Clozapine orally-disintegrating tablets

What are clozapine orally-disintegrating tablets?

CLOZAPINE (Fazoclo®) helps to treat emotional and mental problems like schizophrenia. Clozapine can help keep you in touch with reality and reduce your symptoms. It is not a cure. Clozapine is sometimes also used for the treatment of other severe emotional or mental problems. Clozapine is used to help people that have not responded to other medications. It is available only through a monitoring and dispensing system (special doctors, pharmacists, and laboratories). For the first several months of treatment, you will be required to have weekly or every-other-week blood testing before your doctor or pharmacist will be allowed to dispense the next supply of tablets. Generic clozapine orally-disentegrating tablets are not available.

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 clots

• blood disease or disorder, like leukemia

• constipation, fecal impaction, or a history of an intestinal obstruction

• diabetes

• difficulty passing urine

• fever

• glaucoma

• heart disease or lung disease

• kidney disease

• liver disease

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

• Parkinson's disease

• phenylketonuria

• prostate trouble

• seizure disorder (convulsions)

• stroke

• uncontrollable movements, especially of the face and mouth

• an unusual or allergic reaction to clozapine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. The tablets are made to dissolve in the mouth without having to take them with water. Place the tablet in the mouth and allow it to dissolve, then swallow. You can take these tablets with water, but you do not have to. If this medicine upsets your stomach, take it with food or milk. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

The tablets should stay in the original 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.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

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 medication for more than 2 days, you should not restart your medicine at the same dose. Contact your prescriber for instructions.

You will only be able to receive a 7 or 14 day supply of your medication at any one time, due to the rules of the clozapine medication watch system. It is important that you receive your blood tests on time so that your medication can be refilled by your pharmacist or health care provider before your supply has run-out. Keep all appointments for these required tests.

What drug(s) may interact with clozapine?

• alcohol

• caffeine

• carbamazepine

• cisapride

• digoxin

• divalproex sodium or valproic acid

• donepezil

• erythromycin or clarithromycin

• galantamine

• guarana

• haloperidol

• lithium

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• medicines for colds, hay fever, and other allergies

• medicines for diabetes

• medicines for high blood pressure

• medicines for mental depression, anxiety, or other mood problems

• medicines for muscle spasms such as gastrointestinal spasm or breathing difficulty

• medicines for pain

• olanzapine

• phenytoin

• rifampin or rifabutin

• risperidone

• ritonavir

• rivastigmine

• some medicines used to treat irregular heartbeats

• tacrine

• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking clozapine?

Visit your prescriber or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of clozapine. Do notify your prescriber if your symptoms get worse or you have new symptoms, if you are having an unusual effect from clozapine, or if you feel out of control, very discouraged or think you might harm yourself or others.

You must have a weekly blood test when you first begin clozapine; 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. Do not suddenly stop taking clozapine. You may need to gradually reduce the dose. Only stop taking clozapine on your prescriber's advice.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how clozapine 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.

If you have diabetes (high blood sugar), a family history of diabetes, or are obese (extremely overweight) you may be at risk for worsened diabetes or getting diabetes while using clozapine. You should monitor your blood sugar levels closely if you currently have diabetes. Discuss this potential side effect with your heath care provider. All patients using clozapine should watch for signs of excessive urination, thirst, and hunger while taking clozapine, which may indicate a high blood sugar level. Your health care provider may check your blood sugar with a simple blood test before you start taking clozapine.

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

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. Be careful when brushing and flossing your teeth to avoid mouth infections or damage to your gums. See your dentist regularly. Sometimes clozapine can make your mouth water a lot, especially at night.

If you are going to have surgery tell your prescriber or health care professional that you are taking clozapine.

What side effects may I notice from taking clozapine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

More common:

• fainting spells, loss of balance

• fast heartbeat

Rare or Infrequent:

• changes in vision, inability to control eye movements

• chest pain or irregular heartbeat (palpitations)

• confusion

• difficulty breathing or shortness of breath

• difficulty in speaking or swallowing

• difficulty sleeping, nightmares

• difficulty passing urine

• fever, chills, sore throat, or mouth sores

• inability to control muscle movements in the face, hands, arms, or legs

• jaundice, or yellowing of the skin or whites of the eyes

• muscle and joint aches and pains

• nausea, vomiting, or severe loss of appetite

• restlessness or need to keep moving

• seizures (convulsions)

• stiffness, spasms, trembling

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

• unusual tiredness or weakness

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

Less common:

• anxiety or a depressed mood

• changes in sexual desire or performance

• diarrhea

• dry mouth

• heartburn

• increased sweating

More common:

• constipation

• dizziness, especially on standing from a sitting or lying position

• drowsiness

• headache

• increased watering of the mouth, drooling

• weight gain

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature below 30 degrees C (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 tablets

What are clozapine tablets?

