Viglita

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.

This product did not meet its defined quality requirements due to a negative test result for the friability of uncoated tablets ("tablets crumbled after the test"). Potential effects: possible problems with dosing and treatment effectiveness.

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Risk Level

Medium

Manufacturer

Zentiva k.s. z siedzibą w Pradze, Republika Czeska

Batch Number

CLB05146, wszystkie serie

Notice Date

01.08.2024

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 may use the product as prescribed by their doctor; in case of any doubts about the batch or quality, consult a pharmacist or doctor.

Actions Taken

Initially, the marketing of Viglita in all pack sizes was suspended nationwide, and subsequently the suspension decision was fully repealed and the first-instance proceedings were discontinued.

Need Help?

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

Viglita

What to do if you have this product?

What You Should Know

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Actions Taken

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