Natazia

Name: Natazia

What happens if I miss a dose?

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill by more than 12 hours increases your risk of becoming pregnant. Vomiting or having diarrhea within 4 hours after taking a pill is the same as missing that dose.

If you miss one pill:

  • During Days 1 through 17, take the missed pill as soon as you remember, then take your next pill at the usual time. Use back-up birth control for at least 9 days.

  • During Days 18 through 24, throw out the rest of the pack and start a new one the same day. Take the Day 1 pill from the new pack and then take one pill per day in the order directed on the pack. Use back-up birth control for at least 9 days.

  • During Days 25 through 28, take the missed pill as soon as you remember, then take your next pill at the usual time. You do not need back-up birth control if you miss one pill during Days 25 through 28.

If you miss two pills:

  • During Days 1 through 16, skip the missed pills and start with the pill that corresponds to the day you remember you missed your doses. Then take one pill per day in the order directed on the pack. Use your back up birth control for at least 9 days

  • During Days 17 through 24, throw out the rest of the pack and start a new one the same day. Take the Day 3 pill from the new pack and then take one pill per day in the order directed on the pack. Use your back up birth control for at least 9 days.

  • During Days 25 through 28, throw out the rest of the pack. Start a new pack on the same day or on the day you would normally start a new pack. Take one pill per day in the order directed on the pack. No back up birth control is needed.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking dienogest and estradiol?

Do not smoke while taking this medicine, especially if you are older than 35 years of age.

Dienogest and estradiol will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Precautions While Using Natazia

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.

What are some things I need to know or do while I take Natazia?

  • Tell all of your health care providers that you take Natazia. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
  • Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Certain drugs, herbal products, or health problems could cause Natazia to not work as well. Be sure your doctor knows about all of your drugs and health problems.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • Do not use in children who have not had their first menstrual period.
  • If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Natazia Description

Natazia (estradiol valerate and estradiol valerate/dienogest) tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets:

• 2 dark yellow tablets each containing 3 mg estradiol valerate • 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest • 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest • 2 dark red tablets each containing 1 mg estradiol valerate • 2 white tablets (inert)

Natazia also contains the excipients lactose monohydrate, maize starch, maize starch pre-gelatinized, povidone 25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide, and ferric oxide pigment, yellow, or ferric oxide pigment, red.

The empirical formula of estradiol valerate is C23 H32 O3 and the chemical structure is:

Estradiol Valerate

The chemical name of estradiol valerate is Estra-1,3,5(10)-triene-3,17-diol(17ß)-,17-pentanoate.

The empirical formula of dienogest is C20 H25 NO2 and the chemical structure is:

Dienogest

The chemical name of dienogest is (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile.

Patient Counseling Information

See “FDA-approved patient labeling (Patient Information).”

• Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs. • Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC. • Counsel patients that Natazia does not protect against HIV infection (AIDS) and other sexually transmitted diseases. • Counsel patients on Warnings and Precautions associated with COCs. • Inform patients that Natazia is not indicated during pregnancy. If pregnancy occurs during treatment with Natazia, instruct the patient to stop further intake. • Counsel patients to take one tablet daily by mouth at the same time every day in the exact order noted on the blister. Instruct patients what to do in the event pills are missed. See What Should I Do if I Miss any Pills section in FDA-Approved Patient Labeling. • Counsel women who are taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) not to choose Natazia as their oral contraceptive due to the possibility of decreased contraceptive efficacy. • Counsel patients to use a back-up or alternative method of contraception when weak or moderate enzyme inducers are used with Natazia. • Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established. • Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken Natazia for 9 consecutive days. • Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.

What is Natazia?

Natazia contains a combination of dienogest and estradiol. Dienogest and estradiol are female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Natazia is used to prevent pregnancy.

Natazia is also used to treat heavy menstrual bleeding that is not caused by any medical condition of the uterus.

What other drugs will affect Natazia?

Many drugs can interact with dienogest and estradiol and make them less effective, which may result in pregnancy. Estradiol can also affect blood levels of certain other drugs, making them less effective or increasing side effects. You may need to use a back-up birth control method while using certain other drugs. Tell your doctor about all your current medicines and any you start or stop using. Not all possible interactions are listed in this medication guide.

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