Patient Medication Information: uses, side effects, how to take - AA-Clozapine
Serious Warnings and Precautions
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What is AA-CLOZAPINE used for?
AA-CLOZAPINE is a drug for the treatment of symptoms of schizophrenia. It is used in adults over 18 years of age who do not respond to, or who experience serious side-effects with other drugs used for the same purpose.
Important Information:
AA-CLOZAPINE is only available through a distribution system.
Why does my doctor need my consent?
Clozapine is available from many different suppliers and each supplier has a different monitoring system to ensure patient safety. If your doctor and/or pharmacist (with your doctor’s approval)
change the brand of clozapine you are taking, you will be moved to that supplier’s monitoring system. Your doctor needs your consent so that your supplier can:
- Access your past white blood cell count results from other suppliers
- See if you have experienced a decrease in your white blood cell count in the past while taking clozapine
Why is personal information such as my initials, birth date, gender and health card number being collected and used for identification purposes?
Since this information is specific to you, it helps to ensure that your test results are not mixed up with those of another person. Using this information also avoids the need to use your full name, which protects your privacy.
Can my personal information be used for other purposes?
No. Your information will only be used to make sure that you are properly monitored while using any brand of clozapine.
Where can I find information on the protection of health-related personal information in the private sector?
Information on this topic can be found on the website of Industry Canada, at the following address:
https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/the-personal-information-protection-and-electronic-documents-act-pipeda/
How does AA-CLOZAPINE work?
AA-CLOZAPINE belongs to a group of medicines called antipsychotic drugs. Antipsychotic medications affect dopamine and serotonin (chemicals found in the brain) that allow for the communication between your nerve cells. Exactly how this medication works is not known. However, it seems that AA-CLOZAPINE improves the balance of dopamine and serotonin in your body.
What are the ingredients in AA-CLOZAPINE?
Medicinal ingredients: clozapine.
Non-medicinal ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate, methylcellulose and sodium lauryl sulfate.
AA-CLOZAPINE comes in the following dosage forms:
Tablets; 25 mg, 50 mg, 100 mg and 200 mg
Do not use AA-CLOZAPINE if:
- You are allergic to clozapine or to any of the other ingredients listed in “What are the ingredients in AA-CLOZAPINE”.
- You are unable to undergo regular blood tests
You have ever had a low number of white blood cells, except if this was following a
- treatment for cancer (chemotherapy)
- You have or have ever had bone marrow disease or are taking medication to suppress bone marrow function
- You have or have ever had a disease that affect your blood cell formation
- You have liver disease
- You have kidney disease or kidney failure
- You have heart problems such as myocarditis, cardiomyopathy, or heart failure
- You have severe nervous system depression
- You have uncontrolled seizures
- You have or have ever had a “paralytic ileus”, severe constipation, an obstruction of the bowel or any other condition which has affected your large bowel
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AA-CLOZAPINE. Talk about any health conditions or problems you may have, including if you:
- Have a fever or an infection
- Suffer from enlargement of the prostate
- Have a history of seizures (e.g., epilepsy)
- Have glaucoma (an eye condition)
- Have or have a family history of diabetes
Have risk factors for developing blood clots such as:
- a family history of blood clots
- being over the age of 65
- smoking
- being overweight
- having a recent major surgery (such as hip or knee replacement)
- not being able to move due to air travel or other reasons
- taking oral birth control (“The Pill”)
- Have a history of colon disease or lower abdominal surgery
- You have stable pre-existing liver disorder
- Have heart disease or family history of abnormal conduction in the heart called “prolongation of the QT interval”
- Have low blood pressure
- Have a fast heart rate (tachycardia)
- Have had a stroke
- Have or have had lung disease
- Have Alzheimer's disease
- Have a condition called dementia
Are pregnant or planning to become pregnant
- Are breast-feeding or planning to breast-feed, you should not breast-feed if you are taking AA-CLOZAPINE
- Have a history of or are at risk of sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
- Are at risk for aspiration pneumonia
Tell your doctor or pharmacist what your coffee intake is and if you smoke. Abrupt changes in your habits may change the effect of AA-CLOZAPINE
Other warnings you should know about:
Effects on Newborns: In some cases, babies born to a mother taking AA-CLOZAPINE during pregnancy may have symptoms that are severe and require the newborn to go to the hospital. Sometimes, the symptoms may resolve on their own. Get emergency medical help for your newborn, if they:
- Have trouble breathing
- Are overly sleepy
- Have muscle stiffness or floppy muscles (like a rag doll)
- Are shaking
- Are having difficulty feeding
Falls: AA-CLOZAPINE can cause you to feel sleepy or dizzy and can affect your balance. This increases your risk of falling, which can cause fractures or other fall related-injuries, especially if you:
- Take sedatives
Consume alcohol
- Are elderly
- Have a condition that causes weakness or frailty
Monitoring and Tests: Your doctor will do tests before you start treatment with AA-CLOZAPINE and while you are taking it. These tests may include:
Blood tests to monitor:
- White blood cell count
- Blood sugar (glucose) levels in your body
- Fat (lipid) levels in your body
- Liver function
- Tests to monitor body weight as AA-CLOZAPINE may cause you to gain weight
Why is the testing of your blood by your doctor necessary?
