Novo-Warfarin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

$ NOVO-WARFARIN is an anticoagulant drug. AAnti@ means

against and Acoagulant@ refers to blood clotting. An anticoagulant helps reduce clots from forming in the blood. $ NOVO-WARFARIN is a narrow therapeutic index drug,

which means that there is a narrow margin between too much and too little of the drug. Too much drug may cause you to bleed more. Too little drug may let a harmful clot form.

What it does:

NOVO-WARFARIN Tablets partially block the re-use of vitamin K in your liver. Vitamin K is needed to make clotting factors that help the blood to clot and prevent bleeding. Vitamin K is found naturally in foods such as leafy, green vegetables and certain vegetable oils.

NOVO-WARFARIN Tablets begin to reduce blood clotting within 24 hours after taking the drug. The full effect may take 72 to 96 hours to occur. The anti-clotting effects of a single dose of NOVO-WARFARIN Tablets last 2 to 5 days, but it is important for you to take your dose everyday.

When it should not be used:

$Do not take NOVO-WARFARIN if you are allergic to it or any of the nonmedicinal ingredients listed below. $Do not take NOVO-WARFARIN Tablets during pregnancy. $Do not take NOVO-WARFARIN if you have an blood disorders or tend to bleed, unless your doctor recommends otherwise.

What the medicinal ingredient is:

Warfarin Sodium.

What the nonmedicinal ingredients are:

Magnesium stearate, lactose anhydrous, pregelatinized corn starch and colour dye which varies in each tablet strength.

1 mg: D&C Red #6 - Lake

2 mg: FD&C Blue #2 - Lake and FD&C Red #40 - Lake 2.5 mg: FD&C Blue #2 - Lake and D&C Yellow #10 - Lake 3 mg: FD&C Red #40 - Lake, D&C Yellow #10 - Lake and FD&C Blue #2 - Lake

4 mg: FD&C Blue # 1- Lake

5 mg: D&C Yellow #10 - Lake and D&C Red #6 - Lake 6 mg: D&C Yellow #10 - Lake and FD&C Blue #2 - Lake 7.5 mg: D&C Yellow #10 - Lake

10 mg: Dye free

What dosage forms it comes in:

NOVO-WARFARIN Tablets are available in many strengths, and each strength has a unique tablet color:

Each round, single-scored tablet is imprinted on one side with the word AWARFARIN@ and the numeric strength of the tablet. The other side of the tablet is imprinted with the name AN@.

Be sure to check that the tablet shows AWARFARIN@ and the right numeric strength before you take it

WARNINGS AND PRECAUTIONS

$Do not take NOVO-WARFARIN Tablets during pregnancy. Use effective measures to avoid pregnancy while taking NOVO-WARFARIN Tablets.

$Eat a normal balanced diet maintaining a consistent level of green leafy vegetables that contain high amounts of Vitamin K since the amount of vitamin K in your daily diet may affect NOVO-WARFARIN Tablet therapy. Do not make drastic changes in your diet, such as eating large amounts of green, leafy vegetables. The amount of vitamin K in your daily diet may affect therapy with NOVO-WARFARIN Tablets. $Report any illness, such as throwing up (vomiting), loose or runny stools (diarrhea), an infection or fever to your health care provider.

$Tell anyone giving you medical or dental care that you are taking NOVO-WARFARIN Tablets.

$Carry identification stating that you are taking NOVO-WARFARIN Tablets.

$Do not attempt to change your weight by dieting, without first checking with your health care provider.

$Avoid alcohol consumption.

$Do not participate in any activity or sport that may result in serious injury.

$Avoid cutting yourself

INTERACTIONS WITH THIS MEDICATION

Do not start, stop, or change any medicine except on advice of your health care provider. NOVO-WARFARIN Tablets interact with many different drugs, including aspirin and aspirin-containing ointments and skin creams. Tell your health care provider about any prescription and non-prescription (over-the-counter) drugs that you are taking including occasional use of headache medications.

