LEVORA- levonorgestrel and ethinyl estradiol
Mayne Pharma Inc.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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, including LEVORA 0.15/30-28, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].
LEVORA® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 white active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 peach inert tablets (without hormones).
The structural formulas for the active components are:
C21H28O2 MW: 312.4
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α) (-)-.
C20H24O2 MW: 296.4
Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.
Each white active tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.
Each peach inert tablet contains the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
LEVORA 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy.
LEVORA 0.15/30-28 is contraindicated in females who are known to have the following conditions:
COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.
LEVORA 0.15/30-28 is contraindicated in women over 35 years of age who smoke (see CONTRAINDICATIONS). Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs (see CONTRAINDICATIONS). While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years.
The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.
LEVORA 0.15/30-28 is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS). Discontinue LEVORA 0.15/30-28 if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of COC use until the liver tests return to normal and COC causation has been excluded.
LEVORA 0.15/30-28 is contraindicated in females with benign or malignant liver tumors (see CONTRAINDICATIONS). COCs increase the risk of hepatic adenomas. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death from abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. The attributable risk of liver cancers in COC users is less than one case per million users.
LEVORA 0.15/30-28 is contraindicated in females with uncontrolled hypertension or hypertension with vascular disease (see CONTRAINDICATIONS). For all females, including those with well- controlled hypertension, monitor blood pressure at routine visits and stop LEVORA 0.15/30-28 if blood pressure rises significantly.
An increase in blood pressure has been reported in females using COCs, and this increase is more likely in older women with extended duration of use. The effect of COCs on blood pressure may vary according to the progestin in the COC.
The risk for cardiovascular disease and prevalence of risk factors for cardiovascular disease increase with age. Certain conditions, such as smoking and migraine headache without aura, that do not contraindicate COC use in younger females, are contraindications to use in women over 35 years of age [see CONTRAINDICATIONS and WARNINGS (1) ]. Consider the presence of underlying risk factors that may increase the risk of cardiovascular disease or VTE, particularly before initiating a COC for women over 35 years, such as:
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/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 LEVORA 0.15/30-28 prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see CONTRAINDICATIONS).
LEVORA 0.15/30-28 can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
Studies suggest an increased risk of developing gallbladder disease among COC users. Use of COCs may also worsen existing gallbladder disease.
A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Females with a history of pregnancy-related cholestasis may be at an increased risk for COC- related cholestasis.
LEVORA 0.15/30-28 is contraindicated in diabetic women over age 35, or females who have diabetes with hypertension, nephropathy, retinopathy, neuropathy, other vascular disease, or females with diabetes of > 20 years duration (see CONTRAINDICATIONS). LEVORA 0.15/30-28 may decrease glucose tolerance. Carefully monitor prediabetic and diabetic females who are using LEVORA 0.15/30-28.
Consider alternative contraception for females with uncontrolled dyslipidemia. LEVORA 0.15/30-28 may cause adverse lipid changes.
Females with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using LEVORA 0.15/30-28, which may increase the risk of pancreatitis.
LEVORA 0.15/30-28 is contraindicated in females who have headaches with focal neurological symptoms or have migraine headaches with aura, and in women over age 35 years who have migraine headaches with or without aura (see CONTRAINDICATIONS).
If a woman using LEVORA 0.15/30-28 develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue LEVORA 0.15/30-28 if indicated. Consider discontinuation of LEVORA 0.15/30-28 if there is an increased frequency or severity of migraines during COC use (which may be prodromal of a cerebrovascular event).
Females using LEVORA 0.15/30-28 may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy.
In two clinical trials of LEVORA (1084 subjects reporting for a total of 8186 treatment cycles and 238 subjects reporting for a total of 1102 treatment cycles), breakthrough bleeding occurred in 6.9% and 8.1% of reported cycles, and spotting occurred in 8.6% and 7.9% of reported cycles over the total study duration, respectively. In the two trials, intermenstrual bleeding (i.e., breakthrough bleeding and/or spotting) occurred in 13.1% and 12.9% of reported cycles over the total study duration, respectively. In one trial, 33 subjects out of 1084 (3.0%) discontinued due to bleeding irregularities (i.e., breakthrough bleeding and spotting); in the other trial, 6 subjects out of 238 (2.5%) discontinued due to bleeding irregularities.
