Flegafortan

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.

It was found that the patient leaflet regarding recommended dosing was inconsistent with the Summary of Product Characteristics, which could lead to incorrect use of the product and overdose manifested by unintended increased volume of bronchial secretions. Potential effects: overdose, increased bronchial secretion, respiratory complications.

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Risk Level

High

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Batch Number

0131G

Notice Date

14.02.2020

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

Patients should use Flegafortan in accordance with the current leaflet and the recommendations of a doctor or pharmacist; in case of any doubts about dosing, they should consult a healthcare professio...

Actions Taken

The decision to withdraw batch 0131G of Flegafortan 1.6 mg/ml, syrup from the national market was revoked after the leaflet was updated and correct repackaging in line with Good Manufacturing Practice...

Need Help?

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

Flegafortan

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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