PROPER USE OF THIS MEDICATION

Usual dose:

$ Take NOVO-WARFARIN Tablets exactly the way your health care provider tells you and take it at the same time every day. You can take NOVO-WARFARIN Tablets either with food or on an empty stomach. Your dosage may change from time to time depending on your response to NOVO-WARFARIN Tablets.

$The dose of NOVO-WARFARIN Tablets may be different for each patient. For example, older patients (age 60 years of age or older) appear to have a greater-than-expected response to NOVO-WARFARIN Tablets so that as patient age increases, a lower dose of NOVO-WARFARIN Tablets may be needed. Your health care provider will decide what dose is best for you. This dose may change from time to time.

$ To decide on the dosage of NOVO-WARFARIN Tablets you need, your health care provider will take a small amount of your blood to find out your prothrombin time, protime, or PT, for short. Protimes are often recorded as an INR (International Normalized Ratio), a standard way of reporting protimes. $PT/INR tests are very important. They help your health care provider see how fast your blood is clotting and whether your dosage of NOVO-WARFARIN Tablets should change. $ When you start taking NOVO-WARFARIN Tablets, you may have PT/INR test every day for a few days, then perhaps one time every week. These PT/INR tests and regular visits to a health care provider are very important for the success of therapy with NOVO-WARFARIN Tablets. PT/INR tests will be needed at periodic intervals (such as one time per month) throughout your course of therapy to keep your PT/INR in the best range for your medical condition. Discuss with your health care provider the range that is right for you.

Overdose:

If you take too much NOVO-WARFARIN or if someone else takes your medicine by mistake, tell your doctor immediately and go to the emergency room.

Missed Dose:

If you miss a dose of NOVO-WARFARIN Tablets, notify your health care provider right away. Take the dose as soon as possible on the same day, but do not take a double dose of NOVO-WARFARIN Tablets the next day to make up for a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all prescription drugs, NOVO-WARFARIN Tablets may cause side effects. The most common side effect of NOVO-WARFARIN Tablets is bleeding, which may be serious. However, the risk of serious bleeding is low when the effect of NOVO-WARFARIN Tablets is within a range that is right for your specific medical condition. Notify your health care provider right away of any unusual bleeding or if signs or symptoms of bleeding occur.

Your health care provider can tell you about possible side effects of NOVO-WARFARIN Tablets, which include bleeding and allergic reactions. Please contact your health care provider right away if you experience signs or symptoms of bleeding or allergic reactions.

To lower the risk of bleeding, your PT/INR should be kept within a range that is right for you. Signs or symptoms of bleeding include:

C headache, dizziness, or weakness

C bleeding from shaving or other cuts that does not stop C nosebleeds

C bleeding of gums when brushing your teeth

C throwing up blood

C unusual bruising (black-and-blue marks on your skin) for unknown reasons

C dark brown urine

C red or black color in your stool

C more bleeding than usual when you get your menstrual period or unexpected bleeding from the vagina

C unusual pain or swelling

Serious, but rare, side effects of NOVO-WARFARIN Tablets include skin necrosis (death of skin tissue) and Apurple toes syndrome@, either of which may require removal of unhealthy tissue and/or amputation of the affected area. Talk with your health care provider for further information on these side effects.

Hypersensitivity/allergic reactions are reported infrequently. Signs or symptoms of these reactions may range from mild reactions (rash, itching, hives) to more severe reactions (trouble breathing, throat tightening or constriction, facial swelling, swollen lips or tongue, sudden low blood pressure).

This is not a complete list of side effects. For any unexpected effects while taking NOVO-WARFARIN, contact your doctor or pharmacist.

HOW TO STORE IT

Store at controlled room temperature (15 °C to 30 °C). Store tablets in light-resistant container as provided by pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Novopharm Limited. at:

at: 1-800-268-4127 ext. 5005

or druginfo@novopharm.com

Novopharm Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: February 7, 2005.