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Foreign product alert

Amana Care Seven Slim Herbal Capsules

Starting date:
November 22, 2010
Posting date:
November 22, 2010
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Undeclared Substance
Audience:
General Public
Identification number:
RA-120001299

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

Israel Ministry of Health

Product names

Amana Care Seven Slim Herbal Capsules

Manufacturer / Place of origin

Amana, Lebanon

Product description

mana Care Seven Slim Herbal Capsules is promoted as a dietary supplement used for weight loss.

Reason for warning

TThe Israel Ministry of Health informed consumers that it found the product Amana Care Seven Slim Herbal Capsules to contain undeclared sibutramine and residue of sildenafil.

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke.

Sildenafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner.

Possible side effects

In addition to heart attack and stroke, side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Sildenafil should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

  • Call toll-free at 1-866-234-2345
  • Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

Images

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