The following Structured Product Label (SPL) was submitted to the FDA by Aurobindo Pharma Limited for the product Lo Simpesse (NDC 65862-866). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warning: cigarette smoking and serious cardiovascular events, 1 indications and usage, 2 dosage and administration, 3 dosage forms and strengths, 4 contraindications, 5.1 vascular events, 5.2 carcinoma of the breast and cervix, 5.3 liver disease, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See CONTRAINDICATIONS (4).]
Lo SimpesseTM (Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) is indicated for use by women to prevent pregnancy.
Take one tablet by mouth at the same time every day. The dosage of Lo Simpesse is one light pink tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one light blue ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Lo Simpesse must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking Lo Simpesse on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first light pink tablet is taken that day. One light pink tablet should be taken daily for 84 consecutive days, followed by one light blue tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a light pink tablet has been taken daily for 7 consecutive days. A scheduled period 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 Lo Simpesse, following the same schedule: 84 days taking a light pink tablet followed by 7 days taking a light blue tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light pink tablet daily for 7 consecutive days.
If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
For patient instructions regarding missed pills, see PATIENT COUNSELING INFORMATION (17.2).
For postpartum women who are not breastfeeding, start Lo Simpesse no earlier than four to six weeks postpartum. If the patient starts on Lo Simpesse postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a light pink tablet for 7 consecutive days.
Lo Simpesse is available in Extended-Cycle Wallets, each containing a 13-week supply of tablets: 84 light pink tablets, each containing 0.1 mg of levonorgestrel and 0.02 mg ethinyl estradiol, and 7 light blue tablets each containing 0.01 mg of ethinyl estradiol. The light pink tablets are round, biconvex, beveled-edge, debossed with “S” on one side and “46”on other side. The light blue tablets are mottled, round, biconvex, beveled-edge, debossed with “S” on one side and “45” on other side.
Do not prescribe Lo Simpesse to women who are known to have the following conditions:
Stop COCs if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. 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.
Use of Lo Simpesse provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year).
If feasible, stop COCs at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start COCs no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
Stop COCs if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
Women who currently have or have had breast cancer should not use COCs because breast cancer may be hormonally sensitive.
There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.
Discontinue COCs if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function.
Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.
Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.
During clinical trials with the Hepatitis C combination drug regimen that contains obmitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Lo Simpesse prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Lo Simpesse can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
For women with well-controlled hypertension, monitor blood pressure and stop COCs if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
Studies suggest a small increased relative risk of developing gallbladder disease among COC users.
Carefully monitor prediabetic and diabetic women who are taking COCs. COCs may decrease glucose tolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs.
If a woman taking COCs develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue COCs if indicated.
Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If bleeding persists, 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 COC product.
When prescribing Lo Simpesse, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased unscheduled bleeding and/or spotting. The clinical trial that evaluated the efficacy of Lo Simpesse also assessed unscheduled bleeding. The participants in this 12-month clinical trial (N=2,185) completed the equivalent of over 20,000 28-day cycles of exposure and were composed primarily of women who had used OCs previously (89%), as opposed to new users (11%). A total of 209 subjects (9.6%) discontinued Lo Simpesse, at least in part, due to bleeding and/or spotting.
Scheduled (withdrawal) bleeding and/or spotting remained fairly constant over time, with an average of 2 to 3 days of bleeding and/or spotting per each 91-day cycle. Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 1 below presents the number of days with unscheduled bleeding in treatment cycles 1 and 4. Table 2 presents the number of days with unscheduled spotting in treatment cycles 1 and 4.
