WHAT IS Alesse/Levonorgestrel ethinyl estradiol TABLETS?

ALESSE is used for preventing pregnancy. It may be used for other conditions as determined by your doctor.

Alesse is a combination birth control pill. It works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus.

WHERE SHOULD I KEEP Alesse/Levonorgestrel ethinyl estradiol?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed.

HOW SHOULD I USE Alesse/Levonorgestrel ethinyl estradiol?

Use Alesse as directed by your doctor. Check the label on the medicine for exact dosing instructions. Take Alesse by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Begin taking Alesse on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Alesse on that day. Try to take Alesse at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.

For Alesse to be effective it must be taken every day. Do not skip doses. Ask your health care provider any questions you may have about how to use Alesse .

WHAT IF I MISS A DOSE?

If you miss a dose of Alesse and remember it on the same day, take it as soon as possible and go back to your regular dosing schedule. If you do not remember until the next day or if you miss more than 1 dose of Alesse , see the additional patient information leaflet that comes with Alesse or contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of Alesse , use an extra form of birth control (eg, condoms) until you talk with your doctor.

WHAT SHOULD I WATCH FOR WHILE USING Alesse/Levonorgestrel ethinyl estradiol?

Alesse may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Alesse with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Alesse .

Alesse may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.

Use of Alesse will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs). Bleeding or spotting may occur while taking Alesse . Do not stop taking Alesse if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.

Smoking while using Alesse may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.

If you wear contact lenses and you develop problems with them, contact your doctor. If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.

Alesse may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Alesse .Discuss any concerns with your doctor or pharmacist. Lab tests, such as PAP tests, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

WHAT MAY INTERACT WITH Alesse/Levonorgestrel ethinyl estradiol?

• oxcarbazepine/Trileptal
• HIV protease inhibitors
• azole antifungals
• nevirapine
• salicylic acidrin
• dexamethasone/Decadron
• atorvastatin/Lipitor
• cyclosporine/Sandimmune
• barbiturates
• hydantoins
• lamotrigine/Lamictal
• penicillins
• tetracyclines
• temazepam
• corticosteroids
• beta-blockers
• theophylline/Uniphyl tr
• phenylbutazone
• morphine
• modafinil
• rifabutin
• indinavir/Crixivan
• troleandomycin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alesse may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

WHAT SIDE EFFECTS MAY I NOTICE FROM Alesse/Levonorgestrel ethinyl estradiol?

Side effects that you should report to your doctor or health care professional as soon as possible:

• coughing of blood
• persistent or recurrent abnormal vaginal bleeding
• persistent headache or migraines
• changes in vision or speech
• sudden severe headache or vomiting
• severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
• breast discharge, breast lumps
• calf or leg pain, swelling, or tenderness
• severe pain or tenderness in the stomach
• sudden partial or complete loss of vision
• crushing chest pain or heaviness in the chest
• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• vomiting
• stomach cramps or bloating
• changes in sexual interest
• changes in weight
• breast tenderness or enlargement
• dizziness
• changes in appetite
• nausea
• unusual spotting or bleeding

This list may not describe all possible side effects.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDERS BEFORE I TAKE Alesse/Levonorgestrel ethinyl estradiol?

They need to know if you have any of these conditions:

• estrogen-dependent growths
• smoke 15 or more cigarettes per day
• endometrial, cervical, vaginal or breast cancer
• blood clotting problems, severe blood clots, certain blood vessel problems
• severe or uncontrolled high blood pressure
• liver disease or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
• risk for developing severe blood clots or have certain heart problems
• chest pain caused by angina
• have had surgery and are or will be confined to a bed or a chair for an extended period of time
• diabetes
• pregnant or trying to get pregnant

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.