Enema

GIF decision: Re-authorization for marketing

What does this decision mean?

  • Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

Cloudiness and opalescence of the solution caused by micro sediment originating from the active substance (trace amounts of titanium compounds in the solution); initially suspected quality defect of the medicinal product. Potential effects: possible irritation of the rectal mucosa or reduced treatment efficacy.

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Enema
Risk Level
Medium
Manufacturer
Laboratorium Galenowe Olsztyn sp. z o.o. z siedzibą w Dywitach
Batch Number
05424
Notice Date
31.03.2025
View official statement
Source: GIF view the official alert

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

  1. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 2

    Check the batch number and expiry date

    Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.

  3. 3

    Return it to the shop

    You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.

  4. 4

    Get help and report it

    If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Patients may use the product according to the leaflet and their doctor’s instructions; if they have any doubts about the appearance of the solution or its safety, they should consult a doctor or pharm...

Actions Taken

Initially, nationwide marketing of the specified batches of Enema was suspended with immediate enforceability; subsequently, this decision was fully revoked and the first‑instance proceedings were dis...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Related

Other Notices