"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.
Climara Pro Patient Information Including Side Effects
Brand Names: Climara Pro
Generic Name: estradiol and levonorgestrel (topical patches) (Pronunciation: ess tra DY ol and LEE vo nor JESS trell)
- What are estradiol and levonorgestrel (Climara Pro)?
- What are the possible side effects of estradiol and levonorgestrel (Climara Pro)?
- What is the most important information I should know about estradiol and levonorgestrel (Climara Pro)?
- What should I discuss with my healthcare provider before using estradiol and levonorgestrel (Climara Pro)?
- How should I use estradiol and levonorgestrel (Climara Pro)?
- What happens if I miss a dose (Climara Pro)?
- What happens if I overdose (Climara Pro)?
- What should I avoid while using estradiol and levonorgestrel (Climara Pro)?
- What other drugs will affect estradiol and levonorgestrel (Climara Pro)?
- Where can I get more information?
What are estradiol and levonorgestrel (Climara Pro)?
Estradiol is a form of estrogen, a female hormone involved in the development and maintenance of the female reproductive system. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
Estradiol and levonorgestrel is used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women. This medication will not prevent dementia, heart attack, heart disease, or stroke.
Estradiol and levonorgestrel may also be used for purposes other than those listed here.
What are the possible side effects of estradiol and levonorgestrel (Climara Pro)?
Stop using this medication and 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.
Call your doctor at once if you have any of the following serious side effects:
- signs of a blood clot (sharp chest pain, coughing up blood, shortness of breath, pain in your calf);
- signs of a heart attack (crushing chest pain, left-arm numbness);
- signs of a stroke (sudden severe headache, problems with vision or speech, weakness, numbness);
- nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- new or changing breast lumps.
Other less serious side effects are more likely to occur, such as:
- nausea and vomiting;
- tender or swollen breasts;
- swelling of the hands or feet;
- darkened spots on the skin of your face;
- contact lens discomfort;
- vaginal irritation or discomfort;
- headache, depressed mood;
- a skin rash or reaction where the patch is worn; or
- changes in your menstrual periods.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the Climara Pro (estradiol, levonorgestrel transdermal) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about estradiol and levonorgestrel (Climara Pro)?
This medication should not be used to prevent heart disease or dementia. Using estrogens long-term may actually increase your risk of heart attack, stroke, dementia, breast cancer, blood clots.
To be sure this medication is helping your condition, you will need to have regular physical exams every 3 to 6 months. You may also need breast mammograms. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.
This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.
Additional Climara Pro Information
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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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