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CLINICAL PHARMACOLOGY Mode of Action ORTHO MICRONOR® (norethindrone) progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. Pharmacokinetics Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

CLINICAL PHARMACOLOGY Mode of Action Nor-QD (norethindrone) ® progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. Pharmacokinetics Absorption: Norethindrone is rapidly absorbed with maximum plasma concentrations occurring within 1 to 2 hours after Nor-QD® administration (see Table 1). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first pass metabolism resulting in an absolute bioavailability of approximately 65%. Figure 1: Mean ± SD Norethindrone Plasma Concentrations Following Nor-QD (norethindrone) ® Administration. Peak plasma concentrations occur approximately 1 hour after administration (mean Tmax 1.2 hours). The mean (SD) Cmax was 4816.8 (1532.6) pg/mL and generally occurred within 1 hour (mean) of tablet administration, ranging from 0.5 to 2 hours. The mean (SD) Cavg was 885 (250) pg/mL, however, the mean concentration at 24 hrs was 130 (47) pg/mL. Table 1 provides summary statistics of the pharmacokinetic parameters associated with single dose Nor-QD (norethindrone) ® administration. Table 1: Mean ± SD Pharmacokinetic Parameters Following Single Dose Administration of Nor-QD (norethindrone) ® in 12 Healthy Female Subjects Under Fasting Conditions Pharmacokinetic Parameter Norethindrone 0.35 mg Tmax (hr) 1.2 ± 0.5 Cmax (pg/mL) 4817 ± 1533 AUC(0-48) (pg•h/mL) 21233 ± 6002 t½ (h) 7.7 ± 0.5 The food effect on the rate and extent of norethindrone absorption after Nor-QD (norethindrone) ® administration has not been evaluated. Distribution Following oral administration, norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is approximately 4 L/kg. Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5% of a norethindrone dose is excreted unchanged; greater than 50% and 20-40% of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfate, with glucuronides accounting for most of the urinary metabolites. Excretion Plasma clearance rate for norethindrone has been estimated to be approximately 600 L/day. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following single dose administration of Nor-QD (norethindrone) ® is approximately 8 hours.

CLINICAL PHARMACOLOGY Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone. Pharmacokinetics Absorption Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate is rapidly absorbed from AYGESTIN tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of AYGESTIN in 29 healthy female volunteers are summarized in Table 1. Table 1: Pharmacokinetic Parameters after a Single Dose of AYGESTIN® in Healthy Women AYGESTIN® (n = 29) Arithmetic Mean ± SD Norethindrone (NET) AUC (0-inf)(ng/ml*h) 166.90 ± 56.28 Cmax (ng/ml) 26.19 ± 6.19 tmax (h) 1.83 ± 0.58 t½ (h) 8.51 ± 2.19 AUC = area under the curve, Cmax = maximum plasma concentration, tmax = time at maximum plasma concentration, t½ = half-life, SD = standard deviation Figure 1: Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions Effect Of Food The effect of food administration on the pharmacokinetics of AYGESTIN has not been studied. Distribution Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is about 4 L/kg. Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites. Excretion Plasma clearance value for norethindrone is approximately 0.4 L/hr/kg. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following a single dose administration of AYGESTIN is approximately 9 hours. Special Populations Geriatrics The effect of age on the pharmacokinetics of norethindrone after AYGESTIN administration has not been evaluated. Race The effect of race on the disposition of norethindrone after AYGESTIN administration has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of norethindrone after AYGESTIN administration has not been evaluated. In premenopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma norethindrone concentration was unchanged compared to concentrations in premenopausal women with normal renal function. Hepatic Insufficiency The effect of hepatic disease on the disposition of norethindrone after AYGESTIN administration has not been evaluated. However, AYGESTIN is contraindicated in markedly impaired liver function or liver disease. Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with AYGESTIN have been conducted.

Find Lowest Prices on ORTHO MICRONOR® (norethindrone) Tablets Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION ORTHO MICRONOR® (norethindrone) Tablets Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5 , D&C Yellow No. 10, lactose, magnesium stearate, and povidone.

