ospemifene

What is the most important information I should know about ospemifene?

You should not use this medicine if you have: undiagnosed vaginal bleeding, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

What is ospemifene?

Ospemifene is used in menopausal women to relieve vaginal dryness and painful sexual intercourse.

Ospemifene may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ospemifene?

• a history of heart attack, stroke, or blood clot;
• unusual vaginal bleeding that a doctor has not checked; or
• any type of breast, uterine, or hormone-dependent cancer.

Some drugs should not be used together with ospemifene. Your doctor may change your treatment plan if you also use:

• bazedoxifene;
• clomiphene;
• fluconazole;
• rifampin;
• tamoxifen;
• toremifene;
• birth control pills; or
• hormone replacement therapy.

Tell your doctor if you have ever had:

• liver disease;
• breast cancer (in you or a family member); or
• risk factors for heart problems or blood clots (such as diabetes, smoking, being overweight, having high blood pressure, high cholesterol, or lupus).

You may need to have a negative pregnancy test before starting this treatment.

How should I take ospemifene?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular pelvic exams and mammograms while taking ospemifene.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using ospemifene.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking ospemifene?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of ospemifene?

• signs of a stroke --sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot deep in the body --swelling, warmth, or redness in an arm or leg; or
• any unusual vaginal bleeding.

Common side effects may include:

• vaginal discharge or heavy bleeding;
• hot flashes;
• headache;
• increased sweating, night sweats; or
• muscle spasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ospemifene?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• birth control pills; or
• hormone replacement therapy.

Where can I get more information?

Your pharmacist can provide more information about ospemifene.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 3.01. Revision date: 1/31/2020.