PULNEO O SMAKU COLI

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 ratio of medicinal products containing fenspiride is not favourable, and therefore withdrawal of marketing authorisations for these products was recommended. Potential effects: lack of adequate treatment efficacy, possible serious adverse reactions.

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Risk Level

Critical

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

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 Pulneo, check the medicine name at home and, if you have this syrup, stop using it and consult a doctor for alternative treatment.

Actions Taken

A temporary ban on placing all Pulneo batches on the market and their suspension in trade was imposed, then the marketing authorisation was revoked and a decision was issued to withdraw the product fr...

Need Help?

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

PULNEO O SMAKU COLI

What to do if you have this product?

What You Should Know

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Actions Taken

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