Nor-QD® Tablets (norethindrone 0.35 mg) Tablets, USP Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. DESCRIPTION Each yellow Nor-QD (norethindrone) ® tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include D&C Yellow No. 10, FD&C Yellow No. 6, lactose, magnesium stearate, povidone, and starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows:

Find Lowest Prices on AYGESTIN® (norethindrone acetate) Tablets USP DESCRIPTION AYGESTIN® (norethindrone acetate tablets USP) - 5 mg oral tablets. AYGESTIN® (norethindrone acetate tablets USP), (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. The structural formula is as follows: C22H28O3 M.W. 340.46 AYGESTIN® (norethindrone acetate tablets USP) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

INDICATIONS Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method(1) Typical Use 1(2) Perfect Use2(3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal6 2 Post-Ovulation 1 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4 Condom8 Female (Reality®) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Norplant® and 0.05 0.05 88 Norplant-2® Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Adapted from Hatcher et al, 1998, Ref. # 1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10 Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7With spermicidal cream or jelly. 8Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: OvralR (1 dose is 2 white pills), AlesseR (1 dose is 5 pink pills), NordetteR or LevlenR (1 dose is 2 light-orange pills), Lo/OvralR (1 dose is 4 white pills), TriphasilR or Tri-LevlenR (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. ORTHO MICRONOR® (norethindrone) Tablets have not been studied for and are not indicated for use in emergency contraception. DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, ORTHO MICRONOR® (norethindrone) must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no in terruption between pill packs. See Detailed Patient Labeling for detailed instruction. HOW SUPPLIED ORTHO MICRONOR® (0.35 mg norethindrone) Tablets are available in a DIALPAK® Tablet Dispenser (NDC 0062-1411-16) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted “ORTHO 0.35” on both sides. STORAGE: Store at 25°C Keep out of reach of children. REFERENCE McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994. Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3. Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol.; 186 (6):1250-1258. Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51(2004): 539-579. Cooke ID, Back DJ, Shroff NE: Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diactetate administration. Contraception 1985; 31:611-21. ORTHO-McNEIL, PHARMACEUTICAL, INC., Raritan, New Jersey 08869. REVISED June, 2008. FDA rev date: 6/20/2008

INDICATIONS Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method Typical Use1 Perfect Use2 (1) (2) (3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal6 2 Post-Ovulation 1 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4 Condom8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUDs Progesterone T 2 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Levonorgestrel Implants (Norplant®) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.1 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell, J, Contraceptive Efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. 2. Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Nor-QD (norethindrone) ® must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions. HOW SUPPLIED Nor-QD® (norethindrone) tablets are available in 28-tablet dispensers. Storage Store at controlled room temperature 15 - 25°C (59 - 77°F). Revised: MARCH 2006. Address medical inquires to: WATSON PHARMA, INC., Medical Communications, P.O. Box 1953, Morristown, NJ 07962-1953. 800-272-5525. Mfg. for: WATSON PHARMA, INC., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 USA. FDA revision date: 10/20/2005

INDICATIONS AYGESTIN (norethindrone acetate tablets USP) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. AYGESTIN (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopaus al women for endometrial protection. DOSAGE AND ADMINISTRATION Therapy with AYGESTIN must be adapted to the specific indications and therapeutic response of the individual patient. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology 2.5 to 10 mg AYGESTIN may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing AYGESTIN therapy. Patients with a past history of recurrent episodes of abnormal uterine bleedingmay benefit from planned menstrual cycling with AYGESTIN. Endometriosis Initial daily dosage of 5 mg AYGESTIN for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of AYGESTIN is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination. HOW SUPPLIED AYGESTIN® (norethindrone acetate tablets USP) is available as: 5 mg: White, oval, flat-faced, beveled edge, tablet scored on one side. Debossed with 5 AYGESTIN on the unscored side and stylized b / 424 on the scored side. Available in bottles of 50 tablets (NDC 51285-424-10). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA WOMEN'S HEALTH, INC. Subsidiary of TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. Revised: Oct 2015

