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.

The patient leaflet regarding recommended dosing was inconsistent with the approved Summary of Product Characteristics, which could lead to incorrect use and overdose manifested by increased volume of bronchial secretions. Potential effects: overdose, worsening cough and adverse drug reactions.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play

Risk Level

High

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Batch Number

0129G, 0130G

Notice Date

27.01.2020

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 medicine only in accordance with the updated leaflet and the recommendations of your doctor or pharmacist; if you have any doubts about dosing or leaflet content, consult a pharmacist or docto...

Actions Taken

The Chief Pharmaceutical Inspector revoked the decision to withdraw from the market nationwide Flegafortan 1.6 mg/ml, syrup, batches 0129G and 0130G after leaflet correction and confirmation that repa...

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?

Other Notices

Teicoplanin AptaPharma

Teicoplanin AptaPharma

Azaneson

Imuldosa

Loperamid APTEO MED