CLOZAPINE (Clozaril®) helps to treat emotional and mental problems like schizophrenia. Clozapine can help keep you in touch with reality and reduce your symptoms. It is not a cure. Clozapine is sometimes also used for the treatment of other severe emotional or mental problems. Clozapine is used to help people that have not responded to other medications. It is available only through a monitoring and dispensing system (special doctors, pharmacists, and laboratories). For the first several months of treatment, you will be required to have weekly or every-other-week blood testing before your doctor or pharmacist will be allowed to dispense the next supply of tablets. Generic clozapine tablets are available.

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 clots

• blood disease or disorder, like leukemia

• constipation, fecal impaction, or a history of an intestinal obstruction

• diabetes

• difficulty passing urine

• fever

• glaucoma

• heart disease or lung disease

• kidney disease

• liver disease

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

• Parkinson's disease

• prostate trouble

• seizure disorder (convulsions)

• stroke

• uncontrollable movements, especially of the face and mouth

• an unusual or allergic reaction to clozapine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take clozapine tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If clozapine upsets your stomach, take it with food or milk. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

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 medication for more than 2 days, you should not restart your medicine at the same dose. Contact your prescriber for instructions.

You will only be able to receive a 7 or 14 day supply of your medication at any one time, due to the rules of the clozapine medication watch system. It is important that you receive your blood tests on time so that your medication can be refilled by your pharmacist or health care provider before your supply has run-out. Keep all appointments for these required tests.

What drug(s) may interact with clozapine?

• alcohol

• caffeine

• carbamazepine

• cisapride

• digoxin

• divalproex sodium or valproic acid

• donepezil

• erythromycin or clarithromycin

• galantamine

• guarana

• haloperidol

• lithium

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• medicines for colds, hay fever, and other allergies

• medicines for diabetes

• medicines for high blood pressure

• medicines for mental depression, anxiety, or other mood problems

• medicines for muscle spasms such as gastrointestinal spasm or breathing difficulty

• medicines for pain

• olanzapine

• phenytoin

• rifampin or rifabutin

• risperidone

• ritonavir

• rivastigmine

• some medicines used to treat irregular heartbeats

• tacrine

• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking clozapine?

Visit your prescriber or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of clozapine. Do notify your prescriber if your symptoms get worse or you have new symptoms, if you are having an unusual effect from clozapine, or if you feel out of control, very discouraged or think you might harm yourself or others.

You must have a weekly blood test when you first begin clozapine; 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. Do not suddenly stop taking clozapine. You may need to gradually reduce the dose. Only stop taking clozapine on your prescriber's advice.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how clozapine 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.

If you have diabetes (high blood sugar), a family history of diabetes, or are obese (extremely overweight) you may be at risk for worsened diabetes or getting diabetes while using clozapine. You should monitor your blood sugar levels closely if you currently have diabetes. Discuss this potential side effect with your heath care provider. All patients using clozapine should watch for signs of excessive urination, thirst, and hunger while taking clozapine, which may indicate a high blood sugar level. Your health care provider may check your blood sugar with a simple blood test before you start taking clozapine.

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

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. Be careful when brushing and flossing your teeth to avoid mouth infections or damage to your gums. See your dentist regularly. Sometimes clozapine can make your mouth water a lot, especially at night.

If you are going to have surgery tell your prescriber or health care professional that you are taking clozapine.

What side effects may I notice from taking clozapine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

More common:

• fainting spells, loss of balance

• fast heartbeat

Rare or Infrequent:

• changes in vision, inability to control eye movements

• chest pain or irregular heartbeat (palpitations)

• confusion

• difficulty breathing or shortness of breath

• difficulty in speaking or swallowing

• difficulty sleeping, nightmares

• difficulty passing urine

• fever, chills, sore throat, or mouth sores

• inability to control muscle movements in the face, hands, arms, or legs

• jaundice, or yellowing of the skin or whites of the eyes

• muscle and joint aches and pains

• nausea, vomiting, or severe loss of appetite

• restlessness or need to keep moving

• seizures (convulsions)

• stiffness, spasms, trembling

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

• unusual tiredness or weakness

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

Less common:

• anxiety or a depressed mood

• changes in sexual desire or performance

• diarrhea

• dry mouth

• heartburn

• increased sweating

More common:

• constipation

• dizziness, especially on standing from a sitting or lying position

• drowsiness

• headache

• increased watering of the mouth, drooling

• weight gain

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.