Patient information: uses, side effects, how to take - TriNessa Kit NDA019653

What is the most important information I should know about MonoNessa or TriNessa?

Do not use MonoNessa or TriNessa 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 MonoNessa or TriNessa?

MonoNessa or TriNessa is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

TriNessa 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"). TriNessa should only be used to treat acne in women who want to take birth control pills to prevent pregnancy.

How does MonoNessa or TriNessa 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 MonoNessa or TriNessa.

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 MonoNessa or TriNessa?

Do not take MonoNessa or TriNessa 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 MonoNessa or TriNessa, stop taking MonoNessa or TriNessa right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking MonoNessa or TriNessa.

What should I tell my healthcare provider before taking MonoNessa or TriNessa?

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. MonoNessa or TriNessa may decrease the amount of breast milk you make. A small amount of the hormones in MonoNessa or TriNessa 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.

MonoNessa or TriNessa may affect the way other medicines work, and other medicines may affect how well MonoNessa or TriNessa 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 MonoNessa or TriNessa?

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

What are the possible serious side effects of MonoNessa or TriNessa?

Like pregnancy, MonoNessa or TriNessa 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
sudden severe shortness of breath
sudden change in vision or blindness
chest pain
a sudden, severe headache unlike your usual headaches
weakness or numbness in your arm or leg
trouble speaking

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 MonoNessa or TriNessa.
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 MonoNessa or TriNessa. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of MonoNessa or TriNessa?

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 MonoNessa or TriNessa. 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 MonoNessa or TriNessa?

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

How should I store MonoNessa or TriNessa?

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

General information about the safe and effective use of MonoNessa or TriNessa.

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

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

For more information, call 1-800-272-5525.

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 MonoNessa or TriNessa?

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 MonoNessa or TriNessa, 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 MonoNessa or TriNessa?

MonoNessa:

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

Inactive ingredients:

Blue pills: carnauba wax, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, and titanium dioxide.

Dark-green pills: FD & C Blue No. 2 Aluminum Lake, ferric oxide, lactose, magnesium stearate, polyethylene glycol, pregelatinized corn starch, purified water, polyvinyl alcohol, talc, and titanium dioxide.

TriNessa:

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

Inactive ingredients:

White pills: carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water, and titanium dioxide.

Light-blue pills: carnauba wax, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water, and titanium dioxide.

Instructions For Use

MonoNessa [mä-nō-nes-a]

TriNessa [trī-nes-a]

(norgestimate and ethinyl estradiol)

Tablets

Important Information about taking MonoNessa or TriNessa

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 MonoNessa or TriNessa, talk to your healthcare provider. When you first start taking MonoNessa or TriNessa, 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 MonoNessa or TriNessa. 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 MonoNessa or TriNessa 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 MonoNessa or TriNessa 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 MonoNessa or TriNessa.
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 MonoNessa or TriNessa 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 MonoNessa or TriNessa:

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 MonoNessa or TriNessa?

If you start taking MonoNessa or TriNessa 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 MonoNessa or TriNessa. You do not need back-up contraception if you use the Day 1 Start.

If you start taking MonoNessa or TriNessa and you are switching from another birth control pill:

Start your new MonoNessa or TriNessa 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 MonoNessa or TriNessa and previously used a vaginal ring or transdermal patch:

Start using MonoNessa or TriNessa on the day you would have reapplied the next ring or patch.

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

Start taking MonoNessa or TriNessa on the day of removal of your implant or on the day when you would have had your next injection.

If you start taking MonoNessa or TriNessa and you are switching from an intrauterine device or system (IUD or IUS):

Start taking MonoNessa or TriNessa 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 MonoNessa or TriNessa.

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 MonoNessa or TriNessa? " 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 MonoNessa or TriNessa.

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.

MonoNessa or TriNessa comes in a VERIDATE pill dispenser. Read the instructions below for using your VERIDATE pill dispenser.

Instructions for using your VERIDATE pill dispenser:

Each VERIDATE pill dispenser has 28 pills. See Figure A .
- MonoNessa
  - 21 blue pills with hormones, for Days 1 to 21
  - 7 dark green pills (without hormones), for Days 22 to 28
- TriNessa
  - 7 white pills with hormone, for Days 1 to 7
  - 7 light-blue pills with hormone, for Days 8 to 14
  - 7 blue pills with hormones, for Days 15 to 21
  - 7 dark green pills (without hormones), for Days 22 to 28

Figure A

Figure B	Step 1. Place the refill in the VERIDATE Pill Dispenser so that the "V" notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under all the nibs. See Figure B .
Figure C	Step 2. Starting your pills. Sunday Start: Remove the first pill at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser. See Figure C. If your healthcare provider tells you to start taking your pill on Sunday, take your first pill on the first Sunday after your period begins. If your period begins on Sunday, take your first pill that day.
Figure D	Day 1 Start: If you take MonoNessa: If your healthcare provider tells you to start taking your pill on "Day 1," choose a blue pill that corresponds with the day of the week on which you are taking the first pill. Remove that blue pill by pressing the pill through the hole in the bottom of the dispenser. See Figure D .
Figure E	If you take TriNessa: If your healthcare provider tells you to start taking your pill on a day other than Sunday, you will need the calendar label found in your pill package and place it over the calendar in the center of the VERIDATE. See Figure E .
Figure F	To correctly place the calendar label on the VERIDATE: find your correct starting day find that day printed in blue on the label line your blue starting day up with the first white pill which is directly under the V notch at the top of the dispenser. Remove the label from the backing. Press the center of the label down onto the center of the printed calendar. Remove that white pill by pressing the pill through the hole in the bottom of the dispenser. See Figure F .
Figure G	Step 3. Continue taking 1 pill every day from the VERIDATE in a clockwise direction until no pills remain in the outer ring. See Figure G.
Figure H	Step 4. The next day take a dark green pill from the inner ring. See Figure H. Continue to take a dark green pill each day until all 7 pills are taken. During this time your period should begin.
Figure I	Step 5. Insert a new refill: After you have taken all the dark green pills, insert a new refill into the VERIDATE and take the first pill on the next day, even if your period is not yet over. Lift the empty refill out of the VERIDATE Pill Dispenser. See Figure I. Follow the instructions in Step 1 to replace the new refill.

What should I do if I miss any MonoNessa or TriNessa 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.

TriNessa Kit NDA019653: Uses, Side Effects and Dosage