Afirmelle is used as contraception to prevent pregnancy. There are many brands and forms of Afirmelle available. Not all brands are listed on this leaflet.

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

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 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 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 Afirmelle 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 or a spermicide, when you first start using Afirmelle. 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.

You should chew the chewable tablet (pill) and then swallow it with a glass of water, or if you prefer you should swallow the chewable tablet (pill) whole. Take it on an empty stomach.

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 or will be on 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 at room temperature away from moisture, heat, and light.

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).

Tell your doctor if you have ever had:

• heart disease, high blood pressure, or if you are prone to 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.

Afirmelle can slow breast milk production. You should not breastfeed while using this medicine.

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.

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

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.

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), severe headache, slurred speech, balance problems;

• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, 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;

• gallbladder problem--chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back;

• 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 of Afirmelle 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.

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.