drospirenone and ethinyl estradiol

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

Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

The combination of drospirenone and ethinyl estradiol is used as contraception to prevent pregnancy. It is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills to prevent pregnancy.

This medication is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.

Drospirenone and ethinyl estradiol may also be used for other purposes not listed in this medication guide.

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

• uncontrolled high blood pressure, migraine headaches, or a heart valve disorder;
• a history of stroke, blood clot, or circulation problems of diabetes;
• kidney or liver disease;
• adrenal gland disorder;
• unusual vaginal bleeding;
• any type of breast, uterine, or hormone-dependent cancer; or
• a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

• high blood pressure or heart disease;
• high cholesterol or if you are overweight;
• liver cancer;
• gallbladder disease;
• diabetes;
• seizures or epilepsy; or
• a history of depression, irregular menstrual cycles, or 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).

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. 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.

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.

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

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.

Drospirenone 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.

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, 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;
• stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes);
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• 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; or
• changes in your menstrual periods.

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. You may report side effects to FDA at 1-800-FDA-1088.

Some drugs can make drospirenone and ethinyl estradiol less effective, which may result in pregnancy. Other drugs may be affected by drospirenone 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.

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