Class 4 Medicines Defect Information: Naprosyn Tablets (all strengths), Naprosyn EC 500mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)

Class 4 Medicines Defect Information: Naprosyn Tablets (all strengths), Naprosyn EC 500mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)

Drug alert number: EL (22)A/09

Date issued: 23 February 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

  • Naprosyn 250mg Tablets (PL 43252/0004)
  • Naprosyn 500mg Tablets (PL 43252/0005)
  • Naprosyn EC 500mg Gastro-Resistant Tablets (PL 43252/0008)
Product Name Batch Number Pack Size Expiry Date First Distributed
Naprosyn 250mg Tablets E0098E5 56 tablets Feb-24 Jul-19
Naprosyn 250mg Tablets E0098E6 56 tablets Feb-24 Oct-19
Naprosyn 250mg Tablets E0102E1 56 tablets Jul-24 Nov-19
Naprosyn 250mg Tablets E0102E2 56 tablets Jul-24 Feb-20
Naprosyn 250mg Tablets E0103E1 56 tablets Sep-24 Feb-20
Naprosyn 250mg Tablets E0174E2 56 tablets Feb-24 Dec-19
Naprosyn 250mg Tablets E0183E1 56 tablets Apr-24 Apr-20
Naprosyn 250mg Tablets E0186E2 56 tablets Mar-24 Aug-20
Naprosyn 250mg Tablets E0187E1 56 tablets Mar-24 Oct-20
Naprosyn 250mg Tablets E0188E1 56 tablets Mar-24 Jul-21
Naprosyn 250mg Tablets E0188E4 56 tablets Mar-24 Aug-21
Naprosyn 250mg Tablets E0189E2 56 tablets Mar-24 Nov-20
Naprosyn 250mg Tablets E0190E1 56 tablets Mar-24 Nov-19
Naprosyn 250mg Tablets E0191E1 56 tablets Mar-24 Aug-20
Naprosyn 500mg Tablets E0962E1 56 tablets Apr-24 Aug-20
Naprosyn 500mg Tablets E0963E1 56 tablets Apr-24 Sep-20
Naprosyn 500mg Tablets E0964E1 56 tablets Apr-23 Apr-19
Naprosyn 500mg Tablets E0965E2 56 tablets Apr-23 Jul-19
Naprosyn 500mg Tablets E0972E1 56 tablets Apr-24 Aug-20
Naprosyn 500mg Tablets E0973E1 56 tablets Apr-24 Sep-20
Naprosyn 500mg Tablets E0974E1 56 tablets Apr-24 Oct-19
Naprosyn 500mg Tablets E0975E1 56 tablets Apr-24 Nov-21
Naprosyn EC 500mg Gastro-Resistant Tablets E0596E1 56 tablets Mar-22 Nov-19
Naprosyn EC 500mg Gastro-Resistant Tablets E0601E1 56 tablets Apr-22 May-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0601E4 56 tablets Apr-22 Aug-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0615E1 56 tablets Apr-22 Aug-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0622E1 56 tablets Jun-22 Feb-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0623E1 56 tablets Jun-22 Feb-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0626E1 56 tablets Jun-22 Jul-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0627E1 56 tablets Jun-22 Nov-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0628E1 56 tablets Jun-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0628E2 56 tablets Jun-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0632E3 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0633E2 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0634E3 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0635E2 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0636E1 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0637E1 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0640E2 56 tablets Jul-22 Mar-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0656E1 56 tablets Aug-22 Nov-20
Naprosyn EC 500mg Gastro-Resistant Tablets E0657E1 56 tablets Aug-22 Feb-22
Naprosyn EC 500mg Gastro-Resistant Tablets E0658E1 56 tablets Sep-22 Jan-22
Naprosyn EC 500mg Gastro-Resistant Tablets E0665E1 56 tablets Sep-22 Oct-21
Naprosyn EC 500mg Gastro-Resistant Tablets E0666E1 56 tablets Sep-22 Oct-21

Active Pharmaceutical Ingredient: naproxen.

Brief description of the problem

Additional to the batches included in the previous Class 4 Medicines Notification (reference EL(22)A/05), Atnahs Pharma UK Limited have informed us that the Patient Information Leaflets (PILs) in 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 for healthcare professionals

There is no risk to the product quality as a result of this issue, therefore these 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:

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. Hard copies of the updated PIL could be provided by the MAH upon request, so that any affected batch remaining in the dispensary can be supplemented with the updated PIL.

View full alert here

Further Information

For medical information please contact:

info@pharmanovia.com