Elenium

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The identified non-compliance in the active substance release parameter affects the quality of the medicine and may impact its efficacy and safety; a health risk from keeping the defective batches on the market cannot be excluded. Potential effects: lack of therapeutic effect, disease complications.

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Risk Level

High

Manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna z siedzibą w Warszawie

Batch Number

11221

Notice Date

09.04.2025

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

Do not eat or use the product

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

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

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

Do not use Elenium tablets from the listed batches. Check the batch number and expiry date on the packaging, and if you have the product, return it to a pharmacy or consult a doctor or pharmacist.

Actions Taken

Withdrawal from the market throughout the country of the specified batches of the medicinal product Elenium, prohibition of placing these batches on the market, and granting the decision immediate enf...

Need Help?

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

Elenium

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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