Clozapine Oral disintegrating tablet

What is this medicine?

CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.

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:

• being treated for cancer

• blood disease or disorder, like leukemia

• cigarette smoker

• constipation, fecal impaction, or a history of an obstruction of the intestine

• dementia

• diabetes

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low levels of potassium or magnesium in the blood

• lung or breathing disease, like asthma

• Parkinson's disease

• phenylketonuria

• seizures

• an unusual or allergic reaction to clozapine, 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. Follow the directions on the prescription label. These tablets are made to dissolve in the mouth. Place the tablet in the mouth and allow it to dissolve, then swallow. While you may take these tablets with water, it is not necessary to do so. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop taking this medicine. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

The tablets should stay in the unopened blister package until immediately before you take your dose. If you split the tablet as part of your dose, the half-tablet that is not taken should be destroyed. Do not save this half-tablet for later use.

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

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. If you miss your medicine for more than 2 days, you should not restart your medicine at the same dose. Contact your doctor for instructions.

What may interact with this medicine?

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

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• mesoridazine

• metoclopramide

• pimozide

• quinidine

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• atropine

• birth control pills

• caffeine

• certain antibiotics like ciprofloxacin, erythromycin, mefloquine, moxifloxacin, pentamidine, rifabutin, rifampin

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for blood pressure

• certain medicines for cancer

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, sotalol

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for seizures

• certain medicines for sleep

• certain medicines for stomach problems like cimetidine, dicyclomine, dolasetron, hyoscyamine

• certain medicines for travel sickness like scopolamine

• ipratropium

• lithium

• medicines that lower your chance of fighting infection

• methadone

• nicotine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• skeletal muscle relaxants

• St. John's Wort

• tacrolimus

• terbinafine

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. Contact your doctor or health care professional if your symptoms get worse or if you have new symptoms.

You must have a weekly blood test when you first begin this medicine. If your blood counts stay in the right range, your tests may be reduced after 6 months to every other week. Your name will go on a national registry of patients that take this medicine, to make sure that you have never had a serious reaction to it.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug 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 make you more drowsy and dizzy. Avoid alcoholic drinks.

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

If you notice an increased hunger or thirst, different from your normal hunger or thirst, or if you find that you have to urinate more frequently, you should contact your health care provider as soon as possible. You may need to have your blood sugar monitored. This medicine may cause changes in your blood sugar levels. You should monitor you blood sugar frequently if you have diabetes.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

If you are going to have surgery tell your doctor or health care professional that you are taking this medicine.

If you have phenylketonuria, you should be aware that each 25 mg, orally-disintegrating tablet contains 3.1 mg of aspartame (1.74 mg of phenylalanine) and each 100 mg, orally-disintegrating tablet contains 12.4 mg of aspartame (6.96 mg of phenylalanine).

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

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

• breathing problems

• changes in vision

• chest pain, fast or irregular heartbeat

• confusion

• difficulty sleeping, nightmares

• excessive thirst and/or hunger

• feeling faint or lightheaded, falls

• fever, chills, sore throat, or mouth sores

• muscle and joint aches and pains

• nausea, vomiting, or severe loss of appetite

• restlessness

• seizures

• shortness of breath, chest pain, swelling in a leg

• stiffness, spasms, trembling

• trouble passing urine or change in the amount of urine

• trouble with balance, talking, walking

• uncontrollable tongue or chewing movements, smacking lips or puffing cheeks

• unusually weak or tired

• yellowing of the eyes, skin

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

• constipation

• dry mouth

• headache

• increased watering of the mouth, drooling

• 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). Keep the tablets in the packaging until the time of use. Protect from moisture. Throw away any unused medicine after the expiration date.

Clozapine Oral suspension

What is this medicine?

CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.

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:

• being treated for cancer

• blood disease or disorder, like leukemia

• cigarette smoker

• constipation, fecal impaction, or a history of an obstruction of the intestine

• dementia

• diabetes

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low levels of potassium or magnesium in the blood

• lung or breathing disease, like asthma

• Parkinson's disease

• seizures

• an unusual or allergic reaction to clozapine, 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. Follow the directions on the prescription label. Also follow the Instructions for Use sheet which provides detailed steps for preparing and taking your dose, and disposing of empty bottles. This medicine may be taken with or without food. Shake the bottle well for 10 seconds before each use. Use the oral syringe that comes with your medicine to measure each dose. Household spoons are not accurate. Take your medicine as soon as you draw it into the syringe. Do not store the medicine in the syringe for later use. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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.

Overdosage: If you think you've 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. If you miss a dose for more than 2 days, check with your healthcare provider before starting to take it again to make sure you take the correct dose.

What may interact with this medicine?

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

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• mesoridazine

• metoclopramide

• pimozide

• quinidine

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• atropine

• birth control pills

• caffeine

• certain antibiotics like ciprofloxacin, erythromycin, mefloquine, moxifloxacin, pentamidine, rifabutin, rifampin

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for blood pressure

• certain medicines for cancer

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, sotalol

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for seizures

• certain medicines for sleep

• certain medicines for stomach problems like cimetidine, dicyclomine, dolasetron, hyoscyamine

• certain medicines for travel sickness like scopolamine

• ipratropium

• lithium

• medicines that lower your chance of fighting infection

• methadone

• nicotine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• skeletal muscle relaxants

• St. John's Wort

• tacrolimus

• terbinafine

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. Contact your doctor or health care professional if your symptoms get worse or if you have new symptoms.

