Ospemifene, Oral

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KEY POINTS

• This medicine is taken by mouth to treat severe pain with sex caused by menopause. Take it exactly as directed.
• You need regular checkups and exams while taking this medicine. Keep all appointments.
• This medicine increases your risk of stroke and blood clots. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: selective estrogen receptor modulator (SERM)

Generic and brand names: ospemifene, oral; Osphena

What is this medicine used for?

This medicine is taken by mouth to treat severe pain with intercourse due to menopause (when monthly menstrual periods stop). It may be used alone or with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• A heart attack or stroke
• A hysterectomy (removal of the uterus)
• An allergic reaction to any hormones or medicines
• Blood clots in your legs, lungs, brain, or eyes
• Cancer of the breast, uterus, cervix, or vagina
• Diabetes
• Endometrial hyperplasia (thickening of the lining of the uterus)
• High blood pressure
• High cholesterol
• Liver disease
• Lupus
• Unexplained vaginal bleeding

Tell your healthcare provider if you have recently had a long period of bed rest after major surgery or illness, or a broken bone in a cast. Also, tell your healthcare provider if you are scheduled for surgery.

Tell your provider if you have a family history of breast cancer, heart disease, heart attack, blood clots, lupus, or strokes.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Females of childbearing age: This medicine should only be taken after menopause. Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine without your healthcare provider’s approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Read the information sheet that comes in the medicine package. Follow these directions carefully.

This medicine is intended for use only after menopause. Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed.

To help you remember to take your daily dose, try to take the tablets at the same time each day. Take this medicine with food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

This medicine may increase the risk of stroke and blood clots. Also, taking this medicine without progestin increases the risk of uterine cancer if you still have your uterus. You should take this medicine at the lowest effective dosage, and only for as long as you need it. Talk with your healthcare provider about this.

You need to see your provider regularly (every 3 to 6 months) for checkups to find out if this medicine is still needed and if you are having any side effects. Keep all your appointments. You should also have a breast exam and mammogram every year or as often as your healthcare provider advises.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; swelling of your lips, tongue and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; sudden, severe vomiting; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; pain, redness, or swelling in your leg.

Serious (Report these to your healthcare provider right away.): Unexplained bleeding from your vagina; dizziness; fainting; breast lumps; pain, redness, warmth, or swelling in your hands, ankles or feet; increased blood pressure.

Other: Hot flashes, vaginal discharge, muscle spasms, increased sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), sulfadiazine, and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as enzalutamide (Xtandi), idelalisib (Zydelig), mitotane (Lysodren), tamoxifen, and toremifene (Fareston)
• Conivaptan (Vaprisol)
• Dexamethasone
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone) and nicardipine (Cardene)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)
• Natural remedies such as alfalfa, black cohosh, bloodroot, chasteberry, dong quai, evening primrose oil, ginseng, red clover, saw palmetto, soy, St. John's wort, topical progesterone, and wild yam
• Nefazodone
• Raloxifene (Evista)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tolbutamide

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.