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    A “normal” period (or menstrual flow) may occur every 28 days on average, last 4 to 5 days, and typically result in a total blood loss of 35 mL to 40 mL (2 to 3 tablespoons). 

    Women with HMB may lose 80 mL of blood (about 5 to 6 tablespoons) or more during their period and may have bleeding that lasts longer than 7 days. 

    While uterine-related problems, hormone-related problems, and other illnesses or disorders may cause HMB, doctors have been unable to find the cause in some women who have HMB. 

    Some women who have heavy periods have no evidence of any physical abnormality and their doctors are unable to find a cause. If there is no gynecological problem, and other causes are ruled out, you may be a candidate for hormonal treatment. Talk with your doctor to see what treatment options are available. 

    Natazia is a birth control pill. It contains two female hormones, an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in your body. 

     

    Natazia is used to treat heavy menstruation (your monthly period) that is not caused by any diagnosed conditions of the uterus (womb) in women who decide to use an oral contraceptive for birth control. Talk to your doctor to determine if your bleeding is heavier than normal.

    Birth control pills prevent your ovaries from producing and releasing mature eggs. Natazia decreases menstrual bleeding by thinning the lining of the uterus. 

    Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. 

     

    Based on the results of two clinical studies, 1 to 2 women out of 100 women may get pregnant during the first year they use Natazia. 

    In two clinical trials in women with heavy menstrual bleeding who were treated with Natazia, their menstrual bleeding was reduced by an average of 90% in one trial and 87% in the other. For women treated with placebo, their menstrual bleeding was reduced by an average of 14% and 32% in the two trials, respectively. 

    • Take one pill every day at the same time. Take the pills in the order directed on the blister pack
    • Do not skip pills or delay taking your pill by more than 12 hours. If you miss pills (including starting the pack late), you could get pregnant. The more pills you miss, the more likely you are to get pregnant
    • If you have trouble remembering to take Natazia, talk to your healthcare provider about how to make pill-taking easier, or about using another method of birth control
    • You may have spotting or light bleeding when you first take Natazia. Spotting or light bleeding is normal at first 
    • You may feel sick to your stomach (nauseous), especially during the first few months that you take Natazia. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea doesn't go away, call your healthcare provider
    • If you vomit or have diarrhea within 4 hours of taking your pill, follow the instructions for “What Should I Do if I Miss Any Pills” 
    • Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach

    What should I do if I miss any pills?

      If you forgot to start a new blister pack, you may already be pregnant. Use back-up contraception (such as condoms and spermicides) anytime you have sex. Call your healthcare provider if you are unsure whether you are pregnant.

      • Do not take more than 2 pills in one day. On the days you take 2 pills to make up for missed pills, you may feel a little sick to your stomach (nauseous)
      • If you start vomiting or have diarrhea within 4 hours of taking your pill, take another pill of the same color from your extra blister pack
      • Take your pill as soon as you remember
      • Take the next pill at the usual time
      • You do not need to use back-up contraception
        • Take your missed pill immediately 
        • Take your next pill at the usual time (you may have to take two pills that day)
        • Use back-up contraception for the next 9 days 
        • Continue taking one pill each day at the same time for the rest of your cycle 
        • Do not take any pills from your current blister pack and throw the pack away
        • Take Day 1 pill from a new blister pack
        • Use back-up contraception for the next 9 days
        • Continue taking one pill from the new blister pack at the same time each day
        • Take your missed pill immediately   
        • Take your next pill at the usual time (you may have to take two pills that day) 
        • No back-up contraception is needed  
        • Continue taking one pill each day at the same time for the rest of your cycle  

          (If you miss the pills for Days 17 and 18, follow the instructions for Days 17–25 instead)

          • Do not take the missed pills. Instead, take the pill for the day on which you first noticed you had missed pills 
          • Use back-up contraception for the next 9 days 
          • Continue taking one pill each day at the same time for the rest of your cycle

          (If you miss the pills for Days 25 and 26, follow the instructions for Days 25–28 instead)

          • Do not take any pills from your current blister pack and throw the pack away 
          • Take Day 3 pill from a new blister pack 
          • Use back-up contraception for the next 9 days
          • Continue taking one pill from the new blister pack at the same time each day
          • Do not take any pills from your current blister pack and throw the pack away
          • Start a new pack on the same day or start a new pack on the day you usually start a new pack
          • No back-up contraception is needed
          • Continue taking one pill from the new pack at the same time each day, for the rest of your cycle

          Irregular vaginal bleeding or spotting may occur while you are taking Natazia. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider.

           

          Also, your menstrual period while using oral contraceptives may be shorter and lighter than usual. Some women may not have a menstrual period but this should not be cause for alarm as long has you have taken the pills according to direction.

          It is not uncommon to miss your period. However, if you miss more than two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider checks you to find out if you are pregnant. Stop taking Natazia if you are pregnant. 

          Your healthcare provider will not give you Natazia if you have: 

          • Ever had breast cancer or any cancer that is sensitive to female hormones 
          • Liver disease, including liver tumors 
          • Ever had blood clots in your arms, legs, or lungs 
          • Ever had a stroke 
          • Ever had a heart attack 
          • Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart 
          • An inherited problem with your blood that makes it clot more than normal 
          • High blood pressure that medicine can't control 
          • Diabetes with kidney, eye, or blood vessel damage 
          • Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision

           

          If any of these conditions happen for the first time while using Natazia, stop taking Natazia right away and talk to your healthcare provider. You should use non-hormonal contraceptive measures when you stop using Natazia.

           

          Also, do not take birth control pills if you: 

          • Smoke and are over 35 years old 
          • Are pregnant 
          • Have any unexplained bleeding from the vagina 

           

          Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy). 

          Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. 

           

          It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

          • Legs (deep vein thrombosis)
          • Lungs (pulmonary embolus)
          • Eyes (loss of eyesight)
          • Heart (heart attack)
          • Brain (stroke)

           

          A few women who take birth control pills may get: 

          • High blood pressure
          • Gallbladder problems
          • Rare cancerous or noncancerous liver tumors

           

          All of these events are uncommon in healthy women. 

           

           

          Call your healthcare provider right away if you have:

          • Persistent leg pain 
          • Sudden shortness of breath 
          • Sudden blindness, partial or complete 
          • Severe pain in your chest 
          • Sudden, severe headache unlike your usual headaches 
          • Weakness or numbness in an arm or leg, or trouble speaking 
          • Yellowing of the skin or eyeball 

          The most common side effects of birth control pills are: 

          • Spotting or bleeding between menstrual periods 
          • Nausea 
          • Breast tenderness 
          • Headache 

           

          These side effects are usually mild and usually disappear with time. 

           

          Less common side effects are:

          • Acne 
          • Less sexual desire 
          • Bloating or fluid retention 
          • Blotchy darkening of the skin, especially on the face 
          • High blood sugar, especially in women who already have diabetes 
          • High fat levels in the blood 
          • Depression, especially if you have had depression in the past

           

          Call your healthcare provider immediately if you have any thoughts of harming yourself. 

          • Problems tolerating contact lenses
          • Weight changes 

           

          This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088. 

           

          No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children. 

          Natazia does not protect against HIV infection (AIDS) and other sexually transmitted diseases