Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].

The efficacy of Junel Fe 24 in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.

Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets) is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

• 24 light yellow, round, flat-faced, beveled-edge, unscored (active) tablets debossed with stylized b on one side and 977 on the other side and each containing 1 mg norethindrone acetate and 0.02 mg ethinyl estradiol.
• 4 brown, round, flat-faced, beveled-edge, unscored (non-hormonal inert) tablets debossed with stylized b on one side and 247 on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

Do not prescribe Junel Fe 24 to women 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 and Precautions (5.1)]
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
  • Have cerebrovascular disease [see Warnings and Precautions (5.1)]
  • Have coronary artery disease [see Warnings and Precautions (5.1)]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
  • Have uncontrolled hypertension [see Warnings and Precautions (5.4)]
  • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]
  • Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7)]
    • Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)]
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

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

• Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)]
• Vascular events [see Warnings and Precautions (5.1)]
• Liver disease [see Warnings and Precautions (5.2)]

Adverse reactions commonly reported by COC users are:

• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache

Consult the labeling of concurrently used drugs to obtain further information about interactions with oral contraceptives or the potential for enzyme alterations.

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) is a combination oral contraceptive for oral administration consisting of 24 light yellow active tablets containing norethindrone acetate, USP, a progestin, and ethinyl estradiol, USP, an estrogen, and 4 brown inert tablets containing ferrous fumarate, which serve no therapeutic purpose.

• Each light yellow tablet contains 1 mg norethindrone acetate, USP and 0.02 mg ethinyl estradiol, USP. Each light yellow tablet also contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
• Each brown tablet contains ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay.

The chemical name of ethinyl estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol, and the structural formula is:

C20H24O2 M.W. 296.40

The chemical name of norethindrone acetate, USP is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate, and the structural formula is:

C22H28O3 M.W. 340.46

In an active-controlled clinical trial, 743 women 18 to 45 years of age were studied to assess the efficacy of Junel Fe 24, for up to six 28-day cycles. The racial demographic of women randomized to Junel Fe 24 was: 69.5% Caucasian, 15.5% African-American, 10.4% Hispanic, 2.3% Asian and 2.3% Native American/Other. Women with body mass index (BMI) greater than 35 mg/m2 were excluded from the study. The weight range for those women treated was 90 to 260 pounds, with a mean weight of 147 pounds. Among the women in the study randomized to Junel Fe 24, 38.9% had not used hormonal contraception immediately prior to enrolling in this study.

A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies among women aged 18 to 45 years in 3,565 treatment cycles during which no back-up contraception was used. The Pearl Index for Junel Fe 24 was 1.82 (95% confidence interval 0.59 to 4.25).

See FDA-approved Patient Labeling (Patient Information and Instructions for Use).

Counsel patients about the following information:

• Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning].
• Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1)].
• Junel Fe 24 does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
• Junel Fe 24 is not to be used during pregnancy; if pregnancy occurs during use of Junel Fe 24 instruct the patient to stop further use [see Warnings and Precautions (5.9)].
• 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 (2.2)].
• Use a back-up or alternative method of contraception when enzyme inducers are used with Junel Fe 24 [see Drug Interactions (7.1)].
• COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.3)].
• Women who start COCs postpartum, and who has not yet had a period, must use an additional method of contraception until she has taken a light yellow tablet for 7 consecutive days [see Dosage and Administration (2.2)].
• Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions (5.8)].

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. C 12/2017

Junel Fe 24 (Joo-nell Fe 24)

(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)

What is the most important information I should know about Junel Fe 24?

Do not use Junel Fe 24 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 Junel Fe 24?

Junel Fe 24 is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy.

How does Junel Fe 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 from the clinical study, about 1 to 4 out of 100 women may get pregnant during the first year they use Junel Fe 24.

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 Junel Fe 24?

Do not take Junel Fe 24 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 that increases your risk of having blood clots
  • had a stroke
  • had a heart attack
  • have high blood pressure that cannot be controlled by medicine
  • have diabetes with kidney, eye, nerve, or blood vessel damage
  • have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
  • have liver problems, including liver tumors
  • have any unexplained vaginal bleeding
  • are pregnant
  • had breast cancer or any cancer that is sensitive to female hormones
  • 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 Junel Fe 24, stop taking Junel Fe 24 right away and talk to your healthcare provider. Use non-hormonal contraception (such as condoms and spermicide) when you stop taking Junel Fe 24.

What should I tell my healthcare provider before taking Junel Fe 24?

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. Junel Fe 24 may decrease the amount of breast milk you make. A small amount of the hormones in Junel Fe 24 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.

Junel Fe 24 may affect the way other medicines work, and other medicines may affect how well Junel Fe 24 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 Junel Fe 24?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of Junel Fe 24?

• Like pregnancy, Junel Fe 24 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:

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
• depression
• possible cancer in your breast and cervix
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.
• 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 Junel Fe 24. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Junel Fe 24?

• • headache
  • vaginal infections
  • nausea
  • menstrual cramps
  • breast tenderness
  • mood changes
  • acne
  • weight gain

These are not all the possible side effects of Junel Fe 24. 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 Junel Fe 24?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Junel Fe 24. Certain blood tests may be affected by Junel Fe 24.
• Junel Fe 24 does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Junel Fe 24?

