Levora (28 Day)

Levora (28 Day) is used to prevent pregnancy as a form of contraception. There are many different brands and forms of this medicine available. Not all brands are included in this leaflet.

Levora (28 Day) may also be used for other reasons that are not mentioned in this medication guide.

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, like condoms or a spermicide, when you first start using this medicine. 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 help 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 can swallow the chewable tablet (pill) whole. Take it on an empty stomach.

Use 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.

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 this medicine if you smoke and are over 35 years old.

Taking this medicine can raise your chances of getting blood clots, a stroke, or a heart attack. You are at an even higher risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clots is highest during the first year of taking birth control pills. Your risk is also high if you restart this medicine after not taking it for 4 weeks or longer.

Smoking can significantly increase your risk of blood clots, stroke, or heart attack. Your risk goes up as you get older 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.

Levora (28 Day) can slow breast milk production. You should not breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 immediately 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, sharp 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);
• high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• gallbladder problem--light-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, feeling tired, mood changes.

Common side effects of Levora (28 Day) 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.

Follow the patient instructions that come with your medicine. Missing a pill increases your chance of getting pregnant.

If you miss one active pill, take two pills on the day you remember. Then take one pill each day for the rest of the pack.

If you miss two active pills in a row during Week 1 or 2, take two pills each day for two days in a row. Then take one pill each day for the rest of the pack. Use back-up birth control for at least 7 days after the missed pills.

If you miss two active pills in a row during Week 3, throw away 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 one pill each day until Sunday. On Sunday, throw away 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 away 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 one pill each day until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

If you miss two or more active pills, you might not have a period during that month. If you miss a period for two months in a row, call your doctor because you could be pregnant.

If you miss a reminder pill, throw it away and continue taking one reminder pill each day until the pack is empty.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Symptoms of an overdose may include nausea, vomiting, and drowsiness.

Do not smoke while taking birth control pills, especially if you are over 35 years old.

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.

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.