Uses of Olaparib Tablets:

• It is used to treat ovarian cancer.
• It is used to treat breast cancer.
• It is used to treat pancreatic cancer.

What do I need to tell my doctor BEFORE I take Olaparib Tablets?

• If you are allergic to this medicine (olaparib tablets); any part of this medicine (olaparib tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had chemo treatments before and you still have blood problems from those treatments.
• If you take any other drugs (prescription or OTC, natural products, vitamins). There are many drugs that interact with this medicine (olaparib tablets), like certain drugs that are used for HIV, infections, or seizures.
• If you are breast-feeding. Do not breast-feed while you take this medicine (olaparib tablets) or for 1 month after you stop this medicine (olaparib tablets).

This is not a list of all drugs or health problems that interact with this medicine (olaparib tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (olaparib tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Olaparib Tablets?

• Tell all of your health care providers that you take this medicine (olaparib tablets). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor.
• Some people have had certain bone marrow problems while taking this medicine (olaparib tablets). This includes a type of cancer called acute myeloid leukemia (AML). These problems may be deadly. These people all had other treatments with chemo or certain other drugs for their cancer before taking this medicine (olaparib tablets). Call your doctor right away if you have blood in the urine or stools, fever, infections that happen often, shortness of breath, any bruising or bleeding, feel very tired or weak, or have weight loss.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are 65 or older, use this medicine (olaparib tablets) with care. You could have more side effects.
• This medicine is found in semen. Do not donate semen while you take this medicine (olaparib tablets) and for 3 months after your last dose.
• This medicine may cause harm to an unborn baby or loss of an unborn baby. A pregnancy test will be done before you start this medicine (olaparib tablets) to show that you are NOT pregnant.
• Women must use birth control while taking this medicine (olaparib tablets) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking this medicine (olaparib tablets) and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is this medicine (Olaparib Tablets) best taken?

Use this medicine (olaparib tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, or dissolve.
• Avoid Seville oranges.
• Avoid grapefruit and grapefruit juice.
• Keep taking this medicine (olaparib tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Swelling in the arms or legs.
• Some people have had lung problems with this medicine (olaparib tablets). Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.

What are some other side effects of Olaparib Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Not hungry.
• Feeling dizzy, tired, or weak.
• Headache.
• Stomach pain or heartburn.
• Back, muscle, or joint pain.
• Nose or throat irritation.
• Change in taste.
• Mouth irritation or mouth sores.
• Signs of a common cold.
• Flu-like signs.
• Constipation, diarrhea, throwing up, and upset stomach are common with this medicine (olaparib tablets). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Olaparib Tablets?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Store in original container.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (olaparib tablets) is refilled. If you have any questions about this medicine (olaparib tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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