PATIENT INFORMATION ORTHO MICRONOR® (norethindrone) Tablets This product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) or other sexually transmitted diseases. DESCRIPTION ORTHO MICRONOR® (norethindrone) Tablets Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, and povidone. INTRODUCTION This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your healthcare professional. Progestin-only pills are often called “POPs” or “the minipill.” POPs have less progestin than the combined birth control pill (or “the pill”) which contains both an estrogen and a progestin. HOW EFFECTIVE ARE POPs? About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 “typical” POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. Table 2 will help you compare the efficacy of different methods. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method(1) Typical Use 1(2) Perfect Use2(3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal6 2 Post-Ovulation 1 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4 Condom8 Female (Reality®) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Norplant® and 0.05 0.05 88 Norplant-2® Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Adapted from Hatcher et al, 1998, Ref. # 1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception. 10 Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7With spermicidal cream or jelly. 8Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: OvralR (1 dose is 2 white pills), AlesseR (1 dose is 5 pink pills), NordetteR or LevlenR (1 dose is 2 light-orange pills), Lo/OvralR (1 dose is 4 white pills), TriphasilR or Tri-LevlenR (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. ORTHO MICRONOR® (norethindrone) Tablets have not been studied for and are not indicated for use in emergency contraception. HOW DO POPs WORK? POPs can prevent pregnancy in different ways including: They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg. They prevent ovulation (release of the egg from the ovary) in about half of the cycles. They also affect other hormones, the fallopian tubes and the lining of the uterus. YOU SHOULD NOT TAKE POPs If there is any chance you may be pregnant. If you have breast cancer. If you have bleeding between your periods that has not been diagnosed. If you are taking certain drugs for epilepsy (seizures) or for TB. (See “Using POPs with Other Medicines” below.) If you are hypersensitive, or allergic, to any component of this product. If you have liver tumors, either b enign or cancerous. If you have acute liver disease. RISKS OF TAKING POPs Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. WARNING If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately. Ectopic Pregnancy An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods. Ovarian Cysts These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems. Cancer of the Reproductive Organs and Breasts Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk. A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix. Liver Tumors In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors. Diabetic Women Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your healthcare professional may monitor you more closely under these conditions. SEXUALLY TRANSMITTED DISEASES (STDs) WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes. SIDE EFFECTS Irregular Bleeding: The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can result in some spotting or bleeding. Other Side Effects: Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare. If you are concerned about any of these side effects, check with your healthcare professional. USING POPs WITH OTHER MEDICINES Before taking a POP, inform your healthcare professional of any other medication, including over-the-counter medicine, that you may be taking. These medicines can make POPs less effective: Medicines for seizures such as: Phenytoin (Dilantin®) Carbamazepine (Tegretol) Phenobarbital Medicine for TB: Rifampin (Rifampicin) Before you begin taking any new medicines be sure your healthcare professional knows you are taking a progestin-only birth control pill. HOW TO TAKE POPs IMPORTANT POINTS TO REMEMBER POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant. Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready. You may have some menstrual spotting between periods. Do not stop taking your pills if this happens. If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours. If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don't wish to egnant, be certain to use another birth control method. If you are not sure about how to take POPs, ask your healthcare professional. STARTING POPs It's the first day of your menstrual period.best to take your first POP on If you decide to take your first POP on another day, use a backup method (such as a condom and/or a spermicide) every time you have sex during the next 48 hours. If you have had a miscarriage or an abortion, you can start POPs the ne xt day. IF YOU ARE LATE OR MISS TAKING YOUR POPs If you are more than 3 hours late or you miss one or more POPs: TAKE a missed pill as soon as you remember that you missed it, THEN go back to taking POPs at your regular time, BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours. If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional. IF YOU ARE BREASTFEEDING If you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery. If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery. IF YOU ARE SWITCHING PILLS If you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected. If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished. If you switch to another brand of PO Ps, start the new brand anytime. If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery. PREGNANCY WHILE ON THE PILL If you think you are pregnant, contact your healthcare professional. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don't need when you are pregnant. You should get a pregnancy test: If your period is late and you took one or more pills late or missed taking them and had sex without a backup method. Anytime it has been more than 45 days since the beginning of your last period. WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER? If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant. BREASTFEEDING If you are breastfeeding, POPs should not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. OVERDOSE No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose. OTHER QUESTIONS OR CONCERNS If you have any questions or concerns, check with your healthcare professional. You can also ask for the more detailed “Professional Labeling” written for doctors and other healthcare professionals. HOW TO STORE YOUR POPs Store at 25°C Keep out of reach of children.

