EContra One-Step

EContra One-Step is used to stop pregnancy after having unprotected sex or if other birth control methods fail (like a condom breaking, or missing 2 or more birth control pills).

EContra One-Step might also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor.

EContra One-Step must be taken as soon as possible after unprotected sex (no later than 72 hours afterward).

Call your doctor right away if you vomit within 2 hours after taking EContra One-Step. Do not take a second dose without first asking your doctor.

If your period is late by 1 week or longer after the expected date, you may be pregnant. Get a pregnancy test and contact your doctor if you are pregnant. EContra One-Step will not terminate pregnancy if the fertilized egg has attached to the uterus.

Within 3 weeks after taking EContra One-Step, a doctor should confirm that you are not pregnant, and that this medicine has not caused any harmful effects.

Store at room temperature away from moisture and heat.

EContra One-Step will not end a pregnancy if the fertilized egg has already attached to the uterus.

Talk to a doctor or pharmacist before using levonorgestrel if you take medication regularly for seizures, tuberculosis, or HIV/AIDS. Some other medications can reduce how well levonorgestrel works.

EContra One-Step is not meant to be used as a regular form of birth control. Talk to your doctor about the different types of birth control options available.

Do not use this medicine if you are already pregnant. EContra One-Step will not end a pregnancy that has already started (if the fertilized egg has attached to the uterus).

Not approved for use by anyone younger than 17 years old.

You should not use levonorgestrel if you are allergic to it.

Ask a doctor or pharmacist before taking levonorgestrel if you regularly use medications for seizures, tuberculosis, or HIV/AIDS. Some medications can make levonorgestrel less effective as an emergency contraceptive.

Levonorgestrel may reduce breast milk production. Tell your doctor if you are breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor or seek emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

Common side effects of EContra One-Step may include:

• stomach pain;
• breast pain or tenderness;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• feeling tired; or
• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since EContra One-Step is taken as a single dose, you do not need to take it every day.

Because EContra One-Step comes as a single tablet with a specific strength, an overdose is unlikely if you use the levonorgestrel as directed. Do not take more than one tablet at the same time.

EContra One-Step will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. Avoid having unprotected sex.

Certain other medicines can make EContra One-Step less effective, which may lead to pregnancy. Ask a doctor or pharmacist if it is safe to use EContra One-Step while taking any of the following medications:

• efavirenz;
• rifampin; or
• seizure medication--carbamazepine, felbamate, fosphenytoin, phenobarbital, phenytoin, primidone.

This list is not complete. Other drugs may also affect levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.