Generic Name: estradiol valerate/dienogest (ES-tra-DYE-ol VAL-er-ate/dye-EN-oh-jest)
Brand Name: Natazia
Cigarette smoking increases the risk of serious heart problems associated with use of estradiol valerate/dienogest. This risk increases with age (especially in women older than 35 years old) and with frequent smoking. Women who are older than 35 years old and smoke should not use estradiol valerate/dienogest.
Estradiol valerate/dienogest is used for:
Preventing pregnancy. It may also be used to treat heavy menstrual bleeding in women who use estradiol valerate/dienogest for birth control. It may be used for other conditions as determined by your doctor.
Estradiol valerate/dienogest is a combination birth control pill. It works by preventing ovulation. It may also change cervical mucus to prevent the sperm from reaching the egg and change the lining of the uterus to prevent a fertilized egg from implanting in the uterus. It works to decrease heavy menstrual bleeding by thinning the lining of the uterus.
Do NOT use estradiol valerate/dienogest if:
- you are allergic to any ingredient in estradiol valerate/dienogest
- you are pregnant or think you may be pregnant
- you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or certain cancers (eg, breast cancer, endometrial cancer, cervical cancer)
- you are at risk of developing severe blood clots or have certain heart problems (eg, certain heart valve problems, certain types of irregular heartbeat)
- you have certain types of headaches or migraines with or without aura; severe or uncontrolled high blood pressure; undiagnosed abnormal vaginal bleeding; or diabetes that affects your eyes, kidneys, or circulation
- you have liver disease, liver tumors or cancer, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
- you have had surgery and are or will be confined to a bed or a chair for an extended period of time
- you are older than 35 years old and you smoke cigarettes
- you are taking carbamazepine, phenytoin, rifampin, or St. John's wort
Contact your doctor or health care provider right away if any of these apply to you.
Before using estradiol valerate/dienogest:
Some medical conditions may interact with estradiol valerate/dienogest. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, or cancer (eg, breast, endometrial, cervical)
- if you have a history of heart problems, angina, blood vessel problems, diabetes, headaches or migraines, gallbladder problems, high blood pressure, kidney problems, liver problems, blood problems (eg, porphyria), blood in the urine, mental or mood problems (eg, depression), lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), thyroid problems, or seizures (eg, epilepsy)
- if you have high blood cholesterol or triglyceride levels, or if someone in your family has a history of high blood triglyceride levels
- if you have a condition called hereditary angioedema
- if you are overweight, you have not yet had your first menstrual period, or you use tobacco
- if you have given birth or otherwise ended a pregnancy within the past 4 weeks
Some MEDICINES MAY INTERACT with estradiol valerate/dienogest. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Ketoconazole, tranexamic acid, or troleandomycin because they may increase the risk of estradiol valerate/dienogest's side effects
- Aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, clobazam, dexamethasone, efavirenz, felbamate, griseofulvin, protease inhibitors (eg, ritonavir, telaprevir), hydantoins (eg, phenytoin), mifepristone, modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), primidone, rifamycins (eg, rifabutin, rifampin), rufinamide, St. John's wort , tetracyclines (eg, doxycycline), thiazolidinediones (eg, pioglitazone), or topiramate because they may decrease estradiol valerate/dienogest's effectiveness, resulting in breakthrough bleeding or pregnancy
- Lamotrigine, thyroid hormones (eg, levothyroxine), or valproic acid because their effectiveness may be decreased by estradiol valerate/dienogest
This may not be a complete list of all interactions that may occur. Ask your health care provider if estradiol valerate/dienogest may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use estradiol valerate/dienogest:
Use estradiol valerate/dienogest as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with estradiol valerate/dienogest. Talk to your pharmacist if you have questions about this information.
- Take estradiol valerate/dienogest by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Begin taking estradiol valerate/dienogest on the first day of your period, unless your doctor tells you otherwise. Try to take estradiol valerate/dienogest at the same time every day, not more than 24 hours apart. Take the first pill in the pack when starting a new pack. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
- You will need to use an additional form of birth control for the first 9 days after you start estradiol valerate/dienogest. Check with your doctor if you have questions about other forms of birth control.
- If you are switching to estradiol valerate/dienogest from another type of hormonal birth control (eg, patch, vaginal ring, another type of birth control pill), ask your doctor or pharmacist about when to start taking estradiol valerate/dienogest.