| Q1=Quartile 1: 25% of women had this number of days of unscheduled bleeding Median: 50% of women had ≤ this number of days of unscheduled bleeding Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled bleeding | |||||
| 91-Day Treatment Cycle | Days per 84-Day Interval | Days per 28-Day Interval | |||
| Q1 | Median | Q3 | Mean | Mean | |
| 1st | 0 | 5 | 11 | 7.5 | 2.5 |
| 4th | 0 | 0 | 5 | 3.5 | 1.2 |
| Q1=Quartile 1: 25% of women had ≤ this number of days of unscheduled spotting Median: 50% of women had ≤ this number of days of unscheduled spotting Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled spotting | |||||
| 91-Day Treatment Cycle | Days per 84-Day Interval | Days per 28-Day Interval | |||
| Q1 | Median | Q3 | Mean | Mean | |
| 1st | 3 | 10 | 19 | 14 | 4.7 |
| 4th | 0 | 3 | 10 | 6.5 | 2.2 |
Figure 1 shows the percentage of Lo Simpesse subjects participating in the primary clinical trial with ≥ 7 days or ≥ 20 days of unscheduled bleeding and/or spotting, or just unscheduled bleeding, during each 91-day treatment cycle.
Figure 1: Percent of Women Taking Lo Simpesse who Reported Unscheduled Bleeding and/or Spotting (Based on Daily Diaries)
Figure-1 (Levonorethinyl Fig1)
The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid binding globulin increase with use of COCs.
A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical trial that evaluated the safety and efficacy of Lo Simpesse was a 12-month, multicenter, non-comparative open-label study, which enrolled women aged 18 to 41, of whom 2,185 took at least one dose of Lo Simpesse.
Adverse Reactions Leading to Study Discontinuation: 11% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions leading to discontinuation were irregular and/or heavy uterine bleeding, headache, mood changes, nausea, acne, and weight gain.
Common Treatment-Emergent Adverse Reactions (≥ 5% of women): headaches (33%); irregular and/or heavy uterine bleeding (13%), dysmenorrhea (11%), nausea and/or vomiting (11%), back pain (8%).
No formal drug-drug interaction studies were conducted with Lo Simpesse.
If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include:
HIV protease inhibitors: Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Do not co-administer Lo Simpesse with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4)].
Combination OCs containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Combination OCs have been shown to significantly decrease plasma concentrations of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.
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.
The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. Combination OCs should not be used during pregnancy to treat threatened or habitual abortion.
Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum.
When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing OCs 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 estrogen and progestin from low dose COCs are present in breast milk, but these doses have not produced adverse effects in breastfeeding infants.
Safety and efficacy of Lo Simpesse have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated.
This product has not been studied in postmenopausal women and is not indicated in this population.
There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
Lo Simpesse (levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) provide an oral contraceptive regimen of 84 light pink tablets each containing 0.1 mg levonorgestrel USP and 0.02 mg ethinyl estradiol USP, followed by 7 light blue tablets each containing 0.01 mg ethinyl estradiol USP.
The structural formulas for the active components are:
Levonorgestrel Chemical Structure (Levonorethinyl Str1)
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.
Ethinyl Estradiol Chemical Structure (Levonorethinyl Str2)
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
Inactive ingredients for the light pink tablets include croscarmellose sodium, FD&C Red #40, lactose monohydrate, magnesium stearate, methylene chloride, microcrystalline cellulose, and povidone.
Inactive ingredients for the light blue tablets include colloidal silicon dioxide, FD&C Blue No. 1, lactose monohydrate, povidone, pregelatinized starch (maize), stearic acid, and vitamin E.
Combination OCs 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.
Absorption
No specific investigation of the absolute bioavailability of Lo Simpesse in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the systemic bioavailability of ethinyl estradiol is approximately 43%.
The mean plasma pharmacokinetic parameters of Lo Simpesse following a single oral dose of three levonorgestrel/ethinyl estradiol combination tablets in normal healthy women under fasting conditions are reported in Table 3.
| AUC0-∞ = area under the drug concentration curve from time 0 to infinity Cmax = maximum concentration Tmax = time to maximum concentration | ||||
| | AUC0-∞ | Cmax | Tmax | T½ |
| Levonorgestrel | 76.5 ± 24.9 ng*hr/mL | 6 ± 1.6 ng/mL | 1.6 ± 0.6 hours | 28.5 ± 8.7 hours |
| Ethinyl estradiol | 1335.8 ± 365.3 pg*hr/mL | 122.8 ± 39.5 pg/mL | 1.8 ± 0.7 hours | 17.5 ± 7.4 hours |
The effect of food on the rate and the extent of levonorgestrel and ethinyl estradiol absorption following oral administration of Lo Simpesse has not been evaluated.