PATIENT INFORMATION Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. INTRODUCTION This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your doctor or clinic. Progestin-only pills are often called “POPs” or “the minipill.” POPs have less progestin than the combined birth control pill (or “the pill”) which contains both an estrogen and a progestin. HOW EFFECTIVE ARE POPS? About 1 in 200 (0.5%) POPs users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 (5%) “typical” POPs users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. The following table will help you compare the efficacy of different methods. IUD: 1-2% Depo-Provera® (injectable progesterone): 0.3% Norplant® System (levonorgestrel implants): 0.1% Diaphragm with spermicides: 18% Spermicides alone: 21% Male condom alone: 12% Female condom alone: 21% Cervical cap: Women who have never given birth: 18% Women who have given birth: 36% Periodic abstinence: 20% No methods: 85% HOW DO POPS WORK? They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg. They prevent ovulation (release of the egg from the ovary) in about half the time. They also affect other hormones, the fallopian tubes and the lining of the uterus. YOU SHOULD NOT TAKE POPS If there is any chance you may be pregnant. If you have breast cancer. If you have bleeding between your periods which has not been diagnosed. If you are taking certain drugs for epilepsy (seizures) or for TB. (See USING POPS WITH OTHER MEDICINES below.) If you are hypersensitive or allergic to any component of this product. If you have liver tumors, either benign or cancerous. If you have acute liver disease. RISKS OF TAKING POPS WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your doctor or clinic immediately. Ectopic pregnancy. An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods. Ovarian cysts. These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems. Cancer of the reproductive organs and breasts. Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix. Liver tumors. In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with combined oral contraceptives and liver cancers in studies in which a few women who developed these very rare cancers were found to have used combined oral contraceptives for long periods of time. There is insufficient data to determine whether POPs increase the risk of liver tumors. SEXUALLY TRANSMITTED DISEASES (STDS) WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as Chlamydia, gonorrhea, genital warts or herpes. SIDE EFFECTS Irregular bleeding. The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can also result in some spotting or bleeding. Other side effects.Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare. If you are concerned about any of these side effects, check with your doctor or clinic. USING POPS WITH OTHER MEDICINES Before taking a POP, inform your health care provider of any other medication, including over-the-counter medicine, that you may be taking. If you are taking medicines for seizures (epilepsy) or tuberculosis (TB), tell your doctor or clinic. These medicines can make POPs less effective: Medicines for seizures: Phenytoin (Dilantin®) Carbamazepine (Tegretol®) Phenobarbital Medicine for TB: Rifampin (Rifampicin) Before you begin taking any new medicines be sure your doctor or clinic knows you are taking birth control pills that contain a progestin. HOW TO TAKE POPS IMPORTANT POINTS TO REMEMBER POPs must be taken at the same time every day, so choose a time and then take the pill at the same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant. Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready. You may have some menstrual spotting between periods. Do not stop taking your pills if this happens. If you vomit soon after taking a pill, use a backup method (such as condom and/or spermicide) for 48 hours. If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don't wish to become pregnant, be certain to use another birth control method. If you are not sure about how to take POPs, ask your doctor or clinic. STARTING POPS It's best to take your first POP on the first day of your menstrual period. If you decide to take your first POP on another day, use a backup method (such as condom and/or spermicide) every time you have sex during the next 48 hours. If you have had a miscarriage or an abortion, you can start POPs the next day. IF YOU ARE LATE OR MISS TAKING YOUR POPS If you are more than 3 hours late or you miss one or more POPs: TAKE a missed pill as soon as you remember that you missed it, THEN go back to taking POPs at your regular time, BUT be sure to use a backup method (such as condom and/or spermicide) every time you have sex for the next 48 hours. If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your doctor or clinic. IF YOU ARE BREASTFEEDING If you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery. If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery. IF YOU ARE SWITCHING PILLS If you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected. If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished. If you switch to another brand of POPs, start the new brand anytime. If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery. PREGNANCY WHILE ON THE PILL If you become pregnant, or think you might be, stop taking POPs and contact your physician. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don't need when you are pregnant. You should get a pregnancy test: If your period is late and you took one or more pills late or missed taking them and had sex without a backup method. Anytime you miss 2 periods in a row. WILL POPS AFFECT YOUR ABILITY TO GET PREGNANT LATER? If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant. BREASTFEEDING If you are breastfeeding, POPs will not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. If you suspect that you are not producing enough milk for your baby, contact your doctor or clinic. OVERDOSE No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose. OTHER QUESTIONS OR CONCERNS Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions. If you have any questions or concerns, check with your doctor or clinic. You can also ask for the more detailed “professional package labeling” written for doctors and other health care providers. HOW TO STORE YOUR POPS Store your POPs at room temperature 15 - 25°C (59 - 77°F). Be certain to read new revisions of this leaflet. You may check the date of the most recent revision by phoning the manufacturer toll-free at 1-800-272-5525 or by writing to the address below.

