OTTAWA, ONTARIO -- (Marketwire) -- 08/16/10 -- The issue:

"Fulda Unitang Herbs Sleep Plus", an unauthorized product promoted as an herbal sleep aid, has been found to contain high levels of the undeclared drug estazolam and may pose serious health risks to consumers. Estazolam is a prescription sedative that can impair mental alertness; it can also be habit-forming and should only be used under the supervision of a healthcare practitioner.

Who is affected:

Consumers who have purchased or used "Fulda Unitang Herbs Sleep Plus," including pregnant or breastfeeding women, children, the elderly, people with respiratory (breathing), kidney or liver problems, people with depression and those with a history of substance abuse; and retailers who may have this product in stock.

What consumers should do:

--  Consult your healthcare practitioner immediately, before stopping use,
    if you are presently taking this product or have been taking it on an
    ongoing basis. Estazolam can be habit-forming and stopping suddenly may
    cause symptoms of withdrawal.

--  Avoid driving, operating heavy machinery or performing other activities
    requiring mental alertness until you have safely stopped taking this
    product.

--  Read the labelling of any health products you buy to verify that they
    have been assessed by Health Canada for safety, effectiveness and
    quality. Health products that have been authorized for sale by Health
    Canada will have a single eight-digit Drug Identification Number (DIN),
    a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM)
    on the label.

--  Report any side effects potentially related to this product to Health
    Canada (see below).

--  Return any unused product to a pharmacy for safe disposal.

What retailers should do:

--  Remove this product from their stock and take to a pharmacy for safe
    disposal. Retailers are also encouraged to report to Health Canada if
    they have this product for sale by calling, toll free, 1-800-267-9675.

What Health Canada is doing:

In response to a report from a consumer who experienced headache, disorientation and excessive sleepiness after taking one dose of the product, Health Canada tested a sample of "Fulda Unitang Herbs Sleep Plus" and found it to contain high levels of estazolam.

Health Canada has not found evidence that this product is still being manufactured or sold. As there is no expiry date on the product analysed, Health Canada is issuing a Public Advisory as it is possible that other "Fulda Unitang Herbs Sleep Plus" products with no expiry date on the label may still be on store shelves or in consumers' medicine cabinets. Should Health Canada find this product on the market, Health Canada will take immediate and appropriate action.

Background:

Health Canada conducted a laboratory analysis of the product and found each capsule to contain 1.8 mg of estazolam, which is roughly equivalent to the maximum daily recommended dose for healthy adults. Taking the product as directed on the label (1-2 capsules daily) may result in consuming an amount that exceeds the recommended dosage.

Estazolam belongs in the class of prescription drugs known as benzodiazepines, which should only be prescribed by a healthcare practitioner. Estazolam should not be used by people with an allergy to any benzodiazepines, such as Valium (the brand name for diazepam), Restoril (temazepam) and Ativan (lorazepam), or those individuals affected by the neuromuscular disorder myasthenia gravis or by sleep apnea. Benzodiazepines, including estazolam, should be used with caution in certain groups, including the elderly, people with respiratory (breathing), kidney or liver problems, people with depression, and those with a history of substance abuse. As well, benzodiazepines, including estazolam, are not recommended for use in pregnant or breastfeeding women or in children under the age of 18. The side-effects associated with estazolam vary according to the individual and can include headache, dizziness, drowsiness, sleep-related behaviours such as sleep-driving, behavioural changes, confusion, anxiety, depression, and breathing problems. Estazolam may interact with other drugs, including alcohol, which can lead to increased side-effects.

People can experience withdrawal symptoms when they stop taking estazolam. Withdrawal symptoms can range from anxiety and sleeplessness, to abdominal and muscle cramps, vomiting, sweating, tremors and convulsions, and is usually associated with taking higher doses of estazolam for a longer period of time.

Pictures of the products affected: "Fulda Unitang Herbs Sleep Plus"(i) are available at the following address: http://media3.marketwire.com/docs/Health_Canada_0816.pdf

(i) Health Canada is aware there are products available in Canada with a similar product name, e.g., "Sleep +." The information in this advisory applies only to the product shown in the photographs here.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Reporting Form and send it to us using one of these methods:

- Fax:              1-866-678-6789
- E-mail:           CanadaVigilance@hc-sc.gc.ca
- Internet:         www.healthcanada.gc.ca/medeffect
- Mail:             Canada Vigilance Program
                    Marketed Health Products Directorate
                    Ottawa, ON, Address Locator 0701C
                    K1A 0K9

Related Health Canada Web content:

--  Advisory - Sleep supplements found to contain habit-forming drug (June
    14, 2007) ( http://www.hc-sc.gc.ca/ahc-asc/media/advisories-
    avis/_2007/2007_71-eng.php )

--  Advisory - Herbal sleep supplement found to contain habit-forming drug
    (April 8, 2007)
    ( http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2007/2007_49-
    eng.php )

--  Advisory - Health Canada advises consumers not to use herbal sleep
    supplement Sleepees which contains a habit-forming drug (February 23,
    2007)
    ( http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2007/2007_16-
    eng.php )

--  Advisory - Health Canada advises consumers not to use dietary supplement
    due to potential health risks (August 30, 2006) ( http://www.hc-
    sc.gc.ca/ahc-asc/media/advisories-avis/_2006/2006_82-eng.php )

--  Advisory - Health Canada advises consumers not to use herbal sleep
    supplement containing habit-forming drug (December 13, 2006) (
    http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2006/2006_127-
    eng.php )

--  It's Your Health - Proper Use and Disposal of Medication (
    http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php ).

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories ( http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/ ).

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

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