SEROquel XR

Quetiapine is an antipsychotic medicine that is used to treat schizophrenia in adults and children who are at least 13 years old.

Quetiapine is used to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Quetiapine is also used together with antidepressant medications to treat major depressive disorder in adults.

Quetiapine may also be used for purposes not listed in this medication guide.

You should not use quetiapine if you are allergic to it.

Quetiapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Quetiapine is not approved for use by anyone younger than 10 years old.

Tell your doctor if you have ever had:

• liver disease;
• heart problems;
• high or low blood pressure;
• low white blood cell (WBC) counts;
• abnormal thyroid tests or prolactin levels;
• constipation or urination problems;
• an enlarged prostate;
• a seizure;
• glaucoma or cataracts;
• high cholesterol or triglycerides;
• diabetes (in you or a family member); or
• trouble swallowing.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking quetiapine without your doctor's advice.

This medicine may temporarily affect fertility (your ability to have children) in women.

You should not breastfeed while you are using quetiapine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

High doses or long-term use of quetiapine can cause a serious movement disorder that may not be reversible. The longer you use quetiapine, the more likely you are to develop this disorder, especially if you are an older adult. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

You may take Seroquel with or without food.

You should take Seroquel XR without food or with a light meal.

Swallow the tablet whole and do not crush, chew, or break it.

Quetiapine may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis.

Drink plenty of liquids while you are taking quetiapine.

Blood pressure may need to be checked often in a child or teenager taking quetiapine.

You should not stop using quetiapine suddenly. Stopping suddenly may make your condition worse.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use quetiapine.

Store at room temperature away from moisture and heat.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of quetiapine can be fatal.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated during exercise and in hot weather. You may be more prone to heat stroke.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• mask-like appearance of the face, trouble swallowing, problems with speech;
• a light-headed feeling, like you might pass out;
• severe constipation;
• painful or difficult urination;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed.

Common side effects may include:

• speech problems;
• dizziness, drowsiness, tiredness;
• lack of energy;
• fast heartbeats;
• stuffy nose;
• increased appetite, weight gain;
• upset stomach, vomiting, constipation;
• dry mouth; or
• problems moving.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Quetiapine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect quetiapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about quetiapine.