ESTRADIOL VALERATE/DIENOGEST - ESTRADIOL VALERATE - ORAL

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ESTRADIOL VALERATE/DIENOGEST - ESTRADIOL VALERATE - ORAL

PHONETIC PRONUNCIATION: (ES-tra-DYE-ol VAL-er-ate/dye-EN-oh-jest - ES-tra-DYE-ol VAL-er-ate)

COMMON BRAND NAME(S): Natazia

GENERIC NAME(S): estradiol valerate/dienogest

Uses

USES: This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: dienogest (a progestin) and estradiol valerate (an estrogen). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. 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 - ESTRADIOL VALERATE - ORAL

HOW TO USE: 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, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. It is very important to continue taking this medication exactly as prescribed by your doctor. With certain brands of birth control pills, the amount of estrogen and progestin in each active tablet will vary at different times in the cycle. Follow the package instructions to find the first tablet, start with the first tablet 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. If you have vomiting or diarrhea within 3 to 4 hours after taking your tablet, read the Patient Information Leaflet section titled "What to Do if You Miss Tablets." Follow the instructions as if you had missed your dose because vomiting/diarrhea can stop the tablet from working. 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 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. Your pill pack contains 26 pills with active medication. It also contains 2 reminder pills with no medication. Take one active pill (with hormones) once daily for 26 days in a row. After you have taken the last active pill, take one reminder pill once daily for 2 days in a row unless otherwise directed by your doctor. You should have your period during the fourth week of the cycle. After you have taken the last reminder tablet in the pack, start a new pack the next day even if your period is continuing or if you do not have your period. If you do not get your period, consult your doctor. 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), take the first tablet in the pack on the first day of your period. For the first cycle of use only, 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) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Side Effects

SIDE EFFECTS: Nausea, vomiting, headache, abdominal cramps/bloating, breast tenderness, swelling of the ankles/feet (retaining fluid), or weight change may occur. 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, tell your doctor or pharmacist 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: a lump in your breast, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding), mental/mood changes (such as new/worsening depression), dark urine, yellowing eyes/skin, severe stomach/abdominal/pelvic pain, unusual tiredness. This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes. 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before using this medication, tell your doctor or pharmacist if you are allergic to estradiol or dienogest; or to any estrogens (such as mestranol) or any progestins (such as norethindrone, desogestrel); 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: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, family medical history (especially angioedema), gallbladder problems, severe headaches/migraine, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), kidney disease, liver disease (including tumors), stroke, swelling (edema), thyroid problems, unexplained vaginal bleeding. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as on a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use 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 should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. 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 may decrease breast milk production. A small amount passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane, letrozole), ospemifene, tamoxifen, tranexamic acid. 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 medication may interfere with certain laboratory tests (such as blood tests for clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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.

Images

NATAZIA 28 TABLET
NATAZIA 28 TABLET
NATAZIA 28 TABLET
color
multi-color (5)
shape
round
imprint
DD or DJ or DH or DN or DT
NATAZIA 28 TABLET
NATAZIA 28 TABLET
NATAZIA 28 TABLET
color
multi-color (5)
shape
round
imprint
DD or DJ or DH or DN or DT

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Faq for ESTRADIOL VALERATE/DIENOGEST - ESTRADIOL VALERATE - ORAL

Estradiol valerate/dienogest is used as a hormone replacement therapy (HRT) to relieve menopausal symptoms such as hot flashes, night sweats, and vaginal dryness. It can also be prescribed for the treatment of certain conditions such as endometriosis and abnormal uterine bleeding.

Estradiol valerate is a form of the hormone estrogen, which is important for the development and maintenance of female reproductive tissues. It helps to alleviate menopausal symptoms by replacing the estrogen that the body no longer produces naturally.

Common side effects may include headaches, breast tenderness, nausea, bloating, mood changes, and irregular menstrual bleeding. If any side effects become severe or persistent, it is important to consult a healthcare professional.

The onset of relief from menopausal symptoms can vary, but most women report improvement within a few weeks of starting treatment. However, the full benefits may take several months to become noticeable.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double up on doses to make up for a missed dose.

No, estradiol valerate/dienogest should not be used during pregnancy or while breastfeeding. It can harm an unborn baby and may pass into breast milk, potentially causing harm to a nursing infant. It is important to discuss alternative treatment options with a healthcare provider if pregnancy or breastfeeding is a possibility.

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Warning

WARNING: Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.