Le Lézard
Classified in: Health
Subject: RCL

Important Alert on ALYSENAtm 28 and ALYSENAtm 21 with Chipped Pills


TORONTO, March 8, 2018 /CNW/ -

ALYSENAtm 28 BLISTER (CNW Group/Apotex Inc.)

AUDIENCE
Consumers, Physicians, Family Doctors, Gynaecologists, Obstetricians, Pharmacists and Nurses

KEY MESSAGES
Apotex Inc. is advising consumers and health care professionals that complaints have been received for packages of ALYSENAtm 28 (21 active pills, and 7 inactive pills that contain no hormones) and ALYSENAtm 21 (21 active pills).

WHAT IS THE ISSUE?
Health Canada and Apotex Inc. have received reports for packages of ALYSENAtm 28 and ALYSENAtm 21 where the blister packages contained chipped active (pink) pill.

PRODUCTS AFFECTED

Product

DIN

Strength

Package / Format

ALYSENAtm 28
(Levonorgestrel and Ethinyl
Estradiol Tablets, USP)

02387883

100 mcg / 20 mcg

28 Tablets Blister Pack

Triple Pack

3x28 Tablets Blister Pack

ALYSENAtm 21
(Levonorgestrel and Ethinyl
Estradiol Tablets, USP)

02387875

100 mcg / 20 mcg

 21 Tablets Blister Pack

Triple Pack

3x21 Tablets Blister Pack

 

BACKGROUND INFORMATION
ALYSENAtm is a prescription medicine used for:
1- Conception control.
2- Treatment of moderate acne vulgaris in women ?14 years of age who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche.

This product is manufactured by a 3rd party in Europe for Apotex Inc. During manufacturing, it is possible for pills to chip. However, the overall quality of the intact pills is not affected.

INFORMATION FOR CONSUMERS
ALYSENAtm is a birth control tablet (oral contraceptive) that contains two female sex hormones (levonorgestrel and ethinyl estradiol). Packages of ALYSENAtm 28 should have three rows of pink (active) pills and one row of white inactive (no hormones) pills. Packages of ALYSENAtm 21 should have three rows of pink (active) pills.

Patients are advised to:

Patients should not stop taking birth control pills unless advised to do so by their health care provider, as they could get pregnant. Patients should talk to their health care provider if they have questions or concerns about their birth control product, including missed doses and alternatives.

INFORMATION FOR HEALTH CARE PROFESSIONALS
Apotex Inc. advises health care professionals to remind their patients of the following:

REPORT HEALTH OR SAFETY CONCERNS
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of unexpected side effects in patients receiving ALYSENAtm28 and ALYSENAtm 21 should be reported to Apotex Inc. or Health Canada.

APOTEX INC. CONTACT INFORMATION
150 Signet Drive
Toronto, ON
M9L 1T9

Telephone: To report a suspected adverse reaction associated with the use of ALYSENAtm 28 and ALYSENAtm 21 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/ 20 mcg) patients may contact Apotex Inc. by calling 1-800-667-4708 (select prompt 2), by email at [email protected] or by fax at 1-866-429-9133 or 416-401-3819.

To correct your mailing address or fax number, contact Apotex Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

Yours Sincerely,
Original signed by
Colin D'Cunha MBBS,MHSc,FRCPC
Director, Global Medical Affairs
Apotex Inc

ALYSENAtm 21 BLISTER (CNW Group/Apotex Inc.)

SOURCE Apotex Inc.


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