Details for: PMS-URSODIOL C
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02273497 | PMS-URSODIOL C | URSODIOL | 250 MG | TABLET | ORAL |
| 02273500 | PMS-URSODIOL C | 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
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.
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 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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect‐canada/adversereaction-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.
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