Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05
Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05
MDR Number: MDR 005-01/22
Company name: Atnahs Pharma UK Limited
Product description:
Naprosyn 250mg Tablets PL 43252/0004
Naprosyn 500mg Tablets PL 43252/0005
Naprosyn EC 250mg Gastro-Resistant Tablets PL 43252/0006
Details of the affected batch:
|
Product Name |
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
Naprosyn EC 250mg Tablets |
E0174E1 |
Feb 2022 |
56 |
June 2019 |
|
Naprosyn 250mg Tablets |
E0098E1 |
Feb 2024 |
56 |
June 2019 |
|
Naprosyn 250mg Tablets |
E0097E1 |
June 2023 |
56 |
May 2019 |
|
Naprosyn 500mg Tablets |
E0961E1 |
Feb 2024 |
56 |
Sep 2020 |
|
Naprosyn 500mg Tablets |
E0960E1 |
Feb 2024 |
56 |
Apr 2020 |
|
Naprosyn 500mg Tablets |
E0959E1 |
Feb 2024 |
56 |
Nov 2019 |
|
Naprosyn 500mg Tablets |
E0958E1 |
Feb 2024 |
56 |
Oct 2019 |
|
Naprosyn 500mg Tablets |
E0946E2 |
Sep 2023 |
56 |
May 2019 |
|
Naprosyn 500mg Tablets |
E0965E1 |
Apr 2023 |
56 |
Jun 2019 |
Brief description of problem:
Atnahs Pharma UK Limited have informed us that the Patient Information Leaflets (PILs) that have been provided with the above batches are missing the following information (in bold):
Section 2: Other medicines and Naprosyn Tablets Talk to your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular tell you doctor or pharmacist if you are taking: Medicine to stop your blood clotting, like aspirin/acetylsalicylic acid, warfarin, heparin or clopidogrel
Advice to Healthcare Professionals:
There is no risk to the product quality as a result of this issue, therefore the affected batches are not being recalled.
Healthcare professionals are advised to exercise caution when dispensing this product. Please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, please provide an updated PIL. The updated PILs are available via the electronic Medicines Compendium website:
Naprosyn EC 250mg Gastro-Resistant Tablets PIL
Healthcare professionals should also remind patients to seek medical advice if taking aspirin/acetylsalicylic acid with Naprosyn Tablets or Naprosyn EC Gastro-Resistant Tablets, due to the increased risk of bleeding when these medicines are taken concurrently. Patients who experience adverse reactions should seek immediate medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme
Atnahs Pharma UK Limited have confirmed that all other batches of Naprosyn Tablets and Naprosyn EC Gastro-Resistant Tablets contain the correct PILs.
Company contacts for further information:
For more information, medical information queries or stock control queries, please contact: info@pharmanovia.com