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Ultra Men For Men tablets

Safety advisory

29 August 2012

Ultra Men for Men tablets poses a serious risk to your health, and should not be taken. The packaging states the goods are capsules, however the product is in tablet form.

The Therapeutic Goods Administration (TGA) has tested Ultra Men For Men tablets, and found that:

• it contains the undeclared prescription substances tadalafil and glibenclamide - this is despite the claim made on the box that it is made of 100% herbal extracts and contains no medicines.
• consumers are advised that tadalafil is a prescription-only medicine (which is the active ingredient in Cialis) and glibenclamide is a prescription only substance used for blood glucose controlling.

The commercial supply of Ultra Men for Men tablets in Australia is illegal.

Ultra Men For Men tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

TGA investigations have shown that a number of people in Australia have bought the product online.

Information for consumers

• Stop taking Ultra Men For Men tablets and discard any remaining tablets.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Customs and Border Protection Service (Customs) to help stop future shipments of Ultra Men For Men tablets from entering Australia.

If these tablets are found at the border by Customs, they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites. Products purchased over the Internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

• online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
• in writing, via post to:
  Chief Investigator
  Regulatory Compliance Unit
  Therapeutic Goods Administration
  PO Box 100
  Woden ACT 2606

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