Ethinyl Estradiol; Levonorgestrel emergency contraceptive kit

What is this medicine?

ETHINYL ESTRADIOL; LEVONORGESTREL (ETH in il es tra DYE ole; LEE voh nor jes trel) is an emergency contraceptive (birth control pill). It prevents pregnancy if taken within the 72 hours after unprotected sex. This medicine will not work if you are already pregnant.

NOTE: This product is discontinued in the United States.

How should I use this medicine?

Take this medicine by mouth. Follow the instructions provided by your health care provider exactly. Your doctor may want you to use a quick-response pregnancy test prior to using the tablets. Take the first dose as soon as you can after having unprotected sex, preferably in the first 24 hours, but no later than 72 hours (3 days) after the event. You MUST take the second dose 12 hours after you take the first dose. Do not take any extra pills. Extra pills will not decrease your risk of pregnancy, but may increase your risk of side effects.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Severe side effects are not common. However, the potential for severe side effects may exist and you may want to discuss these with your health care provider.

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• abdominal pain or cramping

• breast tenderness

• dizziness

• nausea/vomiting (report any vomiting that occurs within 1 hour of a dose)

• spotting

What may interact with this medicine?

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines

• aprepitant

• barbiturate medicines, such as phenobarbital

• bosentan

• carbamazepine

• felbamate

• modafinil

• oxcarbazepine

• phenytoin

• ritonavir or other medicines for HIV infection or AIDS

• St. John's wort

• topiramate

• warfarin

What if I miss a dose?

If you miss a dose or vomit within 1 hour of taking your dose, you MUST contact your health care professional for instructions.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have or ever had any of these conditions:

• blood vessel disease or blood clots

• blood sugar problems, like diabetes

• cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding

• fibroids

• gallbladder disease

• heart disease or recent heart attack

• high blood pressure

• liver disease

• menstrual problems

• migraine headaches

• tobacco smoker

• stroke

• an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Emergency birth control is not to be used routinely to prevent pregnancy. Discuss birth control options with your health care provider. Make a follow-up appointment to see your health care provider in 3 to 4 weeks after using this medicine.

It is common to have spotting after using this medicine. If you miss your next period, the possibility of pregnancy must be considered. See your health care professional as soon as you can and get a pregnancy test.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking birth control pills, especially if you are more than 35 years old. You are strongly advised not to smoke.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.