Tri-Lo-Sprintec

Name: Tri-Lo-Sprintec

Before Using Tri-Lo-Sprintec

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norgestimate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norgestimate combination have not been performed in the geriatric population. This medicine should not be used in elderly women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Dasabuvir
  • Ombitasvir
  • Paritaprevir
  • Ritonavir
  • Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Anagrelide
  • Aprepitant
  • Boceprevir
  • Bosentan
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Dabrafenib
  • Darunavir
  • Dexamethasone
  • Donepezil
  • Eliglustat
  • Enzalutamide
  • Fosphenytoin
  • Griseofulvin
  • Idelalisib
  • Isotretinoin
  • Lesinurad
  • Lixisenatide
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Oxcarbazepine
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Phenytoin
  • Piperaquine
  • Pitolisant
  • Prednisone
  • Rifabutin
  • Rifampin
  • St John's Wort
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topiramate
  • Ulipristal
  • Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Amprenavir
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etoricoxib
  • Fosamprenavir
  • Fosaprepitant
  • Ginseng
  • Lamotrigine
  • Licorice
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Parecoxib
  • Prednisolone
  • Rifapentine
  • Ritonavir
  • Roflumilast
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • Telaprevir
  • Tipranavir
  • Troglitazone
  • Troleandomycin
  • Valdecoxib
  • Voriconazole
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine
  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding or
  • Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
  • Breast cancer, known or suspected or
  • Diabetes with kidney, eye, nerve, or blood vessel damage or
  • Endometrial cancer or
  • Heart attack, history of or
  • Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
  • Hypertension (high blood pressure) that is not under good control or
  • Jaundice during pregnancy or from using hormonal therapy in the past or
  • Liver disease, including tumors or cancer or
  • Major surgery with prolonged periods of immobilization or
  • Migraine headache or
  • Stroke, history of or
  • Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
  • Breast cancer, family history of or
  • Cervical cancer or
  • Chloasma (skin discoloration of the face during pregnancy), history of or
  • Depression, history of or
  • Edema (fluid retention or body swelling) or
  • Epilepsy (seizures) or
  • Gallbladder disease or
  • Hereditary angioedema or
  • Hypertension (high blood pressure)—Use with caution. May make these conditions worse.
  • Diabetes or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Kidney disease or
  • Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

If OVERDOSE is suspected

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.

Adverse Reactions

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

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of norgestimate and ethinyl estradiol was evaluated in 1,723 subjects who participated in a randomized, partially blinded, multicenter, active-controlled clinical trial of norgestimate and ethinyl estradiol for contraception. This trial examined healthy, nonpregnant, volunteers aged 18 to 45 (nonsmoker if 35 to 45 years of age), who were sexually active with regular coitus. Subjects were followed for up to 13 28-day cycles.

Common Adverse Reactions (≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 1,723 women using the 28-day regimen were the following in order of decreasing incidence: headache/migraine (30.5%), nausea/vomiting (16.3%); breast issues (including tenderness, pain, enlargement, swelling, discharge, discomfort, cyst, and nipple pain) (10.3%), abdominal pain (9.2%), menstrual disorders (including dysmenorrhea, menstrual discomfort, menstrual disorder) (9.2%), mood disorders (including depression, mood altered, mood swings and depressed mood) (7.6%); acne (5.1%), vulvovaginal infection (3.5%), abdominal distension (2.8%), weight increased (2.4%) , fatigue (2.1%).

Adverse Reactions Leading to Study Discontinuation: In the clinical trial of norgestimate and ethinyl estradiol 4% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions leading to discontinuation were headache/migraine (1.2%), nausea/vomiting (0.7%), cervical dysplasia (0.7%), abdominal pain (0.4%), ovarian cyst (0.3%), acne (0.2%), flatulence (0.2%) and depression (0.2%).

Serious Adverse Reactions: carcinoma of the cervix in situ (1 subject) and cervical dysplasia (1 subject).

