(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)
Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.
What is Finzala?
Finzala is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norethindrone acetate.
How well does Finzala work?
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 one clinical study of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 mcg tablets lasting six months, about 1 to 4 out of 100 women may get pregnant during the first year they use Finzala.
Women with a BMI above 35 kg/m2 were not studied in the clinical trial, so it is not known how well Finzala protects against pregnancy in such women. If you are overweight, discuss with your healthcare provider whether Finzala is the best choice for you.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
How do I take Finzala?
1. Be sure to read these directions before you start taking your tablets or anytime you are not sure what to do.
2. The tablets may be chewed and swallowed or swallowed whole. You should drink a full glass (8 ounces) of water immediately after chewing or swallowing.
3. The right way to take the tablet is to take one tablet every day at the same time in the order directed on the package. Finzala can be taken without regard to meals.
If you miss tablets you could get pregnant. This includes starting the pack late. The more tablets you miss, the more likely you are to get pregnant. See "What to Do if You Miss Tablets" below.
4. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first 1 to 3 packs of tablets.
If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the tablets. The problem will usually go away. If it does not go away, check with your healthcare provider.
5. Missing tablets can also cause spotting or light bleeding, even when you make up these missed tablets.
On the days you take two tablets, to make up for missed tablets, you could also feel a little sick to your stomach.
6. If you have vomiting (within 3 to 4 hours after you take your tablet), you should follow the instructions for "What to Do if You Miss Tablets". If you have diarrhea or if you take certain medicines, including some antibiotics and some herbal products such as St. John's Wort, your tablets may not work as well.
Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider.
7. If you have trouble remembering to take Finzala, talk to your healthcare provider about how to make tablet-taking easier or about using another method of birth control.
8. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
Before You Start Taking Your Finzala Tablets
1. Decide What Time of Day You Want to Take Your Tablet. It is important to take Finzala tablets in the order directed on the package at the same time every day. Finzala tablets can be taken without regard to meals.
b) In what order to take the tablets (follow the arrows shown in the picture above)
c) The week numbers as shown in the picture above.
4. Be sure you have ready at all times
a) another kind of birth control (such as a condoms and spermicide) to use as a back-up in case you miss tablets, and
You have a choice for which day to start taking your first pack of tablets. Decide with your healthcare provider which is the best day for you. Pick a time of day which will be easy to remember.
When You Switch From a Different Birth Control Tablet or Capsule
When switching from another birth control pill, finish all the tablets or capsules, then Finzala should be started on the same day that a new pack of the previous birth control tablet or capsule would have been started.
When You Switch From Another Type of Birth Control Method
When switching from a transdermal patch or vaginal ring, finish the 21 days of use, wait 7 days, then Finzala should be started when the next application would have been due. When switching from an injection, Finzala should be started when the next injection would have been due. When switching from an intrauterine device or an implant, Finzala should be started on the day of removal.
Finzala may not be as effective if you miss any white tablets, especially if you miss the first few or the last few white tablets in a pack.
If you miss 1 white tablet:
If you miss 2 white tablets in a row in week 1 OR week 2 of your pack:
If you miss 2 white tablets in a row in week 3 or week 4 of your pack:
If you miss 3 or more white tablets in a row during any week:
If you miss any of the 4 brown tablets in Week 4:
Finally, if you are still not sure what to do about the tablets you have missed:
Who should not take Finzala?
Your healthcare provider will not give you Finzala if you have:
Also, do not take birth control pills if you:
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.
Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider may recommend another method of birth control).
What else should I know about taking Finzala?
Birth control pills do not protect you against any sexually transmitted infection, including HIV, the virus that causes AIDS.
Do not skip any tablets, even if you do not have sex often.
If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:
Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
You should stop Finzala at least four weeks before you have surgery and not restart it until at least two weeks after the surgery, due to an increased risk of blood clots.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Finzala, may decrease the amount of milk you make. A small amount of the pill's hormones passes into breast milk.
Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.
If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like a condom and spermicide, until you check with your healthcare provider.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.
If you are scheduled for any laboratory tests, tell your healthcare provider that you are taking birth control pills. Certain blood tests may be affected by birth control pills.
What are the most serious risks of taking Finzala?
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:
Women who take birth control pills may get:
All of these events are uncommon in healthy women.
Call your healthcare provider right away if you have:
What are the common side effects of birth control pills?
The most common side effects of birth control pills are:
These side effects are usually mild and usually disappear with time.
Less common side effects are:
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.
Do birth control pills cause cancer?
It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
What should I know about my period when taking Finzala?
Irregular vaginal bleeding or spotting may occur while you are taking Finzala. 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 tablets 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.
Some women may not have a menstrual period but this should not be cause for alarm as long as you have taken the tablets according to direction.
What if I miss my scheduled period when taking Finzala?
It is not uncommon to miss your period. However, if you go two or more months in a row without a period, or you miss your period after a month where you did not take all your tablets correctly, call your healthcare provider because you may be pregnant. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Finzala if you are pregnant.
What if I want to become pregnant?
You may stop taking the tablets whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the tablets.
General Advice about Finzala
Your healthcare provider prescribed Finzala for you. Please do not share Finzala with anyone else. Keep Finzala out of the reach of children.
If you have concerns or questions, ask your healthcare provider. You may also ask your pharmacist for a more detailed label written for healthcare professionals.