Generic Name: LEVONORGESTREL 0.15mg, ETHINYL ESTRADIOL 0.03mg; ETHINYL ESTRADIOL 0.01mg
Dosage Form: kit
Drug Class: Contraceptives
How to Start and Take Simpesse
Begin Simpesse on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first white tablet that day.
For each 91-day course, take in the following order:
1. Start the first white tablet on the first Sunday after onset of menstruation. Then take one white tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) until a white tablet has been taken daily for 7 consecutive days.
2. Then take one light blue tablet for 7 consecutive days. Bleeding should occur during the 7 days that the light blue tablets are taken.
Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Simpesse, following the same schedule: 84 days taking a white tablet followed by 7 days taking a light blue tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white tablet daily for 7 consecutive days.
Switching to Simpesse from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant)
Start on the Sunday after the patient’s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken a white tablet for 7 consecutive days.
Starting Simpesse after Abortion or Miscarriage
First-trimester
Simpesse may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white tablet for 7 consecutive days.
Second-trimester
Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Simpesse following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)].
Starting Simpesse after Childbirth
Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Simpesse following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)].
If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Simpesse [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
Dosing Simpesse
Take one tablet by mouth at the same time every day. The dosage of Simpesse is one white tablet daily for 84 consecutive days, followed by one light blue tablet daily for 7 days. To achieve maximum contraceptive effectiveness, Simpesse must be taken exactly as directed, in the order directed, and at intervals not exceeding 24 hours. The failure rate may increase when pills are missed or taken incorrectly.
Missed Doses
Table 1. Instructions for Missed Simpesse Tablets
| If one white tablet is missed |
Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex. |
| If two white tablets in a row are missed |
Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. |
| If three or more white pills in a row are missed |
Throw away the missed pills. Continue taking one tablet every day as indicated on the pack until the pack is finished. Bleeding may occur during the week following the missed tablets. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. |
| If any of the seven light blue tablets are missed |
Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed. |
