Tri-Lo- Estarylla ({7 (ethinyl estradiol 0.035 mg / norgestimate 0.18 mg oral tablet) / 7 (ethinyl estradiol 0.035 mg / norgestimate 0.215 mg oral tablet) / 7 (ethinyl estradiol 0.035 mg / norgestimate 0.25 mg oral tablet) / 7 (inert ingredients 1 mg oral tablet) } pack [tr) Dailymed

Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see

Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)].

  Table 1: Instructions for Administration of Tri-Lo-Estarylla Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: •Tri-Lo-Estarylla active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). •Tri-Lo-Estarylla inactive tablets are green (Day 22 to Day 28). Day 1 Start: •Take first active tablet without regard to meals on the first day of menses. •Take subsequent active tablets once daily at the same time each day for a total of 21 days. •Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. •Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start: •Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Tri-Lo-Estarylla . •Take subsequent active tablets once daily at the same time each day for a total of 21 days. •Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. •Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri-Lo-Estarylla from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Tri-Lo-Estarylla Start Tri-Lo-Estarylla: • Transdermal patch •On the day when next application would have been scheduled • Vaginal ring •On the day when next insertion would have been scheduled • Injection •On the day when next injection would have been scheduled • Intrauterine contraceptive •On the day of removal •If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. • Implant •On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

First-trimester •After a first-trimester abortion or miscarriage, Tri-Lo-Estarylla may be started immediately. An additional method of contraception is not needed if Tri-Lo-Estarylla is started immediately. •If Tri-Lo-Estarylla is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Tri-Lo-Estarylla.

•Stop norgestimate and ethinyl estradiol if an arterial thrombotic event or venous thrombotic (VTE) event occurs. •Stop norgestimate and ethinyl estradiol if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see ADVERSE REACTIONS (6.2)]. •If feasible, stop norgestimate and ethinyl estradiol at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. •Start norgestimate and ethinyl estradiol no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. •The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. •Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke. •Use COCs with caution in women with cardiovascular disease risk factors.

Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.

Unscheduled Bleeding and Spotting Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product. In the clinical trial of norgestimate and ethinyl estradiol, the frequency and duration of unscheduled bleeding and/or spotting was assessed in 1,673 women (11,015 evaluable cycles). A total of 3 (0.2%) women discontinued norgestimate and ethinyl estradiol, at least in part, due to bleeding or spotting. Based on data from the clinical trials, 7 to 17% of women using norgestimate and ethinyl estradiol experienced unscheduled bleeding per cycle in the first year. The percent of women who experienced unscheduled bleeding tended to decrease over time.

Amenorrhea and Oligomenorrhea Women who use norgestimate and ethinyl estradiol may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue norgestimate and ethinyl estradiol use if pregnancy is confirmed.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue norgestimate and ethinyl estradiol use if pregnancy is confirmed. Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see USE IN SPECIFIC POPULATIONS (8.1)].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of norgestimate and ethinyl estradiol was evaluated in 1,723 subjects who participated in a randomized, partially blinded, multicenter, active-controlled clinical trial of norgestimate and ethinyl estradiol for contraception. This trial examined healthy, nonpregnant, volunteers aged 18 to 45 (nonsmoker if 35 to 45 years of age), who were sexually active with regular coitus. Subjects were followed for up to 13 28-day cycles.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.

Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets, USP) (nor-JES-ti-mate, ETH-i-nil es-tra-DYE-ol) Important Information about taking Tri-Lo-Estarylla •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 Tri-Lo-Estarylla, talk to your healthcare provider. When you first start taking Tri-Lo-Estarylla, 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 Tri-Lo-Estarylla . 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 Tri-Lo-Estarylla 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 Tri-Lo-Estarylla 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 Tri-Lo-Estarylla. •If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra pill dispenser. If you do not have an extra pill dispenser, take the next 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 Tri-Lo-Estarylla 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 Tri-Lo-Estarylla: •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 Tri-Lo-Estarylla? If you start taking Tri-Lo-Estarylla 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 Tri-Lo-Estarylla. You do not need back-up contraception if you use the Day 1 Start. If you start taking Tri-Lo-Estarylla and you are switching from another birth control pill: •Start your new Tri-Lo-Estarylla 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 Tri-Lo-Estarylla and previously used a vaginal ring or transdermal patch: •Start using Tri-Lo-Estarylla on the day you would have reapplied the next ring or patch. If you start taking Tri-Lo-Estarylla and you are switching from a progestin-only method such as an implant or injection: •Start taking Tri-Lo-Estarylla on the day of removal of your implant or on the day when you would have had your next injection. If you start taking Tri-Lo-Estarylla and you are switching from an intrauterine device or system (IUD or IUS): •Start taking Tri-Lo-Estarylla 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 Tri-Lo-Estarylla. 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 Tri-Lo-Estarylla?" 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 Tri-Lo-EstaryllaTM . 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 buler pack, at the same time each day, for 28 days. •After taking the last pill on Day 28 from the pill buler pack, 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. Tri-Lo-EstaryllaTM comes in buler pack. Read the instructions below for using your buler pack. Each new buler pack 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. BEFORE YOU START TAKING YOUR PILLS 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.The 28-pill pack has 21 white, light blue, and blue "active" pills (with hormones) to take for 3 weeks. This is followed by 1 week of green "reminder" pills (without hormones).   3. ALSO FIND:  1) where on the pack to start taking pills,  2) in what order to take the pills (follow the arrows),  3) The week numbers as shown in the diagram below. 4) BE SURE YOU HAVE READY AT ALL TIMES:ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up method in case you miss pills.AN EXTRA, FULL PILL PACK. What should I do if I miss any Tri-Lo-Estarylla 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. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC. Florham Park, NJ 07932 Product of Spain PIL-121-03 Rev. 02/2023