Espumisan

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.

Information leaflets for the medicinal product Zentel tablets were detected in some packs instead of the correct ESPUMISAN leaflet. Potential effects: improper use of the medicine, incorrect dosing, lack of efficacy or adverse reactions.

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Risk Level

High

Manufacturer

Importer równoległy: Forfarm Sp. z o.o.

Batch Number

91009A

Notice Date

10.06.2020

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

Use the product according to the correct ESPUMISAN leaflet; if there are any doubts about the instructions for use, consult a doctor or pharmacist.

Actions Taken

Initially the product batch was withdrawn from the market due to incorrect leaflets, then after corrective actions, quality confirmation and GMP-compliant repackaging, the withdrawal decision was revo...

Need Help?

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

Espumisan

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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