Norelgestromin Ethinyl Estradiol, Zafemy, Xulane

Ethinyl Estradiol and Norelgestromin

(ETH in il es tra DYE ole & nor el JES troe min)

Xulane

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. Be sure you know your body mass index (BMI). If you do not know, talk with your doctor. If your BMI is 25 or more, this drug may not work as well. Do not use this drug if your BMI is 30 or more. The risk of blood clots may be higher in women with a BMI of 30 or more.

It is used to prevent pregnancy. It may be given to you for other reasons. Talk with the doctor.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. 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 eyesight problems like loss of eyesight from blood vessel problems in the eye. 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 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.

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. You will get more estrogen if you use this drug than if you use some other birth control pills. This may raise the risk of side effects like blood clots. Talk with your 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 weigh 198 pounds (90 kilograms) or more, this drug may not work as well to prevent pregnancy. Talk with your doctor. 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. Tell your doctor if you have 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. This drug may cause high cholesterol and triglyceride levels. Talk with the doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor. Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told. This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug. If you drink grapefruit juice or eat grapefruit often, talk with your doctor. 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. This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, 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. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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 high blood pressure like very bad headache or dizziness, passing out, or change in eyesight. 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. Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. Depression or other mood changes. Feeling very tired or weak. Eyesight changes or loss, bulging eyes, or change in how contact lenses feel. A lump in the breast, breast pain or soreness, or nipple discharge. Vaginal itching or discharge. Spotting or vaginal bleeding that is very bad or does not go away. This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing. 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.

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: Weight gain. Headache. Upset stomach or throwing up. Stomach pain or cramps. Bloating. Enlarged breasts. Breast soreness. Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles. Lowered interest in sex. Irritation where this drug is used. 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Put patch on once a week for 3 weeks. Put it on the same day each week. Do not use patch on the 4th week. Put patch on clean, dry, healthy skin on the buttock, belly, upper arm, or back. Move the site with each patch. Do not put on the breast. Do not put the patch on the waistline. Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes. Do not use patches that are cut or do not look right. Do not use adhesives or wraps to hold the patch in place. Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well. Do not skip doses, even if you do not have sex very often. Do not put on more than 1 patch at a time. If you miss 2 periods in a row, take a pregnancy test before starting a new dosing cycle. If this drug has not been used the right way and 1 monthly period is missed, take a pregnancy test. Put the same patch on the same place if it falls off and has been off for less than 24 hours. Put on a new patch if the patch being used is no longer sticky or if it is sticking to itself or some other surface. If a patch has been off for more than 1 day, you may not be protected from pregnancy. Put a new patch on to start a new 4 week cycle. Use another type of birth control like a condom during the first week of the new cycle.

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.

Store at room temperature. Do not refrigerate or freeze. Store in pouch until ready for use. After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them. 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.

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. 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.

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.