When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to clozapine.

How to Use This Medicine:
Liquid, Tablet, Dissolving Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Make sure your hands are dry before you handle the disintegrating tablet. Peel back the foil from the blister pack, then remove the tablet. Do not push the tablet through the foil. Place the tablet in your mouth. After it has melted, swallow or take a drink of water. The disintegrating tablet may also be chewed.
• Oral suspension: Shake for 10 seconds before each use. Measure the dose with the dosing syringe that comes with the package.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Call you doctor if you miss your dose for longer than 2 days. Your dose may need to be changed.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Oral suspension: Do not refrigerate or freeze. Throw away any unused medicine 100 days after you open the bottle for the first time.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how clozapine works. Tell your doctor if you are using any of the following:
  
  • Bupropion, carbamazepine, cimetidine, dolasetron, duloxetine, enoxacin, escitalopram, fluoxetine, fluvoxamine, halofantrine, levomethadyl acetate, lithium, mefloquine, methadone, paroxetine, pentamidine, phenytoin, rifampin, sertraline, St John's wort, tacrolimus, or terbinafine
  • Birth control pills
  • Blood pressure medicine
  • Diuretic (water pill)
  • Medicine for heart rhythm problems (including amiodarone, encainide, flecainide, procainamide, propafenone, quinidine, sotalol)
  • Medicine to treat an infection (including ciprofloxacin, erythromycin, gatifloxacin, moxifloxacin, sparfloxacin)
  • Other medicine to treat mental health problems (including chlorpromazine, iloperidone, droperidol, pimozide, ziprasidone)
  .
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, digestion problems, glaucoma, heart or blood vessel disease, heart failure, heart rhythm problems, enlarged prostate, or a history of head injury, heart attack, stroke, seizures, or alcohol addiction. Tell your doctor if you smoke or drink products that contain caffeine. Tell your doctor if you have phenylketonuria.
• This medicine may cause the following problems:
  
  • Neutropenia (blood disorder that can lead to serious infections)
  • Heart problems or changes in heart rhythm
  • Changes in blood sugar levels
  • Neuroleptic malignant syndrome, which can be life-threatening
  • Increased risk of blood clots, including stroke
  • Tardive dyskinesia (a movement disorder)
• This medicine can make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Drink plenty of liquids to help avoid constipation.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Chest pain, trouble breathing, numbness or weakness on one side of your body, lower leg pain, problems with vision, speech, or walking
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, body aches
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness
• Increased thirst or hunger
• Jerky muscle movement that you cannot control, often in your face, tongue, or jaw
• Lightheadedness, dizziness, fainting
• Seizures
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea
• Excess saliva or drooling
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088