Osphena (Ospemifene)

(os pem' i feen)

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 ever 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 smoke or if you have ever had a stroke; if you or anyone in your family has or has ever had blood clots; or if you have or have ever had 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 discuss if you should continue taking this medication. If you experience any of the following symptoms, stop taking ospemifene and call your doctor immediately: swelling or pain in your legs; warm or red skin; slow or difficult speech; dizziness or faintness; weakness or numbness of an arm or leg; sudden, severe headache; sudden changes in vision; pain in your chest, arms, back, neck or jaw; or shortness of breath. Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to ospemifene. Talk to your doctor about the risks and benefits of taking this medication.

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 and vaginal dryness. Ospemifene is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.

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 vaginal dryness and 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.

Before taking ospemifene,
• tell your doctor and pharmacist if you are allergic to ospemifene, any other medications, 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, nutritional supplements, and herbal products 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 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, or will be on bed rest, tell the doctor or dentist you are taking ospemifene.

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

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.

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. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• swelling of the face, throat, tongue, lips. eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing
• hives
• rash
• itching

Ospemifene may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.