Females who use LEVORA 0.15/30-28 may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant. In two clinical trials of LEVORA, one including 8186 reported treatment cycles, and the other including 1102 reported treatment cycles, amenorrhea occurred in 1.5% of treatment cycles in each trial.
If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or two 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 perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.
After discontinuation of a COC, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent.
Carefully observe females with a history of depression and discontinue LEVORA 0.15/30-28 if depression recurs to a serious degree. Data on the association of COCs with onset of depression or exacerbation of existing depression are limited.
Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. There is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.
The estrogen component of LEVORA 0.15/30-28 may raise the serum concentrations of thyroxine- binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult [see WARNINGS (7)].
In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
Diarrhea and/or vomiting may reduce hormone absorption (see DOSAGE AND ADMINISTRATION).
The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.
Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.
No drug-drug interaction studies were conducted with LEVORA 0.15/30-28.
Table 1 includes substances that demonstrated an important drug interaction with LEVORA 0.15/30-28.
|Metabolic Enzyme Inducers|
|Prevention or management||
|Examples||Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort*, and certain protease inhibitors (see separate section on protease inhibitors below).|
|Prevention or management||Administer 4 or more hours apart to attenuate this drug interaction.|
Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs.
Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine).
In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).
Table 2 provides significant drug interaction information for drugs co-administered with LEVORA 0.15/30-28.
|Prevention or management||Dose adjustment may be necessary. Consult the approved product labeling for lamotrigine.|
|Thyroid Hormone Replacement Therapy or Corticosteroid Replacement Therapy|
|Clinical effect||Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid- binding and cortisol-binding globulin (see Warnings, EFFECT ON BINDING GLOBULINS).|
|Prevention or management||The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Consult the approved product labeling for the therapy in use (see Warnings, EFFECT ON BINDING GLOBULINS).|
|Clinical effect||Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. Concomitant use with ethinyl estradiol- containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole).|
|Prevention or management||The dosage of drugs that can be affected by this interaction may need to be increased. Consult the approved product labeling for the concomitantly used drug.|
See WARNINGS (11).
LEVORA 0.15/30-28 is contraindicated in pregnancy because there is no reason to use COCs in pregnancy. Discontinue LEVORA 0.15/30-28 if pregnancy occurs. Epidemiologic studies and meta- analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. Animal studies to evaluate embryo/fetal toxicity were not conducted.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. (see DOSAGE AND ADMINISTRATION). The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for LEVORA 0.15/30-28 and any potential adverse effects on the breast-fed child from LEVORA 0.15/30-28 or from the underlying maternal condition.
Safety and efficacy of LEVORA 0.15/30-28 have been established in females of reproductive potential. Use of LEVORA 0.15/30-28 before menarche is not indicated.
LEVORA 0.15/30-28 has not been studied in postmenopausal women and is not indicated in this population.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions reported by COC users and described elsewhere in the labeling are:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.
There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.
LEVORA 0.15/30-28 is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED). LEVORA 0.15/30-28 may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
|Starting LEVORA 0.15/30-28 in females with no current use of hormonal contraception||Day 1 start
|Switching from another contraceptive method
||Start LEVORA 0.15/30-28 :
Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take LEVORA 0.15/30-28 as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.
Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.
||Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.|
||Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.|
||Day 1 start: Throw out the rest of the pack and start a new pack that same day.
Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day.
Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
If vomiting occurs within 3 to 4 hours after taking LEVORA 0.15/30-28, the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.
LEVORA® 0.15/30-28 tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/0.03 mg) are available in packages of 6 compact dispensers, each containing 28 tablets:
|21 Active Tablets:||White, round, unscored, debossed with 15/30 on one side and WATSON on the other side.|
|7 Inert Tablets:||Peach, round, unscored, debossed with WATSON on one side and P1 on the other side.|
Mississauga, Ontario L5N 7K9 Canada
Greenville, NC 27834
Rev. May 2019
(levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg tablets)
What is the most important information I should know about LEVORA 0.15/30-28?
