL250 MGTABLETORAL
02273500PMS-URSODIOL CURSODIOL500 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

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

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

Do not take pms-UROSODIOL 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.
What the medicinal ingredient is

Ursodiol

What the non-medicinal ingredients are

pms-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.

What dosage form it comes in

Tablets: 250 mg and 500 mg

Warnings and precautions

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

  • You have taken pms-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 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, 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 pms-URSODIOL C.

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

You should discuss with your doctor the benefits and risks of taking pms-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

Use of these medicines with pms-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 pms-URSODIOL C you should take each day for your medical condition. pmsURSODIOL 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 pms-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

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
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    
Dermatitis exfoliative    
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 pms-URSODIOL C, contact your doctor or pharmacist.

How to store

pms-URSODIOL C Tablets should be stored between 15°C and 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 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.

More information

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

This leaflet was prepared by
Pharmascience Inc.
Montreal Quebec
H4P 2T4

Last revised: August 24, 2017

Date modified: