FazaClo orally disintegrating tablets

Generic Name: clozapine (KLOE-za-peen)
Brand Name: FazaClo

FazaClo orally disintegrating tablets may cause a serious blood disorder (agranulocytosis). This blood disorder can lead to serious infection and death. Lab tests will be performed before use and while you use FazaClo orally disintegrating tablets to check for this side effect. Call your doctor right away if you have fever, chills, sore throat, or unusual tiredness or weakness. Because of the risk of agranulocytosis, you can only get FazaClo orally disintegrating tablets through a special program. Discuss any questions or concerns with your doctor.

Low blood pressure, slow heartbeat, fainting, and heart attack have occurred with the use of FazaClo orally disintegrating tablets. The risk is highest when the dose is being increased, especially if it is increased too fast. These reactions can occur with any dose of FazaClo orally disintegrating tablets. Take FazaClo orally disintegrating tablets as directed by your doctor. Tell your doctor if you have brain or heart problems (eg, blood vessel problems), if you are dehydrated, or if you take medicine for blood pressure.

Seizures have occurred with the use of FazaClo orally disintegrating tablets. The risk of seizures may be greater with higher doses, if you have a history of seizures, if you take medicines that increase the risk of seizures, or if you abuse alcohol. Do not perform activities in which a sudden loss of consciousness could cause harm to yourself or others (eg, driving, swimming).

Serious and sometimes fatal heart problems have occurred with the use of FazaClo orally disintegrating tablets. Call your doctor right away if you have chest pain, fast or irregular heartbeat, shortness of breath, fever, flu-like symptoms, dizziness, or fainting.

FazaClo orally disintegrating tablets may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. FazaClo orally disintegrating tablets is not approved to treat mental problems caused by dementia.


FazaClo orally disintegrating tablets is used for:

Managing schizophrenia in patients who do not respond to other medicines. It is used to decrease the risk of suicidal behavior in certain patients. It may also be used for other conditions as determined by your doctor.

FazaClo orally disintegrating tablets is an atypical antipsychotic. It may work by affecting certain chemicals in the brain, which has an effect on thinking and behavior.

Do NOT use FazaClo orally disintegrating tablets if:

  • you are allergic to any ingredient in FazaClo orally disintegrating tablets
  • you have bone marrow problems (eg, myeloproliferative disorders) or certain blood problems
  • you have a history of blood or heart problems caused by FazaClo orally disintegrating tablets
  • you have uncontrolled seizures (eg, epilepsy) or bowel blockage (paralytic ileus)
  • you have severe drowsiness
  • you are taking metoclopramide
  • you are taking other medicines that may decrease bone marrow function or cause certain blood problems. Ask your doctor if you are unsure if any of your medicines may cause these problems

Contact your doctor or health care provider right away if any of these apply to you.

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Before using FazaClo orally disintegrating tablets:

Some medical conditions may interact with FazaClo orally disintegrating tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of blood clots, blood vessel problems, heart problems or a heart attack, high or low blood pressure, a stroke or "mini-stroke," lung or breathing problems, or high blood cholesterol levels
  • if you or a member of your family have had a certain type of irregular heartbeat (QT prolongation, long QT syndrome)
  • if you have low blood potassium or magnesium levels, or if you are at risk for low blood potassium or magnesium levels
  • if you have a history of blood problems caused by another medicine
  • if you have a history of an enlarged prostate, liver or kidney problems, seizures (eg, epilepsy), neuroleptic malignant syndrome (NMS), glaucoma, stomach or bowel problems (eg, blockage), or dementia
  • if you have diarrhea, are dehydrated, or have low blood volume, or if you are in poor health
  • if you have phenylketonuria, diabetes, or a family member with diabetes, or you are very overweight
  • if you have decreased metabolism of certain medicines
  • if you smoke or are exposed to tobacco smoke, or you regularly consume food and drinks high in caffeine (eg, coffee, tea, soda)
  • if you are scheduled for surgery or to receive anesthesia

Some MEDICINES MAY INTERACT with FazaClo orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for birth control, cancer, depression or other mental or mood problems, hepatitis C, high blood pressure, HIV, infections, inflammation, irregular heartbeat or other heart problems, narcotic abuse or dependence, nausea or vomiting, pain, Parkinson disease, restless legs syndrome, seizures, stomach or bowel problems, trouble sleeping), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with FazaClo orally disintegrating tablets. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with FazaClo orally disintegrating tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if FazaClo orally disintegrating tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use FazaClo orally disintegrating tablets:

Use FazaClo orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take FazaClo orally disintegrating tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Do not remove the blister from the outer pouch until you are ready to take FazaClo orally disintegrating tablets.
  • Make sure that your hands are dry when you open FazaClo orally disintegrating tablets. Do not push the tablet through the foil.
  • Peel back the foil on the blister pack and place the tablet on the tongue. Allow the tablet to dissolve and swallow with saliva. FazaClo orally disintegrating tablets may be taken with or without water.
  • You may chew the tablets if you desire.
  • Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
  • If you split the tablets, discard the half of the tablet not taken out of the reach of children and away from pets. Do not save for future use. Talk to your pharmacist about proper disposal for FazaClo orally disintegrating tablets.
  • Do not suddenly stop taking FazaClo orally disintegrating tablets. You may have an increased risk of side effects (eg, increased sweating, headache, nausea, vomiting, diarrhea). If you need to stop FazaClo orally disintegrating tablets or add a new medicine, your doctor will gradually lower your dose.
  • Continue to take FazaClo orally disintegrating tablets even if you feel well. Do not miss any doses.
  • Taking FazaClo orally disintegrating tablets at the same time each day will help you to remember to take it.
  • If you miss a dose of FazaClo orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking a dose of FazaClo orally disintegrating tablets for more than 2 days, do not start taking it again. Contact your doctor right away for instructions.

Ask your health care provider any questions you may have about how to use FazaClo orally disintegrating tablets.

Important safety information:

  • FazaClo orally disintegrating tablets may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use FazaClo orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks while you take FazaClo orally disintegrating tablets.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using FazaClo orally disintegrating tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • FazaClo orally disintegrating tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you think you may be dehydrated.
  • Do not take more than the recommended dose without checking with your doctor.
  • FazaClo orally disintegrating tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice any signs of infection such as fever, sore throat, rash, chills, mouth or nose sores, or unusual tiredness or weakness.
  • Women and patients of Jewish background may be at greater risk of developing blood problems with FazaClo orally disintegrating tablets.
  • Seizures may occur in patients who take FazaClo orally disintegrating tablets, which may cause you to suddenly lose consciousness. Avoid activities where loss of consciousness could be dangerous to you or others (eg, driving, swimming, climbing, operating machinery).
  • Serious, and possibly fatal, heart problems have rarely occurred in patients who take FazaClo orally disintegrating tablets. Symptoms may include chest pain; fast or irregular heartbeat; fever; rapid or difficult breathing; swelling of the hands, feet, or ankles; or unusual tiredness. Seek immediate medical attention if you experience any of these symptoms.
  • FazaClo orally disintegrating tablets contains phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
  • FazaClo orally disintegrating tablets may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Avoid food and drink high in caffeine, such as coffee, tea, cocoa, cola, and chocolate.
  • Tell your doctor or dentist that you take FazaClo orally disintegrating tablets before you receive any medical or dental care, emergency care, or surgery.
  • NMS is a possibly fatal syndrome that can be caused by FazaClo orally disintegrating tablets. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take FazaClo orally disintegrating tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take FazaClo orally disintegrating tablets in high doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your tongue, face, mouth, jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements), arms, or legs while taking FazaClo orally disintegrating tablets.
  • Lab tests, including complete blood cell counts, fasting blood glucose, cholesterol, and heart function, may be performed while you use FazaClo orally disintegrating tablets and for at least 4 weeks after you stop taking it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use FazaClo orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems, dizziness (especially when standing), constipation, fast heartbeat, and urinary problems.
  • FazaClo orally disintegrating tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Use of FazaClo orally disintegrating tablets is not recommended in INFANTS.
  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking FazaClo orally disintegrating tablets while you are pregnant. Using FazaClo orally disintegrating tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if FazaClo orally disintegrating tablets is found in breast milk. Do not breast-feed while taking FazaClo orally disintegrating tablets.

Possible side effects of FazaClo orally disintegrating tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; heartburn; increased sweating or saliva production; light-headedness when you stand up; nausea; trouble sleeping; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); agitation; calf or leg pain or tenderness; chest pain; confusion; dark urine; decreased coordination; delirium; fainting; fast or difficult breathing; fast or irregular heartbeat; fever, chills, persistent cough, or sore throat; involuntary movements of the tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements); loss of appetite; muscle spasms or stiffness; new or worsening mental or mood changes; numbness of an arm or leg; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or vomiting; severe or persistent nausea, vomiting, or constipation; severe stomach pain; shortness of breath; sluggishness; symptoms of a stroke (eg, one-sided weakness, slurred speech); tremor; trouble swallowing; trouble urinating; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; delirium; excessive salivation; fainting; fast or irregular heartbeat; seizures; severe or persistent dizziness or drowsiness; slow or shallow breathing.

Proper storage of FazaClo orally disintegrating tablets:

Store FazaClo orally disintegrating tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep FazaClo orally disintegrating tablets in the original packaging; do not remove the tablet from the blister until ready to use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep FazaClo orally disintegrating tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about FazaClo orally disintegrating tablets, please talk with your doctor, pharmacist, or other health care provider.
  • FazaClo orally disintegrating tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take FazaClo orally disintegrating tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about FazaClo orally disintegrating tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to FazaClo orally disintegrating tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using FazaClo orally disintegrating tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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