Do not use LEVORA 0.15/30-28 if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What is LEVORA 0.15/30-28?
LEVORA 0.15/30-28 is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does LEVORA 0.15/30-28 work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use LEVORA 0.15/30-28.
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.
Who should not take LEVORA 0.15/30-28? Do not take LEVORA 0.15/30-28 if you:
If any of these conditions happen while you are taking LEVORA 0.15/30-28, stop taking LEVORA 0.15/30-28 right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking LEVORA 0.15/30-28.
What should I tell my healthcare provider before taking LEVORA 0.15/30-28?
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
LEVORA 0.15/30-28 may affect the way other medicines work, and other medicines may affect how well LEVORA 0.15/30-28 works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take LEVORA 0.15/30-28?
Read the Instructions for Use at the end of this Patient Information.
What are the possible serious side effects of LEVORA 0.15/30-28?
Call your healthcare provider or go to a hospital emergency room right away if you have:
Other serious side effects include:
What are the most common side effects of oral contraceptives?
These are not all the possible side effects of LEVORA 0.15/30-28. For more information, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088.
What else should I know about taking LEVORA 0.15/30-28?
How should I store LEVORA 0.15/30-28?
General information about the safe and effective use of LEVORA 0.15/30-28.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LEVORA 0.15/30-28 for a condition for which it was not prescribed. Do not give LEVORA 0.15/30-28 to other people, even if they have the same symptoms that you have.
This Patient Information Leaflet summarizes the most important information about LEVORA 0.15/30-28. You can ask your pharmacist or healthcare provider for information about LEVORA 0.15/30-28 that is written for health professionals.
For more information, call 1-844-825-8500.
Do birth control pills cause cancer?
Birth control pills do not seem 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 if I want to become pregnant?
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
What should I know about my period when taking LEVORA 0.15/30-28?
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking LEVORA 0.15/30-28, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
What are the ingredients in LEVORA 0.15/30-28?
Active ingredients: Each white pill contains levonorgestrel and ethinyl estradiol.
White pills: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.
Peach pills: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
Mississauga, Ontario L5N 7K9 Canada
Greenville, NC 27834
Rev. May 2019
(levonorgestrel 0.15 mg and ethinyl estradiol tablets 0.03 mg)
Important Information about taking LEVORA 0.15/30-28
Before you start taking LEVORA 0.15/30-28:
If you start taking LEVORA 0.15/30-28 and you have not used a hormonal birth control method before:
If you start taking LEVORA 0.15/30-28 and you are switching from another birth control pill:
If you start taking LEVORA 0.15/30-28 and previously used a vaginal ring:
If you start taking LEVORA 0.15/30-28 and previously used a transdermal patch:
If you start taking LEVORA 0.15/30-28 and you are switching from a progestin-only method such as an implant or injection:
If you start taking LEVORA 0.15/30-28 and you are switching from an intrauterine device or system (IUD or IUS):
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 LEVORA 0.15/30-28?" above. Follow these instructions for either a Sunday Start or a Day 1 Start.
Instructions for using your LEVORA 0.15/30-28 Pill
Dispenser: Sunday Start:
You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.
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.
If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:
If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
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 have any questions or are unsure about the information in this leaflet, call your healthcare provider.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
L5N 7K9 Canada
Greenville, NC 27834
Revised: May 2019
Levonorgestrel and Ethinyl Estradiol Tablets
USP, 0.15 mg/0.03 mg
Each white tablet (21) contains levonorgestrel 0.15 mg and ethinyl
estradiol 0.03 mg; each peach tablet (7) contains inert ingredients.
6 Blister Cards, 28 Tablets Each
levonorgestrel and ethinyl estradiol kit
|Labeler - Mayne Pharma Inc. (867220261)|
|Patheon, Inc.||240769596||MANUFACTURE(51862-097) , ANALYSIS(51862-097) , PACK(51862-097) , LABEL(51862-097)|