Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
April 21, 2015
Health Canada has issued new information concerning the use of methylphenidate controlled release. To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.
A previous advisory on methylphenidate controlled release was issued on March 30, 2015. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Behaviour or mood changes: There have been reports of agitation, aggression, hallucinations, and symptoms of depression in people taking this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Blood pressure: This medication can increase blood pressure. If you have high blood pressure, or heart problems, talk to your doctor before taking this medication.
Drowsiness/reduced alertness: Methylphenidate controlled release may cause dizziness, which could affect your ability to drive or operate machinery. Avoid activities requiring alertness until you have determined how this medication affects you.
Drug dependence: There does not appear to be an increased risk of dependence or addiction with the use of methylphenidate by children and adolescents. However, abuse of methylphenidate is possible by certain individuals. Regular, long-term abuse can lead to high levels of tolerance and psychological dependence, and a wide range of abnormal behaviours. If you have a history of drug or alcohol dependence, you should be closely monitored by your doctor while using this medication.
Drug holidays: It is sometimes helpful to stop methylphenidate to determine whether it is still needed to help the ADHD symptoms. Talk to your doctor about whether a drug holiday might be appropriate for you or your child. Do not stop this medication without discussing it with your doctor first.
Exercise: People participating in strenuous exercise or activities should consult their doctor before taking methylphenidate controlled release. Strenuous exercise combined with the effects of methylphenidate of the heart and blood pressure may increase the risk of sudden death.
Heart problems and blood pressure: This medication can increase heart rate and blood pressure. It may also increase the risk of sudden death for people with heart problems. This medication should generally not be used by people with known structural heart abnormalities (such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart), or a family history of sudden or cardiac death. People taking more than one stimulant medication for ADHD should be closely monitored by their doctor.
Misuse of methylphenidate may also be associated with sudden death and other serious heart-related effects.
Long-term use: If you will be using methylphenidate controlled release for a long period of time, your doctor will want you to have regular heart checkups, blood pressure checks and lab tests to monitor your liver and blood.
Prolonged Erections: Rarely, prolonged and painful erections (called priapism) have been reported by patients using methylphenidate. Priapism is a very rare condition that can affect children as well as adults. It may occur after increasing the dose or stopping the medication for a short period of time.
Patients who develop priapism should seek immediate medical attention to prevent potential long-term effects on the penis.
Seizures: There is some evidence that methylphenidate extended release may increase the risk of seizures, particularly for people who have had seizures in the past. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Stopping the medication: Check with your doctor before stopping this medication.
Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Suppression of growth: Growth suppression (i.e., less increase in height or weight than usual) has been reported for children using stimulants such as methylphenidate for long periods of time. It is not known if this medication causes growth suppression in children (i.e., less increase in height or weight than usual). Children who need long-term treatment should be carefully monitored for growth.
Tics: This medication may cause tics or worsening of motor or verbal tics. If you have Tourette's syndrome or develop tics while on this medication, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Vision: Rarely, people taking methylphenidate controlled release have experienced vision changes. If you notice any changes in your vision, contact your doctor.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking methylphenidate controlled release, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication have not been established for and should not be used by children less than 6 years of age.