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BALCOLTRA- levonorgestrel and ethinyl estradiol kit


  1. Counsel Patients On The Following Information:
  2. Manufactured For:
  3. Manufactured By:
  4. Patient Information
  5. What Is The Most Important Information I Should Know About Balcoltra?
  6. What Is Balcoltra?
  7. How Does Balcoltra Work For Contraception?
  8. Do Not Take Balcoltra If You:
  9. What Are The Possible Serious Side Effects Of Balcoltra?
  10. Serious Blood Clots Are More Likely To Happen When You:
  11. Call Your Healthcare Provider Or Go To A Hospital Emergency Room Right Away If You Have:
  12. Liver Problems, Including:
  13. The Most Common Side Effects Of Balcoltra Include:
  14. What Else Should I Know About Taking Balcoltra?
  15. How Should I Store Balcoltra?
  16. Do Birth Control Pills Cause Cancer?
  17. What Should I Know About My Period When Taking Balcoltra?
  18. What If I Miss My Scheduled Period When Using Balcoltra?
  19. Active Ingredients:
  20. Inactive Ingredients:
  21. If You Start Taking Balcoltra And You Have Not Used A Hormonal Birth Control Method Before:
  22. If You Start Taking Balcoltra And You Are Switching From Another Birth Control Pill:
  23. If You Start Taking Balcoltra And Previously Used A Vaginal Ring Or Transdermal Patch:
  24. If You Start Taking Balcoltra And You Are Switching From A Progestin-only Method Such As An Implant Or Injection:
  25. If You Start Taking Balcoltra And You Are Switching From An Intrauterine Device Or System (iud Or Ius):
  26. Keep A Calendar To Track Your Period:
  27. When Should I Start Taking Balcoltra?
  28. Sunday Start:
  29. If You Miss 1 Pill In Weeks 1, 2, Or 3, Follow These Steps:
  30. If You Miss 2 Pills In Week 1 Or Week 2 Of Your Pack, Follow These Steps:
  31. If You Are A Day 1 Starter:
  32. If You Are A Sunday Starter:

Counsel Patients On 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[seeBoxed 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)].
Balcoltra does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.
Balcoltra is not to be used during pregnancy; if pregnancy occurs during use of Balcoltra, instruct the patient to stop further use[see Use in Specific Populations (8.1)].
Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed[see Dosage and Administration (2.3)].
Use a back-up or alternative method of contraception when enzyme inducers are used with Balcoltra[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 (8.2)].
A woman who starts COCs postpartum and who has not yet had a period should use an additional method of contraception until she has taken a blue tablet for 7 consecutive days[see Dosage and Administration (2.2)].
Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles[see Warnings and Precautions (5.8)].

Manufactured For: 

Avion Pharmaceuticals, LLC.,
1880 McFarland Pkwy.,
Alpharetta, GA 30005.
1-888-612-8466

Manufactured By: 

Novast Laboratories, Ltd.,
Nantong, China 226009

Date: 02/2018

I0090 Rev. A

Patient Information 

PATIENT INFORMATION
Balcoltra (BALL-coll-TRAA)
(levonorgestrel and ethinyl estradiol tablets, and ferrous bisglycinate tablets)
for oral administration

What Is The Most Important Information I Should Know About Balcoltra? 

Do not use Balcoltra if you smoke cigarettes and are over 35 years old.Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from 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 Balcoltra? 

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

Balcoltra doesnotprotect against HIV infections (AIDS) and other sexually transmitted infections.

How Does Balcoltra 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 one clinical study of a 28-day regimen of levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets, about 1 out of 100 women may get pregnant within the first year they use Balcoltra.

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.

How does Balcoltra work for contraception

Do Not Take Balcoltra If You: 

smoke and are over 35 years of age
have or have had blood clots in your arms, legs, lungs, or eyes
have 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
have or have had breast cancer or any cancer that is sensitive to female hormones
are allergic to levonorgestrel, ethinyl estradiol, ferrous bisglycinate or any of the ingredients in Balcoltra. Some people who are allergic to aspirin may also be allergic to FD&C Yellow No. 5 (tartrazine). FD&C Yellow No. 5 (tartrazine) is an ingredient in Balcoltra which also may cause an allergic type reaction such as bronchial asthma.

