Gianvi is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Gianvi 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.

Gianvi is used as contraception to prevent pregnancy. This medicine 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.

Yaz 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.

Gianvi may also be used for purposes not listed in this medication guide.

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

You should not take Gianvi if you have: an adrenal gland disorder, kidney disease, 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 will 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 this medicine 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 with spermicide, when you first start using this medication.

Take one pill 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.

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 or will be on long-term bed rest, you may need to stop using Gianvi for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

Store at room temperature away from moisture and heat.

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 birth control pills after not taking them 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 this medicine 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 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take this medicine if you have:

• an adrenal gland disorder;

• kidney disease;

• untreated or uncontrolled high blood pressure;

• heart disease (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;

• if you smoke and are over 35 years old; or

• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

Tell your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to having blood clots;

• high levels of potassium in your blood;

• high cholesterol or triglycerides, or if you are overweight;

• depression;

• liver or kidney disease;

• underactive thyroid, diabetes, gallbladder disease; or

• a migraine headache.

The hormones in this medicine 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.

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day that you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then take 1 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 2 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 3 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 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking 1 reminder pill per day until the pack is empty.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause nausea or vaginal bleeding.

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

This medicine 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 signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Birth control pills may cause serious side effects. 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, 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;

• a change in the pattern or severity of migraine headaches; or

• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects of Gianvi may include:

• nausea, vomiting;

• breast tenderness;

• headache, mood changes, feeling tired or irritable;

• weight gain; or

• changes in your menstrual periods, decreased sex drive.

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.

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