Mili

• It is used to prevent pregnancy.
• It is used to treat pimples (acne).
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to ethinyl estradiol, norgestimate, or any other part of Mili (ethinyl estradiol and norgestimate).
• 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 Mili (ethinyl estradiol and norgestimate) 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 Mili (ethinyl estradiol and norgestimate).

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 Mili (ethinyl estradiol and norgestimate) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.
• 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.
• Low mood (depression).
• Mood changes.
• 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.
• Change in eyesight.
• 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.

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.
• Gas.
• Feeling nervous and excitable.
• Belly pain.
• Enlarged breasts.
• Tender breasts.
• Period (menstrual) changes. These include spotting or bleeding between cycles.
• This medicine 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 http://www.fda.gov/medwatch.

• 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.