Yaz

Do not take this medication if you are allergic to drospirenone or ethinyl estradiol, or if you have:

• uncontrolled high blood pressure, or a heart valve disorder;

• a history of stroke, blood clot, or circulation problems of diabetes;

• kidney or liver disease;

• adrenal gland disorder;

• migraine headaches;

• unusual vaginal bleeding;

• any type of breast, uterine, or hormone-dependent cancer;

• a history of jaundice caused by birth control pills; or

• if you have not yet started having menstrual periods.

Before using this medication, tell your doctor if you have any of the following conditions. You may not be able to use drosperinone and ethinyl estradiol, or you may need a dosage adjustment or special tests during treatment.

• high blood pressure or heart disease;

• high cholesterol or if you are overweight;

• liver cancer;

• a history of depression;

• gallbladder disease;

• diabetes;

• seizures or epilepsy;

• a history of irregular menstrual cycles; or

• a history of breast or uterine cancer.

FDA pregnancy category X. This medication can cause birth defects. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

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.

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels, including liver disease, kidney disease, and adrenal gland disorders. Before using drospirenone and ethinyl estradiol, tell your doctor if you have any of these conditions.

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor’s instructions).

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.

The 28-day birth control pack contains both "active” and "reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

Take one pill every day, no more than 24 hours apart. Taking the pill at night may reduce side effects such as headache and nausea. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

You may have breakthrough bleeding. 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 pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments. Self-examine your breasts monthly to check for lumps while you are taking drospirenone and ethinyl estradiol.

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

Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.

If you miss one"active” pill, take the dose as soon as you remember or take two pills at the time of your next regularly scheduled dose. You do not need to use backup birth control.

If you miss two"active” tablets in a row in week one or two, 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). Use another form of birth control for at least 7 days following the missed tablets.

If you miss two "active” tablets in a row in week three, or if you miss three tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new package 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 of pills that same day. You may not have a period that month, but this is expected. However, if you miss your period 2 months in a row, call your doctor because you might be pregnant.

If you miss one of the reminder pills in week four, skip that dose and take the next one as directed.

If you miss a pill, you may become pregnant if you have sex in the 7 days after your missed pill. You MUST use another birth control method (such as condoms or spermicides) as a back-up for those 7 days.

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;

• 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;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• a breast lump; or

• symptoms of depression (sleep problems, weakness, mood changes).

Continue using the medication and talk with your doctor if you have any of these less serious side effects:

• mild nausea, vomiting, bloating, stomach cramps;

• breast pain, tenderness, or swelling;

• freckles or darkening of facial skin, increased hair growth, or loss of scalp hair;

• changes in weight or appetite, swelling of your hands or feet;

• problems with contact lenses;

• vaginal itching or discharge;

• changes in your menstrual periods; or

• headache, nervousness, dizziness.

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.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a heart valve disorder, breast or uterine cancer, abnormal vaginal bleeding, kidney or liver disease, an adrenal gland disorder, severe high blood pressure, migraine headaches, or a history of jaundice caused by birth control pills.

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

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels, including liver disease, kidney disease, and adrenal gland disorders. Before using drospirenone and ethinyl estradiol, tell your doctor if you have any of these conditions.

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

Drosperinone and ethinyl estradiol 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 drosperinone and ethinyl estradiol less effective, which may result in pregnancy. Other drugs may be affected by drosperinone and ethinyl estradiol. Before using this medication, 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.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of drospirenone and ethinyl estradiol may cause nausea, vomiting, or vaginal bleeding.