Opcicon One-Step

Levonorgestrel emergency contraceptive 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.

Before using this medication, tell your doctor if you are using any of the following drugs:

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• seizure medicines such as phenytoin (Dilantin), or carbamazepine (Tegretol).

This list is not complete and there may be other drugs that can affect levonorgestrel emergency contraceptive. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

The first dose of levonorgestrel emergency contraceptive must be taken as soon as possible after unprotected sex (no later than 72 hours afterward). The second dose must be taken 12 hours after the first dose. The timing of these doses is very important for this medication to be effective.

Call your doctor right away if you vomit within 1 hour after taking either dose of levonorgestrel emergency contraceptive. Do not take another dose until you talk with your doctor.

You should be examined by your doctor within 3 weeks after taking levonorgestrel emergency contraceptive. The doctor will need to confirm that you are not pregnant and that this medication has not caused any harmful effects.

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. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Store levonorgestrel emergency contraceptive at room temperature away from moisture and heat.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea and vomiting.

Missing a dose of this medication increases your risk of being pregnant.

Contact your doctor if you miss a dose of levonorgestrel emergency contraceptive. The timing of these doses is very important for this medication to be effective.

Use Opcicon One-Step as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine within 72 hours after unprotected sex. Take it as soon as you can.
• If you throw up within 2 hours of taking Opcicon One-Step, you may need to take 1 more dose. Call your doctor right away.

What do I do if I miss a dose?

• Call your doctor to find out what to do.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad belly pain.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Breast soreness.
• Dizziness.
• Period (menstrual) changes.
• Belly pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Opcicon One-Step or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Opcicon One-Step. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017