You must have a weekly blood test when you first begin this medicine. If your blood counts stay in the right range for the first 6 months, the frequency of your test may then be reduced. Your name will go on a national registry of patients who take this medicine, to make sure that you have never had a serious reaction to it.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug 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 make you more drowsy and dizzy. Avoid alcoholic drinks.

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

If you notice an increased hunger or thirst, different from your normal hunger or thirst, or if you find that you have to urinate more frequently, you should contact your health care provider as soon as possible. You may need to have your blood sugar monitored. This medicine may cause changes in your blood sugar levels. You should monitor you blood sugar frequently if you have diabetes.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

If you are going to have surgery tell your doctor or health care professional that you are taking this medicine.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

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

• breathing problems

• changes in vision

• chest pain, fast or irregular heartbeat

• confusion

• difficulty sleeping, nightmares

• excessive thirst and/or hunger

• feeling faint or lightheaded, falls

• fever, chills, sore throat, or mouth sores

• muscle and joint aches and pains

• nausea, vomiting, or severe loss of appetite

• restlessness

• seizures

• shortness of breath, chest pain, swelling in a leg

• stiffness, spasms, trembling

• trouble passing urine or change in the amount of urine

• trouble with balance, talking, walking

• uncontrollable tongue or chewing movements, smacking lips or puffing cheeks

• unusually weak or tired

• yellowing of the eyes, skin

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

• constipation

• dry mouth

• headache

• increased watering of the mouth, drooling

• 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 20—25 degrees C (68—77 degrees F). Do not refrigerate or freeze. Protect from light. The opened bottle expires 100 days after the initial opening. 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.

Clozapine Oral tablet

What is this medicine?

CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.

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:

• being treated for cancer

• blood disease or disorder, like leukemia

• cigarette smoker

• constipation, fecal impaction, or a history of an obstruction of the intestine

• dementia

• diabetes

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low levels of potassium or magnesium in the blood

• lung or breathing disease, like asthma

• Parkinson's disease

• seizures

• an unusual or allergic reaction to clozapine, 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 with a glass of water. Follow the directions on the prescription label. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Only stop taking this medicine on the advice of your doctor or health care professional.

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

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. If you miss your medicine for more than 2 days, you should not restart your medicine at the same dose. Contact your doctor for instructions.

What may interact with this medicine?

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

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• mesoridazine

• metoclopramide

• pimozide

• quinidine

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• atropine

• birth control pills

• caffeine

• certain antibiotics like ciprofloxacin, erythromycin, mefloquine, moxifloxacin, pentamidine, rifabutin, rifampin

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for blood pressure

• certain medicines for cancer

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, sotalol

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for seizures

• certain medicines for sleep

• certain medicines for stomach problems like cimetidine, dicyclomine, dolasetron, hyoscyamine

• certain medicines for travel sickness like scopolamine

• ipratropium

• lithium

• medicines that lower your chance of fighting infection

• methadone

• nicotine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• skeletal muscle relaxants

• St. John's Wort

• tacrolimus

• terbinafine

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. Contact your doctor or health care professional if your symptoms get worse or if you have new symptoms.

All patients receiving clozapine must be enrolled in a program called the Clozapine REMS Program. Your doctor is responsible for making sure you are enrolled in this program. You must have a weekly blood test when you first begin this medicine. If your blood counts stay in the right range, your doctor will reduce the frequency of the testing. Be sure to report any side effects from using clozapine to your healthcare provider. For more information, visit the Clozapine REMS Program website at www.clozapinerems.com and read the material in the information guide called "What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers".

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug 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 make you more drowsy and dizzy. Avoid alcoholic drinks.

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

If you notice an increased hunger or thirst, different from your normal hunger or thirst, or if you find that you have to urinate more frequently, you should contact your health care provider as soon as possible. You may need to have your blood sugar monitored. This medicine may cause changes in your blood sugar levels. You should monitor you blood sugar frequently if you have diabetes.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

If you are going to have surgery tell your doctor or health care professional that you are taking this medicine.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

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

• breathing problems

• changes in vision

• chest pain, fast or irregular heartbeat

• confusion

• difficulty sleeping, nightmares

• excessive thirst and/or hunger

• feeling faint or lightheaded, falls

• fever, chills, sore throat, or mouth sores

• muscle and joint aches and pains

• nausea, vomiting, or severe loss of appetite

• restlessness

• seizures

• shortness of breath, chest pain, swelling in a leg

• stiffness, spasms, trembling

• trouble passing urine or change in the amount of urine

• trouble with balance, talking, walking

• uncontrollable tongue or chewing movements, smacking lips or puffing cheeks

• unusually weak or tired

• yellowing of the eyes, skin

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

• constipation

• dry mouth

• headache

• increased watering of the mouth, drooling

• 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 below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.