- Take estradiol valerate/dienogest at the same time each day. For estradiol valerate/dienogest to be effective, it must be taken every day. Do not skip doses, even if you do not have sex very often. Do not miss a dose by more than 12 hours.
- If you vomit or have diarrhea within 4 hours after taking a colored tablet, this may be considered a missed tablet. Check with your doctor about what to do if this occurs.
- If you miss a dose of estradiol valerate/dienogest and remember it within 12 hours, take it as soon as possible and go back to your regular dosing schedule. If you do not remember within 12 hours or if you miss more than 1 dose of estradiol valerate/dienogest, see the additional patient information leaflet that comes with estradiol valerate/dienogest or contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of estradiol valerate/dienogest, use an extra form of birth control (eg, condoms) and talk with your doctor.
Ask your health care provider any questions you may have about how to use estradiol valerate/dienogest.
Important safety information:
- Estradiol valerate/dienogest may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use estradiol valerate/dienogest with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
- If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor at least 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking estradiol valerate/dienogest.
- You should usually not take estradiol valerate/dienogest within 4 weeks after giving birth or otherwise ending a pregnancy. If you are starting estradiol valerate/dienogest after giving birth and you have not yet had a period, you will need to use an additional form of birth control for the first 9 days you take estradiol valerate/dienogest. Discuss any questions or concerns with your doctor.
- Estradiol valerate/dienogest may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
- Use of estradiol valerate/dienogest will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).
- Diabetes patients - Estradiol valerate/dienogest may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Bleeding or spotting may occur while taking estradiol valerate/dienogest, especially during the first 3 months. Do not stop taking estradiol valerate/dienogest if this occurs. If bleeding or spotting is persistent, or if it occurs after menstrual cycles that were previously regular, contact your doctor.
- Smoking while using estradiol valerate/dienogest may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
- Certain antibiotics, anticonvulsants, or other medicines may decrease the effectiveness of estradiol valerate/dienogest. Ask your pharmacist if you have questions about which medicines may decrease estradiol valerate/dienogest's effectiveness. To prevent pregnancy while taking these medicines, use an extra form of birth control (eg, condoms). You may also need to use an extra form of birth control for a period of time after you stop taking these medicines. Check with your doctor for more information.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you miss more than 2 periods in a row, or if you miss 1 period when you have not taken your pills correctly, contact your doctor. Also, if you have morning sickness or unusual breast tenderness, contact your doctor. You may be pregnant if any of these occur.
- Estradiol valerate/dienogest may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping estradiol valerate/dienogest. Discuss any concerns with your doctor or pharmacist.
- Estradiol valerate/dienogest may interfere with certain lab tests, such as cholesterol or diabetes tests. Be sure your doctor and lab personnel know you are using estradiol valerate/dienogest.
- Lab tests, including breast exams, Pap tests, physicals, and blood pressure, may be performed while you use estradiol valerate/dienogest. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Estradiol valerate/dienogest should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: Do not use estradiol valerate/dienogest if you are pregnant. If you think you may be pregnant, contact your doctor right away. Estradiol valerate/dienogest is found in breast milk. Do not breast-feed while taking estradiol valerate/dienogest.
Possible side effects of estradiol valerate/dienogest:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; breast tenderness or enlargement; changes in sexual interest; changes in weight; headache; mild fluid retention; nausea; spotting or breakthrough bleeding; stomach cramps or bloating; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); breast discharge; breast discomfort, pain, or lumps; bulging eyes; calf or leg pain, swelling, or tenderness; chest pain; coughing up blood; fainting; mental or mood changes (eg, new or worsening depression); missed menstrual period; new, persistent, or worsening headaches or migraines; persistent or recurrent abnormal vaginal bleeding; persistent or severe dizziness; severe pain or tenderness in the stomach; shortness of breath; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden, severe nausea or vomiting; shortness of breath; sudden, unusual sweating); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal irritation, odor, or discharge; vision loss or other vision changes (eg, double vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea or unusual vaginal bleeding.Proper storage of estradiol valerate/dienogest:
Store estradiol valerate/dienogest at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep estradiol valerate/dienogest out of the reach of children and away from pets.
- If you have any questions about estradiol valerate/dienogest, please talk with your doctor, pharmacist, or other health care provider.
- Estradiol valerate/dienogest is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take estradiol valerate/dienogest or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 estradiol valerate/dienogest. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to estradiol valerate/dienogest. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using estradiol valerate/dienogest.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.