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Consumer information use and disclaimer.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Ethinyl Estradiol and Levonorgestrel

PRONUNCIATION (ETH in il es tra DYE ole & LEE voe nor jes trel)

BRAND NAME(S): Altavera, Amethia, Amethia Lo, Amethyst [DSC], Ashlyna, Aubra, Aviane, Balcoltra, camrese, camrese lo, Chateal, Daysee, Delyla, Enpresse, FaLessa Kit, Falmina, Fayosim, Introvale, Jolessa, Kurvelo, Larissia, Lessina, Levonest, Levora, Lillow, LoSeasonique, Lutera, Marlissa, Myzilra, Orsythia, Portia, Quartette, Quasense, Rivelsa, Seasonique, Setlakin, Sronyx, Trivora, and Vienva

WARNING Smoking cigarettes while using this drug raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age.

WHAT IS THIS DRUG USED FOR? It is used to prevent pregnancy.; It may be given to you for other reasons. Talk with the doctor.

WHAT DO I NEED TO TELL MY DOCTOR BEFORE I TAKE THIS DRUG? If you have an allergy to ethinyl estradiol, levonorgestrel, or any other part of this drug.; If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.; If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, liver disease, liver tumor, very bad headache or migraine, or diabetes that affects blood flow.; If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.; If you have surgery and need bedrest.; If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.; If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.; If you are breast-feeding or plan to breast-feed.; If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).This is not a list of all drugs or health problems that interact with this drug.Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WHAT ARE SOME THINGS I NEED TO KNOW OR DO WHILE I TAKE THIS DRUG? Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as your doctor has told you. If this drug is stopped, your doctor will tell you when to start taking this drug again after your surgery or procedure.; This drug may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.; Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.; If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.; Check your blood sugar as you have been told by your doctor.; High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.; Have blood work checked as you have been told by the doctor. Talk with the doctor.; Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.; This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.; Certain drugs, herbal products, or health problems could cause this drug to not work as well. Be sure your doctor knows about all of your drugs and health problems.; If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.; This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.; This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.; Do not use in children who have not had their first menstrual period.; If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.

WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.; Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. ; Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.; Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.; Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.; Very upset stomach or throwing up.; Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.; Mood changes.; Low mood (depression).; Feeling very tired or weak.; Very bad belly pain.; Swelling.; Not able to pass urine or change in how much urine is passed.; A lump in the breast, breast soreness, or nipple discharge.; Vaginal itching or discharge.; Spotting or vaginal bleeding that is very bad or does not go away.; Bulging eyes.; Loss of eyesight.; Change in how contact lenses feel in the eyes.; Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling more or less hungry.; Dizziness.; Weight gain.; Headache.; Upset stomach or throwing up.; Cramps.; Bloating.; Enlarged breasts.; Breast soreness.; Hair loss.; Pimples (acne).; Period (menstrual) changes. These include spotting or bleeding between cycles.; Lowered interest in sex.; This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at

HOW IS THIS DRUG BEST TAKEN? Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.; Follow how to use as you have been told by the doctor or read the package insert.; Take this drug at the same time of day.; Take with or without food. Take with food if it causes an upset stomach.; Do not skip doses, even if you do not have sex very often.; If you also take colesevelam, take it at least 4 hours before or after you take this drug.; After starting this drug, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control.; If you throw up or have diarrhea, this drug may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.; If your monthly cycle is 28 days and you miss 2 periods in a row, take a pregnancy test before starting a new dosing cycle.; If you have a cycle longer than 91 days and you miss one period, take a pregnancy test before starting a new dosing cycle.

WHAT DO I DO IF I MISS A DOSE? If a dose is missed, check the package insert or call the doctor to find out what to do. If using this drug to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

HOW DO I STORE AND/OR THROW OUT THIS DRUG? Store at room temperature.; Protect from light.; Store in a dry place. Do not store in a bathroom.; Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.; Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

GENERAL DRUG FACTS If your symptoms or health problems do not get better or if they become worse, call your doctor. ; Do not share your drugs with others and do not take anyone else's drugs.; Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.; Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.; Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.; If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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