Postmarketing Experience

The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations: Urinary tract infection

Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps): Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst

Immune System Disorders: Hypersensitivity

Metabolism and Nutrition Disorders: Dyslipidemia

Psychiatric Disorders: Anxiety, insomnia

Nervous System Disorders: Syncope, convulsion, paresthesia, dizziness

Eye Disorders: Visual impairment, dry eye, contact lens intolerance

Ear and Labyrinth Disorders: Vertigo

Cardiac Disorders: Tachycardia, palpitations

Vascular Events: Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush

Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular accident

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea

Gastrointestinal Disorders: Pancreatitis, abdominal distension, diarrhea, constipation

Hepatobiliary Disorders: Hepatitis

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne

Musculoskeletal, Connective Tissue, and Bone Disorders: Muscle spasms, pain in extremity, myalgia, back pain

Reproductive System and Breast Disorders: Ovarian cyst, suppressed lactation, vulvovaginal dryness

General Disorders and Administration Site Conditions: Chest pain, asthenic conditions.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions (5.2, 5.10) and Use in Specific Populations (8.1).]

Patient Counseling Information

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)]. • Tri-Lo-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections. • Tri-Lo-Sprintec is not to be used during pregnancy; if pregnancy occurs during use of Tri-Lo-Sprintec instruct the patient to stop further use [see Warnings and Precautions (5.8)]. • Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed [see Dosage and Administration (2.2)]. • Use a back-up or alternative method of contraception when enzyme inducers are used with Tri-Lo-Sprintec [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 have not yet had a period, should use an additional method of contraception until they have taken a gray 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 (5.7)].

TEVA PHARMACUETICALS USA, INC.

North Wales, PA 19454

Rev. D 4/2016

Patient Information

Tri-Lo-Sprintec [trī-lō-sprin-tek]

(norgestimate and ethinyl estradiol tablets)

What is the most important information I should know about Tri-Lo-Sprintec?

Do not use Tri-Lo-Sprintec 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 Tri-Lo-Sprintec?

Tri-Lo-Sprintec is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Tri-Lo-Sprintec 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 3 out of 100 women may get pregnant during the first year they use Tri-Lo-Sprintec.

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 Tri-Lo-Sprintec?

Do not take Tri-Lo-Sprintec 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

If any of these conditions happen while you are taking Tri-Lo-Sprintec, stop taking Tri-Lo-Sprintec right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Tri-Lo-Sprintec.

What should I tell my healthcare provider before taking Tri-Lo-Sprintec?

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. Tri-Lo-Sprintec may decrease the amount of breast milk you make. A small amount of the hormones in Tri-Lo-Sprintec 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.

Tri-Lo-Sprintec may affect the way other medicines work, and other medicines may affect how well Tri-Lo-Sprintec 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 Tri-Lo-Sprintec?

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

What are the possible serious side effects of Tri-Lo-Sprintec?

• Like pregnancy, Tri-Lo-Sprintec 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:

  ∘ leg pain that will not go away ∘ a sudden, severe headache unlike your usual headaches
∘ sudden severe shortness of breath ∘ weakness or numbness in your arm or leg
∘ sudden change in vision or blindness ∘ trouble speaking
∘ chest pain

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 • irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Tri-Lo-Sprintec. • 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 Tri-Lo-Sprintec. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Tri-Lo-Sprintec?

• headache (including migraine) • pain with your periods (menstrual cycle)
• nausea and vomiting • mood changes, including depression
• breast problems • acne
∘ tenderness, pain and discomfort • vaginal infections
∘ enlargement and swelling • bloating
∘ discharge • weight gain
∘ nipple pain • fatigue
• stomach pain

These are not all the possible side effects of Tri-Lo-Sprintec. 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 Tri-Lo-Sprintec?

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

How should I store Tri-Lo-Sprintec?

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

General information about the safe and effective use of Tri-Lo-Sprintec.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tri-Lo-Sprintec for a condition for which it was not prescribed. Do not give Tri-Lo-Sprintec to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about Tri-Lo-Sprintec. You can ask your pharmacist or healthcare provider for information about Tri-Lo-Sprintec that is written for health professionals.

For more information, call 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 Tri-Lo-Sprintec?

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 Tri-Lo-Sprintec, 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 Tri-Lo-Sprintec?

Active ingredients: Each gray, light blue, and blue pill contains norgestimate and ethinyl estradiol.