In rare cases, AA-CLOZAPINE can cause a life-threatening decrease of white blood cells. To ensure that your body has enough white blood cells, it is important to have regular blood testing done.
Blood testing must be done:
- Weekly during the first 26 weeks of treatment with clozapine. The risk for developing a deficiency of white blood cells is highest during this time.
- Following this initial period, you and your doctor will evaluate the possibility of doing your blood tests to two-week intervals for the next 26 weeks.
Following 52 weeks of continuous therapy, blood tests could be performed every 4 weeks
- if your clinical condition permits it.
Regular blood testing must be done for as long as you are taking AA-CLOZAPINE.
Tell your doctor immediately at the first signs of a cold, flu-like symptoms, fever, sore throat, weakness, or any other signs of infection. Your doctor may check your blood cell count and take further measures if necessary.
Driving and using machines: Due to the risk of convulsions during AA-CLOZAPINE treatment, you should avoid activities where a sudden loss of consciousness could cause risk to yourself or others (e.g., driving, using machines, swimming, climbing).
AA-CLOZAPINE can cause serious side effects including:
- Neuroleptic Malignant Syndrome (NMS) a condition that affects the nervous system
- Tardive Dyskinesia (TD) a condition that affects your movements that may be irreversible
- Severe skin reactions that can be life-threatening such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP)
See the Serious side effects and what to do about them table below for more information on these and other serious side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AA-CLOZAPINE:
- Carbamazapine
- Phenytoin
- Omeprazole
- Rifampicin
- Erythromycin
- Cimetidine
- Valproic acid
- Medicines used to treat fungal infections such as fluconazole, miconazole, clotrimazole
- Medicines use to treat depression such as fluvoxamine, paroxetine, sertraline, fluoxetine, citalopram
- Ciprofloxacin
- Caffeine
- Tobacco smoking
- Narcotics
- Benzodiazepines
- Norepinephrine
- Epinephrine
- MAO (monoamine oxidase) inhibitors
- Any drugs used to suppress bone marrow function
- Oral birth control medicines
- Medicines used to treat high blood pressure
- Medicines used to treat allergies
- Medicines used to treat psychotic disorders
- Medicines that cause constipation
- Medicines called “anticholinergic agents”
- Alcohol
How to take AA-CLOZAPINE:
- Take exactly as your healthcare professional has told you to
- If you think your dose is too weak or too strong, talk to your doctor
- Try to take AA-CLOZAPINE at the same time each day, this will help you remember to take your medicine
- Tablets can be taken whole or crushed
Usual dose:
The usual starting dose is 12.5 mg (one half of a 25 mg tablet) once or twice on the first day. Your doctor will then slowly increase your dose depending on how severe your disease is and how well your body tolerates the medicine. Your doctor will decide the best dose for you. Take AA-CLOZAPINE exactly as your healthcare professional has told you to.
Do not stop taking AA-CLOZAPINE suddenly as it may cause unwanted side effects. If you need to stop taking AA-CLOZAPINE, discuss with your doctor how to slowly stop the medication
Overdose:
| If you think you, or a person you are caring for, have taken too much AA-CLOZAPINE, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose of AA-CLOZAPINE, and remember within two hours, take the dose right away. Otherwise, skip the missed dose and continue with your regular dosing schedule. Do not take double doses. If you stop taking AA-CLOZAPINE for more than two days, contact your doctor for dosing instructions, do not re-start taking the drug.
