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OSPHENA^™ is an oral prescription medicine used to treat painful intercourse, a symptom of changes in and around the vagina, due to menopause.

1-855-OSPHENA
(1-855-677-4362)

What is the most important information I should know about OSPHENA^™?

• OSPHENA^™ is a medicine that works like estrogen in the lining of the uterus (womb), but can work differently in other parts of the body.
• Taking estrogen-alone or OSPHENA^™ may increase your chance of getting cancer of the lining of the uterus (womb). Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Tell your healthcare provider right away if you have any unusual vaginal bleeding while you are taking OSPHENA^™.
• OSPHENA^™ may increase your chance of getting strokes and blood clots.
• You and your healthcare provider should talk regularly about whether you still need treatment with OSPHENA^™.

What is OSPHENA (os fee' nah)?

OSPHENA^™ is an oral prescription medicine used to treat painful intercourse, a symptom of changes in and around your vagina, due to menopause.

Who should not take OSPHENA^™?

Do not start taking OSPHENA^™ if you:

• have unusual vaginal bleeding
  Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

• currently have or have had certain cancers
  Estrogen may increase the chances of getting certain types of cancers, such as cancer of the lining of the uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take OSPHENA^™.

• currently have or have had blood clots
• had a stroke or heart attack
• think you may be pregnant
  OSPHENA^™ is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take OSPHENA^™ if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before taking OSPHENA^™?
Before you take OSPHENA^™, tell your healthcare provider if you:

• have any unusual vaginal bleeding
  Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• have any other medical conditions
  Such as severe liver problems.
• are going to have surgery or will be on bed rest
  Your healthcare provider will let you know if you need to stop taking OSPHENA^™.
• are breast feeding
  It is not known if OSPHENA^™ can pass into your breast milk.

Tell your healthcare provider about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how OSPHENA^™ works. OSPHENA^™ may also affect how other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take OSPHENA^™?

• Take OSPHENA^™ exactly how your healthcare provider tells you to take it.
• Take OSPHENA^™ by mouth 1 time each day with food.
• You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether or not you still need treatment with OSPHENA^™.

What are the possible side effects of OSPHENA^™?

See "What is the most important information I should know about OSPHENA^™?"

Serious, but less common side effects include:

• stroke
• blood clots
• cancer of the lining of the uterus (womb)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• unusual vaginal bleeding
• changes in vision or speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

• hot flushes or flashes
• vaginal discharge
• muscle spasms
• increased sweating

These are not all the possible side effects of OSPHENA^™. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effects that bother you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with OSPHENA^™?

• Talk with your healthcare provider regularly about whether you should continue taking OSPHENA^™.
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
• See your healthcare provider right away if you develop vaginal bleeding while taking OSPHENA^™.
• Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or use tobacco, you may have a higher chance of getting heart disease.

Ask your healthcare provider for ways to lower your chances of getting heart disease.

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