Uses of Fresenius Propoven:

• It is used to put you to sleep for surgery.
• It is used to calm you before a procedure.
• It is used to cause sleep during a procedure.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Fresenius Propoven?

• If you have an allergy to propofol, eggs, soy products, or any other part of Fresenius Propoven (propofol).
• If you are allergic to Fresenius Propoven (propofol); any part of Fresenius Propoven (propofol); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take Fresenius Propoven (propofol).

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Fresenius Propoven (propofol) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fresenius Propoven?

• Tell all of your health care providers that you take Fresenius Propoven (propofol). This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until the effects of Fresenius Propoven (propofol) wear off and you feel fully awake.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Talk with your doctor if you have seizures or have ever had seizures.
• High triglyceride levels have happened with Fresenius Propoven (propofol). Tell your doctor if you have ever had high triglyceride levels.
• If you are 65 or older, use Fresenius Propoven (propofol) with care. You could have more side effects.
• Studies in young animals and children have shown that frequent or long-term use of anesthesia drugs or drugs used for sleep in children younger than 3 years of age may lead to long-term brain problems. This may also happen in unborn babies if the mother uses Fresenius Propoven (propofol) during the third trimester of pregnancy. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Fresenius Propoven (propofol) while you are pregnant.

How is this medicine (Fresenius Propoven) best taken?

Use Fresenius Propoven (propofol) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is given as a shot into a vein or into a vein nonstop for a period of time.

What do I do if I miss a dose?

• This medicine will be given on an as needed basis in a healthcare setting.

What are some side effects that I need to call my doctor about right away?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Trouble breathing, slow breathing, or shallow breathing.
• Slow heartbeat.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• This medicine may rarely cause a severe health problem called propofol infusion syndrome (PRIS). Sometimes, this has been deadly. The chance of PRIS may be higher with high doses of Fresenius Propoven (propofol) or with long-term use. Tell your doctor right away if you feel confused, very sleepy, or very tired or weak. Tell your doctor right away if you have dark urine or are not able to pass urine; fast breathing; a fast or abnormal heartbeat; muscle pain or weakness; severe stomach pain, upset stomach, or throwing up; or shortness of breath, a big weight gain, or swelling in the arms or legs.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

What are some other side effects of Fresenius Propoven?

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:

• Feeling sleepy.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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.

How do I store and/or throw out Fresenius Propoven?

• If you need to store Fresenius Propoven (propofol) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• 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 all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Fresenius Propoven (propofol), 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.