DailyMed Label: Chateal EQ

DailyMed Label: Chateal EQ

2023

DailyMed Prescription

Chateal EQ

Levonorgestrel and Ethinyl Estradiol

Afaxys Pharma, LLC

NDC: 50102-230

NDC: 50102-230

NDC: 50102-230

NDC: 50102-230

Chateal EQ (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 orange active tablets, each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 green inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each green inert tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), magnesium stearate, microcrystalline cellulose, and povidone. Chemical Structure1 Chemical Structure2

Chateal EQ is indicated for use by females of reproductive potential to prevent pregnancy.

1. How to Start and Take Chateal EQ Chateal EQ is dispensed in a blister pack containing 28 tablets (see HOW SUPPLIED ). Chateal EQ 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. Table 3: Instructions for Administration of Chateal EQ Starting Chateal EQ in females with no current use of hormonal contraception Day 1 start Take first tablet without regard to meals on the first day of menses Take subsequent tablets once daily at the same time each day 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 tablet) Sunday start Take first tablet without regard to meals on the first Sunday after the onset of menstrual period Take subsequent tablets once daily at the same time each day Use additional nonhormonal contraception for the first seven days of product use 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 tablet) Switching from another contraceptive method A COC Transdermal patch Vaginal ring Injection Intrauterine contraceptive Implant Start Chateal EQ: On the day when the new pack of the previous COC would have been started On the day when next application would have been scheduled On the day when next insertion would have been scheduled On the day when next injection would have been scheduled On the day of removal On the day of removal Starting Chateal EQ   after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Chateal EQ may be started immediately. An additional method of contraception is not needed if Chateal EQ is started immediately. If Chateal EQ is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle of Chateal EQ.     Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Chateal EQ following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of Chateal EQ (see CONTRAINDICATIONS , WARNINGS (1) ,  PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING) .    Starting Chateal EQ after Childbirth     Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Chateal EQ following the instructions in Table 3 for women not currently using hormonal contraception. Chateal EQ is not recommended for use in lactating women (see  PRECAUTIONS (7) and FDA-APPROVED PATIENT LABELING). If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Chateal EQ (see CONTRAINDICATIONS , WARNINGS (9) ,  PRECAUTIONS (6) and FDA-APPROVED PATIENT LABELING) . 2. Dosing Chateal EQ Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Chateal EQ as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly. 3. Missed doses 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. Table 4: Instructions for Missed Chateal EQ Tablets If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two active tablets are missed in Week 1 or Week 2 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. If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3   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. 4. Advice in Case of Gastrointestinal Disturbances If vomiting occurs within 3 to 4 hours after taking Chateal EQ, 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.

Chateal EQ is contraindicated in females who are known to have the following conditions:   A high risk of arterial or venous thrombotic diseases. Examples include women who are  known to: Smoke, if over age 35 [see  BOXED WARNING and WARNINGS (1) ]. Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1) ] . Have cerebrovascular disease [see WARNINGS (1) ] .     Have coronary artery disease [see WARNINGS (1) ] . Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1) ] . Have inherited or acquired hypercoagulopathies [see WARNINGS (1) ] .  Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3) ] . Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7) ]. Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8) ] . Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive. Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see WARNINGS (2) ] . Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS (5) ] . Undiagnosed abnormal uterine bleeding [see WARNINGS (9) ] .

