Opcicon One-Step

Opcicon One-Step is used to prevent pregnancy after unprotected sex or if other forms of birth control fail (like a broken condom or missing 2 or more birth control pills).

Opcicon One-Step may also be used for reasons not mentioned in this medication guide.

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

Opcicon 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 Opcicon 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. Opcicon One-Step will not terminate pregnancy if the fertilized egg has attached to the uterus.

Within 3 weeks after taking Opcicon 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.

Opcicon 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 regularly take medication for seizures, tuberculosis, or HIV/AIDS. Some other medicines can make levonorgestrel less effective.

Opcicon One-Step is not meant to be used as a regular method of birth control. Talk to your doctor about the different types of birth control that are available.

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

It is not approved for use by anyone younger than 17 years old.

You should not use levonorgestrel if you have an allergy to it.

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

Levonorgestrel may reduce breast milk production. Inform 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 Opcicon 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 Opcicon One-Step is taken as a single dose, it does not require a daily dosing schedule.

Because Opcicon One-Step comes as a single tablet with a specific strength, taking too much is unlikely if you use it as directed. Do not take more than one tablet at the same time.

Opcicon 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 medications can make Opcicon One-Step less effective, which may lead to pregnancy. Ask a doctor or pharmacist if Opcicon One-Step is safe to use if you are 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 affect levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.