"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Estratest Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), breast lumps, swelling of hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal discharge/itching/odor, changes in skin color, yellowing eyes/skin, unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, dark urine, worsening of seizures.
Women may experience signs of masculinization (male characteristics) from methyltestosterone. To prevent these changes from becoming permanent, stop taking this medication and tell your doctor immediately if any of the following occur: hoarseness, deepening of the voice, facial hair growth, new or worsening acne, an enlarged clitoris, menstrual period changes.
This medication may infrequently cause serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest pain, jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling of legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Estratest (esterified estrogens and methyltestosterone) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to methyltestosterone or estrogen; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain cancers (e.g., breast cancer, cancer of the uterus or ovaries), blood clotting disorders (such as protein C or protein S deficiency), current/history of blood clots (such as in the legs, eyes, lungs), history of stroke or heart attack, liver problems.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps, cancer, blood clots, angioedema), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure), kidney disease, underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), mineral imbalance (low or high calcium blood level), mental/mood disorders (e.g., dementia, depression), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, certain blood disorder (porphyria), lupus.
If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and of any symptoms such as increased thirst/urination, weakness, or fainting. Your anti-diabetic medication or diet may need to be adjusted.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Do not smoke cigarettes or use tobacco. Estrogens combined with smoking further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.
If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances (such as stopping this medication) because of the increased risk for blood clots. Consult your doctor for details.
This medication is not meant for use in children.
This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.
This medication is not effective for preventing a miscarriage and should not be used for this purpose.
This medication is not usually used in women of childbearing age. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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