"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
ALESSE® 28 Tablets
(levonorgestrel and ethinyl estradiol) Tablets
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
- Patient Information:
Details with Side Effects
21 pink active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl- 17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are cellulose, hypromellose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and montanic ester wax.
7 light-green inert tablets, each containing cellulose, FD&C blue no. 1, hypromellose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and montanic ester wax.
What are the possible side effects of ethinyl estradiol and levonorgestrel?
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 any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change...
Last reviewed on RxList: 4/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Alesse Information
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.
Find out what women really need.