DailyMed Label: Elinest

DailyMed Label: Elinest

2023

DailyMed Prescription

Elinest

Norgestrel and Ethinyl Estradiol

Northstar Rx LLC

NDC: 16714-365

NDC: 16714-365

NDC: 16714-365

NDC: 16714-365

NDC: 16714-365

NDC: 16714-365

ELINEST TM  is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each pale pink active ELINEST TM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch. Each white placebo tablet contains only the following inert ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pill pack contains 21 pale pink active tablets and 7 white inert tablets. 1

ELINEST TM  is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.

ELINEST TM  is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:     ºSmoke, if over age 35     ºHave deep-vein thrombosis or pulmonary embolism, now or in the past     ºHave inherited or acquired coagulopathies     ºHave cerebrovascular disease     ºHave coronary artery disease     ºHave thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation)     ºHave uncontrolled hypertension     ºHave diabetes mellitus with vascular disease     ºHeadaches with focal neurological symptoms or migraine headaches with aura     ºWomen over age 35 with any migraine headaches Liver tumors, benign or malignant, or liver disease Undiagnosed abnormal uterine bleeding Pregnancy, because there is no reason to use COCs during pregnancy Current diagnosis or history of breast cancer, which may be hormone sensitive Hypersensitivity to any of the components of ELINEST TM Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , Risk of liver enzyme elevations with concomitant hepatitis c treatment ).

The estrogen component of COCs 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. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking ELINEST TM . Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation: Do not co-administer ELINEST TM  with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings , Risk of liver enzyme elevations with concomitant hepatitis c treatment ). Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Colesevelam: Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. Concomitant administration of CYP3A4 inhibitors such as itraconazole, fluconazole, grapefruit juice or ketoconazole may increase plasma hormone concentrations. Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of the estrogen and/or progestin have been noted when COCs are coadministered with some HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir], or increase [e.g., indinavir and atazanavir/ritonavir] HCV protease inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). Effects of Combined Oral Contraceptives on Other Drugs COCs containing EE may inhibit the metabolism of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in the plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs. The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. See WARNINGS Sections 2  and PRECAUTIONS Section 1 . 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 nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Discontinue ELINEST TM use if pregnancy is confirmed. 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. Safety and efficacy of norgestrel and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of ELINEST TM before menarche is not indicated. ELINEST TM  has not been studied in postmenopausal women and is not indicated in this population. See FDA-approved patient labeling ( Patient Information and Instructions for Use ). Counsel patients about the following information: Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ]. Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC. ELINEST TM does not protect against HIV infection and other sexually transmitted infections. ELINEST TM is not to be used during pregnancy; if pregnancy occurs during use of ELINEST TM , instruct the patient to stop further use. Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed. Use a back-up or alternative method of contraception when enzyme inducers are used with ELINEST TM . COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established. Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken an active tablet for 7 consecutive days. Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.

An increased risk of the following serious adverse reactions (see

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.

ELINEST™ Tablets (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg): Each pale pink tablet is biconvex, round, with “E1” debossed on one side, and contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol. ELINEST™ blisters (NDC 16714-365-01) are packaged in cartons of one, three, and six 28-tablet dispensers. Each tablet dispenser contains 21 pale pink (active) tablets and 7 white (inert) tablets. Inert tablets are biconvex, round, with “P” debossed on one side and “N” on the other side. ELINEST™ Tablets are available in the following: Carton of 1 NDC 16714-365-02 Carton of 3 NDC 16714-365-03 Carton of 6 NDC 16714-365-04 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Mechanism of Action Combined oral contraceptives (COCs) prevent pregnancy primarily by suppressing ovulation.

