Norethindrone Acetate and Ethinyl Estradiol (Page 8 of 9)

INSTRUCTIONS FOR USE

Norethindrone Acetate (nor eth’ in drone as’ e tate) and Ethinyl Estradiol (eth’ i nil es” tra dye’ ol) Tablets, USP and Ferrous Fumarate (fer’ us fue’ ma rate) Tablets

Important Information about taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets

  • Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser.

  • Do not skip your pills, even if you do not have sex often. 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 norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, talk to your healthcare provider.

  • When you first start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months.

  • You may feel sick to your stomach (nauseous), especially during the first few months of taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.

  • 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 (see, What should I do if I miss any norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate pills? below), you could also feel a little sick to your stomach.

  • It is not uncommon to miss a period. However, if you miss a period and have not taken norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.

  • If you have vomiting or diarrhea within 3 to 4 hours of taking a white active pill, take another white pill from your extra pill dispenser. If you do not have an extra pill dispenser, take the next white pill in your pill dispenser. Continue taking all your remaining pills in order. Start the first pill of your next pill dispenser the day after finishing your current pill dispenser. This will be 1 day earlier than originally scheduled. Continue on your new schedule.

  • If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider.

  • Stop taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms and spermicide) during this time period.

Before you start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets:

  • Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your pill dispenser.

  • Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.

When should I start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets?

If you start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and you have not used a hormonal birth control method before:

  • There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control pill.

  • If you use the Sunday Start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets. You do not need back-up contraception if you use the Day 1 Start.

If you start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and you are switching from another birth control pill:

  • Start your new norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets pack on the same day that you would start the next pack of your previous birth control method.

  • Do not continue taking the pills from your previous birth control pack.

If you start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and previously used a vaginal ring or transdermal patch:

  • Start using norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets on the day you would have reapplied the next ring or patch.

If you start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and you are switching from a progestin-only method such as an implant or injection:

  • Start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets on the day of removal of your implant or on the day when you would have had your next injection.

If you start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and you are switching from an intrauterine device or system (IUD or IUS):

  • Start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets on the day of removal of your IUD or IUS.

  • You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.

Keep a calendar to track your period:

If this is the first time you are taking birth control pills, read, “When should I start taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets?” above. Follow these instructions for either a Sunday Start or a Day 1 Start.

Sunday Start:

You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.

  • Take pill 1 on the Sunday after your period starts.

  • If your period starts on a Sunday, take pill “1 ” that day and refer to Day 1 Start instructions below.

  • Take 1 pill every day in the order on the pill dispenser at the same time each day for 28 days.

  • After taking the last pill on Day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack (Sunday). Take the first pill in the new pack whether or not you are having your period.

  • Use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.

Day 1 Start:

You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period.

  • Take 1 pill every day in the order of the pill dispenser dial pack, at the same time each day, for 28 days.

  • After taking the last pill on Day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack. Take the first pill in the new pack whether or not you are having your period.

Instructions for using your pill pack:

The norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate pill pack has 24 “active” white pills (with hormones) to be taken for 24 days, followed by 4 “reminder” brown pills (without hormones) to be taken for the next 4 days.

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(click image for full-size original)

Figure A

Look for:

  • Where on the pack to start taking pills

  • In what order to take the pills. Follow the arrows shown in Figure A.

  • The week numbers as shown in Figure A.

What should I do if I miss any norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate white pills? If you miss 1 white pill in Weeks 1, 2, or 3, follow these steps:

  • Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.

  • Then continue taking 1 pill every day until you finish the pack.

  • You do not need to use a back-up birth control method if you have sex.

If you miss 2 white pills in a row in Week 1 or Week 2 of your pack, follow these steps:

  • Take the 2 missed pills as soon as possible and the next 2 pills the next day.

  • Then continue to take 1 pill every day until you finish the pack.

  • Use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills.

If you miss 2 white pills in a row in Week 3 or Week 4, or you miss 3 or more white pills in a row at any time, follow these steps:

  • If you are a Day 1 Starter:

  • Throw out the rest of the pill pack and start a new pack that same day.

  • If you are a Sunday Starter:

  • Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.

  • You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.

  • You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you miss any of the 4 brown “reminder” pills in Week 4, throw away the pills you missed and keep taking 1 pill each day until the pack is empty. You do not need to use a back-up method of birth control.

If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 07-2023-02

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

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