• Store Junel Fe 24 at room temperature between (68° to 77°F) 20° to 25°C.
• Store away from light.
• Keep Junel Fe 24 and all medicines out of the reach of children.

General information about the safe and effective use of Junel Fe 24.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Junel Fe 24 for a condition for which it was not prescribed. Do not give Junel Fe 24 to other people.

This Patient Information summarizes the most important information about Junel Fe 24. You can ask your pharmacist or healthcare provider for information about Junel Fe 24 that is written for health professionals.

For more information, call Teva Pharmaceuticals at 1-888-838-2872.

Do birth control pills cause cancer?

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Junel Fe 24?

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 Junel Fe 24, 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 Junel Fe 24?

Active ingredients:

Light yellow pills: norethindrone acetate and ethinyl estradiol

Inactive ingredients:

Light yellow pills: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch

Brown pills: ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. B 8/2017

INSTRUCTIONS FOR USE

Junel Fe 24 (Joo-nell Fe 24)

(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)

Important Information about taking Junel Fe 24

• Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser.
• Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late), you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
• If you have trouble remembering to take Junel Fe 24, talk to your healthcare provider.
• When you first start taking Junel Fe 24, 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 Junel Fe 24. 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 Junel Fe 24 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 Junel Fe 24 according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Junel Fe 24.
• If you have vomiting or diarrhea within 3 to 4 hours of taking a light yellow active pill, take another light yellow pill from your extra pill dispenser. If you do not have an extra pill dispenser, take the next light yellow pill in your pill dispenser. Continue taking all your remaining pills in order. Start the first pill of your next pill dispenser the day after finishing your current pill dispenser. This will be 1 day earlier than originally scheduled. Continue on your new schedule.
• If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider.
• Stop taking Junel Fe 24 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 and spermicide) during this time period.

Before you start taking Junel Fe 24:

• 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 dispenser.
• Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.

When should I start taking Junel Fe 24?

If you start taking Junel Fe 24 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 and spermicide for the first 7 days that you take Junel Fe 24. You do not need back-up contraception if you use the Day 1 Start.

If you start taking Junel Fe 24 and you are switching from another birth control pill:

• Start your new Junel Fe 24 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 pack.

If you start taking Junel Fe 24 and previously used a vaginal ring or transdermal patch:

• Start using Junel Fe 24 on the day you would have reapplied the next ring or patch.

If you start taking Junel Fe 24 and you are switching from a progestin-only method such as an implant or injection:

• Start taking Junel Fe 24 on the day of removal of your implant or on the day when you would have had your next injection.

If you start taking Junel Fe 24 and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking Junel Fe 24 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 and spermicide for the first 7 days that you take Junel Fe 24.

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 Junel Fe 24?” above. Follow these instructions for either a Sunday Start or a Day 1 Start.

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.
• 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 pill dispenser at the same time each day for 28 days.
• After taking the last pill on Day 28 from the pill dispenser, 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 and spermicide for the first 7 days of the first cycle that you take JUNEL FE 24.

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 pill dispenser, at the same time each day, for 28 days.
• After taking the last pill on Day 28 from the pill dispenser, 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.

Instructions for using your pill pack:

The Junel Fe 24 pill pack has 24 "active" light yellow pills (with hormones) to be taken for 24 days, followed by 4 "reminder" brown pills (without hormones) to be taken for the next 4 days.

Figure A

Look for:

• Where on the pack to start taking pills
• In what order to take the pills. Follow the arrows shown in Figure A.
• The week numbers as shown in Figure A.

What if should I do if I miss any Junel Fe 24 light yellow pills?

If you miss 1 light yellow 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 light yellow pills in a row 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 and spermicide) as a back-up if you have sex during the first 7 days after missing your pills.

If you miss 2 light yellow pills in a row in Week 3 or Week 4, or you miss 3 or more light yellow pills in a row at any time, 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.
• 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.
• 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 and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you miss any of the 4 brown “reminder” pills in Week 4, throw away the pills you missed and keep taking 1 pill each day until the pack is empty. You do not need to use a back-up method of birth control.

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 has been approved by the U.S. Food and Drug Administration.

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. B 8/2017

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP

1 mg/0.02 mg and ferrous fumarate tablets), 28 Tablet Blister Card x 3 Carton Text

NDC 0093-5328-62                Three Blister Cards, 28 Tablets Each

Junel® Fe 24

(norethindrone acetate and

ethinyl estradiol tablets USP

1 mg/0.02 mg

and ferrous fumarate tablets*)

Pharmacist: Each foil pouch contains one combination “Patient Brief Summary/Detailed

Patient Package Insert,” which is to be provided to the patient with each prescription.

Provides 24 days of active therapy

Contains 3 blister cards, each containing a cycle of 28 tablets.  Each of the light yellow

tablets contain norethindrone acetate, 1 mg and ethinyl estradiol, 0.02 mg. Each of the

4 brown tablets contain ferrous fumarate, 75 mg.

*Ferrous fumarate tablets are not USP for dissolution and assay.

Rx only

SHAPING

WOMEN’S HEALTH®

TEVA