1 What is Natazia?

Brand: Natazia

Generic: Estradiol valerate and dienogest

Natazia is hormone used as a birth control pill to prevent pregnancy. This drug combination works by interfering with the development of the ova each month. This drug combination can also be used to treat heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus in women who choose to use birth control pills.

This method does not provide full prevention of pregnancy. Birth control methods such as having surgery to become sterile or not having sex are more effective. This drug does not prevent transmission of HIV or other sexually transmitted diseases. This drug cannot prevent pregnancy if taken after unprotected sexual contact. This drug requires a prescription.

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2 What to Know Before Using

Before using Natazia, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in the elderly regarding the correlation of age to the effects of estradiol valerate and dienogest combination have not been performed while it is not expected to produce any pediatric-specific problems that would limit the utility of this drug in teenagers.

This drug may be used for birth control in teenage females but is not indicated before the start of menstruation. Studies in the elderly regarding the association of age to the effects of estradiol valerate and dienogest combination have not been performed.

Use in elderly women is not recommended. Fetal abnormalities have been determined in studies of animals or pregnant women. This drug is contraindicated in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Infant risk is still undetermined when using this drug during breastfeeding.

Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Tranexamic Acid
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Crizotinib
  • Dabrafenib
  • Darunavir
  • Dasabuvir
  • Donepezil
  • Eliglustat
  • Fentanyl
  • Idelalisib
  • Isotretinoin
  • Lumacaftor
  • Nilotinib
  • Piperaquine
  • Pixantrone
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topotecan
  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Ginseng
  • Griseofulvin
  • Ketoconazole
  • Lamotrigine
  • Levothyroxine
  • Licorice
  • Modafinil
  • Mycophenolate
  • Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Tacrine
  • Telaprevir
  • Tipranavir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Voriconazole
  • Warfarin

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

To use Natazia properly, discuss with your healthcare professional about the risks and benefits of this drug. Follow the instructions on the label or as directed by your healthcare professional.

This drug 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. Your body will require an adjustment period of at least 9 days after initiating treatment with this drug before preventing any pregnancy from occurring.

For the first 9 days of your first cycle of pills, use a second form of contraception such as a condom, spermicide, or diaphragm. Take this drug at the same time each day. Optimal effects can be achieved if the next dose of this drug is taken within 12 hours.

You can get pregnant if you miss a dose. You may experience light bleeding or spotting, feel sick or nauseous when you first take the pill.

Call your health care professional if these symptoms persist. If you vomit or have diarrhea within 3 to 4 hours of taking this drug, follow the instructions in the patient leaflet or call your healthcare professional.

If you are switching from a combination hormonal method to using NataziaВ®, take the first dark yellow pill on the first day of your period. If you do not start your period, see your healthcare professional 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 the second method of birth control for the first 9 days you take this drug.

If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using NataziaВ®, 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 the second method of birth control for the first 9 days you take this drug.

Do not eat grapefruit or drink grapefruit juice while you are using this drug. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. For contraception and to treat heavy menstrual bleeding in adults and teenagers, one tablet is recommended to be taken at the same time each day for 28 days.

Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose. If you a missed your dose consecutively, restart your treatment cycle and wait for 7 days before having unprotected sex.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Natazia, there are some precautions you must take. Regular visits every year should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. The risk of breast cancer in women is still unknown when taking this drug.

Report to your healthcare professional any unusual lumps or discharge in your breast. Unwanted effects can be detected using pelvic exam, breast exam, and mammogram.

Increased risk of having heart disease has been associated with this drug. This risk may continue even after you stop using the drug and this risk is amplified if you have hypertension, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes.

The use of this drug may increase your chance of getting ovarian or uterine cancer. Regular visits to your health professional can help identify these serious side effects early.

Consult with your healthcare professional if you think that you may be pregnant while taking this drug. Inform the healthcare professional in charge that you are using this drug before having any laboratory test because some test results may be affected.

Avoid using latex condoms, diaphragms, or cervical caps for up to 72 hours after using estrogen vaginal creams, as these products may contain oils in the creams that can weaken latex products and cause condoms to break or leak, or cervical caps or diaphragms to wear out sooner.

Check with your health care professional to make sure the vaginal estrogen product you are using can be used with latex devices. This drug is often used at bedtime to increase effectiveness through better absorption.

Using a mini-pad or sanitary napkin will protect your clothing since the vaginal creams or suppositories will melt and leak out of the vagina. Use of tampons is not recommended since they may soak up the drug and make the drug less effective.

Abstinence from sex is recommended to prevent your male partner from absorbing the drug through his penis if it comes in contact with the drug inside your vagina. Seek advice from your healthcare professional if you have problems removing your vaginal insert.

It is not necessary to remove the vaginal insert for sexual intercourse unless you prefer to remove it. Replace your insert with a new one if it comes off accidentally. If it slips down, gently push it upwards and back into place. Replace the vaginal insert every 3 months. Talk to your healthcare professional on a regular basis about how long to use the vaginal insert.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Natazia. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • vaginal yeast infection
  • change in vaginal discharge
  • clear or bloody discharge from the nipple
  • the decrease in the amount of urine
  • dimpling of the breast
  • skin fast heartbeat
  • fever
  • hives
  • itching or rash
  • hoarseness
  • inverted nipple
  • irritation
  • joint pain
  • stiffness or swelling lump in the breast or under the arm
  • noisy, rattling breathing
  • pain or feeling of pressure in the pelvis
  • pain, redness or swelling in the arm or leg
  • persistent crusting or scaling of the nipple
  • redness of the skin
  • redness or swelling of the breast
  • sore on the skin of the breast that does not heal
  • swelling of the eyelids, face, fingers, lips, hands, feet or lower legs
  • tightness in the chest
  • troubled breathing at rest
  • troubled breathing or swallowing
  • vaginal bleeding
  • symptoms of overdose such as abdominal or stomach pain, dizziness, drowsiness, nausea or vomiting, tenderness of the breasts, unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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