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 levonorgestrel and ethinyl estradiol tablets. 4.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 1 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets. Table 1: Significant Drug Interactions Involving Substances That Affect COCs Metabolic Enzyme Inducers            Clinical effect Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding. Prevention or management Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort a , and certain protease inhibitors (see separate section on protease inhibitors below). Colesevelam                                    Clinical effect Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC. Prevention or management Administer 4 or more hours apart to attenuate this drug interaction. a Induction potency of St. John’s wort may vary widely based on preparation. Substances increasing the systemic exposure of COCs:   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, 7 or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs. Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: 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). 4.2 Effects of Combined Oral Contraceptives on Other Drugs Table 2 provides significant drug interaction information for drugs co-administered with levonorgestrel and ethinyl estradiol tablets. Table 2: Significant Drug Interaction Information for Drugs Co-Administered With COCs Lamotrigine                                            Clinical effect Concomitant use of COCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation. Decreased systemic exposure of lamotrigine may reduce seizure control. 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 ). Other Drugs                                                 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.   4.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy - Liver Enzyme Elevation Do not co-administer levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, [see Warnings (5) ], and glecaprevir/pibrentasvir due to potential for ALT elevations . 4.4 Effect on Laboratory Tests The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. See WARNINGS (11) . Risk Summary Discontinue levonorgestrel and ethinyl estradiol tablets if pregnancy occurs because there is no reason to use COCs in 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 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. Risk Summary 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 levonorgestrel and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from levonorgestrel and ethinyl estradiol tablets or from the underlying maternal condition. Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in females of reproductive potential. Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated. Levonorgestrel and ethinyl estradiol tablets has not been studied in postmenopausal women and is not indicated in this population. Counsel patients that 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 and CONTRAINDICATIONS ). Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted infections. Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed (see DOSAGE AND ADMINISTRATION ). Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs [see PRECAUTIONS (4.1) ]. Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established [see PRECAUTIONS (7) ]. Counsel any patient who starts Chateal EQ postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days (see DOSAGE AND ADMINISTRATION ). Counsel patients that amenorrhea may occur. Pregnancy should be considered in the event of amenorrhea, and should be ruled out if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness [see WARNINGS (9) ]. Depression may occur. Women should contact their healthcare provider if depression occurs, including shortly after initiating the treatment [see WARNINGS (10) ].

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Chateal EQ  (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg) are available in a carton of 3 pouches, each containing 28 tablets: 21 Active Tablets: Orange, round, biconvex, beveled-edge, unscored tablets, debossed with “S” on one side and “44” on other side. 7 Inert Tablets: Green, round, mottled biconvex, beveled-edge, unscored and uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet. 1 Pouch of 28 tablets                                      NDC 50102-230-21 Carton of 3 Pouches                                       NDC 50102-230-23 Store at 20º to 25°C (68° to 77ºF) [see USP Controlled Room Temperature]. Manufactured For: Afaxys Pharma, LLC Charleston, SC, 29403, USA. Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302, India Revised: 08/2023

Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.

