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Before menopause, high levels of estrogen stimulate maturation of the vaginal lining to generate a thick layer of mature superficial cells. After menopause, a lack of estrogen leaves the vaginal lining much thinner, with very few or no superficial cells. In many women, this thinning is associated with vaginal dryness, irritation, itching and pain with intercourse, a condition referred to as vaginal atrophy or atrophic vaginitis.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING AND INDICATION

Indication: What is Osphena?

Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause.

Most Important Information you should know about Osphena

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

Osphena works like estrogen in the lining of the uterus (endometrium), but can work differently in other parts of the body. Taking estrogen alone or Osphena may increase your chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell him or her right away if this happens while you are using Osphena.

Osphena may increase your chances of having a stroke or blood clots.

You and your healthcare provider should talk regularly about whether you still need treatment with Osphena.

Call your healthcare provider right away if you have unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, and pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Who should not take OSPHENA?

Osphena should not be used if you have unusual vaginal bleeding, have or have had certain types of cancers, have or have had blood clots, had a stroke or heart attack, have severe liver problems, are allergic to Osphena or any of its ingredients, or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.

POSSIBLE SIDE EFFECTS

Serious but less common side effects can include:

  • stroke
  • blood clots
  • cancer of the lining of the uterus

Less serious, but common side effects include:

  • hot flushes or flashes
  • vaginal discharge
  • muscle spasms
  • headache
  • excessive sweating (hyperhidrosis)
  • heavy vaginal bleeding (vaginal hemorrhage)
  • night sweats

Tell your healthcare provider about all of the medicines and supplements you take, as some medicines may affect how Osphena works. Osphena may also affect how other medicines work.

Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read Patient Information for Osphena (ospemifene) tablets, including Boxed Warning and the Full Prescribing Information.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION: WHAT IS OSPHENA?

Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

See full Prescribing Information for complete Boxed Warning.

Osphena works like estrogen in the lining of the uterus (endometrium), but can work differently in other parts of the body. Taking estrogen alone or Osphena may increase your chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell him or her right away if this happens while you are using Osphena.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION: WHAT IS OSPHENA?

Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

See full Prescribing Information for complete Boxed Warning.

Osphena works like estrogen in the lining of the uterus (endometrium), but can work differently in other parts of the body. Taking estrogen alone or Osphena may increase your chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell him or her right away if this happens while you are using Osphena.

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