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 Alertec (Modafinil).
HEALTH CANADA ADVISORY
June 20, 2019
Health Canada has issued information concerning the use of Alertec (Modafinil). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Birth Control: Birth control pills, patches and other forms of estrogen and estrogen/progestin birth control may be less effective when you are also taking Alertec (Modafinil). Alternative methods of birth control should be used while you are taking Alertec (Modafinil) and for at least 1 month after stopping treatment with Alertec (Modafinil).
Drowsiness/reduced alertness: Some people experience ongoing drowsiness or dizziness while taking Alertec (Modafinil). It may also cause overconfidence and over-stimulation, causing poor judgement. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how Alertec (Modafinil) affects you.
Heart disease: Alertec (Modafinil) may cause an irregular heartbeat or increased blood pressure. The safety of using Alertec (Modafinil) has not been established for people with heart problems. If you have a heart condition or history of heart problems, discuss with your doctor how Alertec (Modafinil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alertec (Modafinil), and whether any special monitoring is needed.
Hypersensitivity syndrome: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of Alertec (Modafinil). Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.
Liver function: People with severe liver disease should take lower doses of Alertec (Modafinil) because of an increased risk of accumulation of the medication in the body and side effects. If you have liver disease or decreased liver function, discuss with your doctor how Alertec (Modafinil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alertec (Modafinil), and whether any special monitoring is needed.
Mental illness: Alertec (Modafinil) may reactivate certain mental disorders or cause confusion and agitation. If you have a history of mental disorders such as depression, psychosis, or mania, discuss with your doctor how Alertec (Modafinil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alertec (Modafinil), and whether any special monitoring is needed. If you experience symptoms of agitation, depression or hallucination, or notice them in a family member who is taking Alertec (Modafinil), contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking Alertec (Modafinil).
Normal fatigue states: Alertec (Modafinil) should not be used to treat normal fatigue states (e.g., fatigue due to lack of sleep rather than narcolepsy), as it can lead to overconfidence in abilities without actually increasing performance. This could make it more dangerous to perform certain activities.
Seizure disorder: If you have a seizure disorder or a history of seizures, discuss with your doctor how Alertec (Modafinil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alertec (Modafinil), and whether any special monitoring is needed.
Skin rash: Alertec (Modafinil) may cause skin rash. Rarely, people taking Alertec (Modafinil) experience a severe skin reaction that can be life-threatening. This usually occurs within the first 5 weeks of taking the medication, but it can develop at any time while you are taking Alertec (Modafinil). If you experience a rash that gets worse, or develops into blisters, sores on the lips or eyes or covers a large area of the body, contact your doctor immediately.
Pregnancy: Alertec (Modafinil) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Alertec (Modafinil), contact your doctor immediately.
Breast-feeding: It is not known if Alertec (Modafinil) passes into breast milk. If you are a breast-feeding mother and are taking Alertec (Modafinil), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: Serious reactions have been associated with the use of Alertec (Modafinil) by children. The risks and benefits of Alertec (Modafinil) have not been established for children. It is not recommended that children be given Alertec (Modafinil).
Seniors: Seniors may be more sensitive to the effects of Alertec (Modafinil). They should use lower starting doses.
