estradiol valerate-dienogest Oral

This medication is a combination of 2 hormones (an estrogen and a progestin) and is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also can work by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and by changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.
Besides preventing pregnancy, birth control pills have been shown to help make your periods more regular, decrease blood loss and painful periods (dysmenorrhea), and decrease your risk of ovarian cysts.
Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How to use estradiol valerate-dienogest Oral
Read the Patient Information Leaflet provided by your pharmacist before you start taking this medication and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily. It is very important to continue taking this medication exactly as prescribed. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.
Follow the package instructions to find the first pill, start with the first pill in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill 12 hours later than the usual time.
Your pill pack contains 28 tablets (enough for 4 weeks). There are 5 different types of tablets in each 28-day pack. Each active tablet contains different amounts of either estradiol alone or a combination of estradiol and dienogest. The last 2 tablets in the pack are reminder pills with no active medication. It is very important to take the tablets in the correct order because the tablets have different amounts of medication.
Take one tablet every day for 28 days in a row. Most women will have their period during the fourth week of the cycle. After you have taken the last tablet in the pack, start a new pack the next day whether or not you have your period. If you do not get your period, consult your doctor.
Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to regularly take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart.
If vomiting or severe diarrhea occurs within 3-4 hours of taking a dose or if your dose is more than 12 hours late, your pregnancy risk may be the same as if you had missed a dose. Consult the Patient Information Leaflet for pregnancy risk and need for back-up contraception. Ask your doctor or pharmacist if you have any questions
If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (such as patch, other birth control pills, implant), take the first tablet in the pack on the first day of your period. For the first cycle of use only, you need to use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 9 days to prevent pregnancy until the medication has enough time to work.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as patch, other birth control pills, IUD, implant) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Nausea, vomiting, headache, stomach cramping/bloating, or breast tenderness/enlargement may occur. Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, notify your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, weight changes (gain or loss).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as pulmonary embolism, stroke, heart attack). Get medical help right away if you experience: chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you have experienced before (such as headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes (such as blindness, double vision).
Tell your doctor immediately if any of these rare but serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (such as depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to estradiol or dienogest; or to any other estrogen or progestin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this product, tell your doctor or pharmacist your medical history, especially of: personal or family history of stroke or other blood clots (such as in the legs, eyes, lungs), high blood pressure, cancer (especially endometrial or breast cancer), blood clotting disorders (such as protein C or protein S deficiency), history of heart disease (such as heart attack, chest pain, irregular heartbeat), heart valve disease, liver problems (such as liver tumor, active liver disease, yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills), recent major surgery/trauma/pregnancy, high cholesterol or triglyceride (blood fat) levels, kidney disease, depression, diabetes, swelling (edema), headaches/migraine, unexplained vaginal bleeding, thyroid problems.
If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and of any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Tell your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as a long plane flight). You may need to stop the medication for a time or take special precautions.
This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.
This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. The risk of a serious blood clot is higher if you have just given birth or had a pregnancy loss/abortion after the first 3 months. Talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
This medication passes into breast milk. This may affect milk production and may have harmful effects on a nursing infant. Breast-feeding is not recommended while using this product. Consult your doctor before breast-feeding.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor\'s approval.
Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane), estrogen blockers (such as raloxifene, tamoxifen), romidepsin, sodium tetradecyl sulfate.
Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John\'s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include cyclosporine, lamotrigine, tizanidine, corticosteroids such as prednisolone, among others. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.
This medication can affect the results of certain lab tests (such as blood tests for clotting factors). Make sure laboratory personnel and all your doctors know you use this medication.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea and vomiting, sudden/unusual vaginal bleeding.

NOTES:
Do not share this medication with others.
Keep all appointments with your doctor and the laboratory. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor\'s instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.

MISSED DOSE:
Refer to the product package information for advice on missed or late doses. You may need to use back-up birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.
If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.

STORAGE:
Store at room temperature. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.