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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.

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:

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

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.