Levonorgestrel Vaginal insert

What is this medicine?

LEVONORGESTREL IUD (LEE voe nor jes trel) is a contraceptive (birth control) device. It is used to prevent pregnancy and to treat heavy bleeding that occurs during your period. It can be used for up 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.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time.

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.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.