Dutasteride

What is dutasteride used for?

• In men, it is used to treat the signs of an enlarged prostate.
• Dutasteride may be given to you for other reasons. Talk to your doctor.

Before taking dutasteride, tell your doctor:

For all patients taking dutasteride:

• If you are allergic to dutasteride; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are a woman. This medicine is not approved for use in women. If you are a woman using dutasteride, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

Children:

• If the patient is a child. Do not give dutasteride to a child.

This is not a list of all drugs or health problems that interact with dutasteride.

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 dutasteride 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 dutasteride?

For all patients taking dutasteride:

• Tell all of your health care providers that you take dutasteride. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a rectal exam (to check prostate gland) and blood work (PSA test). Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take dutasteride.
• Do not donate blood while using dutasteride and for 6 months after stopping.
• A very bad form of prostate cancer was seen more often in some men taking drugs like this one than in those who were not. This was seen in a trial of men taking these drugs to lower the chance of prostate cancer. Talk with your doctor.
• This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
• Pregnant women or females of childbearing age must not touch the capsules. Talk with the doctor.
• If a woman who is pregnant or may get pregnant touches a leaking capsule, the area must be washed right away with soap and water. Tell your doctor right away.

Women:

• This medicine may cause harm to the unborn baby if you take it while you are pregnant.

How is dutasteride best taken?

Use dutasteride as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking dutasteride as you have been told by your doctor or other health care provider, even if you feel well.
• Take with or without food.
• Swallow whole. Do not chew, open, or crush.
• Do not take or touch the capsule if it is deformed, changes color, or is leaking.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next 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 the side effects of dutasteride that I need to call my doctor about immediately?

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.
• Enlarged breasts.
• Breast pain.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Low mood (depression).

What are some other side effects of dutasteride?

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:

• Dizziness.
• This medicine may cause a change in sex ability in men or lowered interest in sex. This could go on after you stop dutasteride. Talk with your doctor if these effects go on or bother you.

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 dutasteride?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about dutasteride, please talk with your doctor, nurse, 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.

This information should not be used to decide whether or not to take dutasteride or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dutasteride. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.