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®.
Indication: What is Osphena®?
Osphena® is a prescription oral pill that treats:
- moderate to severe painful intercourse,
- moderate to severe vaginal dryness, symptoms of changes in and around your vagina, due to menopause.
Most Important Information you should know about 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 (including cancer of the breast or uterus), 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:
- blood clots
- cancer of the lining of the uterus
Less serious, but common side effects include:
- hot flushes or flashes
- vaginal discharge
- muscle spasms
- 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 accompanying Patient Information for Osphena®(ospemifene) tablets, including Boxed Warning in the U.S. Full Prescribing Information.