Tri-Linyah

Medication Guide

PATIENT INFORMATION

TRI-LINYAH
[TRI-lin-YAH]
(norgestimate and ethinyl estradiol) Tablets

What is the most important information I should know about TRI-LINYAH?

Do not use TRI-LINYAH 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-LINYAH?

TRI-LINYAH is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

TRI-LINYAH is also used to treat moderate acne vulgaris in females 15 years of age and older, who have no known history of allergies or problems taking birth control pills, and have started their menstrual cycle ("period"). TRI-LINYAH should only be used to treat acne in women who want to take birth control pills to prevent pregnancy.

How does TRI-LINYAH 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 of clinical studies, about 1 out of 100 women may get pregnant during the first year they use TRILINYAH.

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 MONO-LINYAH? Do not take MONO-LINYAH 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
• 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.
• 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-LINYAH, stop taking TRI-LINYAH right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking TRI-LINYAH.

What should I tell my healthcare provider before taking TRI-LINYAH?

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-LINYAH may decrease the amount of breast milk you make. A small amount of the hormones in TRI-LINYAH 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-LINYAH may affect the way other medicines work, and other medicines may affect how well TRI-LINYAH 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-LINYAH?

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

What are the possible serious side effects of TRI-LINYAH?

• Like pregnancy, TRI-LINYAH 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-LINYAH.
• 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 if 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-LINYAH. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of TRI-LINYAH?

• headache (migraine)
• breast pain or tenderness, enlargement or discharge
• stomach pain, discomfort, and gas
• vaginal infections and discharge
• mood changes, including depression
• nervousness
• changes in weight
• skin rash

These are not all the possible side effects of TRI-LINYAH. 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-LINYAH?

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

How should I store TRI-LINYAH?

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

General information about the safe and effective use of TRI-LINYAH.

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

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

For more information, call 1-800-206-7821.

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-Linyah?

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-LINYAH, 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-LINYAH?

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

Inactive ingredients:

Green pills: FD&C Blue No.2 Aluminum Lake,FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black, iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

Light Blue pills: FD&C Blue #2 Aluminum Lake,FD&C Red #40 Aluminum Lake, titanium dioxide,iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

Blue pills: FD&C Blue No. 2 Aluminium Lake,FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol,talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

White pills: titanium dioxide, polydextrose,hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

Instructions for Use

TRI-LINYAH
[TRI-lin-YAH]
(norgestimate and ethinyl estradiol) Tablets

Important Information about taking Tri-Linyah

• 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 TRI-LINYAH, talk to your healthcare provider. When you first start taking TRILINYAH, 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-LINYAH. 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-LINYAH 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-LINYAH 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-LINYAH.
• If you have vomiting or diarrhea within 3-4 hours of taking your pill, take another pill of the same color from your extra pill dispenser. If you do not have an extra pill dispenser, take the next 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 TRI-LINYAH 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-Linyah:

• 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 TRI-LINYAH?

If you start taking TRI-LINYAH 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 first7 days that you take TRI-LINYAH. You do not need back-up contraception if you use the Day 1 Start.

If you start taking TRI-LINYAH and you are switching from another birth control pill:

• Start your new TRI-LINYAH 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-LINYAH and previously used a vaginal ring or transdermal patch:

• Start using TRI-LINYAH on the day you would have reapplied the next ring or patch.

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

• Start taking TRI-LINYAH 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-LINYAH and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking TRI-LINYAH 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 first7 days that you take TRI-LINYAH.

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-LINYAH?" above.

TRI-LINYAH is available as a blister card placed within a white compact with the days of the week imprinted on the white compact preset for a Sundaystart. The TRI-LINYAH blister card has 21 (7 green,7 light blue and 7 blue) "active" pills (with hormones)to take for 3 weeks. This is followed by 1 week of 7 white "reminder" pills (without hormones). The TRI-LINYAH blister card and the imprinted days of the week on the compact is shown in the picture below.

On the above blister card find where on the card to start taking pills, in what order to take the pills and the week numbers. Day 1 stickers are also provided.

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 pill1 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.
• Take1 pill every day in the order on the pill dispenser at the same time each day for28 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 first7 days of the first cycle that you take TRI-LINYAH.

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. Refer to Day 1 Start instructions below.

1. Pick the day label strip that starts with the first day of your period.
2. Place this day label strip over the area on the plastic compact which already has the days of the week (starting with Sunday) imprinted and press firmly. See the picture below as an example.

• Take1 pill every day in the order of the pill dispenser dial pack, at the same time each day, for28 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.

What should I do if I miss any TRI-LINYAH 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 take2 pills in1 day.
• Then continue taking1 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 nonhormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first7 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 first7 days after you restart your pills.

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.