Tri-Sprintec

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medicine. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

The 28 day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store this medication at room temperature away from moisture and heat.

In the U.S.

• Estarylla
• MonoNessa
• Ortho-Cyclen
• Ortho Tri-Cyclen
• Ortho Tri-Cyclen Lo
• Previfem
• Sprintec
• Tri-Lo-Sprintec
• TriNessa
• TriNessa 28
• Tri-Previfem
• Tri-Sprintec

Available Dosage Forms:

• Tablet

Therapeutic Class: Triphasic Contraceptive Combination

Pharmacologic Class: Estrogen

This section provides information on the proper use of a number of products that contain ethinyl estradiol and norgestimate. It may not be specific to Tri-Sprintec. Please read with care.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser or a Veridate® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Ortho-Cyclen®: One blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho Tri-Cyclen®: One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.
  • For acne:
    • Adults and teenagers 15 years of age and older—One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
    • Teenagers and children younger than 15 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active tablet in weeks 1, 2, or 3: Take the tablet as soon as possible and take the next tablet at your regular schedule. Continue taking one tablet a day until you finish the pack.
• If you miss two active tablets in week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (such as a condom, spermicide) for 7 days after you miss a dose.
• If you miss two active tablets in week 3, or you miss three or more active tablets in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (such as a condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (such as a condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take Tri-Sprintec. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Certain drugs, herbal products, or health problems could cause Tri-Sprintec to not work as well. Be sure your doctor knows about all of your drugs and health problems.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• Do not use in children who have not had their first menstrual period.
• If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Weight gain.
• Headache.
• Upset stomach or throwing up.
• Gas.
• Feeling nervous and excitable.
• Belly pain.
• Enlarged breasts.
• Tender breasts.
• Period (menstrual) changes. These include spotting or bleeding between cycles.
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tri-Sprintec (ethinyl estradiol and norgestimate), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tri-Sprintec. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Tri-Sprintec.

Review Date: October 4, 2017

Do not prescribe Tri-Sprintec 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: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] o Have cerebrovascular disease [see Warnings and Precautions (5.1)] o Have coronary artery disease [see Warnings and Precautions (5.1)] o 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)] o Have uncontrolled hypertension [see Warnings and Precautions (5.3)] o Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5)] o Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.6)] ▪ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.6)] • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)] • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7)] • Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) 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 (5.10)]

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

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) Carton Text

NDC 0555-9018-58

6 Blister Cards, 28 Tablets Each 28 Day

Tri-Sprintec®

(norgestimate and
ethinyl estradiol tablets USP)

Usual Dosage: One tablet daily for 28 consecutive days per menstrual

cycle as prescribed. See enclosed package insert for full prescribing

information.

To the Dispenser: This carton contains one combination labeling piece

of information intended for the patient. Informational pieces are to be

provided to the patient with each prescription.

Rx only

Shaping
Women's Health®

TEVA

Tri-Sprintec  norgestimate and ethinyl estradiol kit

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0555-9018

Packaging # Item Code Package Description 1 NDC:0555-9018-58 6 POUCH in 1 CARTON 1 1 BLISTER PACK in 1 POUCH 1 1 KIT in 1 BLISTER PACK

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 7  Part 2 7  Part 3 7  Part 4 7

Part 1 of 4 Tri-Sprintec  norgestimate and ethinyl estradiol tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.18 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   LACTOSE MONOHYDRATE   ALUMINUM SULFATE   ALUMINUM CHLORIDE   FD&C BLUE NO. 2   INDIGOTINDISULFONATE SODIUM   FD&C RED NO. 40   FD&C YELLOW NO. 6   SODIUM BICARBONATE   SODIUM CARBONATE   MAGNESIUM STEARATE   STARCH, CORN

Product Characteristics Color GRAY Score no score Shape ROUND Size 6mm Flavor Imprint Code b;985 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075808 12/29/2003

Part 2 of 4 Tri-Sprintec  norgestimate and ethinyl estradiol tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.215 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   FD&C BLUE NO. 2   INDIGOTINDISULFONATE SODIUM   ALUMINUM SULFATE   ALUMINUM CHLORIDE   SODIUM BICARBONATE   SODIUM CARBONATE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, CORN

Product Characteristics Color BLUE (light blue) Score no score Shape ROUND Size 6mm Flavor Imprint Code b;986 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075808 12/29/2003

Part 3 of 4 Tri-Sprintec  norgestimate and ethinyl estradiol tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.25 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   FD&C BLUE NO. 2   INDIGOTINDISULFONATE SODIUM   ALUMINUM SULFATE   ALUMINUM CHLORIDE   SODIUM BICARBONATE   SODIUM CARBONATE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, CORN

Product Characteristics Color BLUE Score no score Shape ROUND Size 6mm Flavor Imprint Code b;987 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075808 12/29/2003

Part 4 of 4 INERT  inert tablet

Product Information Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   HYPROMELLOSE 2208 (3 MPA.S)   MAGNESIUM STEARATE   MICROCRYSTALLINE CELLULOSE

Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code b;143 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075808 12/29/2003

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075808 12/29/2003

Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 06/2017   Teva Pharmaceuticals USA, Inc.