Ospemifene (os-PEM-i-feen)

Treats pain during sex and vaginal dryness caused by vaginal changes during menopause.

Brand Name(s):

Osphena

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ospemifene works. Tell your doctor if you are using any of the following:
  • Fluconazole, ketoconazole, rifampin
  • Medicine that contains estrogen

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding, or if you have liver disease, diabetes, heart disease, high blood pressure, high cholesterol, lupus, or a history of cancer. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of endometrial cancer
• Tell any doctor who treats you that you are using this medicine. Because of the risk of blood clots, you may need to stop using this medicine before you have surgery or if you need to stay in bed for a long time.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread, trouble breathing, coughing up blood, nausea, unusual sweating, faintness
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf), sudden or severe headache, problems with vision, speech, or walking
• Unusual vaginal bleeding, pain or pressure in the pelvis

If you notice these less serious side effects, talk with your doctor:

• Warmth or redness in your face, neck, arms, or upper chest
• White or brownish vaginal discharge

If you notice other side effects that you think are caused by this medicine, tell your doctor

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