What is the most important information I should know about Alesse?

• Take your pill at the same time every day. Each dose should come no more than 24 hours after the last dose.
• Avoid smoking cigarettes while taking Alesse. Smoking greatly increases the risk of having a heart attack, stroke, or blood clot.
• Use another form of birth control if you miss several doses (see the package insert) or if you are taking drugs that decrease the effectiveness of Alesse (see the section of this leaflet titled “What other drugs will affect my Alesse?”).

What are Alesse?

• Alesse contain a combination of hormones that is used to prevent ovulation (the release of an egg from an ovary). The pills contain a form of estrogen and a form of progesterone, which are both female hormones involved in conception.
• Alesse also have other effects that inhibit pregnancy. They cause the cervical mucous to thicken, which makes it harder for sperm to move toward the uterus, and they prevent the attachment of an egg to the uterus.
• Alesse are used to prevent pregnancy.
• Alesse may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Alesse?

• Before taking this medication, tell your doctor if you
  • have high blood pressure, angina, or heart disease;
  • have had a stroke;
  • have a bleeding or blood-clotting disorder;
  • have breast, uterine, or another hormone-related cancer;
  • have liver disease or a history of jaundice (yellowing of the skin and eyes) caused by use of birth control in the past;
  • have undiagnosed, abnormal vaginal bleeding;
  • have migraines;
  • have asthma; or
  • have seizures or epilepsy.
• You may not be able to take Alesse, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
• Alesse are in the FDA pregnancy category X. This means that Alesse will cause birth defects in an unborn baby. Hormonal changes during pregnancy can have very serious negative effects on a developing baby. Do not take Alesse if you are pregnant or if you think you might be pregnant.
• The hormones in Alesse pass into breast milk and may decrease milk production. Do not take Alesse without first talking to your doctor if you are breast-feeding a baby.

How should I take my Alesse?

• Take your Alesse exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take the first pill in a package on the first Sunday after your period begins (unless otherwise directed by your doctor).
• Take one pill every day, no more than 24 hours after your last dose. Try to take the pills at a time that you will remember every day — for example just before bed, with a meal, or first thing in the morning.
• Taking your pill at night may help to reduce any nausea or headache that you may experience because of the hormones.
• If you are on a 28-day cycle, take one pill every day. When the pack runs out, throw it away. Begin a new pack the following day. The 28-day cycle contains seven pills that are either placebos (with no active ingredients) or iron supplements. These are “reminder” pills to keep you on your regular cycle. They are taken while you are menstruating.
• If you are on a 21-day cycle, take one pill every day for 21 days, then do not take any pills for 7 days. You should have your period during the 7 days with no pills. Resume your pills on the 8th day with a new package.
• Follow your doctor's instructions about using a second form of birth control when you first start taking Alesse, when you are taking antibiotics, or if you miss a pill. If you are unsure what to do in any of these cases, talk to your pharmacist, nurse, or doctor about how to ensure that you will not become pregnant.
• Store Alesse at room temperature away from moisture and heat.

What happens if I miss a dose?

• Missing a pill increases the risk of becoming pregnant.
• Follow the exact directions on your package information insert concerning missed doses. If you do not have a package information insert, call your pharmacist, doctor, or nurse to find out what to do.
• In general:
• If you miss one dose, take it as soon as you remember or take two pills at the time of your next regularly scheduled dose. There is little likelihood that ovulation will occur. You may, however, want to use a second method of birth control such as a condom or a spermicidal cream, jelly, or foam for at least seven consecutive days following the missed tablet to ensure protection from pregnancy.
• If you miss two tablets in a row, take the two missed tablets as soon as you remember or with your next regularly scheduled dose (three total). Or, you may take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). Chances are much greater that you may ovulate so you must use another form of birth control for at least 7 days following the missed tablets. It is even better to use a second method of birth control until your next period.
• If you miss three tablets in a row, throw away the package and start a new package on the 7th day after the last day you took a pill. Use another method of birth control until you have taken a pill for 7 days in a row. Your period should occur during the 7 days without pills. If it doesn't, have a pregnancy test before beginning a new package of pills.
• Read all of the information in your package information insert. It may have slightly different instructions in the case of missed pills. Talk to your pharmacist, nurse, or doctor if you have any questions.

What happens if I overdose?

• Death is not likely to occur from an overdose of Alesse. Consult a doctor, an emergency room, or a poison control left for advice.
• Symptoms of an overdose include nausea, vomiting, and menstrual bleeding.

What should I avoid while taking my Alesse?

• Avoid smoking. Smoking greatly increases your risk of a heart attack, stroke, or blood clot formation.
• Alesse do not protect you from sexually transmitted diseases — including HIV and AIDS.

What are the possible side effects of my Alesse?

• If you experience any of the following serious side effects, stop taking your Alesse and seek emergency medical attention:
  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a blood clot in the lung (shortness of breath or pain in the chest);
  • a blood clot in an arm or leg (pain, redness, swelling, or numbness of an arm or leg);
  • high blood pressure (severe headache, flushing, blurred vision); or
  • liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).
• Other, less serious side effects may be more likely to occur. Continue to take your Alesse and talk to your doctor if you experience
  • headache or dizziness;
  • nausea, vomiting, or diarrhea;
  • breakthrough bleeding; or
  • breast tenderness.
• These side effects may disappear or be less noticeable after 3 to 6 months of birth control use. Ask your doctor or pharmacist for advice if you find any side effect very bothersome.
• The side effects listed below generally occur very rarely and are not considered serious. If you experience any of the following, talk to your doctor:
  • depression,
  • changes in weight or appetite,
  • vaginal yeast infection,
  • changes in your menstrual cycle,
  • oily skin or acné,
  • changes in your sex drive,
  • lethargy or fatigue,
  • bloating,
  • changes in your skin color, or
  • changes in your blood sugar.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect my Alesse?

• Some drugs may decrease the effectiveness of Alesse, which may result in pregnancy. Use a second form of birth control if you are taking
  • a penicillin antibiotic such as amoxicillin (Amoxil, Polymox, Trimox, Wymox, Utimox, A-Cillin, Larotid, Augmentin, others), ampicillin (Principen, Omnipen, Penamp, Polycillin, Amplin, Amcill, Totacillin, others), bacampicillin (Spectrobid), carbenicillin (Geocillin), cloxacillin (Cloxapen, Tegopen), dicloxacillin (Dynapen, Dycill, Pathocil), nafcillin (Nafcil, Nallpen, Unipen), oxacillin (Bactocill, Prostphlin), or penicillin (Veetids, Pen Vee K, Bicillin, Permapen, others);
  • a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Doxy, Vibramycin, Vibra-Tabs, others), minocycline (Minocin), or tetracycline (Sumycin, Teracyn, Achromycin, Robitet, Panmycin, others);
  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);
  • rifampin (Rifadin);
  • phenytoin (Dilantin);
  • carbamazepine (Tegretol); or
  • griseofulvin (Grisactin, Grifulvin V, Fulvicin PG).
• Drugs other than those listed here may also interact with Alesse. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.