Distribution
The apparent volume of distribution of levonorgestrel and ethinyl estradiol is reported to be approximately 1.8 L/kg and 4.3 L/kg, respectively. Levonorgestrel is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Ethinyl estradiol is about 95 to 97% bound to serum albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Following repeated daily dosing of combination levonorgestrel/ethinyl estradiol OCs, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by ethinyl estradiol, and a possible reduction in hepatic metabolic capacity.
Metabolism
Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.
First-pass metabolism of ethinyl estradiol involves formation of ethinyl estradiol-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed ethinyl estradiol by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of ethinyl estradiol hydroxylation. Hydroxylation at the 4-, 6-, and 16-positions may also occur, although to a much lesser extent than 2-hydroxylation. The various hydroxylated metabolites are subject to further methylation and/or conjugation.
Excretion
About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and then undergoes enterohepatic recirculation.
Race
The effect of race on the pharmacokinetics of Lo Simpesse has not been evaluated.
Renal and Hepatic Impairment
No formal studies were conducted to evaluate the effect of hepatic or renal disease on the disposition of Lo Simpesse. However, steroid hormones may be poorly metabolized in patients with impaired liver function.
In a 12-month multicenter open-label clinical trial, 2,185 women aged 18 to 41 were studied to assess the safety and efficacy of Lo Simpesse, completing the equivalent of 20,937 28-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (75%), African-American (12%), Hispanic (10%), Asian (2%), and Other (2%). There were no exclusions for body mass index (BMI) or weight. The weight range for those women treated was 87 to 381 lbs., with a mean weight of 159 lbs. Among the women in the trial, 59% were current or recent hormonal contraceptive users, 30% were prior users (had used hormonal contraceptives in the past but not in the 6 months prior to enrollment) and 11% were new starts. Of treated women, 14.2% were lost to follow-up, 11.6% discontinued due to an adverse event, and 10.3% discontinued by withdrawing their consent.
The pregnancy rate (Pearl Index [PI]) in women aged 18 to 35 years was 2.74 pregnancies per 100 women-years of use (95% confidence interval 1.92 to 3.78), based on 36 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.
Lo Simpesse (Levonorgestrel and Ethinyl Estradiol Tablets USP 0.1 mg/0.02 mg and Ethinyl Estradiol Tablets USP 0.01 mg) are available in an Extended-Cycle Wallets, that contains 84 round, light pink tablets and 7 round, light blue tablets. Each light pink tablet (biconvex, beveled edge debossed with “S” on one side and “46” on other side) contains 0.1 mg levonorgestrel USP and 0.02 mg ethinyl estradiol USP. Each light blue tablet (mottled, biconvex, beveled-edge debossed with “S” on one side and “45” on other side) contains 0.01 mg ethinyl estradiol USP.
They are supplied as follows:
Lo Simpesse (Levonorgestrel and Ethinyl Estradiol Tablets USP 0.1 mg/0.02 mg and Ethinyl Estradiol Tablets USP 0.01 mg) are available in an Extended-Cycle Wallet of 91 tablets which is packed in a pouch (NDC 65862-866-94). Such two pouches are packed in a carton (NDC 65862-866-95).
The tablets should not be removed from the protective blister packaging and outer wallet to avoid damage to the product.
The wallet should be kept in the foil pouch until dispensed to the patient.
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Guide for Using
Lo SimpesseTM (Levonorgestrel and Ethinyl Estradiol Tablets USP 0.1 mg/0.02 mg
and Ethinyl Estradiol Tablets USP 0.01 mg)
| WARNING TO WOMEN WHO SMOKE Do not use Lo Simpesse if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. |
Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
WHAT IS Lo Simpesse?
