Ethinyl estradiol and norgestimate oral contraceptives may cause heart attacks, blood clots, and strokes. Tell your doctor if you smoke cigarettes or are over 35 years of age or if you have or have ever had blood clots in your legs, lungs, or eyes; conditions in which the blood clots easily; coronary artery disease (clogged blood vessels leading to the heart); cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain); a stroke or mini-stroke; an irregular heartbeat; heart or heart valve disease; a heart attack; or chest pain. Your doctor will probably tell you that you should not take ethinyl estradiol and norgestimate oral contraceptives.
If you experience any of the following symptoms while receiving ethinyl estradiol and norgestimate, call your doctor immediately or get emergency medical treatment: shortness of breath, leg pain, sudden chest pain, sudden severe headache, sudden changes in vision, weakness or numbness in an arm or leg, trouble speaking.
Why is this medicine prescribed?
Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and norgestimate (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries).
Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Are there other uses for this medicine?
Oral contraceptives are also sometimes used to treat heavy or irregular menstruation and endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Talk to your doctor about the risks of using this medication for your condition.
Oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Ethinyl estradiol and norgestimate oral contraceptives come as tablets to take by mouth. Take once a day on the days specified by your doctor. Take your oral contraceptive at around the same time on those days.
Take ethinyl estradiol and norgestimate oral contraceptives exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Ethinyl estradiol and norgestimate oral contraceptives come in many different brands. Different brands of oral contraceptives contain different doses and may also contain inactive tablets or ones containing iron. Oral contraceptives are taken on specific schedules. Be sure that you know which brand of oral contraceptives you are using and exactly how you should use it. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.
Your doctor will tell you when you should start taking your oral contraceptive. It is usually started on the first day of your menstrual period or on the first Sunday after bleeding begins. You will probably be told to use another method of birth control during the first 7 days that you take your oral contraceptive. Talk to your doctor or pharmacist about what method is best for you. Follow these directions carefully to prevent pregnancy.
You will probably experience withdrawal bleeding similar to a menstrual period while you are taking the inactive tablets or during the time that you do not take your oral contraceptive. If you are taking the type of packet that only contains active tablets, you will not experience any scheduled bleeding, but you may experience unexpected bleeding and spotting, especially at the beginning of your treatment. Be sure to start taking your new packet on schedule even if you are still bleeding.
If you vomit or have diarrhea while you are taking ethinyl estradiol and norgestimate oral contraceptives, it may not work as well. If this happens, contact your doctor about what to do. You may be told to use a back-up method for 7 days. Talk to your doctor about an appropriate backup method of birth control in case it is needed at any point during therapy.
Ethinyl estradiol and norgestimate oral contraceptives will work only as long as they are taken regularly. Continue to take them as directed even if you are spotting or bleeding, have an upset stomach, or do not think that you are likely to become pregnant. Do not stop taking oral contraceptives without talking to your doctor.
What special precautions should I follow?
Before taking ethinyl estradiol and norgestimate oral contraceptives,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- you should know that some medications should not be taken with ethinyl estradiol and norgestimate oral contraceptives. Make sure you have discussed any medications you are currently taking or plan to take before starting ethinyl estradiol and norgestimate oral contraceptives with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking ethinyl estradiol and norgestimate oral contraceptives, please get the advice of your doctor or pharmacist.
- the following nonprescription or herbal product may interact with ethinyl estradiol and norgestimate oral contraceptives: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking ethinyl estradiol and norgestimate oral contraceptives. Do not start this medication while taking ethinyl estradiol and norgestimate oral contraceptives without discussing with your healthcare provider.
- tell your doctor if you have or have ever had diabetes that has affected your circulation; migraines or headaches that come along with other symptoms such as vision changes, weakness, and dizziness; high blood pressure that medication can not control; breast cancer; liver cancer, liver tumors, or other types of liver disease; or unexplained vaginal bleeding. Your doctor will probably tell you that you should not take ethinyl estradiol and norgestimate oral contraceptives.
- tell your doctor if you are overweight, and if you have or have ever had high blood cholesterol or fats; diabetes; depression; gallbladder disease; swelling in a part of your body.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.
- you should know that oral contraceptives may cause dark skin patches, especially on the face. If you have experienced changes in your skin color during pregnancy or while you were taking oral contraceptives in the past, you should avoid exposure to real or artificial sunlight while you are taking oral contraceptives. Wear protective clothing, sunglasses, and sunscreen.
- tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking oral contraceptives, see an eye doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ethinyl estradiol and norgestimate oral contraceptives.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you miss doses of your oral contraceptive, you may not be protected from pregnancy. You may need to use a backup method of birth control for 7 days or until the end of the cycle. Every brand of oral contraceptives comes with specific directions to follow if you miss one or more doses. Carefully read the directions in the manufacturer's information for the patient that came with your oral contraceptive when you first start taking it. If you have any questions, call your doctor or pharmacist.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222
. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
- nausea
- vaginal bleeding
What side effects can this medicine cause?
Ethinyl estradiol and norgestimate oral contraceptives may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- nausea, vomiting
- weight gain
- spotting or irregular bleeding between periods
- swelling, redness, irritation, burning, or itching of the vagina
- breast tenderness, enlargement, or discharge
- swelling of the hands, arms, feet, and leg
- difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking ethinyl estradiol and norgestimate and call your doctor immediately or get emergency medical treatment:
- yellowing of the skin or eyes
- pain or tenderness in the abdomen
- a lump in your breast
- unusual bleeding, including menstrual bleeding that is unusually heavy or that lasts for longer than 7 days in a row
Oral contraceptives may increase the chance that you will develop liver tumors. These tumors are not a form of cancer, but they can break and cause serious bleeding inside the body. Oral contraceptives may also increase the chance that you will develop breast or liver cancer. Talk to your doctor about the risks of using oral contraceptives.
Ethinyl estradiol and norgestimate oral contraceptives may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website ( https://goo.gl/c4Rm4p ) for more information.
What other information should I know?
Keep all appointments with your doctor and the laboratory. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. Follow your doctor's directions for examining your breasts; report any lumps immediately.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ethinyl estradiol and norgestimate oral contraceptives.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.