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It's over. The popular painkiller will now be available only by prescription.

It's over. The popular painkiller will now be available only by prescription.

Author: prepared by JW • Source: Rynek ZdrowiaPublished: July 16, 2025 07:46Updated: July 16, 2025 07:46

According to the decision of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, two painkillers containing the same active substance will be available only on prescription.

Popular pain medications will no longer be available over the counter.
  • The drugs Pyralgina MAX and Dialginum - containing metamizole in a dose of 1000 mg and 500 mg, changed their availability category from OTC to Rp
  • This means that they will only be available on prescription, according to the mgr.farm website.
  • Whether a pharmacist will request a prescription depends in practice on the drug's batch number.
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In the case of Pyralgina MAX, the decision came into effect on June 17. For the drug Dialginum, it came into effect on June 25.

"Theoretically, it might seem that since their entry into force, Pyralgina MAX and Dialginum are available by prescription. This would mean that patients can no longer buy them without a prescription, even if pharmacies carry packages of the drug manufactured for sale as OTC. In practice, however, the situation is different," notes M.Pharm.

According to Polpharma's announcement, only Pyralgina MAX drug packages released for sale after June 17, 2025, were affected by the category change. This means that Pyralgina MAX released for sale before that date should continue to be available without a prescription until the batches of drugs intended for sale in the OTC category are sold out.

In a separate announcement, the company will inform pharmacies of the batch number from which the drug will be available by prescription. These will be packages containing 50 tablets. Packages of 6, 12, and 20 tablets will remain on the market and will be available as before, i.e., without a prescription.

Polpharma explains that the request to change the category from OTC to Rx was based on safety concerns. Pyralgina MAX contains a high dose of the active ingredient (metamizole).

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Pyralgina MAX and Dialginum: action and use

Dialginum is a pyrazolone derivative with analgesic and antipyretic properties and weak antispasmodic properties. Dialginum is indicated for the short-term treatment of severe pain of various origins and fever when other medications are inadvisable or ineffective in:

  • headaches,
  • migraine,
  • toothache,
  • muscle and joint pain,
  • post-traumatic and post-operative pain,
  • pain caused by renal colic,
  • biliary colic,
  • pain in cancer diseases,
  • fever.

Pyralgina MAX contains the active ingredient metamizole sodium monohydrate, which belongs to a group of medicines called pyrazolone derivatives, with analgesic and antipyretic effects. Pyralgina MAX is indicated for use in adolescents aged 15 years and older and adults for the treatment of:

  • acute, severe pain after injuries or surgeries,
  • crampy abdominal pain (colic),
  • cancer pain,
  • other acute or chronic severe pain when the use of other therapeutic agents is contraindicated,
  • high fever that does not respond to other measures.
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