Warfarin Sodium (Page 8 of 8)

What is WARFARIN?

WARFARIN is an anticoagulant medicine. It is used to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions such as blood clots in the legs or lungs.

Who should not take WARFARIN?

Do not take WARFARIN if:

your chance of having bleeding problems is higher than the possible

benefit of treatment.

Your healthcare provider will decide if WARFARIN is right for you.

Talk to your healthcare provider about all of your health conditions.

you are pregnant or plan to become pregnant.

WARFARIN can cause death or birth defects to an unborn baby. Use

effective birth control if you can get pregnant.

you are allergic to warfarin or to anything else in WARFARIN.

What should I tell my healthcare provider before starting 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 WARFARIN dose and should be avoided.

are pregnant or planning to become pregnant. See “Who should not

take WARFARIN?”

are breastfeeding. 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 WARFARIN, both you and your baby should be carefully monitored for bleeding problems.

Tell your healthcare provider about all the medicines you take includingprescription and non-prescription medicines, vitamins, and herbalsupplements. See “What is the most important information I should knowabout WARFARIN?”

How should I take WARFARIN?

Take WARFARIN exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to WARFARIN.

You must have regular blood tests and visits with your healthcare provider to monitor your condition.

Take WARFARIN at the same time every day. You can take WARFARIN either with food or on an empty stomach.

If you miss a dose of WARFARIN, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of WARFARIN the next day to make up for a missed dose.

Call your healthcare provider right away if you take too much WARFARIN.

Call your healthcare provider if you are sick with diarrhea, an infection, or have a fever.

Tell your healthcare provider about any planned surgeries, medical or dental procedures. Your WARFARIN may have to be stopped for a short time or you may need your dose adjusted.

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.

What should I avoid while taking WARFARIN?

• Do not start, stop, or change any medicine without talking with your healthcare provider.

• Do not make changes in your diet, such as eating large amounts of green, leafy vegetables.

• Do not change your weight by dieting, without first checking with your

healthcare provider.

• Avoid drinking alcohol.

• Do not do any activity or sport that may cause a serious injury.

What are the possible side effects of WARFARIN?

• WARFARIN is very important for your health, but it can cause serious and lifethreatening bleeding problems. See “What is the most important information

I should know about WARFARIN?”

Serious side effects of WARFARIN also include:

death of skin tissue (skin necrosis or gangrene). This can happen soon after starting WARFARIN. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.

•“purple toes syndrome.”Call your healthcare provider right away if you

have pain in your toes and they look purple in color or dark in color.

Other side effects with WARFARIN include allergic reactions, liver problems, low blood pressure, swelling, low red blood cells, paleness, fever, and rash. Call your healthcare provider if you have any side effect that bothers you.

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

How should I store WARFARIN?

• Store WARFARIN at room temperature between 59° and 86° F. Protect from light.

Keep WARFARIN and all medicines out of the reach of children.

General Information about WARFARIN

Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use WARFARIN for a condition for which it was not prescribed. Do not give WARFARIN to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about WARFARIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about WARFARIN that was written for healthcare professionals.

If you would like more information, call

1-866-436-9155

Rx only

WARFARIN is distributed by:

Genpharm, L.P.

Napa, CA 94558

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This leaflet was prepared by:

Genpharm Inc.

85 Advance Road

Etobicoke, OntarioM8Z 2S6

Issue date: November 2006

WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 1 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
FD&C Red # 40 Aluminum Lake
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color PINK (dark pink) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;1;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-100-10 1000 TABLET (1000 TABLET) in 1 BOTTLE None
2 NDC:15330-100-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 2.5 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
D&C Yellow # 10 Aluminum Lake
FD&C Blue # ! Aluminum LAke
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color GREEN (green) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;2.5;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-102-10 1000 TABLET (1000 TABLET) in 1 BOTTLE None
2 NDC:15330-102-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin sodium (Warfarin) Warfarin 2 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
FD&C Blue #2 Aluminum Lake
FD&C Red # 40 Aluminum Lake
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color PURPLE (lavendar) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;2;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-101-10 1000 TABLET (1000 TABLET) in 1 BOTTLE None
2 NDC:15330-101-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-266
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin sodium (Warfarin) Warfarin 3 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
FD&C Blue # 2 Aluminum Lake
FD&C Red # 40 Aluminum Lake
FD&C Yellow # 6 Aluminum LAke
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color BROWN (brown) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;3;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-266-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-267
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 4 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
FD&C Blue # 1 Aluminum Lake
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color BLUE (blue) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;4;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-267-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 7.5 ug
Inactive Ingredients
Ingredient Name Strength
corn starch
D&C Yellow # 10 Aluminum Lake
FD&C Yellow # 6 Aluminum Lake
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color YELLOW (yellow) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;7.5;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-107-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 6 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
FD&C Blue # 1 Aluminum Lake
FD&C Yellow # 6 Aluminum Lake
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color GREEN (dark green) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;6;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-106-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-268
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 5 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
FD&C Yellow # 6 Aluminum Lake
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;5;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-268-10 1000 TABLET (1000 TABLET) in 1 BOTTLE None
2 NDC:15330-268-01 100 TABLET (100 TABLET) in 1 BOTTLE None
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15330-108
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin 10 mg
Inactive Ingredients
Ingredient Name Strength
corn starch
lactose monohydrate
magnesium stearate
stearic acid
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WF;10;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15330-108-01 100 TABLET (100 TABLET) in 1 BOTTLE None
Labeler — Genpharm, L.P.

Revised: 01/2007 Genpharm, L.P.

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