Beyaz (Drospirenone/Ethinyl Estradiol/Levomefolate Calcium)

Do not use Beyaz if you are pregnant or if you recently had a baby.

You should not take Beyaz if you have any of the following conditions: kidney disease, uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes, an adrenal gland disorder, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, a history of breast or uterine cancer, or if you ever had a heart attack, stroke, or blood clot.

You should not take Beyaz if you smoke and are older than 35 years of age. Smoking can increase your risk of blood clot, stroke, or heart attack while taking Beyaz.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Beyaz or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your Beyaz.

Before taking this medicine

Smoking can increase your risk of blood clots, stroke, or heart attack while taking Beyaz, especially if you are older than 35 years of age. Your risk increases the more you smoke. You should not take birth control pills if you smoke and are older than 35 years of age.

Do not use birth control pills if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take Beyaz if you have:

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack or stroke);
• a history of blood clots;
• untreated or uncontrolled high blood pressure;
• a blood-clotting disorder or circulation problems;
• kidney disease;
• an adrenal gland disorder;
• problems with your eyes, kidneys, or circulation caused by diabetes;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes);
• abnormal vaginal bleeding that has not been checked by a doctor; or
• a history of hormone-related cancer such as breast or uterine cancer.

To make sure Beyaz is safe for you, tell your doctor if you have:

• high levels of potassium in your blood;
• high cholesterol or triglycerides, or if you are overweight;
• underactive thyroid, diabetes, gallbladder disease; or
• a history of jaundice caused by pregnancy or birth control pills.

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

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

Stop using BEYAZ and call your doctor at once if you have:

• a change in the pattern or severity of migraine headaches;
• swelling in your hands, ankles, or feet;
• symptoms of depression - sleep problems, weakness, tired feeling, mood changes;
• 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 in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs;
• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• liver problems - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common BEYAZ side effects may include:

• light vaginal bleeding or spotting;
• breast pain or tenderness;
• nausea;

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 other drugs will affect BEYAZ?

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

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

BEYAZ 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.

Take BEYAZ exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. You will 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 and spermicides) when you first start using this medicine. Follow your doctor's instructions.

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

You must take the BEYAZ pills in the right order for this medicine to be effective in preventing pregnancy. Follow the arrows shown on each row of pills in your blister pack. The last few pills you will take contain only levomefolate and not the contraceptive (birth control) medicines.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

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

If you need surgery or medical tests or if you will be on 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 take BEYAZ.

Store BEYAZ at room temperature away from moisture and heat.