Ospemifene oral tablets

What is this medication?

OSPEMIFENE (os PEM i feen) is used to treat vaginal dryness and painful sexual intercourse due to menopause; these symptoms occur 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.

COMMON BRAND NAME(S): Osphena

What should I tell my care team before I take this medication?

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 medication?

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. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have 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 medication?

• amiodarone
• bosentan
• carbamazepine
• certain medicines for fungal infections like ketoconazole, itraconazole, fluconazole, and voriconazole
• certain medicines for HIV or hepatitis
• estrogens
• glyburide
• griseofulvin
• mitotane
• modafinil
• omeprazole
• phenobarbital
• phenytoin
• primidone
• raloxifene
• rifampin
• St. John's wort
• tamoxifen
• toremifene
• 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 medication?

Visit your doctor or 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.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine. You are strongly advised not to smoke.

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

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 with this medicine. You should know, however, that taking a progestin may have additional health risks. You should discuss the use of these medicines with your health care professional to determine the benefits and risks for you.

If you are going to have surgery, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.

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 medication?

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

• allergic reactions like skin rash, itching or hives; swelling of the face, lips, or tongue
• breathing problems
• breast tissue changes or discharge
• signs and symptoms of a blood clot such as chest pain; shortness of breath; pain, swelling, or warmth in the leg
• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination
• vaginal bleeding

Side effects that usually do not require medical attention (report 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 medication?

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.