Ospemifene Tablets

What is this medication?

OSPEMIFENE (os PEM i feen) relieves the symptoms of menopause, such as vaginal irritation, dryness, or pain during sex. It works by acting like the hormone estrogen in your body.

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
• Tobacco use
• An unusual or allergic reaction to ospemifene, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take this medication with food. Follow the directions on the prescription label. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team about the use of this medication in children. This medication 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 medications for fungal infections, such as ketoconazole, itraconazole, fluconazole, and voriconazole
• Certain medications 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 care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow their guidelines for these tests.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are over the age of 35.

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

This medication 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 medication, with this medication lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your care team may prescribe a progestin for you to take with this medication. You should know, however, that taking a progestin may have additional health risks. You should discuss the use of these medications with your care team to determine the benefits and risks for you.

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

If you have any reason to think you are pregnant, stop taking this medication at once and contact your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Excessive sweating
• Headache
• Hot flashes
• Muscle spasms
• Vaginal discharge

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 and pets.

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 medication 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.