Norgestimate

What it is used for

Sprintec ® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. 1.1 Oral Contraceptive Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.

When should I start taking norgestimate and ethinyl estradiol tablets?

If you start taking norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol tablets. You do not need back-up contraception if you use the Day 1 Start.

If you start taking norgestimate and ethinyl estradiol tablets and you are switching from another birth control pill:

• Start your new norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol tablets and previously used a vaginal ring or transdermal patch:

• Start using norgestimate and ethinyl estradiol tablets on the day you would have reapplied the next ring or patch.

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

• Start taking norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol tablets and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol 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 blister at the same time each day for 28 days.

• After taking the last pill on Day 28 from the blister, 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 norgestimate and ethinyl estradiol 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 blister pack, at the same time each day, for 28 days.

• After taking the last pill on Day 28 from the blister, 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.

Norgestimate and ethinyl estradiol tablets come in blister pack. Read the instructions below for using your blister:

Instructions for using your blister:

Each new blister has 28 pills

• 7 white pills with hormone, for Days 1 to 7

• 7 light blue pills with hormone, for Days 8 to 14

• 7 blue pills with hormones, for Days 15 to 21

• 7 green pills (without hormones), for Days 22 to 28.

Step 1.

SET THE DAY on your BLISTER

Sunday Start:

Each blister has been preprinted with the days of the week, starting with Sunday ( Sun), to facilitate a Sunday-Start regimen.

Day 1 Start:

• Six different day label strips of the week have been provided with this pack in order to accommodate a Day-1 Start regimen.

• Pick the day label strip that starts with the first day of your period. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the blister ( Refer figure below ).

Step 2.

Remove pill "1" by pushing down on the pill. The pill will come out through a hole in the back of the strip.

Step 3.

Swallow the pill. You will take 1 pill every day, at the same time each day.

Step 4.

Wait 24 hours to take your next pill. Continue to take 1 pill each day until all the pills have been taken.

Step 5.

Take your pill at the same time every day. It is important to take the correct pill each day and not miss any pills.

To help you remember, take your pill at the same time as another daily activity, like turning off your alarm clock or brushing your teeth.

Step 6.

When your blister is empty, you will start a new blister on the day after pill "28." Remember to take your first pill in every refill on the same day of the week, no matter when your next period starts.

What should I do if I miss any norgestimate and ethinyl estradiol tablets pills?

If you miss 1 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 pills 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 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, 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.

• 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 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.

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

Distributed by:

Lupin Pharmaceuticals, Inc.

Naples, FL 34108

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) - 454 775

India

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

Revised: November 2024 ID#: 277047