Levonorgestrel Oral tablet [Emergency Contraception]

What is this medicine?

LEVONORGESTREL (LEE voe 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.

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

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 sugar problems, like diabetes

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

• fibroids

• liver disease

• menstrual problems

• migraine headaches

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Your doctor may want you to use a quick-response pregnancy test prior to using the tablets. Take your medicine 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. Follow the dose instructions of your health care provider exactly. Do not take any extra pills. Extra pills will not decrease your risk of pregnancy, but may increase your risk of side effects.

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.

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.

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 medicine?

Do not take this medicine with any of the following medications:

• amprenavir

• bosentan

• fosamprenavir

This medicine may also interact with the following medications:

• aprepitant

• barbiturate medicines for inducing sleep or treating seizures

• bexarotene

• griseofulvin

• medicines to treat seizures like carbamazepine, ethotoin, felbamate, oxcarbazepine, phenytoin, topiramate

• modafinil

• pioglitazone

• rifabutin

• rifampin

• rifapentine

• some medicines to treat HIV infection like atazanavir, indinavir, lopinavir, nelfinavir, tipranavir, ritonavir

• St. John's wort

• 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 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.

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

• 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 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.

Levonorgestrel Vaginal insert

What is this medicine?

LEVONORGESTREL IUD (LEE voe nor jes trel) is a contraceptive (birth control) device. The device is placed inside the uterus by a healthcare professional. It is used to prevent pregnancy and can also be used to treat heavy bleeding that occurs during your period. Depending on the device, it can be used for 3 to 5 years.

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

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

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

• abnormal Pap smear

• cancer of the breast, uterus, or cervix

• diabetes

• endometritis

• genital or pelvic infection now or in the past

• have more than one sexual partner or your partner has more than one partner

• heart disease

• history of an ectopic or tubal pregnancy

• immune system problems

• IUD in place

• liver disease or tumor

• problems with blood clots or take blood-thinners

• use intravenous drugs

• uterus of unusual shape

• vaginal bleeding that has not been explained

• an unusual or allergic reaction to levonorgestrel, other hormones, silicone, or polyethylene, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This device is placed inside the uterus by a health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amprenavir

• bosentan

• fosamprenavir

This medicine may also interact with the following medications:

• aprepitant

• barbiturate medicines for inducing sleep or treating seizures

• bexarotene

• griseofulvin

• medicines to treat seizures like carbamazepine, ethotoin, felbamate, oxcarbazepine, phenytoin, topiramate

• modafinil

• pioglitazone

• rifabutin

• rifampin

• rifapentine

• some medicines to treat HIV infection like atazanavir, indinavir, lopinavir, nelfinavir, tipranavir, ritonavir

• St. John's wort

• 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 medicine?

Visit your doctor or health care professional for regular check ups. See your doctor if you or your partner has sexual contact with others, becomes HIV positive, or gets a sexual transmitted disease.

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

You can check the placement of the IUD yourself by reaching up to the top of your vagina with clean fingers to feel the threads. Do not pull on the threads. It is a good habit to check placement after each menstrual period. Call your doctor right away if you feel more of the IUD than just the threads or if you cannot feel the threads at all.

The IUD may come out by itself. You may become pregnant if the device comes out. If you notice that the IUD has come out use a backup birth control method like condoms and call your health care provider.

Using tampons will not change the position of the IUD and are okay to use during your period.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fever, flu-like symptoms

• genital sores

• high blood pressure

• no menstrual period for 6 weeks during use

• pain, swelling, warmth in the leg

• pelvic pain or tenderness

• severe or sudden headache

• signs of pregnancy

• stomach cramping

• sudden shortness of breath

• trouble with balance, talking, or walking

• unusual vaginal bleeding, discharge

• yellowing of the eyes or skin

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

• acne

• breast pain

• change in sex drive or performance

• changes in weight

• cramping, dizziness, or faintness while the device is being inserted

• headache

• irregular menstrual bleeding within first 3 to 6 months of use

• nausea

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 medicine?

This does not apply.