Zenchent

• Actavis Pharma, Inc.

Zenchent is part of the drug class:

• Combination Progesterone and Estrogen Contraceptives

Zenchent® 28 Day (norethindrone and ethinyl estradiol tablets USP) provide a continuous regimen for oral contraception derived from 21 light peach tablets composed of norethindrone, USP and ethinyl estradiol, USP to be followed by 7 white tablets of inert ingredients. The structural formulas are:

  Norethindrone, USP Ethinyl Estradiol, USP   C20H26O2 M.W. 298.42 C 20 H 24 O 2 M.W. 296.40

The light peach active tablets each contain 0.4 mg norethindrone, USP and 0.035 mg ethinyl estradiol, USP, and contain the following inactive ingredients: anhydrous lactose, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate. The white tablets contain only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized corn starch.

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE 1: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use

Reproduced with permission of the Population Council from J. Trussell, et. al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990.
* The author’s best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. † This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. ‡ Combined typical rate for both combined and progestin only. § Combined typical rate for both medicated and nonmedicated IUD.
Method	Lowest Expected*	Typical†
(No contraception)	(85)	(85)
Oral contraceptives
combined	0.1	3‡
progestin only	0.5	3‡
Diaphragm with spermicidal cream or jelly	6	18
Spermicides alone (foam, creams, jellies and vaginal suppositories)	3	21
Vaginal sponge
nulliparous	6	18
multiparous	9	28
IUD	0.8 to 2	3§
Condom without spermicides	2	12
Periodic abstinence (all methods)	1 to 9	20
Injectable progestogen	0.3 to 0.4	0.3 to 0.4
Implants
6 capsules	0.04	0.04
2 rods	0.03	0.03
Female sterilization	0.2	0.4
Male sterilization	0.1	0.15

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

• Thrombophlebitis • Arterial thromboembolism • Pulmonary embolism • Myocardial infarction • Cerebral hemorrhage • Cerebral thrombosis • Hypertension • Gallbladder disease • Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

• Mesenteric thrombosis • Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

• Nausea • Vomiting • Gastrointestinal symptoms (such as abdominal cramps and bloating) • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea • Temporary infertility after discontinuation of treatment • Edema • Melasma which may persist • Breast changes: tenderness, enlargement, and secretion • Change in weight (increase or decrease) • Change in cervical ectropion and secretion • Possible diminution in lactation when given immediately postpartum • Cholestatic jaundice • Migraine • Rash (allergic) • Mental depression • Reduced tolerance to carbohydrates • Vaginal candidiasis • Change in corneal curvature (steepening) • Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:

• Premenstrual syndrome • Cataracts • Changes in appetite • Cystitis-like syndrome • Headache • Nervousness • Dizziness • Hirsutism • Loss of scalp hair • Erythema multiforme • Erythema nodosum • Hemorrhagic eruption • Vaginitis • Porphyria • Impaired renal function • Hemolytic uremic syndrome • Budd-Chiari syndrome • Acne • Changes in libido • Colitis

The following is a summary of the instructions given to the patient in the “HOW TO TAKE THE PILL” section of the DETAILED PATIENT LABELING.

The patient is given instructions in five (5) categories:

1. IMPORTANT POINTS TO REMEMBER: The patient is told (a) that she should take one pill every day at the same time, (b) many women have spotting or light bleeding or gastric distress during the first one to three cycles, (c) missing pills can also cause spotting or light bleeding, (d) she should use a back-up method for contraception if she has vomiting or diarrhea or takes some concomitant medications, and/or if she has trouble remembering the pill, (e) if she has any other questions, she should consult her physician.

2. BEFORE SHE STARTS TAKING HER PILLS: She should decide what time of day she wishes to take the pill, check whether her pill pack has 28 pills, and note the order in which she should take the pills (diagrammatic drawings of the pill pack are included in the patient insert).

3. WHEN SHE SHOULD START THE FIRST PACK: The Day-One start is listed as the first choice and the Sunday start (the Sunday after her period starts) is given as the second choice. If she uses the Sunday start she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills.

4. WHAT TO DO DURING THE CYCLE: The patient is advised to take one pill at the same time every day until the pack is empty. If she is on the 28 day regimen, she should start the next pack the day after the last inactive tablet and not wait any days between packs.

5. WHAT TO DO IF SHE MISSES A PILL OR PILLS: The patient is given instructions about what she should do if she misses one, two or more than two pills at varying times in her cycle for both the Day-One and the Sunday start. The patient is warned that she may become pregnant if she has unprotected intercourse in the seven days after missing pills. To avoid this, she must use another birth control method such as condom, foam, or sponge in these seven days.

Zenchent® 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 735 on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and 944 on the other side.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

References are available upon request.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. A 4/2017

BRIEF SUMMARY PATIENT PACKAGE INSERT

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.

Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:

• Smoke • Have high blood pressure, diabetes, high cholesterol • Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice or malignant or benign liver tumors.

You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.

The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:

1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris), or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. 2. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. 3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.

Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.

Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.

DOSAGE AND ADMINISTRATION

HOW TO TAKE THE PILL

The instructions given in the COMBINATION DETAILED PATIENT LABELING AND BRIEF SUMMARY insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.

Instructions on how to use the blister card are included in the BRIEF SUMMARY PATIENT PACKAGE INSERT.

Zenchent® 0.4/35 (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 Tablets Each, Carton Text

New NDC

New Product

Appearance

NDC 0093-3305-16

6 Blister Card Dispensers, 28 Tablets Each

Zenchent® 0.4/35

(norethindrone and

ethinyl estradiol tablets USP)

0.4 mg/0.035 mg

Contains 6 blister cards, each containing a cycle of 28 tablets, 21 light

peach tablets each containing 0.4 mg norethindrone and 0.035 mg

ethinyl estradiol; and 7 white tablets containing inert ingredients.

Rx only

SHAPING

WOMEN’S HEALTH®

TEVA

Zenchent 0.4/35  norethindrone and ethinyl estradiol kit

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0093-3305

Packaging # Item Code Package Description 1 NDC:0093-3305-16 6 POUCH in 1 CARTON 1 NDC:0093-3305-28 1 BLISTER PACK in 1 POUCH 1 1 KIT in 1 BLISTER PACK

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 21  Part 2 7

Part 1 of 2 NORETHINDRONE AND ETHINYL ESTRADIOL  norethindrone and ethinyl estradiol tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 0.4 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   DIBASIC CALCIUM PHOSPHATE DIHYDRATE   FD&C YELLOW NO. 6   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POVIDONE K30   SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color ORANGE (light peach) Score no score Shape ROUND Size 6mm Flavor Imprint Code b;735 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076238 04/06/2017

Part 2 of 2 INERT  inert tablet

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, CORN

Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code b;944 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076238 04/06/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076238 04/06/2017

Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 05/2017   Teva Pharmaceuticals USA, Inc.