Levonorgestrel; Ethinyl Estradiol Emergency Contraceptive Kit

What is this medication?

LEVONORGESTREL; ETHINYL ESTRADIOL (LEE voh nor jes trel; ETH in il es tra DYE ole) 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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Preven

What should I tell my care team before I take this medication?

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
• gallbladder disease
• heart disease or recent heart attack
• high blood pressure
• liver disease
• 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

How should I use this medication?

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medication?

Do not take this medicine with the following medication:

• dasabuvir; ombitasvir; paritaprevir; ritonavir
• ombitasvir; paritaprevir; ritonavir

This medicine may also interact with the following medications:

• acetaminophen
• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
• aprepitant
• ascorbic acid (vitamin C)
• atorvastatin
• barbiturate medicines, such as phenobarbital
• bosentan
• carbamazepine
• caffeine
• clofibrate
• cyclosporine
• dantrolene
• doxercalciferol
• felbamate
• grapefruit juice
• hydrocortisone
• medicines for anxiety or sleeping problems, such as diazepam or temazepam
• medicines for diabetes
• mineral oil
• modafinil
• mycophenolate
• nefazodone
• oxcarbazepine
• phenytoin
• prednisolone
• ritonavir or other medicines for HIV infection or AIDS
• rosuvastatin
• selegiline
• soy isoflavones supplements
• St. John's wort
• tamoxifen or raloxifene
• theophylline
• thyroid hormones
• topiramate
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.