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What is ethinyl estradiol and levonorgestrel?
Ethinyl estradiol and levonorgestrel 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 levonorgestrel are used as contraception to prevent pregnancy. Ethinyl estradiol and levonorgestrel may also be used for other purposes not listed in this medication guide.

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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 in the pattern or severity of migraine headaches;

• nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet; or

• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;

• breast pain, tenderness, or swelling;

• freckles or darkening of facial skin;

• increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge;

• changes in your menstrual periods, decreased sex drive; or

• headache, nervousness, dizziness, tired feeling.

This list is not complete and other side effects may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take ethinyl estradiol and levonorgestrel?
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. Some 28-day birth control packs contain seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

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What is the most important information I should know about ethinyl estradiol and levonorgestrel?
Do not use ethinyl estradiol and levonorgestrel if you are pregnant or if you recently had a baby. Do not use this medication if you have 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. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

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What happens if I miss a dose?
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.

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What other drugs will affect ethinyl estradiol and levonorgestrel?
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: acetaminophen (Tylenol) or ascorbic acid (vitamin C); prednisolone (Orapred); theophylline (Respbid, Theo-Dur); cyclosporine (Neoral, Sandimmune, Gengraf); St. John's wort; an antibiotic; seizure medications; a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or HIV or AIDS medications.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Oral contraceptive combinations have been assigned to pregnancy category X. Although some reports have suggested that oral contraceptive hormones may cause a variety of congenital malformations, recent studies (including a meta-analysis of prospective studies) have suggested that an association between oral contraceptive use and congenital malformations does not exist. Some progestins may cause masculinization of female infants. There is no indication for the use of oral contraceptive combinations during pregnancy. Oral contraceptive combinations are contraindicated for use during pregnancy.

One case report has suggested that oral contraceptive hormones may cause choreoathetosis in infants exposed in utero. A recent case control study has suggested a weak association between use of older high dose contraceptives (particularly those containing 1.0 mg of ethynodiol diacetate) and the occurrence of congenital limb defects. However, the authors concluded that "this weak causal relationship was probable in the past when relatively high doses of contraceptive pills were used. This risk is apparently minimized by the use of new type (e.g., D-norgestrel) and lower dose of contraceptive pills".

Both the estrogens and progestins occurring in commercially available oral contraceptive formulations are excreted into human milk in very small amounts. The American Academy of Pediatrics considers use of oral contraceptive combinations to be compatible with breast-feeding despite rare reports of breast enlargement in the nursing infant and the possibility of a decrease in milk production and protein content.

Some studies have examined the effect of progestin-only contraceptives on breast-feeding. The extent to which such studies have bearing on oral contraceptive combinations is uncertain. Use of such formulations have not been associated with deleterious effects on breast-fed infants.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

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What should I discuss with my healthcare provider before taking ethinyl estradiol and levonorgestrel?
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: a history of a stroke or blood clot; circulation problems (especially if caused by diabetes); a hormone-related cancer such as breast or uterine cancer;

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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