Advisory - Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

OTTAWA,  /CNW/ -

Issue
Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

This issue does not impact the safety or effectiveness of the pills. Canadians should continue to take their medication as prescribed. It is important to keep track of when you take your pills to avoid missing any doses.

Merck Canada Inc., the importer of Marvelon 28, is currently working to correct this issue. Merck Canada Inc. will distribute day-of-the-week stickers to pharmacies, beginning the week of September 10. Customers who use Marvelon 28 will be able to pick up the day-of-the-week stickers at no additional cost.

Who is affected

• Women who take birth control pills
• Health professionals who dispense these products

Affected products

                 Product Name 
     
      DIN                 Lot Number               Expiry

    ---

                 Marvelon 28      02042479  
      R000269             
      March 31, 2020

        Birth
         control
         pills                             
      R014281             
      March 31, 2021

                                           
      N032638             
      March 31, 2020

                                           
      R006559             
      March 31, 2020

                                           
      R000270             
      March 31, 2020

                                           
      N023314                October 31, 2019

    ---

There is no need to return Marvelon 28 products that you currently have, since this issue does not impact the efficacy or safety of the tablet itself if taken as prescribed. Note that Marvelon 21 is not affected by this situation.

What consumers should do

• Take your pills as prescribed. If your package of Marvelon 28 does not include a day-of-the-week sticker, you can:
  • Keep track of your daily pill intake and consider using ways to remind yourself to take them, such as a daily alarm on a cellphone;
  • Go to your pharmacy to request day-of-the week stickers. Merck Canada Inc. will start the distribution of the stickers to Canadian pharmacies the week of September 10, 2018; or
  • Contact Merck Canada Inc. directly at 1-800-567-2594 ext. 3, or by e-mail at medinfocanada@merck.com, to request day-of-the-week stickers.
• Talk to a health care professional if you have questions or concerns about your birth control product, including about missed doses.
• Report adverse events related to health products to Health Canada by calling toll-free at 1?866?234?2345, or by reporting online, by mail or by fax. Report complaints about health products to Health Canada by calling toll-free at 1?800?267?9675, or complete an online complaint form.

What Health Canada is doing
Health Canada continues to follow up with Merck Canada Inc. to make sure that appropriate measures are taken to correct the issue.

Background
Health Canada has confirmed with Merck Canada Inc. that the day-of-the-week stickers must be present in all packages of Marvelon 28.

Merck Canada Inc. has issued a letter to health care professionals to advise them of the issue and to ask them to proactively advise patients when prescribing or dispensing the product. The company will issue the day-of-week stickers to retail pharmacies starting the week of September 10, and to clinics that received samples starting the week of September 17, to include with any product already distributed.

Related links

• Merck Canada Inc.'s letter to health care professionals

For more information

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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SOURCE Health Canada