Aygestin (Norethindrone Acetate)

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, breast cancer, abnormal vaginal bleeding, liver disease, or if you have recently had an incomplete miscarriage or abortion.

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.

AYGESTIN does not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases.

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Do not use this medication if you are allergic to AYGESTIN, or if you have:

• a history of a stroke, blood clot, or circulation problems;
• breast cancer;
• abnormal vaginal bleeding; or
• if you have recently had an incomplete miscarriage or abortion.

Before using AYGESTIN, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take AYGESTIN.

• high blood pressure or a history of heart disease;
• migraines;
• kidney disease;
• liver disease or liver cancer;
• a history of depression or mental illness;
• high cholesterol or triglycide (fatty acid) levels in your blood;
• asthma; or
• seizures or epilepsy.

AYGESTIN can pass into breast milk. Make sure your doctor knows if you are breast-feeding a baby while taking this medication.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

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;
• pain or swelling in one or both legs;
• migraine headache;
• swelling in your hands or feet, rapid weight gain;
• symptoms of depression (sleep problems, weakness, mood changes);
• severe pelvic pain;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, swelling, or tenderness;
• dizziness;
• freckles or darkening of facial skin;
• increased acne or hair growth;
• changes in weight;
• vaginal itching or discharge;
• skin itching or rash;
• changes in your menstrual periods, decreased sex drive; or
• mild headache.

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.

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

AYGESTIN 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.

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

• griseofulvin (Fulvicin, Grisactin);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• John's wort;
• ketoconazole (Nizoral) or itraconazole (Sporanox);
• 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), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).

There may be other drugs that can interact with AYGESTIN. 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.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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.

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 AYGESTIN.

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.

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

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Missing a pill increases your risk of becoming pregnant. If you are more than 3 hours late in taking your dose, use back-up birth control such as condoms or a spermicide for at least the next 48 hours.

If you miss a period for two months in a row, call your doctor because you might be pregnant.