Attention! GIF withdraws the drugs Furosemidum Polfarmex and Nasen. Important reason

On June 15, the Main Pharmaceutical Inspectorate issued two decisions on withdrawing Furosemidum Polfarmex and Nasen from the market. Unit cartons of these drugs have been found to contain unit cartons of other drugs. The products were immediately withdrawn from the market, and GIF additionally made a statement.

Withdrawal of Furosemidum Polfarmex and Nasen

The Main Pharmaceutical Inspectorate issued a decision to withdraw a series of drugs from the market: Furosemidum Polfarmex and Nasen. As we read in the justification, the decision is caused by the identification of a quality defect consisting in:

  1. statement in the outer carton of NASEN 10 mg film-coated tablets, the presence of unit cartons of FUROSEMIDUM POLFARMEX 40 mg tablets,

and

  1. presence in the unit carton of FUROSEMIDUM POLFARMEX of blisters with NASEN 10 mg film-coated tablets.

What series have been discontinued?

  1. Furosemide Polfarmex (Furosemidum), 40 mg tablets, batch number: 020320, expiry date 03.2023
  2. Nasen (Zolpidemi tartras), 10 mg film-coated tablets, batch number: 020320, expiration date 03.2023

The entity responsible is Polfarmex SA with its seat in Kutno. The content of the decision can be found on the GIF website

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Mistake in the contents of Furosemidum Polfarmex and Nasen packages

Furosemide Polfarmex is a medicinal product used, inter alia, in in the treatment of hypertension, and Nasen is used as a sedative and hypnotic drug. As we read in the statement of the Main Pharmaceutical Inspectorate, interchangeable consumption of these two medicinal products may pose a threat to health and life.

GIF asks patients taking one of the above-mentioned drugs to first check whether they have packages from the withdrawn batch. If so, the drug should be immediately returned to the pharmacy where it was purchased.

At the same time, the “Main Pharmaceutical Inspectorate informs that it is the responsibility of the MAH to determine the mode and scope of return or replacement of a defective medicinal product” – which means that at the pharmacy, the pharmacist will not refund the money for the purchased medicine. The decision to return the funds lies with the responsible entity, i.e. in this case Polfarmex SA

Worth knowing: Returning drugs to the pharmacy? We check what the regulations say

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