Consumer Information for: APO-RISPERIDONE

BEFORE you use APO-RISPERIDONE, talk to your doctor or pharmacist if you / the patient you are caring for:

• have/has serious allergic reactions to other medications, including paliperidone;
• have/has a history of stroke, mini-strokes, high cholesterol or high blood pressure. Medicines like APO-RISPERIDONE can raise the risk of death in elderly people who have dementia;
• have/has neuroleptic malignant syndrome (a disorder that causes you to have high fever and stiffness in your muscles);
• have/has tardive dyskinesia (a disorder that causes you to have uncontrolled and repeated movements of the tongue, face or other body parts);
• have/has or are at risk for diabetes or high blood sugar or a family history of diabetes;
• are/is pregnant, think you may be pregnant or planning to become pregnant;
• are/is breast-feeding or planning to breast-feed;
• have or have had prolonged and/or painful erections;
• have/has ever had blackouts or seizures;
• have/has a history of kidney or liver problems;
• have/has a history of:
  • problems with the heart and/or blood vessels;
  • any problems with the way your heart beats
• are being treated for high blood pressure;
• are taking any medications that affect how your heart beats;
• are/is prone to hypotension (low blood pressure), have or have had a heart disease or heart disease treatment that makes you more likely to have low blood pressure or feeling dizzy or faint when you stand up from lying or sitting positions;
  
  
• are at risk for developing blood clots. Risk factors include:
  • 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/ had low white blood cell counts in your blood. Let your doctor know right away if you develop a fever or infection while being treated with APO-RISPERIDONE;
• have high levels of cholesterol or fats (triglycerides) in your blood
• have, have a history of or are at risk of:
  • sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
  • sleep walking
  • sleep-related eating disorder
• have/has Parkinson’s disease;
• are/is taking or planning to take any other medicines (prescription over-the-counter medicines, natural health products);
• drink/drinks alcoholic beverages or use/uses drugs;
• have/has or have had/has had breast cancer;
• have/has pituitary tumours;
• suffer/suffers from Alzheimer's Disease;
• suffer/suffers from Lewy body dementia;
• are/is feeling thirsty and unwell;
• exercise/exercises strenuously. This kind of medication may interfere with your body’s ability to adjust to heat. You should avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking APO-RISPERIDONE;
• are/is planning to have an operation on the eye(s). During surgery to treat the cloudiness of the lens in your eye(s) (known as cataract surgery):
  • the pupil (the black circle in the middle of your eye) may not increase in size as needed;
  • the iris (the coloured part of the eye) may become floppy during surgery. This may lead to eye damage.

Tell your eye doctor you are taking this medicine

Elderly Patients with Dementia

• Studies in elderly patients with dementia have shown that risperidone taken by itself or with furosemide (a “water pill”) is associated with a higher rate of death (see Serious Warnings and Precautions Box).

Tell your doctor if you are taking furosemide. This drug can be used to treat:

• high blood pressure
• some heart problems
• swelling of parts of the body caused by the build-up of too much fluid.

• In elderly patients with dementia:
  • a sudden change in mental state
  • sudden weakness or numbness of the face, arms or legs, especially on one side of the body
  • slurred speech
  • vision problems

have been seen.

If any of these should occur, even for a short period of time, seek medical attention right away.

If you are taking blood pressure medication
Low blood pressure can result from using risperidone together with medications used to treat high blood pressure. If you need to use both APO-RISPERIDONE and medications used to reduce blood pressure, consult your doctor.

Effects on newborns
You should not take APO-RISPERIDONE while you are pregnant or if you are planning on becoming pregnant unless you have talked to your doctor about it.

If you took APO-RISPERIDONE at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking
• stiffness in their muscles and/or weakness
• sleepiness
• agitation
• breathing problems
• difficulty feeding

Get medical help right away if your newborn baby has any of these symptoms.

In some cases, babies born to a mother taking risperidone during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized.

Other cautions
Driving and using machines: Do not drive or operate machinery until you know how you respond to APO-RISPRIDONE Some people experience drowsiness or blurred vision while taking APO-RISPRIDONE.

Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision and speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall related injuries. Certain medications, diseases or conditions can make this worse.

Weight gain: Weight gain has been seen in patients who are taking antipsychotic drugs. Your doctor may monitor your body weight when you are taking APO-RISPERIDONE.

Blood tests: Your doctor should do blood tests before you start taking APO-RISPRIDONE. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your doctor should continue to check your blood for as long as you are being treated with APO-RISPRIDONE.

It is important for the doctor to have all the above information before prescribing treatment and dosage. This list should be carefully reviewed by you / the caregiver and discussed with the doctor.