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Ospemifene (By mouth)

Ospemifene (os-PEM-i-feen)

Treats painful sex (dyspareunia) that is a result of menopause in women.

Brand Name(s):

Osphena

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to ospemifene. Do not use this medicine if you are pregnant or have unusual vaginal bleeding that has not been checked by a doctor. Do not use this medicine if you have had blood clot or blood circulation problems, such as heart attack, stroke, deep vein thrombosis, or pulmonary embolism. Make sure your doctor knows if you have had cancer, because you may not be able to use this medicine.

How to Use This Medicine:

Tablet

  • Take your medicine as 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.

If a dose is missed:

  • 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.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you also use fluconazole (Diflucan®), ketoconazole (Nizoral®), rifampin (Rifadin®, Rimactane®), or any medicine that contains estrogen (such as conjugated estrogens, estradiol).

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.
  • Make sure your doctor knows if you are breastfeeding, or if you have liver disease, diabetes, lupus, or a history of cancer. Tell your doctor if you have heart disease, blood clotting problems, high blood pressure, or high cholesterol.
  • This medicine may increase your risk for heart attack, stroke, or blood clots. The risk is greater if you have high blood pressure, high cholesterol, or diabetes, or are overweight or smoke tobacco. Talk to your doctor about this risk.
  • This medicine may increase your risk for endometrial or uterine cancer. The risk is greater if you use the medicine for a long time. Talk to your doctor about this risk. Check with your doctor right away if you have unusual vaginal bleeding.
  • Make sure any doctor who treats you knows that you are using this medicine. 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 check your progress and the effects of this medicine at regular visits. Keep all appointments.

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 to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness
  • Chest pain, trouble breathing, coughing up blood
  • 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 speech or walking
  • Unusual, unexpected, or heavy vaginal bleeding

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

  • Increased sweating
  • Warmth or redness in your face, neck, arms, or upper chest

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


Last Updated: 11/4/2014


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