Simpesse (Page 6 of 6)

INSTRUCTIONS FOR USE

Simpesse®
(sim pe’ see)

(levonorgestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg

and ethinyl estradiol tablets USP 0.01 mg)

How do I take Simpesse?

  1. Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
  2. Many women have spotting or light bleeding or may feel sick to their stomach during the first few months of taking Simpesse. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your healthcare provider.
  3. 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.
  4. If you have trouble remembering to take Simpesse, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before you start taking Simpesse

  1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
  2. Look at your Extended-Cycle Wallet. Your Wallet consists of 3 blister strips that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 white and 7 light blue pills. Blister strips 1 and 2 each contain 28 white pills (4 rows of 7 pills). Blister strip 3 contains 35 pills consisting of 28 white pills (4 rows of 7 pills) and 7 light blue pills (1 row of 7 pills).
Figure 5
(click image for full-size original)

3. Also find:

  • Where on the first blister strip in the pack to start taking pills (upper left corner at the start arrow) and
  • In what order to take the pills (follow the weeks and arrow).

4. Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills.

If you are switching from another birth control method:

If you have been using a different hormonal method of birth control (such as a different pill, the “patch,” or the “vaginal ring”), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken Simpesse for 7 days.

If you have recently given birth and have not yet had a period , use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken Simpesse for 7 days.

When to start Simpesse?

  1. Take the first white pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first white pill that same day.
  2. 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 white pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the “patch,” or the “vaginal ring”), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken Simpesse for 7 days.

How to take Simpesse?

1. Take one pill at the same time every day until you have taken the last pill in the wallet.

  • Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).
  • Do not skip pills even if you do not have sex very often.

2. When you finish a wallet

  • After taking the last light blue pill, start taking the first white pill from a new Extended-Cycle Wallet the very next day (this should be on a Sunday) regardless of when your period started.

3. If you miss your scheduled period when you are taking the light blue pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking Simpesse.

What to do if you miss pills

If you MISS 1 white pill:

  1. 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.
  2. 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:

  1. Take 2 pills on the day you remember, and 2 pills the next day.
  2. Then take 1 pill a day until you finish the pack.
  3. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills.

If you MISS 3 OR MORE white pills in a row:

  1. Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may experience bleeding during the week following the missed pills.
  2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills.
  3. You MUST use a non-hormonal birth control method (such as condoms 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 light blue pills, call your healthcare provider because you may be pregnant.

If you MISS ANY of the 7 light blue pills:

  1. Throw away the missed pills.
  2. Keep taking the scheduled pills until the pack is finished.
  3. You do not need a back-up method of birth control.

Finally, if you are still not sure what to do about the pills you have missed

  • Use a back-up method anytime you have sex.
  • Keep taking one pill each day until you contact your healthcare provider.

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

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 04/2023

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.15 mg/0.03 mg and 0.01 mg (91 Tablets Pouch)

NDC 65862-864-94
Simpesse®
(levonorgestrel and ethinyl estradiol
tablets USP, 0.15 mg/0.03 mg and

ethinyl estradiol tablets USP, 0.01 mg)
Rx only 1 Extended-Cycle Wallet,
Containing 91 Tablets

Contains 1 Extended-Cycle Wallet containing 91 tablets: 84 white tablets, each
containing 0.15 mg levonorgestrel USP and 0.03 mg ethinyl estradiol USP, and
7 light blue tablets, each containing 0.01 mg ethinyl estradiol USP.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.15 mg/0.03 mg and 0.01 mg (91 Tablets Pouch)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.15 mg/0.03 mg and 0.01 mg (2 x 91 Tablets Carton)

NDC 65862-864-95

Simpesse®

(levonorgestrel and ethinyl estradiol

tablets USP, 0.15 mg/0.03 mg and

ethinyl estradiol tablets USP, 0.01 mg)

Rx only 2 Extended-Cycle Wallets,

91 Tablets Each

Contains 2 Extended-Cycle Wallets, each containing 91 tablets: 84 white tablets,

each containing 0.15 mg levonorgestrel USP and 0.03 mg ethinyl estradiol USP,

and 7 light blue tablets, each containing 0.01 mg ethinyl estradiol USP.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.15 mg/0.03 mg and 0.01 mg (2 x 91 Tablets Carton)
(click image for full-size original)
SIMPESSE levonorgestrel and ethinyl estradiol and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-864
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-864-95 2 POUCH in 1 CARTON contains a POUCH (65862-864-94)
1 NDC:65862-864-94 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (65862-864-95) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (65862-864-94) and a CARTON (65862-864-95)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 84
Part 2 7
Part 1 of 2
SIMPESSE levonorgestrel/ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code S;27
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206851 04/07/2017
Part 2 of 2
ETHINYL ESTRADIOL ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.01 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
POVIDONE K30
STARCH, CORN
STEARIC ACID
.ALPHA.-TOCOPHEROL, DL-
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code S;45
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206851 04/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206851 04/07/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-864), MANUFACTURE (65862-864)

Revised: 04/2023 Aurobindo Pharma Limited

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