Alesse

Alesse

     * Generic Name: levonorgestrel and ethinyl estradiol
     * Brand Name: Alesse


     * What is ethinyl estradiol and levonorgestrel?
     * What are the possible side effects of ethinyl estradiol and
       levonorgestrel?
     * What is the most important information I should know about
       ethinyl estradiol and levonorgestrel?
     * What should I discuss with my healthcare provider before taking
       ethinyl estradiol and levonorgestrel?
     * How should I take ethinyl estradiol and levonorgestrel?
     * What happens if I miss a dose?
     * What happens if I overdose?
     * What should I avoid while taking ethinyl estradiol and
       levonorgestrel?
     * What other drugs will affect ethinyl estradiol and
       levonorgestrel?
     * Where can I get more information?

What is ethinyl estradiol and levonorgestrel?

   Ethinyl estradiol and levonorgestrel is a combination birth
   control pill containing female hormones that prevent ovulation (the
   release of an egg from an ovary). This medicine 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 is used as contraception to
   prevent pregnancy. There are many available brands of ethinyl estradiol
   and levonorgestrel. Not all brands are listed on this leaflet.

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

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

   Get emergency medical help if you have signs of an allergic reaction:
   hives; difficult breathing; swelling of your face, lips, tongue, or
   throat.

   Stop using birth control pills and call your doctor at once if you
   have:
     * signs of a stroke--sudden numbness or weakness (especially on
       one side of the body), sudden severe headache, slurred speech,
       problems with vision or balance;
     * signs of a blood clot--sudden vision loss, stabbing chest pain,
       feeling short of breath, coughing up blood, pain or warmth in
       one or both legs;
     * heart attack symptoms--chest pain or pressure, pain spreading to
       your jaw or shoulder, nausea, sweating;
     * liver problems--loss of appetite, upper stomach pain,
       tiredness, fever, dark urine, clay-colored stools, jaundice
       (yellowing of the skin or eyes);
     * increased blood pressure--severe headache, blurred vision, pounding
       in your neck or ears;
     * swelling in your hands, ankles, or feet;
     * changes in the pattern or severity of migraine headaches;
     * a breast lump; or
     * symptoms of depression--sleep problems, weakness, tired feeling,
       mood changes.

   Common side effects may include:
     * nausea, vomiting (especially when you first start taking this
       medicine);
     * breast tenderness;
     * breakthrough bleeding;
     * acne, darkening of facial skin;
     * weight gain; or
     * problems with contact lenses.

   This is not a complete list of side effects and others may occur. Call
   your doctor for medical advice about side effects. You may report side
   effects to FDA at 1-800-FDA-1088.

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

   Do not use birth control pills if you are pregnant or if you have
   recently had a baby.

   You should not use birth control pills if you have: uncontrolled
   high blood pressure, heart disease, coronary artery
   disease, circulation problems (especially with diabetes),
   undiagnosed vaginal bleeding, liver disease or liver
   cancer, severe migraine headaches, if you also take certain
   hepatitis C medication, if you have major surgery, if you smoke and
   are over 35, or if you have ever had a heart attack, a stroke,
   a blood clot, jaundice caused by pregnancy or birth control pills,
   or cancer of the breast, uterus/cervix, or vagina.

   Taking birth control pills can increase your risk of blood clots,
   stroke, or heart attack.

   Smoking can greatly increase your risk of blood clots, stroke, or heart
   attack. You should not take this medicine if you smoke and are over 35
   years old.

   Alesse Patient Information including How Should I Take
   Birth Control: Methods, Side Effects and Effectiveness

   Birth Control Slideshow Pictures
   RxList

   Think You Know Birth Control? Quiz

What should I discuss with my healthcare provider before taking ethinyl
estradiol and levonorgestrel?

   Taking this medicine can increase your risk of blood clots, stroke, or
   heart attack. You are even more at risk if you have high blood
   pressure, diabetes, high cholesterol, or if you are overweight.
   Your risk of stroke or blood clot is highest during your first year of
   taking birth control pills. Your risk is also high when you restart
   this medicine after not taking it for 4 weeks or longer.