Inactive ingredients:

Gray pills: anhydrous lactose, black iron oxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Light blue pills: anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Blue pills: anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

White pills: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. D 4/2016

Instructions For Use

Tri-Lo-Sprintec [trī-lō-sprin-tek]

(norgestimate and ethinyl estradiol tablets)

Important Information about taking Tri-Lo-Sprintec

• Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack tablet 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 Tri-Lo-Sprintec, talk to your healthcare provider. When you first start taking Tri-Lo-Sprintec, 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 Tri-Lo-Sprintec. 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 Tri-Lo-Sprintec 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 Tri-Lo-Sprintec 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 Tri-Lo-Sprintec. • If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra tablet dispenser. If you do not have an extra tablet dispenser, take the next pill in your tablet dispenser. Continue taking all your remaining pills in order. Start the first pill of your next blister pack tablet dispenser the day after finishing your current tablet 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 Tri-Lo-Sprintec 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 Tri-Lo-Sprintec:

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

When should I start taking Tri-Lo-Sprintec?

If you start taking Tri-Lo-Sprintec 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 Tri-Lo-Sprintec. You do not need back-up contraception if you use the Day 1 Start.

If you start taking Tri-Lo-Sprintec and you are switching from another birth control pill:

• Start your new Tri-Lo-Sprintec 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 Tri-Lo-Sprintec and previously used a vaginal ring or transdermal patch:

• Start using Tri-Lo-Sprintec on the day you would have reapplied the next ring or patch.

If you start taking Tri-Lo-Sprintec and you are switching from a progestin-only method such as an implant or injection:

• Start taking Tri-Lo-Sprintec on the day of removal of your implant or on the day when you would have had your next injection.

If you start taking Tri-Lo-Sprintec and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking Tri-Lo-Sprintec 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 Tri-Lo-Sprintec.

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 Tri-Lo-Sprintec?” 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 tablet dispenser at the same time each day for 28 days. • After taking the last pill on Day 28 from the tablet 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 Tri-Lo-Sprintec.

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 blister pack tablet 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.

Tri-Lo-Sprintec comes in a blister pack tablet dispenser.

How to Use the Blister Cards

There are two ways to start taking birth control pills, Sunday Start or Day 1 Start. Your healthcare professional will tell you which to use.

1. Pick the Days of the Week Sticker that starts the first day of your period. (This is the day you begin bleeding or spotting, even if it is midnight when bleeding begins.) When you have picked the right sticker, throw away the others and place the sticker on the blister card over the pre-printed days of the week and make sure it lines up with the pills. 2. Your blister package consists of three parts, the foil pouch, wallet, and a blister pack containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. There are 7 gray “active” pills, 7 light blue “active” pills, 7 blue “active” pills, and 7 white “reminder” pills. Refer to the sample of the blister card below: 3. After taking the last white pill, start a new blister card the very next day no matter when your period started. You will be taking a pill every day without interruption. Anytime you start the pills later than directed, protect yourself by using another method of birth control until you have taken a pill a day for seven consecutive days. After taking the last white pill, start taking the first gray pill from the blister card the very next day. 4. Take the pills in each new package as before. Start with the gray pill on row #1 and take one pill each day, left to right, until the last white pill has been taken.

Three Ways to Remember in What Order to Take the Pills

1. Follow the sticker with the days of the week (placed above the pills). 2. Always go from left to right. 3. Always finish all your pills

What should I do if I miss any Tri-Lo-Sprintec pills?

If you miss 1 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 pills 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 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, 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. ▪ 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 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. ▪ 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 have any questions or are unsure about the information in this leaflet, call your healthcare provider.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. D 4/2016

For Healthcare Professionals

Applies to ethinyl estradiol / norgestimate: oral tablet

Other

Many of the adverse effects experienced by women on oral contraceptive combination products are related to a relative excess or deficiency of the estrogen and progestin components of these formulations. The following categorizes many of the frequent adverse effects by relative excess or deficiency of these components.

Progestin Excess:

Acne, oily skin
Breast tenderness
Depression
Tiredness, fatigue
Hair loss
Hypertension
Increased appetite
Weight gain
Cholestatic jaundice

Progestin Deficiency:

Late breakthrough bleeding
Amenorrhea
Hypermenorrhea

Estrogen Excess:

Nausea
Headache
Melasma
Hypertension
Breast tenderness
Edema

Estrogen Deficiency:

Early/mid-cycle breakthrough bleeding
Increased spotting
Hypomenorrhea[Ref]

General

Women taking oral contraceptive combinations experience several non-contraceptive health benefits. These benefits include protection against two malignant neoplasms (endometrial carcinoma and ovarian cancer). In addition, use of oral contraceptive combinations decreases the frequency of benign breast tumors, decreases the risk of ovarian cysts, decreases the risk of ectopic pregnancy, increases menstrual regularity, decreases the incidence of iron deficiency anemia, decreases the incidence of dysmenorrhea, and decreases the incidence of pelvic inflammatory disease.[Ref]

A number of studies have suggested that use of oral contraceptives decreases the risk of ovarian cancer. Specifically, the risk of epithelial ovarian cancers is decreased by 40%. The protection against ovarian cancer may last for 10 to 15 years after discontinuation of oral contraceptives. After long term use (12 years), the risk of ovarian cancer is decreased by as much as 80%.