Lo Simpesse is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.
HOW WELL DOES Lo Simpesse WORK?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.
Based on the results of a single clinical study lasting 12 months, 2 to 4 women, out of 100 women, may get pregnant during the first year they use Lo Simpesse.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Figure2 (Levonorethinyl Fig2)
Before you start taking Lo Simpesse
Figure-3 (Levonorethinyl Fig3)
3. Also find:
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.
When to Start Lo Simpesse?
How to Take Lo Simpesse?
1. Take one pill at the same time every day until you have taken the last pill in the wallet.
2. When you finish a wallet
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 Lo Simpesse.
WHAT TO DO IF YOU MISS PILLS?
If you MISS 1 light pink pill:
If you MISS 2 light pink pills in a row:
If you MISS 3 OR MORE light pink pills in a row:
If you MISS ANY of the 7 light blue pills:
Finally, if you are still not sure what to do about the pills you have missed
WHO SHOULD NOT TAKE Lo Simpesse?
Your healthcare provider will not give you Lo Simpesse if you have:
Also, do not take birth control pills if you:
Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy.
WHAT ELSE SHOULD I KNOW ABOUT TAKING Lo Simpesse?
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
Do not skip any pills, even if you do not have sex often.
Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Lo Simpesse, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants.
Tell your health care provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
Consider using another birth control method when you take medicines that may make birth control pills less effective.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine.
If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your health care provider.
WHAT ARE THE MOST SERIOUS RISKS OF TAKING BIRTH CONTROL PILLS?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age > 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:
A few women who take birth control pills may get:
All of these events are uncommon in healthy women.
Call your health care provider right away if you have:
WHAT ARE COMMON SIDE EFFECTS OF BIRTH CONTROL PILLS?
The most common side effects of birth control pills are:
These side effects are usually mild and usually disappear with time.
Less common side effects are:
This is not a complete list of possible side effects. Talk to your health care provider if you develop any side effects that concern you.
No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
DO BIRTH CONTROL PILLS CAUSE CANCER?
Birth control pills do not appear to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
WHAT SHOULD I KNOW ABOUT MY PERIOD WHEN TAKING Lo Simpesse?
When you take Lo Simpesse, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 light blue pills). Each period is likely to last about 2 to 3 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. This bleeding or spotting tends to decrease with time. Do not stop taking Lo Simpesse because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.
WHAT IF I MISS MY SCHEDULED PERIOD WHEN TAKING Lo Simpesse?
You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking light blue tablets). Since scheduled periods are less frequent when you are taking Lo Simpesse, notify your healthcare provider that you have missed your period and that you are taking Lo Simpesse. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking Lo Simpesse if it is determined that you are pregnant.
WHAT IF I WANT TO BECOME PREGNANT?
You may stop taking the pill whenever you wish. Consider a visit with your health care provider for a pre-pregnancy checkup before you stop taking the pill.
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)-509302
India
Revised: 08/2017
NDC 65862-866-94
Lo SimpesseTM
(Levonorgestrel and Ethinyl Estradiol
Tablets USP 0.1 mg/0.02 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 light pink tablets, each
containing 0.1 mg levonorgestrel USP with 0.02 mg ethinyl estradiol USP,
and 7 light blue tablets, each containing 0.01 mg ethinyl estradiol USP.
Package Label-principal Display Panel (0.1 mg/0.02 mg and 0.01 mg (91 Tablets Pouch))
NDC 65862-866-95
Lo SimpesseTM
(Levonorgestrel and Ethinyl Estradiol
Tablets USP 0.1 mg/0.02 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 light pink tablets,
each containing 0.1 mg levonorgestrel USP with 0.02 mg ethinyl estradiol USP,
and 7 light blue tablets, each containing 0.01 mg ethinyl estradiol USP.
Package Label-principal Display Panel (0.1 mg/0.02 mg and 0.01 mg (91 Tablets Carton))
* Please review the disclaimer below.
