EURESPAL

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It was found that the benefit-risk balance of products containing fenspiride is unfavorable, meaning a risk of use disproportionate to the therapeutic effect and a potential threat to patients’ health or life. Potential effects: serious adverse reactions, life-threatening events, lack of safe therapy.

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Risk Level

Critical

Manufacturer

Les Laboratories Servier, Francja

Batch Number

wszystkie serie

Notice Date

22.08.2019

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 Eurespal 80 mg film-coated tablets. Check the medicine’s name and dosage form; return any packs in your possession to a pharmacy. If in doubt or if you have been using this medicine, consul...

Actions Taken

The Chief Pharmaceutical Inspector withdrew all batches of Eurespal 80 mg film-coated tablets from the market nationwide and granted the decision immediate enforceability after the parallel import aut...

Need Help?

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

EURESPAL

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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