(os PEM i feen) Brand: Osphena
• Do not use ospemifene if you are pregnant or may become pregnant.
• You must not use this medicine if you have unusual vaginal bleeding, breast or uterine cancer, or a history of heart onslaught, stroke, or blood clot.
• Ospemifene may magnify your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Report any unusual vaginal bleeding to your doctor right away.
• Ospemifene may also magnify your risk of a stroke or blood clot. Conversation with your doctor about your individual risks.
• Ospemifene is a non-estrogen medicine that reverses determined changes in vaginal tissue that are caused by menopause.
• Ospemifene is used to relieve pain during sexual intercourse in menopausal women. Ospemifene is not a pain medication.
• Ospemifene may also be used for purposes not listed in this medicine guide.
• You must not use this medicine if you are allergic to ospemifene, if you are pregnant, or if you have:
· a history of heart onslaught, stroke, or blood clot;
· unusual vaginal bleeding that a doctor has not checked; or
· any type of breast, uterine, or hormone-dependent cancer.
• To create certain ospemifene is safety for you, speak your doctor if you have:
· liver disease;
· a history of breast cancer; or
· risk factors for coronary artery malady (such as diabetes, smoking, being overweight, having tall blood pressure or tall cholesterol).
• Ospemifene may magnify your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. If your uterus has not been removed, your doctor may prescribe a progestin for you to take to lower this risk while you are taking ospemifene.
• Ospemifene may also magnify your risk of a stroke or blood clot. Conversation with your doctor about your individual risks.
• FDA pregnancy category X. This medicine can harm an unborn child or reason birth defects. Do not use ospemifene if you are pregnant or may become pregnant. Speak your doctor right away if you become pregnant during treatment. Use effective birth control while you are taking this medication.
• You may need to have a negative pregnancy test till starting this treatment.
• It is not known whether ospemifene passes into breast milk or if it could harm a nursing child. Speak your doctor if you are breast-feeding a baby.
• Ospemifene is generally taken once daily. Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.
• Take with food.
• Report any unusual vaginal bleeding to your doctor right away.
• Your doctor must check your progress on a regular basis (every 3 to 6 months) to determine whether you must continue this treatment. Self-examine your breasts for lumps on a monthly basis while taking ospemifene.
• If you need surgery or if you will be on bed rest, you may need to stop taking this medicine for a short time. Any doctor or surgeon who treats you must know that you are taking ospemifene.
• Store at room temperature away from moisture and heat.
• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Follow your doctor's instructions about any restrictions on food, beverages, or activity.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.
• Call your doctor at once if you have:
· sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
· chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
· pain, swelling, warmth, or redness in one or both legs; or
· any unusual vaginal bleeding.
• General side effects may include:
· hot flashes;
· vaginal discharge;
· heighten sweating; 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 message side effects to FDA at 1-800-FDA-1088.
• You must not use ospemifene together with estrogens, such as birth control pills or hormone replacement medications.
• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with ospemifene, especially:
· fluconazole.
• This list is not complete. Another drugs may interact with ospemifene, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.
• Your pharmacist can provide more information about ospemifene.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.