What is ethinyl estradiol and norgestrel?
Ethinyl estradiol and norgestrel contains a combination of female hormones that prevent
ovulation (the release of an egg from an ovary). This medication also causes changes in your
cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a
fertilized egg to attach to the uterus.
Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy.
Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking ethinyl estradiol and norgestrel?
This medication can cause birth defects.
Do not use if you are pregnant.
Tell your doctor right away if you become pregnant, or if you miss two menstrual
periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control
pills (6 weeks if you are breast-feeding).
Do not use this medication if you have:
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a history of a stroke or blood clot;
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circulation problems (especially if caused by diabetes);
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a hormone-related cancer such as breast or uterine cancer;
-
abnormal vaginal bleeding;
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liver disease or liver cancer;
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severe high blood pressure;
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severe migraine headaches;
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a heart valve disorder; or
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a history of jaundice caused by birth control pills.
Before using this medication, tell your doctor if you have any of the
following conditions. You may need a dose adjustment or special tests to safely take birth
control pills.
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high blood pressure, heart disease, congestive heart failure, angina
(chest pain), or a history of heart attack;
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high cholesterol or if you are overweight;
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a history of depression;
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gallbladder disease;
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diabetes;
-
seizures or epilepsy;
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a history of irregular menstrual cycles; or
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a history of fibrocystic breast disease, lumps, nodules, or an
abnormal mammogram.
The hormones in birth control pills can pass into breast milk and
may harm a nursing baby. This medication may also slow breast milk production. Do not use if
you are breast-feeding a baby.
How should I take ethinyl estradiol and norgestrel?
Take this medication exactly as it was prescribed for you. Do not take larger amounts, or
take it for longer than recommended by your doctor. You will take your first pill on the first day
of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you
first start using this medication. Follow your doctor's instructions.
The 28-day birth control pack contains seven "reminder" pills to keep you on your regular
cycle. Your period will usually begin while you are using these reminder pills.
You may have breakthrough bleeding, especially during the first 3 months. Tell your
doctor if this bleeding continues or is very heavy.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new
pack the following day. Get your prescription refilled before you run out of pills completely.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you
may need to stop using this medication for a short time. Any doctor or surgeon who treats you
should know that you are using birth control pills.
Your doctor will need to see you on a regular basis while you are using this medication.
Do not miss any appointments.
Store this medication at room temperature away from moisture and heat.
What happens if I miss a dose of ethinyl estradiol and norgestrel?
Missing a pill increases your risk of becoming pregnant.
If you miss one "active" pill,
take two pills on the day that you
remember. Then take one pill per day for the rest of the pack.
If you miss two "active" pills in a row in week one or two,
take two
pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use
back-up birth control for at least 7 days following the missed pills.
If you miss two "active" pills in a row in week three, or if you miss three
pills in a row during any of the first 3 weeks,
throw out the rest of the pack and start a
new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill
every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss three "active" pills in a row during any of the first 3 weeks,
throw out the rest of the pack and start a new pack on the same day if you are a Day 1
starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw
out the rest of the pack and start a new one that day.
If you miss two or more pills, you may not have a period during the month.
If you miss a period for two months in a row, call your doctor because you might be
pregnant.
If you miss any reminder pills, throw them away and keep taking one pill per day until the
pack is empty. You do not need back-up birth control if you miss a reminder pill.
Where can I get more information about ethinyl estradiol and norgestrel?
Your pharmacist has information about ethinyl estradiol and norgestrel written for health professionals that you may read.
What are the possible side effects of ethinyl estradiol and norgestrel?
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:
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sudden numbness or weakness, especially on one side of the body;
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sudden headache, confusion, problems with vision, speech,
or balance;
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chest pain or heavy feeling, pain spreading to the arm or
shoulder, nausea, sweating, general ill feeling;
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a change in the pattern or severity of migraine headaches;
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nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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swelling in your hands, ankles, or feet;
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a breast lump; or
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symptoms of depression (sleep problems, weakness, mood
changes).
Less serious side effects may include:
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mild nausea, vomiting, bloating, stomach cramps;
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breast pain, tenderness, or swelling;
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freckles or darkening of facial skin;
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increased hair growth, loss of scalp hair;
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changes in weight or appetite;
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problems with contact lenses;
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vaginal itching or discharge;
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changes in your menstrual periods, decreased sex drive; or
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nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about ethinyl estradiol and norgestrel?
Do not use birth control pills if you are pregnant or if you have recently had a baby.
Do not use this medication if you have any of the following conditions: a history of
stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related
cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer,
severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice
caused by birth control pills.
You may need to use back-up birth control, such as condoms or a spermicide, when you
first start using this medication. Follow your doctor's instructions.
Taking hormones can increase your risk of blood clots, stroke, or heart attack,
especially if you smoke and are older than 35.
Some drugs can make birth control pills less effective, which may result in pregnancy.
Tell your doctor about all the prescription and over-the-counter medications you use, including
vitamins, minerals and herbal products. Do not start using a new medication without telling your
doctor.
What should I avoid while taking ethinyl estradiol and norgestrel?
Do not smoke while using birth control pills, especially if you are older than 35.
Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control
pills.
Birth control pills
will not
protect you from sexually transmitted
diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from
these diseases.
What other drugs will affect ethinyl estradiol and norgestrel?
Some drugs can make birth control pills less effective, which may result in pregnancy.
Before using birth control pills, tell your doctor if you are using any of the following drugs:
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acetaminophen (Tylenol) or ascorbic acid (vitamin C);
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phenylbutazone (Azolid, Butazolidin);
-
modafinil (Provigil);
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dexamethasone (Decadron, Hexadrol);
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an antibiotic;
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seizure medicines such as phenytoin (Dilantin),
carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;
-
a barbiturate such as amobarbital (Amytal), butabarbital
(Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal,
Solfoton); or
-
HIV medicines such as amprenavir (Agenerase), atazanavir
(Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir
(Norvir), and others.
This list is not complete and there may be other drugs that can affect
birth control pills. Tell your doctor about all the prescription and over-the-counter medications
you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other
doctors. Do not start using a new medication without telling your doctor.
What happens if I have an overdose of ethinyl estradiol and norgestrel?
