EContra One-Step (Levonorgestrel) Tablet, 1.5 mg

You are strong.
You are brave.

You are not alone.

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Victims Are
NEVER AT FAULT.

After sexual assault or rape, it’s important to remember that you are not at fault. You may be feeling overwhelmed, angry, scared, or confused. These emotions are not always easy to deal with, and you’re encouraged to take all the time you need to process your feelings. However, there are some immediate steps that you might want to consider.

Preventing pregnancy

  • Emergency contraception, sometimes called the morning-after pill, is a safe and effective way to help prevent pregnancy after sexual assault or rape
  • Emergency contraception is intended to be taken as soon as possible to prevent pregnancy

Emergency contraceptives are different from regular birth control pills

  • No method of birth control is 100% effective, so even if you’re on prescription birth control, you may need emergency contraception

Emergency contraception is not an “abortion pill”

  • Emergency contraception pills will not end an existing pregnancy
  • Emergency contraceptives help prevent pregnancy before it happens
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EContra One-Step® May Be Able to Help

EContra One-Step is an over-the-counter emergency contraception pill that can help reduce your chances of getting pregnant

With 1 pill, EContra One-Step may delay or stop your ovary from releasing an egg (called “ovulation”). EContra One-Step may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

The sooner you take EContra One-Step, the better it works

  • Take EContra One-Step as soon as possible, but no later than 3 days after sexual assault or rape
  • If EContra One-Step is taken as directed, it can significantly decrease the chance that you will get pregnant
  • About 7 out of every 8 women who would have gotten pregnant will not become pregnant

What if I’m already pregnant?

  • EContra One-Step will not work if you are already pregnant and will not affect an existing pregnancy
  • EContra One-Step will not protect you from HIV infection (the virus that causes AIDS) or other sexually transmitted diseases (STDs)
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FAQs

 

Take EContra One-Step as soon as you can, but no later than 3 days after sexual assault or rape. The sooner you take it, the better it will work.

What you might feel

Some (but not all) of the side effects of EContra One-Step are:

  • Changes in your period
  • Nausea
  • Lower stomach (abdominal) pain
  • Tiredness
  • Headache
  • Dizziness
  • Breast tenderness
  • Vomiting

How will I know EContra One-Step worked?

  • You will know EContra One-Step has been effective when you get your next period. If you haven’t gotten your period more than 1 week after the date you expected it, you may be pregnant. Take a pregnancy test and follow up with your healthcare provider.

Tell your doctor if:

  • You experience any side effects that bother you or don’t go away
  • You throw up for any reason within 2 hours of taking EContra One-Step. You may need another dose
  • You are taking efavirenz (an HIV medication) or rifampin (a tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of EContra One-Step. Your doctor may prescribe another form of emergency contraception

EContra One-Step should NOT be used:

  • If you are already pregnant, because it will not work
  • If you are allergic to levonorgestrel or any other ingredients in EContra One-Step

How EContra One-Step works:

  • EContra One-Step contains levonorgestrel, a hormone that has been used in many birth control pills for several decades
  • EContra One-Step contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy
  • EContra One-Step works mainly by stopping your ovary from releasing an egg (called “ovulation”)
  • EContra One-Step may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb)

RAINN (Rape, Abuse & Incest National Network)

www.rainn.org
800-656-HOPE (800-656-4673)

National Organization for Victim Assistance (NOVA)

www.trynova.org/help-for-crime-victims
800-TRY-NOVA (800-879-6682)

U.S. Department of Justice: National Sex Offender Public Website (NSOPW)

www.nsopw.gov/SafetyAndEducation
800-656-HOPE (800-656-4673)

Safe Horizon

www.safehorizon.org/get-help/rape-and-sexual-assault
800-621-HOPE (800-621-4673)

If you wish to report sexual assault or rape, contact your local police department. If you are on a college campus, you may also be able to contact campus-based law enforcement.


EContra One-Step Product Information

What is EContra One-Step?
EContra One-Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.

What EContra One-Step is not.
EContra One-Step will not work if you are already pregnant and will not affect an existing pregnancy. EContra One-Step will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use EContra One-Step?
The sooner you take emergency contraception, the better it works. You should use EContra One-Step within 72 hours (3 days) after you have had unprotected sex.
EContra One-Step is a backup or emergency method of birth control you can use when:

  • your regular birth control was used incorrectly or failed
  • you did not use any birth control method

When not to use EContra One-Step.
EContra One-Step should not be used:

  • as a regular birth control method, because it’s not as effective as regular birth control.
  • if you are already pregnant, because it will not work.
  • if you are allergic to levonorgestrel or any other ingredients in EContra One-Step.

When should I talk to a doctor or pharmacist?
Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of EContra One-Step and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

How does EContra One-Step work?
EContra One-Step is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. EContra One-Step contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that EContra One-Step may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

How can I get the best results from EContra One-Step?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex.
The sooner you take EContra One-Step, the better it works.

How effective is EContra One-Step?
If EContra One-Step is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know EContra One-Step worked?
You will know EContra One-Step has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

Will I experience any side effects?

  • some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.
  • if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
  • when used as directed, EContra One-Step is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
  • if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

What if I still have questions about EContra One-Step?
If you have questions or need more information, call our toll-free number Afaxys Pharma LLC at 1-855-888-2467.

Other Information
Keep out of reach of children:
In case of overdose, get medical help or contact a Poison Control Center right away at
1-800-222-1222.

Do not use if the blister seal is opened.
Store at room temperature 20° to 25°C (68° to 77°F).

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

Manufactured for:
Afaxys Pharma, LLC
Charleston, SC, 29403, USA.
Issued: 11/2017