   Smoking can greatly increase your risk of blood clots, stroke, or heart
   attack. Your risk increases the older you are and the more you smoke.
   You should not take combination birth control pills if you smoke and
   are over 35 years old.

   Do not use if you are pregnant. Stop using this medicine and 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.

   You should not take birth control pills if you have:
     * untreated or uncontrolled high blood pressure;
     * heart disease (chest pain, coronary artery disease, history of
       heart attack, stroke, or blood clot);
     * an increased risk of having blood clots due to a heart problem
       or a hereditary blood disorder;
     * circulation problems (especially if caused by diabetes);
     * a history of hormone-related cancer, or cancer of the breast,
       uterus/cervix, or vagina;
     * unusual vaginal bleeding that has not been checked by a doctor;
     * liver disease or liver cancer;
     * severe migraine headaches (with aura, numbness, weakness, or
       vision changes), especially if you are older than 35;
     * a history of jaundice caused by pregnancy or birth control pills;
       or
     * if you take any hepatitis C medication containing
       ombitasvir/paritaprevir/ritonavir (Technivie).

   To make sure birth control pills are safe for you, tell your doctor if
   you have ever had:
     * heart disease, high blood pressure, or if you are prone having
       blood clots;
     * high cholesterol or triglycerides, or if you are overweight;
     * depression;
     * a seizure or migraine headache;
     * diabetes, gallbladder disease;
     * liver or kidney disease;
     * irregular menstrual cycles; or
     * fibrocystic breast disease, lumps, nodules, or an abnormal
       mammogram.

   The hormones in birth control pills can pass into breast milk and may
   harm a nursing baby. This medicine may also slow breast milk
   production. Do not use if you are breast feeding a baby.

How should I take ethinyl estradiol and levonorgestrel?

   Follow all directions on your prescription label. Do not take this
   medicine in larger or smaller amounts or for longer than recommended.

   Take your first pill on the first day of your period or on the first
   Sunday after your period begins. You may need to use back-up birth
   control, such as condoms or a spermicide, when you first start
   using this medicine. Follow your doctor's instructions.

   Take one pill every day, no more than 24 hours apart. When the pills
   run out, start a new pack the following day. You may get pregnant if
   you do not take one pill daily. Get your prescription refilled before
   you run out of pills completely.

   Some 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.

   Use a back-up birth control if you are sick with severe vomiting or
   diarrhea.

   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 major surgery with long-term bed rest, you may need to stop
   using this medicine for a short time. Any doctor or surgeon who
   treats you should know that you are using birth control pills.

   While taking birth control pills, you will need to visit your doctor
   regularly.

   Store this medicine at room temperature away from moisture and heat.

   Alesse Patient Information including If I Miss a Dose
   Birth Control: Methods, Side Effects and Effectiveness

   Birth Control Slideshow Pictures
   RxList

   Think You Know Birth Control? Quiz

What happens if I miss a dose?

   Follow the patient instructions provided with your medicine. 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 1 or 2, 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 3, throw out the rest of
   the pack and start a new pack 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 pack that
   day.

   If you miss three active pills in a row in Week 1, 2, or 3, throw out
   the rest of the pack and start a new pack on 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 pack that day.

   If you miss two or more active pills, you may not have a period during
   the month. If you miss a period for two months in a row, call your
   doctor because you might be pregnant.

   If you miss a reminder pill, throw it away and keep taking one reminder
   pill per day until the pack is empty.

What happens if I overdose?

   Seek emergency medical attention or call the Poison Help line at
   1-800-222-1222. Overdose symptoms may include nausea, vomiting, and
   drowsiness.

What should I avoid while taking ethinyl estradiol and levonorgestrel?

   Do not smoke while taking birth control pills, especially if you are
   older than 35 years of age.

   Birth control pills 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.

What other drugs will affect ethinyl estradiol and levonorgestrel?

   Other drugs may interact with birth control pills, including
   prescription and over-the-counter medicines, vitamins, and herbal
   products. Some drugs can make birth control pills less effective, which
   may result in pregnancy. Tell your doctor about all your current
   medicines and any medicine you start or stop using.

Where can I get more information?

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