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
January 21, 2015
Health Canada has issued new restrictions concerning the use of Aricept (donepezil). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Asthma and lung conditions: If you have lung conditions such as asthma or COPD (Chronic Obstructive Pulmonary Disease), discuss with your doctor how this medication may affect your medical condition, and whether any special monitoring is needed. Donepezil could cause symptoms of these conditions to worsen.
Chronic illness: In general, people with chronic medical conditions should be cautious when taking donepezil because of the increased risk of side effects. The benefits of taking the medication must be carefully weighed against the risks.
Epilepsy: There is a possibility that donepezil may increase the risk of seizures for susceptible people. If you have a history of seizure disorder, speak to your doctor about the risks and benefits of taking donepezil.
Heart disease: If you have heart disease such as active Coronary Artery Disease or Congestive Heart Failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Donepezil, and whether any special monitoring is needed. Donepezil has the potential to slow the heart rate. People with cardiac conduction abnormalities (e.g., heart rhythm problems such as sick sinus syndrome) should not take donepezil.
Liver function: Liver disease or reduced liver function may cause Sandoz Donepezil to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Sandoz Donepezil may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Donepezil, and whether any special monitoring is needed.
Muscle effects: In rare cases, serious muscle damage has been associated with the use of donepezil. Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.
Neuroleptic malignant syndrome (NMS): Donepezil, can rarely cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS, get immediate medical attention. Symptoms include high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, and fainting.
Stomach problems: Donepezil has the potential to cause an increase in the amount of acid that the stomach produces. If you have a history of ulcers or are at increased risk of developing stomach ulcers, discuss with your doctor how Sandoz Donepezil may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Donepezil, and whether any special monitoring is needed.
Pregnancy: The safety of donepezil for use during pregnancy has not been established. Sandoz Donepezil should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Sandoz Donepezil, contact your doctor immediately.
Breast-feeding: It is not known if donepezil passes into breast milk. If you are a breast-feeding mother and are taking Sandoz Donepezil, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Sandoz Donepezil have not been established for children.