PATIENT INFORMATION AYGESTIN® (norethindrone acetate) Tablets USP Read this PATIENT INFORMATION before you start taking AYGESTIN and read what you get each time you refill AYGESTIN. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition. What is the most important information I should know about AYGESTIN (A Progestin Hormone)? Do not use AYGESTIN if you are pregnant, breastfeeding or are trying to conceive. Do not use AYGESTIN if you have had a previous blood clot, stroke, or heart attack. Do not use AYGESTIN if you are postmenopausal. What is AYGESTIN? AYGESTIN is similar to the progesterone hormones naturally produced by the body. Your healthcare provider may provide AYGESTIN as individual tablets. What are AYGESTIN used for? AYGESTIN are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance. Who should not take AYGESTIN? You should not take AYGESTIN if you are postmenopausal, pregnant or breastfeeding. You should not take AYGESTIN if you have the following conditions: Known or suspected pregnancy. AYGESTIN are not indicated during pregnancy as it may causefetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take AYGESTIN during the first 4 months of pregnancy (mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus). If you take AYGESTIN and later find out you were pregnant, talk with your healthcare provider right away. History of blood clots in the legs , lungs , eyes , brain, or elsewhere, or a past history of these conditions Liver impairment or disease Known or suspected cancer of the breast. If you have or had cancer of the breast, talk with your healthcare provider about whether you should take AYGESTIN. Undiagnosed vaginal bleeding Hypersensitivity to AYGESTIN. See the end of this leaflet for a list of all of the ingredients in AYGESTIN. What are the risks associated with AYGESTIN? Risk To The Fetus AYGESTIN should not be used if you are pregnant. AYGESTIN are contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy. You should avoid using AYGESTIN during pregnancy. If you take AYGESTIN and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible. Abnormal Blood Clotting Use of progestational drugs, such as AYGESTIN, has been associated with changes in the bloodclotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems. Any of these conditions may cause death or serious long-term disability. Call your healthcare provider right away if you suspect you have any of these conditions. He or she may advise you to stop using the drug. Eye Abnormalities Discontinue AYGESTIN tablets and call your healthcare provider right away if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine. These are some of the warning signs of serious side effects with progestin therapy Breast lumps Dizziness and faintness Changes in speech Severe headaches Chest pain Shortness of breath Pains in your legs Changes in vision Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you. Common side effects include Headache Breast pain Irregular vaginal bleeding or spotting Stomach/abdominal cramps/bloating Nausea and vomiting Hair loss Other side effects include High blood pressure Liver problems High blood sugar Fluid retention Enlargements of benign tumors of the uterus (“fibroids”) Vaginal yeast infections Mental depression These are not all the possible side effects of progestin and/or estrogen therapy. For more information, ask your healthcare provider or pharmacist. What can I do to lower my chances of getting a serious side effect with AYGESTIN? Talk with your healthcare provider regularly about whether you should continue taking AYGESTIN. Have a breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart attacks. General information about the safe and effective us e of AYGESTIN Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take AYGESTIN for conditions for which it was not prescribed. Do not give AYGESTIN tablets to other people, even if they have the same symptoms you have. It may harm them. Keep AYGESTIN out of the reach of children. This leaflet provides a summary of the most important information about progestin and/or estrogen therapy. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about AYGESTIN that is written for health professionals. What are the ingredients in AYGESTIN? AYGESTIN contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

WARNINGS Cardiovascular Disorders Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. Visual Abnormalities Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued. PRECAUTIONS General Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, require careful observation. In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated. Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism. The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy. The pathologist should be advised of progestin therapy when relevant specimens are submitted. Information For The Patient Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe AYGESTIN. Carcinogenesis, Mutagenesis, And Impairment Of Fertility Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established. Pregnancy Category X Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman. Pediatric Use AYGESTIN tablets are not indicated in children.