Details for: AA-CLOZAPINE

BEFORE you use AA-CLOZAPINE be sure to tell your doctor or pharmacist if you:

Suffer from enlargement of the prostate
• Have a history of seizures (e.g. epilepsy)
• Have glaucoma (an eye condition)
• Suffer from diabetes
• Have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reasons, or take oral contraceptives (“The Pill”).
• Have a history of bone marrow disorder
• Have a paralytic ileus or other serious
gastrointestinal problems
• Suffer from constipation
• Have or have had heart problems
• Have heart disease or family history of abnormal conduction in the heart called “prolongation of the QT interval”
• Have had a stroke
• Have or have had lung disease
• Have Alzheimer's disease
• Suffer from a condition called dementia
• Are pregnant or planning to become pregnant
• Are breast-feeding

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.

Your doctor should check your body weight before starting AA-CLOZAPINE and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting AACLOZAPINE and for as long as you are being treated to monitor your blood sugar.

Pregnancy and breast-feeding

AA-CLOZAPINE should only be taken during pregnancy if your doctor specifically prescribes it. Therefore, you should consult your doctor if you are or intend to become pregnant

Effects on Newborns

In some cases, babies born to a mother taking AACLOZAPINE during pregnancy may experience symptoms that sometimes resolve on their own, or in other cases may be severe and require the newborn to be hospitalized. Seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.

As AA-CLOZAPINE can pass into breast milk, mothers receiving AA-CLOZAPINE should not breast-feed.

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).

Further safety measures

WHY IS THE TESTING OF YOUR BLOOD BY YOUR DOCTOR NECESSARY? In rare instances (approximately 0.7% of cases), AACLOZAPINE can cause a suppression of white blood cells, necessary to help the body fight infection. Because this condition is potentially life-threatening, it is important to have regular blood testing done. To ensure that the required blood tests are performed, AACLOZAPINE is only available through a special program

Blood testing must be done weekly during the first 26 weeks of treatment with clozapine, because the risk for developing a deficiency of white blood cells is highest during this initial period. Following this initial period, your doctor will evaluate with you the possibility of limiting blood checks to two-week intervals for the next 26 weeks, depending on your health condition. Thereafter, following 52 weeks of continuous therapy, if your clinical condition permits it, blood tests could be performed every four weeks. Regular blood testing must be done for as long as you are taking AA-CLOZAPINE.

In addition, you should consult your doctor immediately at the first signs of a cold, flu-like symptoms, fever, sore throat, or any other signs of infection, as well as weakness or a general feeling of unwellness. The doctor may check your blood cell count and take further measures if necessary.

WHY DOES MY DOCTOR NEED MY CONSENT?
The medication you are taking, clozapine, is produced by several different suppliers. Each supplier has a different monitoring system to ensure patient safety. Should your doctor and/or pharmacist (with the approval of your doctor) change the brand of clozapine you are taking, you will be transferred to a different monitoring system. If this happens, it is very important that your new supplier is able to access your past white blood cell counts results in order to help your doctor ensure that you are properly monitored.

It is also important to check with all registries at the start of the treatment that you have not experienced in the past a decrease of your white blood cell count with clozapine. Your consent is needed to allow this verification and sharing of information to take place.

Why is personal information such as my initials, birth date, gender and health card number being collected and used for identification purposes?

This information will be collected and used for several reasons. Since this information is specific to you, it helps to ensure that your test results are not mixed up with those of another person on the same medication. Using this information also avoids the need to use your full name and therefore protects your privacy.

Can my personal information be used for other purposes?

No. Your information will only be used to ensure 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 from the Office of the Privacy Commissioner of Canada, at the following address:
https://www.priv.gc.ca/resource/fs-fi/02_05_d_15_e.asp