Patient Medication Information: uses, side effects, how to take - Novo-Ursodiol
ABOUT THIS MEDICATION
What the medication is used for:
NOVO-URSODIOL has been prescribed for you by your physician for the management of cholestatic liver disease. NOVO-URSODIOL are only available by prescription.
What it does:
NOVO-URSODIOL 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 NOVO-URSODIOL 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 NOVO-URSODIOL, or any of the nonmedicinal ingredients (see list below).
What the medicinal ingredient is:
ursodiol (USP)
What the nonmedicinal ingredients are:
NOVO-URSODIOL contains the following excipients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulphate, sodium starch glycolate, hypromellose, Ethylcellulose, cetyl alcohol, dibutyl sebacate.
What dosage forms it comes in:
250 mg tablet
Novo-Ursodiol is available in strength of 250 mg as white to off-white, oval shaped, film coated tablet, debossed with “93” on one side of the tablet and with “5360” on the other side of the tablet. They are supplied in HDPE bottles containing 100 and 500 tablets and in unit dose of 100 tablets.
500 mg tablet
Novo-Ursodiol is available in strength of 500 mg as white to off-white, oval shaped, film coated tablet, debossed with “93” on one side of the tablet and with “5361” on the other side of the tablet. They are supplied in HDPE bottles containing 100 and 500 tablets and in unit dose of 100 tablets.
WARNINGS AND PRECAUTIONS
Before you take NOVO-URSODIOL, tell your doctor if:
- You have taken ursodiol 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 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 ursodiol.
NOVO-URSODIOL is not recommended for use in children.
You should discuss with your doctor the benefits and risks of taking NOVO-URSODIOL 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.
INTERACTION 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 NOVO-URSODIOL 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 NOVO-URSODIOL you should take each day for your medical condition. NOVO-URSODIOL 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 NOVO-URSODIOL 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
Side effects while taking ursodiol may include diarrhea, nausea, indigestion, heartburn, stomach ulcers, chest pain, high blood pressure, low blood platelet count, swelling, loss of energy, skin rash, and itching.
If you have severe stomach pain, contact your doctor.
This is not a complete list of side effects. For any unexpected effects while taking NOVO-URSODIOL contact your doctor or pharmacist.
HOW TO STORE IT
NOVO-URSODIOL tablets should be stored at room temperature (15°-30° C) in a closed container.
Keep this and all other medication out of the reach of children.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: June 23, 2011
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:
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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 0701D Ottawa, ON 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 side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.