Before you begin taking 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 take this medication.
HEALTH CANADA ADVISORY
[March 30, 2015]
Health Canada has issued new restrictions concerning the use of drugs used in the management of Attention Deficit Hyperactivity Disorder (ADHD). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Behavioural and emotional changes: Atomoxetine may cause some people to experience unusual feelings of aggression, hostility, or anxiety. They may have hallucinations or have impulsive or disturbing thoughts of harming themselves. If you experience these side effects (or notice them in a family member who is taking this medication), contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking this medication.
Blood pressure: People with low blood pressure or high blood pressure should be closely monitored by their doctor while they are taking this medication. This medication can increase blood pressure or can cause dizziness or fainting for people who have low blood pressure. If you have low blood pressure or high blood pressure, 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.
Drowsiness/reduced alertness: Atomoxetine may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.
Exercise: If you participate in strenuous exercise or activities, consult your doctor before taking atomoxetine.
Growth and weight gain: This medication can cause children to lose weight and can slow their growth rate. Your doctor will monitor for slowed growth while they are taking this medication. Children who are not growing or gaining weight as expected may need to stop their treatment with this medication, as recommended by their doctor.
Heart problems: This medication can increase heart rate and blood pressure. It may also increase the risk of sudden death for people with heart problems. If you have heart problems, including an irregular heartbeat or a family history of sudden death related to heart disease, 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. Atomoxetine is generally not recommended for 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).
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. People with kidney problems may need lower doses of this medication. People with kidney problems should discuss with their doctor how this medication may affect their medical conditions, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. People with decreased liver function may require lower doses of this medication. In rare cases, atomoxetine may cause liver injury. Anyone taking atomoxetine should report yellow eyes or skin, dark urine, itching, upper-right abdominal pain, or unexplained flu-like symptoms to their doctor.
Long-term use: If you use this medication for a long period of time, you will need regular heart checkups by your doctor.
Stopping the medication: Check with your doctor before stopping this medication.
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: It is not known if atomoxetine passes into breast milk. If you are a breast-feeding mother and are taking this medication, 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 young children. Atomoxetine should not be used by children under 6 years of age.