Dienogest/Estradiol Oral Tablet/Estradiol Oral Tablet (ESTRADIOL VALERATE/DIENOGEST - ESTRADIOL VALERATE - ORAL)

Instructions

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Start taking this medicine after your period starts.

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

This medicine does not stop the spread of viruses that are passed through the blood or during sex.

If you are switching from a different birth control pill, start this medicine on the same day you would start your other birth control pack.

If you are using a birth control pack with 28 pills, start the first pill of a new pack on the day after the last pill of the previous pack.

If you forget to take a dose, take it as soon as you remember. If it is time for your next dose, you are allowed to take 2 doses at once. Return to your normal dosing schedule on the following day. If you miss more than one dose, ask your doctor what you should do to get back on schedule.

Ask your doctor about using an extra form of birth control if you forget any doses of your medicine.

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.

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.

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

Vomiting or diarrhea can prevent birth control pills from working well. If you have vomiting or diarrhea, ask if you need to use an extra form of birth control (such as condoms).

Keep all appointments for medical exams and tests while on this 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 is associated with an increased risk of blood clots, heart attack, and stroke. Contact your doctor immediately if you experience leg pain or swelling, difficulty breathing, chest or jaw pain, severe headache, one-sided weakness or slurred speech.

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.

If you miss your period while on this medicine, contact your doctor.

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.

Use condoms to reduce the risk of sexually transmitted diseases.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

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

Do not take St. John's wort while on this medicine.

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

Always refill this medicine before it runs out.

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.

• abdominal cramps
• bloating
• breast pain or swelling
• swelling of the legs, feet, and hands
• headaches
• high blood pressure
• dark patches on skin or face
• menstruation changes (missed or fewer periods)
• nausea and vomiting
• stomach upset or abdominal pain
• vaginal bleeding or spotting between periods
• 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
• 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)
• blurring or changes of vision

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.