What is the most important information I should know about ethinyl estradiol and norelgestromin?

Do not use this medication if you are pregnant or if you have 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.

Using 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.

What is ethinyl estradiol and norelgestromin?

Ethinyl estradiol and norelgestromin 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 norelgestromin are used as contraception to prevent pregnancy.

Ethinyl estradiol and norelgestromin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using ethinyl estradiol and norelgestromin?

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 using this medication (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;
• abnormal vaginal bleeding;
• liver disease or liver cancer;
• severe high blood pressure;
• severe migraine headaches;
• a heart valve disorder; or
• 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 use this medication.

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
• high cholesterol or if you are overweight;
• kidney disease;
• a history of depression;
• gallbladder disease;
• diabetes;
• seizures or epilepsy; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in this medication 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.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

How should I use ethinyl estradiol and norelgestromin?

Use this medication exactly as it was prescribed for you. Do not use more skin patches or wear them for longer than recommended by your doctor. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

Place the patch on your skin and press it into place firmly for 10 seconds. Make sure the edges stick well. You will wear the patch for a full week.

Apply the patch to clean, dry skin on any of these areas: the outside of your upper arm, your stomach, your buttocks, or your upper back. Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).

Remove the patch and apply a new one on the same day each week for three weeks in a row. Check your patch every day to make sure it is sticking well to your skin. At the end of the third week, remove the patch and do not apply a new one for 7 full days. Your period should start during this time Do not allow more than 7 days to pass before starting your next 3-week patch cycle..

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.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

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 skin patches.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store the skin patches at room temperature away from moisture and heat. Keep each patch in its foil pouch until you are ready to apply it.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch on the next regularly scheduled day of the week. Do not use extra patches to make up the missed dose.

Missing a dose increases your risk of becoming pregnant. Follow the weekly patch schedule closely.

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.

What should I avoid while using ethinyl estradiol and norelgestromin?

Do not smoke while using the birth control patch, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by using this medication.

This medication 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.

Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.

What are the possible side effects of ethinyl estradiol and norelgestromin?

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 the patches 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;
• stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects:

• 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 is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect ethinyl estradiol and norelgestromin?

Some drugs can make ethinyl estradiol and norelgestromin less effective, which may result in pregnancy. Before using ethinyl estradiol and norelgestromin, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• phenylbutazone (Azolid, Butazolidin);
• prednisolone (Orapred);
• theophylline (Respbid, Theo-Dur);
• cyclosporine (Neoral, Sandimmune, Gengraf);
• St. John's wort;
• an antibiotic such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), tetracycline (Sumycin, Achromycin, Robitet), and others;
• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;
• a barbiturate such as phenobarbital (Solfoton), and others; or
• any medication to treat HIV or AIDS.

This list is not complete and there may be other drugs that can interact with ethinyl estradiol and norelgestromin. 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.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norelgestromin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 4.03. Revision date: 02/05/2008.