FDA-Approved Patient Labeling ELINEST TM [ee-lin-EST] (norgestrel and ethinyl estradiol tablets) What is the most important information I should know about ELINEST TM ? Do not use ELINEST TM 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 ELINEST TM ? ELINEST TM is a birth control pill (oral contraceptive) used by women to prevent pregnancy. How does ELINEST TM 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 out of 100 women may get pregnant during the first year they use norgestrel and ethinyl estradiol tablets. 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 ELINEST TM ? Do not take ELINEST TM if you: smoke and are over 35 years old had blood clots in the legs, arms, lungs, or eyes had a problem with your blood that makes it clot more than normal have certain heart valve problems or irregular heart beat that increases your risk of having blood clots had a stroke had a heart attack have high blood pressure that cannot be controlled by medicine have diabetes with kidney, eye, nerve or blood vessel damage have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over 35 years of age have liver problems, including liver tumors have any unexplained vaginal bleeding are pregnant have or had breast cancer have a known allergy or hypersensitivity to any of the components of ELINEST TM (norgestrel and ethinyl estradiol tablets) You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. If any of these conditions happen while you are taking ELINEST TM , stop taking ELINEST TM right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking ELINEST TM . What should I tell my healthcare provider before taking ELINEST TM ? Tell your healthcare provider if you: are pregnant or think you may be pregnant are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) have a condition called hereditary angioedema are breastfeeding or plan to breastfeed. ELINEST TM may decrease the amount of breast milk you make. A small amount of the hormones in ELINEST TM may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. ELINEST TM may affect the way other medicines work, and other medicines may affect how well ELINEST TM 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 ELINEST TM ? Read the Instructions for Use at the end of this Patient Information. What are the possible serious side effects of ELINEST TM ? Like pregnancy, ELINEST TM may cause serious side effects, including blood clots in your lungs , heart attack, or a stroke that may lead to death.  Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you: first start taking birth control pills restart the same or different birth control pills after not using them for a month or more Call your healthcare provider or go to a hospital emergency room right away if you have: leg pain that will not go away sudden severe shortness of breath sudden change in vision or blindness chest pain a sudden, severe headache unlike your usual headaches weakness or numbness in your arm or leg trouble speaking Other serious side effects include: liver problems, including:     ºrare liver tumors     ºjaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes. high blood pressure  gallbladder problems  changes in the sugar and fat (cholesterol and triglycerides ) levels in your blood  new or worsening headaches including migraine headaches  depression  possible cancer in your breast and cervix  swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema. What are the most common side effects of ELINEST TM ? menstrual complaints, including unscheduled bleeding and spotting nausea headache (including migraine) weight increase or decrease cervical erosion acne menstrual cramps vaginal discharge stomach pain, discomfort, and gas increase in appetite depression nervousness dark areas on your face fatigue worsening of varicose veins These are not all the possible side effects of ELINEST TM . 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 ELINEST TM ? If you are scheduled for any lab tests, tell your healthcare provider you are taking ELINESTTM. Certain blood tests may be affected by ELINESTTM. ELINESTTM does not protect against HIV infection (AIDS) and other sexually transmitted infections. How should I store ELINEST TM ? Store ELINEST TM at room temperature between 68°F to 77°F (20°C to 25°C). Keep ELINEST TM and all medicines out of the reach of children. Store away from light. General information about the safe and effective use of ELINEST TM : Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ELINEST TM for a condition for which it was not prescribed. Do not give ELINEST TM to other people, even if they have the same symptoms that you have. This Patient Information summarizes the most important information about ELINEST TM . You can ask your pharmacist or healthcare provider for information about ELINEST TM that is written for health professionals . For more information, call 1-800-206-7821. Do birth control pills cause cancer? It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. 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 ELINEST TM ? 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 ELINEST TM , 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 ELINEST TM ? Active ingredients: Each pale pink pill contains norgestrel and ethinyl estradiol. Inactive ingredients: Pale pink pills: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch. White pills: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch. INSTRUCTIONS FOR USE Important Information about taking ELINEST TM 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 ELINEST TM , talk to your healthcare provider. When you first start taking ELINEST TM , 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 ELINEST TM . 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 TO DO IF YOU MISS 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 ELINEST TM 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 ELINEST TM . 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 the dispenser you are currently using. 