"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.
Prefest Patient Information Including Side Effects
Generic Name: estradiol and norgestimate (Pronunciation: ess tra DYE all and nor JESS tih mate)
- What is estradiol and norgestimate ?
- What are the possible side effects of estradiol and norgestimate ?
- What is the most important information I should know about estradiol and norgestimate ?
- What should I discuss with my healthcare provider before taking estradiol and norgestimate ?
- How should I take estradiol and norgestimate ?
- What happens if I miss a dose ?
- What happens if I overdose ?
- What should I avoid while taking estradiol and norgestimate ?
- What other drugs will affect estradiol and norgestimate ?
- Where can I get more information?
What is estradiol and norgestimate ?
Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.
Norgestimate is a form of progesterone, a female sex hormone important for the regulation of ovulation and menstruation.
The combination of estradiol and norgestimate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.
Estradiol and norgestimate may also be used for purposes not listed in this medication guide.
What are the possible side effects of estradiol and norgestimate ?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- unusual vaginal bleeding (especially if you are past menopause);
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- stabbing chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;
- pain in your upper stomach, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet; or
- a lump in your breast.
Less serious side effects may include:
- mild stomach pain, bloating;
- back pain, joint pain;
- flu symptoms;
- breast pain;
- loss of scalp hair;
- vaginal itching or discharge; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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.
Read the Prefest (estradiol, norgestimate) Side Effects Center for a complete guide to possible side effects »
What is the most important information I should know about estradiol and norgestimate ?
You should not take estrogens if you have liver disease, circulation problems, a recent stroke or heart attack, unusual vaginal bleeding, a history of breast or uterine cancer, if you have ever had a blood clot, or if you are pregnant.
Before taking estradiol and norgestimate, tell your doctor if you have heart disease, high blood pressure, asthma, kidney disease, a seizure disorder, migraines, lupus, gallbladder disease, underactive thyroid, high levels of calcium in your blood, endometriosis, or if you have had a hysterectomy.
Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you smoke, or if you are overweight.
Long-term estrogen treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using estradiol and norgestimate long-term.
Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.
Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while taking 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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