*

Brand Name(s):  

  • Osphena®
*

IMPORTANT WARNING  

Taking ospemifene may increase the risk that you will develop endometrial cancer (cancer of the uterus [womb]). Tell your doctor if you have or have had cancer or if you have abnormal vaginal bleeding. Your doctor will probably tell you not to take ospemifene. If you have any unusual vaginal bleeding while you are taking ospemifene call your doctor immediately.

Taking ospemifene also may increase the risk of stroke and blood clots. Tell your doctor if you tell your doctor if you smoke or have or have ever had a stroke, a blood clot in the legs and lungs, high blood pressure, high blood levels of cholesterol or fats, diabetes, heart disease, or lupus (a condition in which the body attacks its own tissues causing damage and swelling). Your doctor will probably tell you not to take ospemifene. Talk to your doctor every 3 to 6 months to decide if you should continue taking this medication.

Talk to your doctor about the risks and benefits of taking this medication.

*

WHY is this medicine prescribed?  

Ospemifene is used to treat changes due to menopause (''change of life,'' the end of monthly menstrual periods) in and around the vagina that can cause painful sexual intercourse. Ospemifene is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.

*

HOW should this medicine be used?  

Ospemifene comes as a tablet to take by mouth. It is usually taken with food once daily. Take ospemifene at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ospemifene exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ospemifene helps to control the symptoms of menopause that can cause pain during intercourse but does not cure it. Continue to take ospemifene even if you feel well. Do not stop taking ospemifene without talking to your doctor.

*

Are there OTHER USES for this medicine?  

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?  

Before taking ospemifene,

  • tell your doctor and pharmacist if you are allergic to ospemifene or any of the ingredients in ospemifene tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: antifungals such as itraconazole (Sporanox), fluconazole (Diflucan), ketoconazole (Nizoral);clarithromycin (Biaxin); estrogens such as (Premarin); estrogen agonists/antagonists such as tamoxifen (Nolvadex); medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Fortovase, Invirase); nefazodone; or rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Ospemifene may cause fetal harm. If you become pregnant while taking ospemifene, call your doctor immediately.
  • if you are having surgery, including dental surgery, tell the doctor or dentist you are taking ospemifene.
*

What SPECIAL DIETARY instructions should I follow?  

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

*

What should I do IF I FORGET to take a dose?  

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

*

What SIDE EFFECTS can this medicine cause?  

*

Ospemifene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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

Some side effects can be serious. f you experience any of these symptoms or those listed in the IMPORTA