The risk of endometrial cancer is decreased by approximately 50%. Protection may last for 15 years after discontinuation and may be greatest for nulliparous women who may be at higher risk for endometrial carcinoma than other women.

The incidence of hospitalization for pelvic inflammatory disease is approximately 50% lower in women taking oral contraceptives. The reason for the decrease in the frequency (or severity) of pelvic inflammatory disease in women taking oral contraceptives has not been fully elucidated.

Some recent studies have suggested that the decrease in frequency of functional ovarian cysts reported with some older formulations may not occur in women taking newer low dose formulations.

One recent study (The Nurses' Health Study) has suggested that long term use of oral contraceptives is safe and does not adversely affect long term risk for mortality.[Ref]

Gastrointestinal

A relatively common gastrointestinal side effect is nausea, which occurs in approximately 10% of treated women and may be more frequent during the first cycles of therapy. Some early reports suggested an association between oral contraceptive use and gallbladder disease.[Ref]

Cases of oral contraceptive-induced esophageal ulceration and geographic tongue have been reported rarely.

More recent studies have suggested that the risk of gallbladder disease is minimal.[Ref]

Oncologic

The World Health Organization committee also noted that some studies "have found a weak association between long-term use of oral contraceptives and breast cancer diagnosed before the age of 36, and perhaps up to the age 45....It is unclear whether this observed association is attributable to bias, the development of new cases of cancer, or accelerated growth of existing cancers."

The World Health Organization committee further concluded that there is no increased risk of breast cancer in women over the age of 45 who have previously taken oral contraceptives. In addition, studies suggest that use of oral contraceptives does not place specific groups of women (like those with a family history of breast cancer) at higher or lower risk, and variations in the hormonal content of oral contraceptives do not influence the risk of breast cancer.

In general, studies evaluating the potential risk of cervical cancer in patients taking oral contraceptives have been complicated by the large number of confounding factors which make investigations into the epidemiology of this neoplasm difficult. Some studies have suggested that women taking oral contraceptives are at increased risk of dysplasia, epidermoid carcinoma, and adenocarcinoma of the cervix. However, other studies have not found such an association.[Ref]

A number of studies have examined a possible relationship between the use of oral contraceptives and the development of breast cancer. Many of the studies have reported conflicting results. A committee of the World Health Organization evaluated these studies and the risks of breast cancer and concluded that: "Numerous studies have found no overall association between oral contraceptive use and risk of breast cancer." In addition, the same committee also examined a possible relationship between oral contraceptive use and neoplasms of the uterine cervix and concluded that: "There are insufficient data to draw any firm conclusions regarding the effects of combined oral contraceptives on the risk of cervical adenocarcinoma."[Ref]

Cardiovascular

Oral contraceptive combinations have been studied extensively for oncologic side effects. A number of studies have examined a possible relationship between the use of oral contraceptives and the development of breast cancer. Many of the studies have reported conflicting results. A committee of the World Health Organization evaluated these studies and the risks of breast cancer and concluded that: "Numerous studies have found no overall association between oral contraceptive use and risk of breast cancer." In addition, the same committee also examined a possible relationship between oral contraceptive use and neoplasms of the uterine cervix and concluded that: "There are insufficient data to draw any firm conclusions regarding the effects of combined oral contraceptives on the risk of cervical adenocarcinoma."[Ref]

Detailed information concerning the effects of oral contraceptive therapy on lipid metabolism is available in the Endocrine paragraph of this side effect monograph.

Some early investigations of women taking high dose estrogen combinations (50 mcg or more of ethinyl estradiol or equivalent daily) suggested that such women may be at increased risk of cardiovascular complications (myocardial infarction, stroke, and vascular thrombosis, including venous thromboembolism). However, more recent large investigations of women taking low dose estrogen combinations have suggested that oral contraceptive use is not associated with an increased risk of serious cardiovascular complications in healthy non smoking women up to the age of 45. (For women aged 35 to 44 who smoke or who have preexisting systemic diseases that may affect the cardiovascular system, use of oral contraceptives is not recommended.)

