IMPORTANT SAFETY INFORMATION
Defective Zarontin Softgel Capsules Associated with Reduced Efficacy (Increased Frequency of Seizures)
Zarontin (ethosuximide)
250 mg capsule
DIN 00022799
SKU : C33001
Do not consume capsules if they look unusual (e.g., dull, cloudy, sticky, coated with film, broken, cracked, leaking, or clumping together).
Bottles containing defective capsules should be returned to the pharmacy where replacement medication can be obtained.
The picture on the left shows leaky and broken Zarontin capsules.
Click on the thumbnail image to enlarge the photograph.
There have also been reports of capsules that are cloudy in appearance.
Erfa Canada 2012 Inc. and Health Canada have received reports of broken or leaking Zarontin soft gel capsules.
Administration of defective Zarontin soft gel capsules can be associated with a lack of efficacy (increased frequency of seizures).
Patients should inspect their medication and not consume capsules that look defective (e.g., cloudy appearance, broken, sticky, or clumping together). They should return the bottles containing defective capsules to the pharmacy where replacement medication can be obtained.
Pharmacists are reminded to:
- Verify the content of each bottle to make sure that there are no defective capsules.
- Make sure that the product is stored in a controlled temperature and humidity environment.
INFORMATION FOR CONSUMERS
Zarontin is a prescription epilepsy drug used to control absence seizures, which are more common in children than adults. Absence seizures last a few seconds and are noticeable by a blank or absent state. Zarontin is available as soft gel caps or in a syrup formulation. The syrup is not affected by this issue.
Patients, parents and caregivers are advised to check their Zarontin capsules. Do not take them if they look unusual (dull, cloudy, sticky, coated with film, or clumping together) or are broken or leaking. Bottles containing defective capsules should be returned to the pharmacy where replacement medication can be obtained.
Zarontin capsules should be stored in a dry place at normal room temperature (15-25 degrees Celsius). Never store in your bathroom or other areas prone to humidity and temperature changes.
Do not stop taking this medication unless advised to do so by your healthcare provider, as suddenly stopping treatment could worsen your condition.
REPORT HEALTH OR SAFETY CONCERNS
You can report any suspected adverse reactions associated with the use of health products to Health Canada by calling toll-free at 1-866-234-2345 OR visiting MedEffect Canada’s Webpage on Adverse Reaction Reporting: http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php
For health product inquiries related to this communication, contact Health Canada at:
Regulatory Operations and Regions Branch
E-mail: [email protected]
Telephone: 1-800-267-9675
Fax: 1-613-946-5636
Health Canada Letter to Healthcare Professionals:
