Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09

Source: MHRA / Gov.uk 23.2.22

Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.

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 500mg Gastro-Resistant Tablets PL 43252/0008

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:

• Naprosyn 250mg Tablets PIL
• Naprosyn 500mg Tablets PIL
• Naprosyn EC 500mg 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. 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.

Further Information

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

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Download document

Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09

Click here for the source.