However, some investigators have suggested that even the new low dose products may result in adverse effects on lipid metabolism and should prompt careful review of a woman's cardiovascular risk factors before a decision to use oral contraceptive combinations is made.

The frequency of both subarachnoid hemorrhage and thrombotic stroke has been reported by some investigators to be higher in women taking oral contraceptive hormones. However, other investigators have suggested that the risk of these effects for women using newer low dose formulations are very small for young women without underlying cardiovascular disease or other risk factors.[Ref]

Endocrine

Endocrine and metabolic effects include complex alterations in plasma lipid profiles and carbohydrate metabolism. In addition, oral contraceptive use has been reported to cause conception delay.[Ref]

All the progestins which occur in commercially available oral contraceptive combinations have adverse effects on lipid profiles. Specifically, these progestins exert antiestrogen and androgen effects and decrease HDL (and HDL2) cholesterol levels and increase LDL cholesterol levels. However, the estrogens in oral contraceptive combinations exert opposing effects. Consequently, alterations in lipid profiles are related to the relative amount and potency of the specific estrogen and progestin in a given product. (Norgestimate exerts strong progestin and antiestrogen effects.)

A number of investigations have suggested that oral contraceptive combinations may decrease glucose tolerance. However, some recent studies with low dose preparations have suggested that decreases in glucose tolerance due to oral contraceptive combinations are generally minimal.

Despite the potentially adverse effects of oral contraceptives on lipid levels and glucose tolerance, some investigators have suggested that young diabetic women without existing vascular disease or severe lipidemias may be candidates for low dose oral contraceptive combinations provided that they receive close monitoring for adverse metabolic effects.[Ref]

Hepatic

Hepatic side effects include focal nodular hyperplasia, intrahepatic cholestasis, liver cell adenomas, hepatic granulomas, hepatic hemangiomas and well-differentiated hepatocellular carcinomas, which have been reported rarely in association with estrogen therapy and therapy with oral contraceptive combinations.[Ref]

The rate of death due to hepatocellular carcinoma in the United States has not changed during the last 25 years (a time during which use of oral contraceptive hormones has increased dramatically).

A committee of the World Health Organization has reported that in developing countries where hepatitis B virus infection and hepatocellular carcinoma are common, "short term use of oral contraceptives does not appear to be associated with an increased risk. Data on the effects of long term use are scarce."

A recent Italian case-control study of women with hepatocellular carcinoma has suggested that the relative risk of hepatocellular carcinoma is 2.2 for oral contraceptive users compared to women who never used oral contraceptives.

A similar American case-control study from 1989 also reported a strong association between oral contraceptive use and hepatocellular carcinoma but concluded that: "If this observed association is causal, the actual number of cases of liver cancer in the United States attributable to oral contraceptive use is small. Therefore, these findings do not have public health importance in the United States and other Western nations."[Ref]

Hematologic

Cases of venous thrombosis, pulmonary embolism (sometimes fatal), and arterial thrombosis have been reported rarely.

Previous thrombotic disease is considered a contraindication to use of oral contraceptive combinations.[Ref]

A hematologic concern is the risk of thromboembolism that is associated with the use of exogenous estrogens. However, because the dose of exogenous estrogens is low in most commercially available preparations, the risk of thromboembolism is minimal for most women (except women who are over age 35 and smoke and women with a history of previous thrombotic diseases).[Ref]

Genitourinary

A common genitourinary side effect is breakthrough bleeding and spotting, especially during the first several cycles of oral contraceptive use. Non-hormonal causes of such bleeding should be excluded.[Ref]

Some women experience oligomenorrhea and amenorrhea following termination or oral contraceptive use.[Ref]

Psychiatric

Psychiatric side effects include depression and precipitation of panic disorder.[Ref]

Immunologic

Immunologic side effects include cases of oral contraceptive-induced systemic lupus erythematosus which have been reported rarely.[Ref]

Other

A case of fatal pulmonary venooclusive disease has been associated with oral contraceptive therapy.[Ref]

Nervous system

Nervous system side effects include chorea, which has been reported once in association with oral contraceptives.[Ref]

Ocular

Ocular side effects include cases of retinal thrombosis, which have been reported rarely. In addition, the manufacturers of oral contraceptive products report that some patients develop changes in contact lens tolerance.[Ref]

Some side effects of Tri-Lo-Sprintec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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