Class 4 Medicines Defect Information: Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)

Class 4 Medicines Defect Information: Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)

Drug alert number: EL (22)A/05

Date issued: 03 February 2022

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

Class 4 Medicines Defect Information: Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)

Brief description of the problem

Atnahs Pharma UK Limited has informed the MHRA that the Patient Information Leaflets (PILs) that have been provided with the batches listed below 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

Product description

Naprosyn 250mg Tablets PL 43252/0004
Naprosyn 500mg Tablets PL 43252/0005
Naprosyn EC 250mg Gastro-Resistant Tablets PL 43252/0006

Product Name Batch Number Expiry Date Pack Size First Distributed
Naprosyn EC 250mg Tablets E0174E1 Feb-22 56 Jun-19
Naprosyn 250mg Tablets E0098E1 Feb-24 56 Jun-19
Naprosyn 250mg Tablets E0097E1 Jun-23 56 May-19
Naprosyn 500mg Tablets E0961E1 Feb-24 56 Sep-20
Naprosyn 500mg Tablets E0960E1 Feb-24 56 Apr-20
Naprosyn 500mg Tablets E0959E1 Feb-24 56 Nov-19
Naprosyn 500mg Tablets E0958E1 Feb-24 56 Oct-19
Naprosyn 500mg Tablets E0946E2 Sep-23 56 May-19
Naprosyn 500mg Tablets E0965E1 Apr-23 56 Jun-19

Active Pharmaceutical Ingredient: naproxen

Advice for 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 250mg Tablets PIL
Naprosyn 500mg Tablets PIL
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.

View full alert here

Further Information

For more information, medical information queries or stock control queries, please contact: info@pharmanovia.com

 

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