Important Alert on ALYSENAtm 28 and ALYSENAtm 21 with Chipped Pills
TORONTO, March 8, 2018 /CNW/ -
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).
Blister packages for ALYSENAtm 28 and ALYSENAtm 21 contain active (pink) pills that may be chipped.
Taking pink pills that have a small chip at the edge will not reduce the product's overall effectiveness in preventing pregnancy.
Health care professionals are advised to remind consumers to:
Check pills before taking them and not consume pills that are chipped or look unusual (including jagged, broken or crumbling);
Examine both sides of each pill thoroughly before taking it. It may not be immediately obvious from looking at the blister package that there is a problem with the pills, since the underside of the pill cannot be seen while in the blister pack.
If a chipped pill is found, the next unchipped pink pill should be taken. Do not miss a dose.
If you have no unchipped pink pills left, then return the package to your pharmacy as soon as possible for a replacement package. Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel) until a replacement package can be obtained and contact your health care provider for medical advice.
Return blister packages containing chipped pills to the pharmacy to get a replacement package. Packages with no chipped pills do not need to be returned.
Seek counsel on the proper use of oral contraceptives, and on what to do if you miss a dose as articulated in the patient information leaflet.
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:
Check pills before and after taking them out of the blister package.
Examine both sides of each pill thoroughly to determine if the pill is chipped. It may not be immediately obvious from looking at the blister package, as the underside of the pill cannot be seen while in the blister package;
If a package has a chipped pill, return it to the pharmacy for a replacement package. Packages with no chipped pills do not need to be returned.
Do not consume a pill if it's chipped or looks unusual (including jagged, broken or crumbling);
Do not miss a dose of the birth control pill.
If a chipped pill is found, the next unchipped pink pill should be taken. Do not miss a dose.
If you have no unchipped pink pills left, then return the package to your pharmacy as soon as possible for a replacement package. Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel) until a replacement package can be obtained and contact your health care provider for medical advice.
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:
Check pills before and after taking them out of the blister package.
Examine both sides of each pill thoroughly to determine if the pill is chipped. It may not be immediately obvious from looking at the blister package, as the underside of the pill cannot be seen while in the blister package;
If a package has a chipped pill, return it to the pharmacy for a replacement package. Packages with no chipped pills do not need to be returned.
Do not consume a pill if it's chipped.
If a chipped pill is found, the next unchipped pink pill should be taken. Do not miss a dose.
If you have no unchipped pink pills left, then return the package to your pharmacy as soon as possible for a replacement package. Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel) until a replacement package can be obtained and contact your health care provider for medical advice.
Do not stop taking birth control pills as this will increase the likelihood of pregnancy. For questions or concerns about birth control products, talk to a health care professional, including about alternatives. Talk to a health care professional if you have any questions or concerns about your birth control product.
Read the Consumer Information Leaflet included in the ALYSENAtm packaging for detailed instructions in case of a missed dose.
Pharmacists are reminded to:
Check each blister pack of ALYSENAtm 21 and ALYSENAtm 28 before dispensing it to make sure the pills look as they should.
Report any unusual pills to the company (Apotex Inc) and to Health Canada.
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:
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