Lariam (Mefloquine) – Updated Patient Information – Letter to Pharmacists – Hoffmann-La Roche Limited

Health Canada Endorsed Important Safety Information on Lariam ^® (mefloquine)

January 24, 2005

Subject: Lariam^® (mefloquine)- Updated Patient Information

Dear Pharmacist,

Hoffmann-La Roche Limited, following discussions with Health Canada, would like to inform you of the availability of an updated Patient Information pamphlet for Lariam^® (mefloquine) that applies to patients taking Lariam^® (mefloquine) as a prophylactic antimalarial drug. A copy is attached.

The updated Patient Information pamphlet:

• is intended to help patients recognize symptoms, including the sudden onset of unexplained anxiety, depression, restlessness, irritability, confusion, a persistently abnormal heart beat, or palpitations, that may precede rare but potentially serious psychiatric, neurologic, or cardiac adverse events;
• advises patients who develop these symptoms to contact a Health Care Professional to assess the need for discontinuation of Lariam^® (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

The Patient Information pamphlet is provided in every box of Lariam^® (mefloquine). As stated in the text printed on every box, you are asked to provide patients with the Patient Information document with each prescription or refill dispensed and to direct patients to the wallet card at the end of the document.

Your professional commitment to the informed use of Lariam^® (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 neurologic, psychiatric, or cardiac adverse events, or other serious and/or unexpected adverse events in patients receiving Lariam^® (mefloquine), should be reported to Hoffmann-La Roche Limited or Health Canada at the following addresses:

Hoffmann-La Roche Limited

Drug Information and Safety Department

2455 Meadowpine Boulevard

Mississauga, Ontario, L5N 6L7

or call toll free at 1-888-762-4388

or fax at 905-542-5610

or email to: Mississauga.canada_medinfo@roche.com

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 (MHPD)

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.

Should you have any questions or require additional information regarding the use of Lariam^® (mefloquine) please contact the Drug Information and Safety Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.

Sincerely,

original signed by

Lorenzo Biondi

Vice President, Medical and Regulatory Affairs