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|FazaClo Orally Disintegrating Tablets

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FazaClo Orally Disintegrating Tablets

Generic Name: Clozapine Orally Disintegrating Tablets (KLOE-za-peen)
Brand Name: FazaClo

FazaClo Orally Disintegrating Tablets may cause serious blood disorders, heart problems, low blood pressure (with or without fainting), breathing problems, and seizures. Blood tests will be required before and during treatment with FazaClo Orally Disintegrating Tablets. You will not be able to have your medicine filled without these blood tests. Discuss these blood tests with your doctor.

The risk of seizures may be greater with higher doses or if you have a history of seizures. Do not perform activities in which a sudden loss of consciousness could cause harm to yourself or others (eg, driving, swimming).

The risk of heart or breathing problems may be greater if you are taking benzodiazepines (eg, lorazepam) or other medicines for mental or mood problems. Tell your doctor about any other medicines that you take.

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. This 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, other blood cell problems, or a history of blood problems caused by FazaClo Orally Disintegrating Tablets
you have uncontrolled seizures (eg, epilepsy) or loss of bowel muscle movement (paralytic ileus)
you have severe drowsiness
you are taking other medicines that may cause blood problems. Ask your doctor if you are unsure if any of your medicines may cause blood problems

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

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 problems, high blood cholesterol levels, heart problems, or lung or breathing problems
if you have a history of an enlarged prostate; prolonged, painful erections; liver or kidney problems; seizures (eg, epilepsy); glaucoma; stomach or bowel problems; or dementia
if you have poor health, phenylketonuria, diabetes, or a family member with diabetes, or you are very overweight
if you have decreased activity of enzymes that metabolize certain medicines

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:

Benzodiazepines (eg, lorazepam) or other medicines for mental or mood problems because the risk of heart or breathing problems may be increased
Cimetidine, erythromycin, quinolone antibiotics (eg, ciprofloxacin), risperidone, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because they may increase the risk of FazaClo Orally Disintegrating Tablets"s side effects
Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), nicotine, or rifampin because they may decrease FazaClo Orally Disintegrating Tablets"s effectiveness
Antiarrhythmics (eg, propafenone, quinidine), anticholinergics (eg, benztropine), carbamazepine, debrisoquin, dextromethorphan, medicines for depression or high blood pressure, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by 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.

FazaClo Orally Disintegrating Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
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.
Do not crush or chew tablets.
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.
Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
If you split the tablets, destroy the half-tablet not taken. Do not save for future use.
Do not suddenly stop taking FazaClo Orally Disintegrating Tablets without first checking with your doctor.
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. 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 lightheadedness. 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 until you know how you react to it.
Do not use alcohol or medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you taking FazaClo Orally Disintegrating Tablets. It may increase their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
FazaClo Orally Disintegrating Tablets may cause dizziness, lightheadedness, 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.
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 like 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.
If you have a history of seizures, you may suddenly lose consciousness while you are taking FazaClo Orally Disintegrating Tablets. Avoid activities where loss of consciousness could be dangerous to you or others (eg, driving, swimming, climbing, operating machinery).
Some of these products contain 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.
Avoid food and drink high in caffeine, like coffee, tea, cocoa, cola, and chocolate.
Tell your doctor or dentist that you take FazaClo Orally Disintegrating Tablets. It could have an effect on the medical or dental care, emergency care, or surgery you may receive.
Neuroleptic malignant syndrome (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 and heart function tests, may be performed to monitor your progress 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 upon standing), fast heartbeat, urinary problems, and constipation.
FazaClo Orally Disintegrating Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been determined.
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 using FazaClo Orally Disintegrating Tablets while you are pregnant. 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; lightheadedness when you stand up; nausea; strange dreams; trouble sleeping; weight gain.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; calf pain or tenderness; chest pain; confusion; dark urine; decreased coordination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; increased hunger, thirst, or urination; infection; involuntary movements of the tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements); loss of appetite; numbness of an arm or leg; rapid breathing; restlessness; seizures; severe headache, dizziness, or vomiting; severe or persistent nausea or constipation; severe stomach pain; shortness of breath; stiff muscles; swelling of the hands, ankles, or feet; sudden, unusual weight gain; tremor; trouble swallowing; uncontrolled muscle movements; unusual mental or mood changes; unusual tiredness or weakness; vision changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

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 original packaging; do not remove tablet from 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.

This information is a summary only. It does not contain all information about FazaClo Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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