Jolessa (Page 7 of 8)

Instructions For Use

JOLESSA® [joe les’ a]

(levonorgestrel and ethinyl estradiol tablets)

Important Information about taking JOLESSA

  • 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 JOLESSA, talk to your healthcare provider.
  • When you first start taking JOLESSA, 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 JOLESSA. 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 JOLESSA 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 JOLESSA according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking JOLESSA.
  • If you have vomiting or diarrhea within 3-4 hours of taking a pink pill, take another pink pill as soon as possible. Continue taking one pill a day until the 91-day course is finished.
  • 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 or spermicide, until you check with your healthcare provider.
  • Stop taking JOLESSA 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 or spermicide) during this time period.

Before you start taking JOLESSA:

  • Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
  • Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consists of 84 pink and 7 white pills. The cards in trays 1 and 2 each contain 28 pink pills (4 rows of 7 pills). See Figure A. The card in tray 3 contains 35 pills consisting of 28 pink pills (4 rows of 7 pills) and 7 white pills (1 row of 7 pills). See Figure B.
Figure A
(click image for full-size original)

Figure B

Figure B
(click image for full-size original)
  • Also find:
    • Where on the first tray in the pack to start taking pills (upper left corner) and
    • In what order to take the pills (follow the weeks)
  • Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking JOLESSA?

If you start taking JOLESSA and you have not used a hormonal birth control method before:

  • Take the first pink pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first pink pill that same day.
  • Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first pink pill until the next Sunday (first 7 days).

If you start taking JOLESSA and you are switching from another birth control pill:

  • Start your new JOLESSA 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 JOLESSA and previously used a vaginal ring:

  • Start using JOLESSA on the day you would have reapplied the next ring.

If you start taking JOLESSA and previously used a transdermal patch:

  • Start using JOLESSA on the day you would have started a new cycle (first patch application).

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

  • Start taking JOLESSA on the day of removal of your implant, or on the day when you would have had your next injection.

If you start taking JOLESSA and you are switching from an intrauterine device or system (IUD or IUS):

  • Start taking JOLESSA 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 or spermicide for the first 7 days that you take JOLESSA.

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 JOLESSA? ” above. Follow these instructions for a Sunday Start.

Instructions for using your JOLESSA Extended-Cycle Tablet Dispenser:

Sunday Start:

  • Take pill 1 on the Sunday after your period starts. To remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser. See Figure C.

Figure C

Figure C
(click image for full-size original)
  • If your period starts on a Sunday, take pill “1 ” that same day.
  • Take 1 pill at about the same time every day until you have taken the last pill in the tablet dispenser.
  • After taking the last white pill on Day 91 from the pill dispenser, start taking the first pink pill from a new Extended-Cycle Tablet Dispenser on the very next day (this should be a 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 or spermicide for the first 7 days of the first cycle that you take JOLESSA.

What should I do if I miss any JOLESSA pills?

If you miss 1 pink pill, 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 pink pills in a row, follow these steps:

  • Take 2 pills on the day you remember and 2 pills the next day.
  • Then continue to take 1 pill every day until you finish the pack.
  • You could become pregnant if you have sex in the 7 days after you miss two pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you miss 3 or more pink pills in a row, follow these steps:

  • Do not take the missed pills. Keep taking 1 pill every day until you have completed all of the remaining pills in the pack. For example, if you start taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may have bleeding during the week following the missed pills.
  • You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the white pills, call your healthcare provider because you may be pregnant.

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

TEVA WOMEN’S HEALTH, INC.
Subsidiary of TEVA PHARMACEUTICALS USA, INC
North Wales, PA 19454

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

JOLIFU-002

Revised August 2017

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