Patient Medication Information: uses, side effects, how to take - Mylan-Warfarin

ABOUT THIS MEDICATION

What the medication is used for:

MYLAN-WARFARIN is an anticoagulant drug. “Anti”
means against, and “coagulant” refers to blood clotting. An anticoagulant helps reduce clots from forming in the blood.
MYLAN-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:

See What the medication is used for.

MYLAN-WARFARIN partially blocks 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.
MYLAN-WARFARIN begins 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 MYLAN-WARFARIN last 2 to 5 days, but it is important for you to take your dose every day.

When it should not be used:

Do not take MYLAN-WARFARIN during pregnancy. Use
effective measures to avoid pregnancy while taking MYLAN-WARFARIN.
Do not start, stop, or change any medicine except on advice
of your health care provider.
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 MYLAN-WARFARIN.
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.

What the medicinal ingredient is:

Warfarin Sodium

What the nonmedicinal ingredients are:

Corn Starch, Lactose Monohydrate, Stearic Acid, Magnesium Stearate and colour dye which varies in each tablet strength. 1 mg: FD&C Red #40 Aluminum Lake

2 mg : FD&C Red #40 Aluminum Lake FD&C Blue #2 Aluminum Lake 2.5 mg: FD&C Blue #1 Aluminum Lake HT D&C Yellow #10 Aluminum Lake 3 mg: Lake Blend Brown LB-1685 4 mg : FD&C Blue #1 Aluminum Lake 5 mg : FD&C Yellow #6 Aluminum Lake 6 mg: Lake Blend Dark Green LB-1236 7.5 mg: FD&C Yellow #6 Aluminum Lake D&C Yellow #10 Aluminum Lake 10 mg: Dye free

What dosage forms it comes in:

MYLAN-WARFARIN tablets are available in 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg and 10 mg strengths.

WARNINGS AND PRECAUTIONS

What should I tell my healthcare provider before starting MYLAN-WARFARIN

Tell your healthcare provider about all of your health conditions, including if you:

have bleeding problems
fall often
have liver or kidney problems
have high blood pressure
have a heart problem called congestive heart failure
have diabetes
drink alcohol or have problems with alcohol abuse.
Alcohol can affect your MYLAN-WARFARIN dose and should be avoided.
are pregnant or planning to become pregnant.
are breastfeeding. MYLAN-WARFARIN may increase bleeding in your baby. Talk to your doctor about the best way to feed your baby. If you choose to breastfeed while taking MYLAN-WARFARIN, both you and your baby should be carefully monitored for bleeding problems.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Like all prescription drugs, MYLAN-WARFARIN may cause side effects. The most common side effect of MYLAN-WARFARIN is bleeding, which may be serious. However, the risk of serious bleeding is low when the effect of MYLAN-WARFARIN 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.
Do not take MYLAN-WARFARIN during pregnancy,
Use effective measures to avoid pregnancy while taking MYLAN-WARFARIN.
The dose of MYLAN-WARFARIN 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 MYLAN-WARFARIN so that as patient age increases, a lower dose of MYLAN-WARFARIN may be needed. Your health care provider will decide IMPORTANT PLEASE READ

what dose is best for you. This dose may change from time to time.

To decide on the dosage of MYLAN-WARFARIN 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 MYLAN-WARFARIN should change.
When you start taking MYLAN-WARFARIN, you may
have PT/INR tests 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 MYLAN-WARFARIN. 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.
A severe elevation (> 50 seconds) in activated partial
thromboplastin time (aPTT) with a PT ration/INR in the desired range has been identified as an indication of increased risk of postoperative haemorrhage. This has been noted in patients undergoing elective hip surgery receiving warfarin alone.
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 MYLAN-WARFARIN therapy.
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 MYLAN-WARFARIN.
Carry identification stating that you are taking MYLAN-
WARFARIN.
Call your healthcare provider right away if you fall or
injure yourself, especially if you hit your head. Your healthcare provider may need to check you.
Tell your healthcare provider about any planned
surgeries, medical or dental procedures. Your MYLAN-WARFARIN may have to be stopped for a short time or you may need your dose adjusted.

INTERACTIONS WITH THIS MEDICATION

MYLAN-WARFARIN interacts with many different drugs, including acetylsalicylic acid and acetylsalicylic acid-containing ointments and skin creams as well as natural medicines (e.g., bromelains, coenzyme Q₁₀, danshen (Colocasia antiquorum), dong quai (Angelica sinensis), garlic, ginkgo biloba, ginseng and St. John’s wort). 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. Avoid cranberry juice or other cranberry products while taking MYLAN-WARFARIN. For more details refer to WARNINGS and PRECAUTIONS section, above.

PROPER USE OF THIS MEDICATION

Please read this leaflet before you start taking MYLAN-WARFARIN (warfarin sodium). Each time you renew your prescription, read the leaflet that comes with your medicine, just in case any information has changed. Remember, this leaflet does not take the place of talking to your health care provider (such as your doctor, nurse, or pharmacist). You and your health care provider should discuss MYLAN-WARFARIN when you start taking your medication and at regular checkups.

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

Overdose:

In case you have taken too much MYLAN-WARFARIN, contact your doctor, regional poison control centre or local hospital. Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing MYLAN-WARFARIN (warfarin sodium) therapy and if necessary, by administration of oral or parenteral vitamin K₁. In case you have taken too much MYLAN-WARFARIN, contact your doctor, regional poison control centre or local hospital.

Missed Dose:

If you miss a dose of MYLAN-WARFARIN, 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 MYLAN-WARFARIN the next day to make up for a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Your health care provider can tell you about possible side effects of MYLAN-WARFARIN, which include bleeding and allergic reactions. To lower the risk of bleeding, your PT/INR should be kept within a range that is right for you.

Please contact your health care provider right away if you experience any of the following signs or symptoms of bleeding problems.

headache, dizziness, or weakness
bleeding from shaving or other cuts that does not stop
nosebleeds
bleeding of gums when brushing your teeth
coughing up blood
vomiting blood or material that looks like coffee grounds
unusual bruising (black-and-blue marks on your skin) for unknown reasons
pink or dark brown urine
red or black color in your stool
more bleeding than usual when you get your menstrual period or unexpected bleeding from the vagina
unusual pain or swelling

Serious, but rare, side effects of MYLAN-WARFARIN include skin necrosis (death of skin tissue) and “purple toe syndrome,” either of which may require removal of unhealthy tissue and/or amputation of the affected area. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body or if you have pain in your toes and they look purple or dark in color. You may need medical care right away. 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).

These are not all of the side effects of MYLAN-WARFARIN. For more information, ask your healthcare provider or pharmacist.

HOW TO STORE IT

As with all medicines, keep MYLAN-WARFARIN out of the reach of children.

Protect from light. Store at room temperature (15 °C to 30 °C).

Keep the container tightly closed.

There is an expiry date on the label. Do not use the medicine after this date.

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 0701D Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TMCanada 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 found by contacting the sponsor, Mylan Pharmaceuticals ULC, at: 1-800-575-1379 or at: customerservice@mylan.ca

Mylan Pharmaceuticals ULC

Etobicoke, Ontario

Revised on September 22, 2011

Mylan-Warfarin: Uses, Side Effects and Dosage