What are possible side effects from using AA-CLOZAPINE?
These are not all the possible side effects you may have when taking AA-CLOZAPINE. If you experience any side effects not listed here, contact your healthcare professional.
- Headache
- Fever
- Confusion
- Drowsiness or feeling sleepy
- Dizziness
- Blurred vision
- Lightheadedness or fainting
- Falls and fractures
- Stuffy nose
- Increased saliva
- Dry mouth
- Trouble swallowing
- Sweating
- Heartburn
- Stomach pain
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Weight gain
- Urinating less
- Nighttime bedwetting
- Abnormal ejaculation (dry orgasm)
- Stuttering or slurred speech
- Obsessive thoughts and behaviours
- Having trouble reading
- Uncontrolled bending of the body to one side
- Feeling restless or not being able to stay still
- Muscle weakness, stiffness or pain
- Joint pain
- Swelling of the cheeks
- Rash on the body or face
- Itchy skin
- Patches of skin discolouration
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| New or worsening constipation | √ | ||
| COMMON | |||
| Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing. | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up). | √ | ||
| Neuroleptic Malignant Syndrome (NMS): pronounced muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, state of confusion or reduced consciousness. | √ | ||
| Seizures: uncontrollable shaking with or without loss of consciousness. | √ | ||
| Sudden weakness or numbness of the face, arms or legs and speech or vision problems. | √ | ||
| UNCOMMON | |||
| Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat. | √ | ||
Signs of infection: fever, severe chills, sore throat or mouth ulcers (sign of decreased white blood cells), nausea, vomiting, diarrhea, generally feeling unwell. | √ | ||
| Tardive Dyskinesia (TD): muscle twitching or unusual/abnormal movement of the face or tongue or other parts of your body. | √ | ||
| RARE | |||
| Anemia (low level of red blood cells): fatigue, pale skin, headache, shortness of | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| breath, dizziness, weakness, difficulty sleeping. | |||
| Diabetes (high sugar levels in the blood): Excessive thirst or eating, dry mouth and passing large amounts of urine, unexplained weight loss, poor wound healing, infections. | √ | ||
| Dysphagia: difficulty swallowing that can cause food or liquid to get into your lungs, problems with your esophagus. | √ | ||
| Heart Problems – Myocarditis and/or Pericarditis, Cardiomyopathy (inflammation of the heart muscle and/or lining around the heart; heart muscle disease): abnormal heartbeat, chest pain that may resemble a heart attack, fatigue, fever and other signs of infection including headache, muscle aches, sore throat, diarrhea, or rashes, joint pain or swelling, leg swelling, shortness of breath. | √ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen. | √ | ||
| Signs of respiratory tract infection or pneumonia such as fever, coughing, difficulty breathing or wheezing. | √ | ||
| Venous thromboembolism (blood clot in a vein or artery): pain, tenderness or swelling in your arm or leg, skin that is | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| red or warm, coldness, tingling or numbness, pale skin, muscle pain or spasms, weakness. | |||
| VERY RARE | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | √ | ||
| Fast and irregular heartbeat that persists when you are at rest, possibly with shortness of breath and swelling of the feet or legs. | √ | ||
| Feeling sick, vomiting with severe/prolonged constipation | √ | ||
| Hyperglycemia (high blood sugar): confusion, nausea, vomiting, excessive thirst or eating, excessive urination, abdominal pain, headache, blurred vision, fatigue. | √ | ||
| Increased liver enzymes in the blood: dark urine, fatigue, loss of appetite, yellowing of the skin or eyes. | √ | ||
| Nephritis (inflammation of the kidney): pelvic pain, pain or burning while urinating, frequent need to urinate, cloudy urine, blood or pus in the urine. Swelling especially face or legs. | √ | ||
| Priapism: Long-lasting (greater than 4 hours in duration) and usually painful erection of the penis. | √ | ||
| Severe skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| body, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine | |||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness. | √ | ||
| Thrombocytosis (high blood platelets); headache, dizziness or lightheadedness, chest pain, weakness, fainting, temporary vision change, numbness or tingling of the hands and feet. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
- Store at room temperature (15° C to 30° C).
- Protect from moisture.
- Do not use after the expiry date shown on the bottle.
Keep out of the reach and sight of children.
If you want more information about AA-CLOZAPINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website http://www.aapharma.ca/products, or by calling 1-877-998-9097.