Estradiol and dienogest (Oral route)
es-tra-DYE-ol VAL-er-ate, es-tra-DYE-ol VAL-er-ate, dye-EN-oh-jest, es-tra-DYE-ol VAL-er-ate, dye-EN-oh-jest, es-tra-DYE-ol VAL-er-ate
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use; this risk increases in women who are over 35 years of age and with number of cigarettes smoked. COCs should not be used by women who are over 35 years of age and smoke .
Uses of This Medicine:
Estradiol valerate and dienogest combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
Estradiol valerate and dienogest combination is also used to treat heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb) in women who choose to use birth control pills.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your doctor your options for birth control.
Estradiol valerate and dienogest combination does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but is not indicated before the start of menstruation.
Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Eslicarbazepine Acetate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mycophenolate Mofetil
- Mycophenolic Acid
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clotting problems, or history of or
- Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or
- Breast cancer, known or suspected, or a history of or
- Cancer of the uterus or cervix or
- Diabetes with kidney, eye, or blood vessel damage or
- Heart attack, history of or
- Heart or blood vessel disease (e.g., coronary artery disease) or
- Heart rhythm problems or
- Hypertension (high blood pressure), uncontrolled or
- Jaundice (yellow eyes or skin) during pregnancy or from using hormonal therapy in the past or
- Liver disease, including tumors or cancer or
- Migraine headache, new or worse or a new kind of headache or
- Problems with circulation or blood clots, now or in the past or
- Problems with heart valves or
- Stroke, history of—Should not be used in patients with these conditions.
- Angioedema (swelling of the face, tongue, or throat), inherited or
- Chloasma gravidarum (brown discoloration of a woman's face caused by hormonal changes such as pregnancy), history of or
- Depression, history of or
- Diabetes or
- Dyslipidemia (high cholesterol or fats in the blood) or
- Gallbladder disease or
- Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.
When you begin using this medicine, your body will require at least 9 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 9 days of your first cycle of pills.
Take this medicine at the same time each day, such as after the evening meal or at bedtime. Do not skip or delay taking your pill by more than 12 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills, or about using another method of birth control.
You may have light bleeding or spotting when you first take the pill.
You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.
If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the instructions in the patient leaflet or call your doctor.
If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Natazia®, take the first dark yellow pill on the first day of your period. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take this medicine.
If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Natazia®, take the first dark yellow pill on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take this medicine.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it.
- For oral dosage form (tablets):
- For contraception (to prevent pregnancy) and to treat heavy menstrual bleeding:
- Adults and teenagers—One tablet taken at the same time each day for 28 days.
- Children—Use and dose must be determined by your doctor.
- For contraception (to prevent pregnancy) and to treat heavy menstrual bleeding:
Call your doctor or pharmacist for instructions.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 12 months, but some doctors require them more often.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you suspect that you may be pregnant, stop using this medicine immediately and check with your doctor.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
- If this should occur, continue with your regular dosing schedule.
- The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
- If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.
Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.
Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.
Check with your doctor immediately if you have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your eyes need to be checked by an ophthalmologist (eye doctor).
Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may not work as well in women who are overweight. If you gain a lot of weight after you start taking this medicine, ask your doctor if you should change to another type of birth control pill.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or certain medical tests.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Breast pain, discomfort, or tenderness
- headache, severe and throbbing
- irregular menstrual periods
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
- Abdominal or stomach pain
- clay-colored stools
- dark urine
- difficulty with breathing
- loss of appetite
- pain in the chest, groin, or legs, especially the calves
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sudden, unexplained shortness of breath
- unpleasant breath odor
- unusual tiredness or weakness
- vision changes
- vomiting of blood
- yellow eyes or skin
- Incidence not known
- Abdominal or stomach bloating
- blood in the stool
- chest pain or discomfort
- decrease in the amount of urine
- itching of the vagina or genitals
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- noisy, rattling breathing
- pain in the ankles or knees
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, or swelling in the arm or leg
- painful, red lumps under the skin, mostly on the legs
- pelvic pain
- pounding in the ears
- redness of the skin
- shortness of breath
- slow or fast heartbeat
- stomach or pelvic discomfort, aching, or heaviness
- swelling of the eyelids, face, lips, hands, lower legs, or feet
- thick, white vaginal discharge with mild or no odor
- tightness in the chest
- troubled breathing at rest
- troubled breathing or swallowing
- upper right abdominal or stomach pain
- weight gain
- Less common
- Blemishes on the skin
- increased weight
- Incidence not known
- Patchy brown or dark brown discoloration of the skin
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014