Uses of Fluphenazine Oral Concentrate:

• It is used to treat problems with how one acts.
• It is used to treat schizophrenia.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Fluphenazine Oral Concentrate?

• If you have an allergy to fluphenazine or any other part of fluphenazine oral concentrate.
• If you are allergic to fluphenazine oral concentrate; any part of fluphenazine oral concentrate; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Brain problem, liver disease, or low blood cell count.
• If you are very sleepy.
• If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.

This is not a list of all drugs or health problems that interact with fluphenazine oral concentrate.

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 fluphenazine oral concentrate 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 Fluphenazine Oral Concentrate?

• Tell all of your health care providers that you take fluphenazine oral concentrate. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how fluphenazine oral concentrate affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Dizziness, sleepiness, and feeling less stable may happen with fluphenazine oral concentrate. These may lead to falling, which can cause broken bones or other health problems.
• This medicine may make you sunburn more easily. Use care if you will be in the sun. Tell your doctor if you sunburn easily while taking this drug.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• If you will be near phosphorous insecticides, talk with your doctor.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping fluphenazine oral concentrate, but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
• Do not stop taking fluphenazine oral concentrate all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop fluphenazine oral concentrate, you will want to slowly stop it as ordered by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may cause the results of some pregnancy tests to be wrong. Talk with the doctor.
• If you are 65 or older, use fluphenazine oral concentrate with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking fluphenazine oral concentrate in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Fluphenazine Oral Concentrate) best taken?

Use fluphenazine oral concentrate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking fluphenazine oral concentrate as you have been told by your doctor or other health care provider, even if you feel well.
• Measure liquid doses carefully. Use the measuring device that comes with fluphenazine oral concentrate. If there is none, ask the pharmacist for a device to measure fluphenazine oral concentrate.
• Mix fluphenazine oral concentrate with at least 2 ounces (60 mL) of milk, orange soda, or some juices. Do not mix with caffeine drinks, tea, or apple juice. Take right away after mixing.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure or a fast heartbeat.
• Shortness of breath.
• Trouble swallowing or speaking.
• Twitching.
• Change in balance.
• Drooling.
• Seizures.
• Swelling in the arms or legs.
• Change in eyesight.
• Not able to control eye movements.
• Any unexplained bruising or bleeding.
• Not able to pass urine or change in how much urine is passed.
• Feeling very tired or weak.
• Breast enlargement.
• Not able to get or keep an erection.
• Nipple discharge.
• Period (menstrual) changes.
• More interest in sex.
• Very bad constipation.
• Very bad belly pain.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.

What are some other side effects of Fluphenazine Oral Concentrate?

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 nervous and excitable.
• Restlessness.
• Strange or odd dreams.
• Constipation.
• Dry mouth.
• Feeling sleepy.
• Feeling tired or weak.
• Headache.
• Upset stomach.
• Not hungry.
• Sweating a lot.
• Weight gain or loss.

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 Fluphenazine Oral Concentrate?

• Store at room temperature. Do not freeze.
• Protect from heat and light.
• Store in a dry place. Do not store in a bathroom.
• 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.

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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about fluphenazine oral concentrate, 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.