Ospemifene Oral tablet

What is this medicine?

OSPEMIFENE (os PEM i feen) is used to treat painful sexual intercourse in females after menopause, a symptom of menopause that occurs due to changes in and around the vagina.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer, such as breast, uterine, or other cancer

• heart disease

• history of blood clots

• history of stroke

• history of vaginal bleeding

• liver disease

• premenopausal

• smoke tobacco

• an unusual or allergic reaction to ospemifene, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Take this medicine with food. Follow the directions on the prescription label. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• doxycycline

• estrogens

• fluconazole

• furosemide

• glyburide

• ketoconazole

• phenytoin

• rifampin

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests. Also, periodically discuss the need to continue taking this medicine. Taking this medicine for long periods of time may increase your risk for serious side effects.

This medicine can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with this medicine lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.

This medicine can rarely cause blood clots. You should avoid long periods of bed rest while taking this medicine. If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine. This medicine should be stopped at least 4—6 weeks before surgery. After surgery, it should be restarted only after you are walking again. It should not be restarted while you still need long periods of bed rest.

You should not smoke while taking this medicine. Smoking may also increase your risk of blood clots. Smoking can also decrease the effects of this medicine.

This medicine does not prevent hot flashes. It may cause hot flashes in some patients.

If you have any reason to think you are pregnant; stop taking this medicine at once and contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breathing problems

• changes in vision

• confusion, trouble speaking or understanding

• new breast lumps

• pain, swelling, warmth in the leg

• pelvic pain or pressure

• severe headaches

• sudden chest pain

• sudden numbness or weakness of the face, arm or leg

• trouble walking, dizziness, loss of balance or coordination

• unusual vaginal bleeding patterns

• vaginal discharge that is bloody or brown

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• hot flushes or flashes

• increased sweating

• muscle cramps

• vaginal discharge (white or clear)

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.