Chateal EQ ® [sha-teÉl] (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg) What is the most important information I should know about Chateal EQ? Do not use Chateal EQ  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 Chateal EQ? Chateal EQ is a birth control pill (oral contraceptive) used by women to prevent pregnancy. How does Chateal EQ  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 Chateal EQ. 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 Chateal EQ? Do not take Chateal EQ  if you: smoke and are over 35 years of age had blood clots in your arms, legs, 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 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 any migraine headaches if you are over 35 years of age had breast cancer or any cancer that is sensitive to female hormones have liver problems, including liver tumors have any unexplained vaginal bleeding are pregnant 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 Chateal EQ, stop taking Chateal EQ right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Chateal EQ. What should I tell my healthcare provider before taking Chateal EQ? 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) are breastfeeding or plan to breastfeed. Chateal EQ may decrease the amount of breast milk you make. A small amount of the hormones in Chateal EQ 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. Chateal EQ may affect the way other medicines work, and other medicines may affect how well Chateal EQ 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 Chateal EQ? Read the Instructions for Use at the end of this Patient Information. What are the possible serious side effects of Chateal EQ? Like pregnancy, Chateal EQ 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 a sudden, severe headache unlike your usual headaches sudden severe shortness of breath weakness or numbness in your arm or leg sudden change in vision or blindness trouble speaking chest pain Other serious side effects include: liver problems, including: rare liver tumors jaundice (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. You should see your healthcare provider for a yearly check of your blood pressure. gallbladder problems changes in the sugar and fat (cholesterol and triglycerides) levels in your blood new or worsening headaches, including migraine headaches irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Chateal EQ. 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 if you have a history of angioedema. dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking Chateal EQ. Use sunscreen if you have to be in the sunlight. What are the most common side effects of oral contraceptives? nausea vomiting bleeding between menstrual periods weight gain breast tenderness difficulty wearing contact lenses  These are not all the possible side effects of Chateal EQ. 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 Chateal EQ? If you are scheduled for any lab tests, tell your healthcare provider you are taking Chateal EQ. Certain blood tests may be affected by Chateal EQ. Chateal EQ does not protect against HIV-infection (AIDS) and other sexually transmitted infections.   How should I store Chateal EQ? Store Chateal EQ at room temperature between 68° to 77°F (20° to 25°C). Protect from light.   General information about the safe and effective use of Chateal EQ. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Chateal EQ for a condition for which it was not prescribed. Do not give   Chateal EQ to other people, even if they have the same symptoms that you have.   This Patient Information Leaflet summarizes the most important information about Chateal EQ. You can ask your pharmacist or healthcare provider for information about Chateal EQ that is written for health professionals .  For more information, call Afaxys Pharma, LLC at 1-855-888-2467 Do birth control pills cause cancer? There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. 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 Chateal EQ? 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 Chateal EQ, 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 Chateal EQ? Active ingredients: Each orange pill contains levonorgestrel and ethinyl estradiol. Inactive ingredients: Orange pills: croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Green pills: anhydrous lactose, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), magnesium stearate, microcrystalline cellulose, and povidone. Chateal EQ ® [sha-teÉl]  (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg) Important Information about taking Chateal EQ Take 1 pill every day at the same time. Take the pills in the order directed on your pill pack. 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 Chateal EQ, talk to your healthcare provider. When you first start taking Chateal EQ, 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 Chateal EQ. 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 Chateal EQ 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 Chateal EQ according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Chateal EQ. If you have vomiting or diarrhea within 3 to 4 hours of taking an orange pill, take another orange pill as soon as possible. Continue taking all your remaining pills in order. Start the first pill of your next pill pack the day after finishing your current pill pack. 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 Chateal EQ 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 or spermicide) during this time period. Before you start taking Chateal EQ: 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 pack. Look at your pill pack. Your pill pack consists of 1 blister pack that holds 28 individually sealed pills. The 28 pills consist of 21 orange pills (3 rows of 7 pills) and 7 green pills (1 row of 7 pills). See Figure A . Also find: Where on the blister pack to start taking pills (upper left corner) and In what order to take the pills (follow the weeks) 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. When should I start taking Chateal EQ? If you start taking Chateal EQ 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 or spermicide for the first 7 days that you take Chateal EQ. You do not need back-up contraception if you use the Day 1 Start. If you start taking Chateal EQ and you are switching from another birth control pill:    Start your new Chateal EQ 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 pill pack.   If you start taking Chateal EQ and previously used a vaginal ring: Start using Chateal EQ on the day you would have started the next ring.   If you start taking Chateal EQ and previously used a transdermal patch: Start using Chateal EQ on the day you would have started a new cycle (first patch application).   If you start taking Chateal EQ and you are switching from a progestin-only method such as an implant or injection: Start taking Chateal EQ on the day of removal of your implant, or on the day when you would have had your next injection.   If you start taking Chateal EQ and you are switching from an intrauterine device or system (IUD or IUS): Start taking Chateal EQ 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 or spermicide for the first 7 days that you take Chateal EQ.   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 Chateal EQ? ” above. Follow these instructions for either a Sunday Start or a Day 1 Start . Instructions for using your Chateal EQ  Blister Pack: 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. To remove your tablet from the blister pack, push the tablet through foil. 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 blister pack at the same time each day for 28 days. After taking the last pill on Day 28 from the blister pack, 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 or spermicide for the first 7 days of the first cycle that you take Chateal EQ. 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 blister pack, at the same time each day, for 28 days. To remove your tablet from the blister pack, push the tablet through foil. After taking the last pill on Day 28 from the blister 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. What should I do if I miss any Chateal EQ  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 or 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 or 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 or 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 have been approved by the U.S. Food and Drug Administration. Manufactured For: Afaxys Pharma, LLC Charleston, SC, 29403, USA. Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302, India Revised: 08/2023 Figure 4 Figure 3

afaxys ® pharma NDC 50102-230-21         Chateal EQ ® (Levonorgestrel and E thinyl Estradiol T ablets USP) 0.15 mg/0.03 mg 21 orange tablets, each containing 0.15 mg levonorgestrel USP and 0.03 mg ethinyl estradiol USP, and 7 green inert tablets. Contains 1 Blister Card of 28 Tablets  Rx only PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.15 mg/0.03 mg (28 Tablets Pouch)