Ethinyl Estradiol/Norethindrone Oral Tablet 0.0025 mg/0.5 mg (ESTROGEN/PROGESTIN - ORAL)

Instructions

This medicine may be taken with or without food.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

You may have mild vaginal bleeding or spotting while on this medicine. Do not stop taking the medicine if this happens. Contact your doctor if bleeding is heavy or lasts more than a few days.

This medicine may cause dark patches to appear on your face. Avoid sunlight and use sunscreen lotion to minimize further darkening of these skin patches.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may affect your blood sugar levels. If you have diabetes, talk to your doctor before changing the dose of your diabetes medicine.

Do not take the medicine more than once during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine may increase the risk of some types of cancer in women. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine is associated with an increased risk for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

Do not use the medication any more than instructed.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

Ask your doctor how to do a breast self-exam. Check monthly. Report any changes to your doctor.

Talk to your doctor about getting a complete physical exam every year while on this medicine.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• bloating
• breast pain or swelling
• dark patches on skin or face
• nausea
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent abdominal pain
• breast lumps
• chest or jaw pain
• changes in memory, mood, or thinking
• depression or feeling sad
• dizziness
• swelling of the legs, feet, and hands
• fainting
• severe or persistent headache
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• excessive thirst
• increased urinary frequency
• cramping of the uterus or bleeding from the vagina
• vaginal bleeding or spotting between periods
• vaginal itching or discharge
• blurring or changes of vision
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.