Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Availability of a revised Patient Information Leaflet for Apo-Mefloquine (mefloquine) - Apotex Inc.
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 159 K)Contact MHPD DPSC
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Apotex
Inc.
Contact the company for a copy of any references, attachments or
enclosures.
January 25, 2005
Subject: Availability of a revised Patient Information Leaflet for Apo-Mefloquine (mefloquine)Dear Health Care Professional,
Apotex Inc., in collaboration with Health Canada, would like to inform you of the availability of a revised Patient Information Leaflet for Apo-Mefloquine that applies to patients taking Apo-Mefloquine as a prophylactic antimalarial drug.
The revised Patient Information Leaflet for Apo-Mefloquine:
- is intended to help patients recognize symptoms, including sudden
onset of unexplained anxiety, depression, restlessness, irritability,
confusion, a persistently abnormal heart beat, or palpitations, that
may precede rare but potentially serious psychiatric, or neurological,
or cardiac adverse events;
- advises patients who develop these symptoms to contact a Health
Care Professional to assess the need for discontinuation of Apo-Mefloquine
treatment; and
- includes a wallet card containing a summary of the most essential information, that may be cut out and carried by the patient during travel to areas with malaria.
Pharmacists are asked to provide patients with the Patient Information Leaflet with each prescription or refill dispensed, and to direct patients to the wallet card at the end of the Leaflet.
The Warnings and Contraindications sections of the Apo-Mefloquine Product Monograph have been modified to inform Health Care Professionals of:
- rare events that may occur with the use of Apo-Mefloquine, including
anxiety, paranoia, depression, hallucinations, and psychotic behavior;
as well as suicidal ideation and suicide, for which no causal relationship
with the use of Apo-Mefloquine has been confirmed; and
- the contraindication of Apo-Mefloquine for malaria prophylaxis in patients with active depression or a history of psychiatric disturbance (including depression, generalized anxiety disorder, psychosis, schizophrenia, or other major psychiatric disorder) or a history of convulsions.
The inclusion of this important safety information in the revised Patient Information Leaflet is intended to enable patients to recognize symptoms of potentially serious adverse events for which timely consultation with a Health Care Professional is advised.
Your professional commitment to the informed use of Apo-Mefloquine represents an important contribution to the protection of patients' well-being through the early recognition of potentially serious adverse events by patients.
The identification, characterization, and management of marketed health product-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of potentially serious psychiatric, neurologic, cardiac adverse events, or other serious and/or unexpected adverse reactions in patients receiving Apo-Mefloquine should be reported to Apotex Inc. or Health Canada at the following addresses:
Apotex Inc.
Pharmacovigilance Division
150 Signet Drive
Weston, Ontario
M9L 1T9
Tel: 1-800-667-4708
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information:
Marketed Health Products Directorate
E-mail: mhpd-dpsc@hc-sc.gc.ca
Tel.: (613) 954-6522
Fax: (613) 952-7738
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
original signed by
Bruce D. Clark Ph.D.
Vice President Regulatory and Medical Affairs
