Ospemifene is used in menopausal women to relieve vaginal dryness and painful sexual intercourse.

Ospemifene may also be used for purposes not listed in this medication guide.

You should not use ospemifene if you have: undiagnosed vaginal bleeding, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Ospemifene may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Ospemifene may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular pelvic exams and mammograms while taking ospemifene.

If you need major surgery or will be on long-term bed rest, you may need to stop using ospemifene for a short time. Any doctor or surgeon who treats you should know that you are using ospemifene.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Dyspareunia:

60 mg orally once a day with food

Comments:
-This drug should be used for the shortest duration consistent with treatment goals and risks; postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Uses: For the treatment of moderate to severe dyspareunia (painful intercourse) and moderate to severe vaginal dryness, both symptoms of vulvar and vaginal atrophy, due to menopause.

You should not use this medication if you are allergic to ospemifene, if you are pregnant, or if you have:

• a history of heart attack, stroke, or blood clot;

• unusual vaginal bleeding that a doctor has not checked; or

• any type of breast, uterine, or hormone-dependent cancer.

Some drugs should not be used together with ospemifene. Your doctor may change your treatment plan if you also use:

• bazedoxifene;

• clomiphene;

• fluconazole;

• rifampin;

• tamoxifen;

• toremifene;

• birth control pills; or

• hormone replacement therapy.

Tell your doctor if you have ever had:

• liver disease;

• breast cancer (in you or a family member); or

• risk factors for heart problems or blood clots (such as diabetes, smoking, being overweight, having high blood pressure, high cholesterol, or lupus).

Ospemifene may increase your risk of blood clots, stroke, heart attack, or breast cancer. Talk with your doctor about your individual risks.

Do not use ospemifene if you are pregnant or plan to become pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

You may need to have a negative pregnancy test before starting this treatment.

You should not breastfeed while using ospemifene.

Ospemifene is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ospemifene may cause serious side effects. Call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg; or

• any unusual vaginal bleeding.

Common side effects of ospemifene may include:

• vaginal discharge or heavy bleeding;

• hot flashes;

• headache;

• increased sweating, night sweats; or

• muscle spasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• birth control pills; or

• hormone replacement therapy.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.