Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05
Atnahs Pharma UK Limited have identified missing information on the PIL of the above 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 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
Brief description of the 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 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 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.
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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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