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 or spermicide, until you check with your healthcare provider. Stop taking ELINEST TM 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 another form of contraception (like condoms or spermicide) during this time period. BEFORE YOU START TAKING ELINEST TM 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 PILL PACK: The pill pack has 21 "active" pale pink pills (with hormones) to take for 3 weeks, followed by 1 week of reminder white pills (without hormones). 3.FIND: 1) where on the pack to start taking pills, and 2) in what order to take the pills (follow the arrows)  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 in case you miss pills•An extra, full pill pack WHEN TO START THE FIRST PACK OF PILLS You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: 1. Pick the day label strip that starts with the first day of your period. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the tablet dispenser. Note: if the first day of your period is a Sunday, you can skip step #1. 2. Take the first “active” pale pink pill of the first pack during the first 24 hours of your period. 3. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period. SUNDAY START: 1.Take the first "active" pale pink pill of the first pack on the Sunday after your period starts , even if you are still bleeding. If your period begins on Sunday, start the pack that same day. 2. Use a non-hormonal method of birth control (such as condoms or spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). WHAT TO DO DURING THE MONTH 1. Take one pill at the same time every day until the pack is empty. Do not skip pills even if you are spotting or bleeding between monthly periods 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 pack: Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs. IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS: If your previous brand had 21 pills: Wait 7 days to start taking ELINEST TM. You will probably have your period during that week. Ideally, be sure that no more than 7 days pass between the 21-day pack and taking the first pale pink ELINEST TM pill (“active” with hormone). If you start ELINEST TM more than 7 days after taking the last pill of your previous contraceptive, you must use a non-hormonal back-up method of birth control during the first 7 days of ELINEST TM use. If your previous brand had 28 pills: Start taking the first pale pink ELINEST TM pill (“active” with hormone) on the day after your last reminder pill. Ideally, do not wait any days between packs. If you do skip any days between the last pill of your previous contraceptive and starting ELINEST TM , you must use a non-hormonal back-up method of birth control during the first 7 days of ELINEST TM use. IF YOU SWITCH FROM ANOTHER TYPE OF BIRTH CONTROL METHOD: If you were previously taking a progestin-only PILL: You may switch to ELINEST TM on any day from a progestin-only pill and should start taking the first pale pink ELINEST TM pill (“active” with hormone) the day after you take your last progestin-only pill. In addition, use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking. If you are switching from a contraceptive vaginal ring or transdermal patch: Start taking the first pale pink ELINEST TM pill (“active” with hormone) on the day that you would have inserted a new ring or applied a new patch. If you are switching from a contraceptive implant: Start taking the first pale pink ELINEST TM pill (“active” with hormone) on the day that the implant is removed. If you are switching from a contraceptive injection: Start taking the first pale pink ELINEST TM pill (“active” with hormone) on the day that the next contraceptive injection is due. If you are switching from an Intrauterine device (IUD) or Intrauterine system (IUS): Start taking the first pale pink ELINEST TM pill (“active” with hormone) on the day the IUD/IUS is removed. If your IUD/IUS is removed on the first day of your period you do not need to use an additional non-hormonal back up method of birth control. If the IUD/IUS is removed on any other day, use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking. WHAT TO DO IF YOU MISS PILLS ELINEST TM may not be as effective if you miss pale pink “active” pills, and particularly if you miss the first few or the last few pale pink “active” pills in a pack. If you MISS 1 pale pink “active” 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 could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days. If you MISS 2 pale pink “active” pills in a row in WEEK 1 OR WEEK 2 of your pack: 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 restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days. If you MISS 2 pale pink“active” pills in a row in THE 3rd WEEK: 1.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.2.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.3.You could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days. If you MISS 3 OR MORE pale pink “active” pills in a row (during the first 3 weeks): 1.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.2.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.3.You could become pregnant if you have sex in the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days. If you forget any of the 7 white “reminder” pills in Week 4: Throw away the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up non-hormonal birth control method if you start your next pack on time. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED Use a back-up non-hormonal birth control method anytime you have sex. Keep taking one pill each day until you can reach your healthcare provider. To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC.Toll-free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Northstar Rx LLC Memphis TN 38141 Manufactured by: Novast Laboratories Ltd. Nantong, China 226009 I0103   Rev. 01/2023 Rev. B 4 5 6 7

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