Read the detailed Instructions for Use at the end of this Patient Information leaflet about the right way to take your Balcoltra.

What Are The Possible Serious Side Effects Of Balcoltra? 

Like pregnancy, Balcoltra 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: 

o
first start taking birth control pills
o
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: 

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

Liver Problems, Including: 

o
rare liver tumors
o
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

The Most Common Side Effects Of Balcoltra Include: 

headache (including migraine)
irregular vaginal bleeding (including absence of period)
nausea
breast tenderness, pain and discomfort
stomach (abdominal) pain
pain with your periods (menstrual cycle)
mood changes, including depression
acne
vaginal infections

These are not all the possible side effects of Balcoltra. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

What Else Should I Know About Taking Balcoltra? 

If you are scheduled for any lab tests, tell your healthcare provider you are taking Balcoltra. Certain blood tests may be affected by Balcoltra.

How Should I Store Balcoltra? 

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

General information about the safe and effective use of Balcoltra.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use Balcoltra for a condition for which it was not prescribed. Do not give Balcoltra to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Balcoltra that is written for health professionals.

Do Birth Control Pills Cause Cancer? 

Birth control pills do not

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 Balcoltra? 

Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Balcoltra, especially during the first few months of use. This usually is not a serious problem. If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles call your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What If I Miss My Scheduled Period When Using Balcoltra? 

Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your Balcoltra correctly, call your healthcare provider because you may be pregnant. Also call your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Balcoltra if you are pregnant.

Active Ingredients: 

Orange tablets: levonorgestrel and ethinyl estradiol.

Inactive ingredients: Orange tablets: FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Inactive Ingredients: 

Blue tablets: ferrous bisglycinate), citric acid NF, glycine, water, maltodextrin NF, silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

For more information, go to www.avionrx.com or call 1-888-612-8466.

Instructions For Use

Balcoltra (BALL-coll-TRAA)

(levonorgestrel and ethinyl estradiol tablets and ferrous biglycinate tablets)
for oral administration

Important Information about taking Balcoltra

Take1pill every day at the same time. Take the pills in the order directed on your blister pack.

Both the orange pills and the blue pills should be swallowed whole.

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 Balcoltra, talk to your healthcare provider. When you first start taking Balcoltra, 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 Balcoltra. 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 take2pills to make up for missed pills (

If You Start Taking Balcoltra And You Have Not Used A Hormonal Birth Control Method Before: 

There are 2 ways to start taking your birth control pills.
o
You can either start on a Sunday (Sunday Start) or
o
You can start 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 or spermicide for the first7days that you take Balcoltra. You do not need back-up contraception if you use the Day 1 Start.

If You Start Taking Balcoltra And You Are Switching From Another Birth Control Pill: 

Start your new Balcoltra 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 Balcoltra And Previously Used A Vaginal Ring Or Transdermal Patch: 

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

If You Start Taking Balcoltra And You Are Switching From A Progestin-only Method Such As An Implant Or Injection: 

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

If You Start Taking Balcoltra And You Are Switching From An Intrauterine Device Or System (iud Or Ius): 

Start taking Balcoltra 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 or spermicide for the first7days that you take Balcoltra.

Keep A Calendar To Track Your Period: 

If this is the first timeyou are taking birth control pills, read,

When Should I Start Taking Balcoltra? 

above. Follow these instructions for either aSunday Startor aDay 1 Start.

Sunday Start: 

You will use aSunday Startif your healthcare provider told you to take your first pill on a Sunday.

Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take Balcoltra.

Instructions for using your pill pack

Look at your Balcoltra pill pack.

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 take2pills in1day.
Then continue taking1pill 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 or spermicide) as a back-up if you have sex during the first 7 days after missing your pills.

If You Are A Day 1 Starter: 

o
Throw out the rest of the pill pack and start a new pack that same day.

If You Are A Sunday Starter: 

o
Keep taking1pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
You could become pregnant if you have sex during the first 7 days after you restart your pills. You should use a non-hormonal birth control method (such as a condom or 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. They have a more technical leaflet called the Professional Labeling which you may wish to read.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.



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