Quetiapine Fumarate Oral tablet

What is this medicine?

QUETIAPINE (kwe TYE a peen) is an antipsychotic. It is used to treat schizophrenia and bipolar disorder, also known as manic-depression.

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:

• brain tumor or head injury
• breast cancer
• cataracts
• diabetes
• difficulty swallowing
• heart disease
• kidney disease
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• low blood pressure or dizziness when standing up
• Parkinson's disease
• previous heart attack
• seizures
• suicidal thoughts, plans, or attempt by you or a family member
• thyroid disease
• an unusual or allergic reaction to quetiapine, 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. Swallow it with a drink of water. Follow the directions on the prescription label. If it upsets your stomach you can take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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

Patients over age 65 years may have a stronger reaction to this medicine and need smaller doses.

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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

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

• chlorpromazine
• cisapride
• droperidol
• grepafloxacin
• halofantrine
• mesoridazine
• pimozide
• sparfloxacin
• thioridazine

This medicine may also interact with the following medications:

• alcohol
• antifungal medicines like fluconazole, itraconazole, ketoconazole, or voriconazole
• antiviral medicines for HIV or AIDS
• cimetidine
• erythromycin
• haloperidol
• lorazepam
• medicines for depression, anxiety, or psychotic disturbances
• medicines for diabetes
• medicines for high blood pressure
• medicines for Parkinson's disease
• medicines for seizures like carbamazepine, phenobarbital, phenytoin
• rifampin
• steroid medicines like prednisone or cortisone

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 checks on your progress. It may be several weeks before you see the full effects of this medicine.

Your health care provider may suggest that you have your eyes examined prior to starting this medicine, and every 6 months thereafter.

If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or your symptoms may get worse. Ask your doctor or health care professional for advice.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for colds, diarrhea or allergies. Ask your doctor or health care professional for advice, some ingredients may increase possible side effects.

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
• difficulty swallowing
• fast or irregular heartbeat
• fever or chills, sore throat
• increased hunger or thirst
• increased urination
• problems with balance, talking, walking
• seizures
• stiff muscles
• suicidal thoughts or other mood changes
• uncontrollable head, mouth, neck, arm, or leg movements
• unusually weak or tired

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

• change in sex drive or performance
• constipation
• drowsy or dizzy
• dry mouth
• stomach upset
• weight gain

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.

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.