Danazol Oral capsule

What is this medicine?

DANAZOL (DA na zole) is used in women to treat endometriosis and the symptoms of fibrocystic breast disease. This medicine may also be used in men and women to prevent serious allergic reactions known as angioedema.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• breast cancer
• heart disease
• kidney disease
• liver disease
• porphyria
• unusual vaginal bleeding
• an unusual or allergic reaction to danazol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food to decrease stomach upset. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride
• pimozide
• ranolazine

This medicine may also interact with the following medications:

• carbamazepine
• medicines that treat or prevent blood clots like warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Check with your doctor or health care professional if you are a female patient and notice any changes in your voice, decrease in breast size, or if hair starts growing on your face.

This medicine should not be used in pregnancy. You should use a non-hormonal form of birth control while on this medicine. If you become pregnant or think you may be pregnant while you are taking this medicine, you should stop taking this medicine and contact your doctor or health care professional. This medicine may cause risk to a female fetus.

This medicine can affect your menstrual cycle and you may stop having menstrual periods. These will return to normal within 2 to 3 months after you stop taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• dark urine
• decrease in breast size
• hair loss or unusual hair growth
• headache
• irregular vaginal bleeding, spotting
• nausea, vomiting, stomach pain
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• unusual bleeding or bruising
• unusual swelling of feet or ankles
• unusually weak or tired
• voice changes
• weight gain
• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne, oily skin
• hot flashes, sweating
• mood changes
• vaginal dryness or irritation

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.