MHRA 对 Omega Pharma Ltd 的 Napralief 250mg 肠溶片发布三级召回（EL(26)A/21）

Contents

1. Post Publication Note
2. DMRC reference number
3. Marketing Authorisation Holder
4. Medicine Details
   1. Napralief 250mg Gastro-Resistant Tablets
5. Affected Lot Batch Numbers
6. Background
7. Advice for Healthcare Professionals
8. Advice for Patients
9. Additional information
10. Download document

Post Publication Note

This recall, first published on 23 April, has been updated. The Marketing Authorisation Holder has provided a corrected expiry date for one of the affected batches.

DMRC reference number

DMRC- 39001103

Marketing Authorisation Holder

Omega Pharma Ltd

Medicine Details

Napralief 250mg Gastro-Resistant Tablets

PL: 02855/0340

Active ingredient: naproxen

SNOMED code: N/A

GTIN: 05012616268236

Affected Lot Batch Numbers

Background

Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets. 

The Carton is missing the following wording:

• Adults (18-50 years): On the first day take two tablets, followed by one tablet 6-8 hours later, if needed. If required on the second and third day, take one tablet every 6-8 hours.

• Do not take more than three tablets a day.

The PIL (Patient Information Leaflet) is missing the following wording highlighted in bold:

Advice for Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Advice for Patients:

Do not take more than three tablets per day.

Patients should be aware that the Patient Information Leaflet (PIL) and Carton in certain batches of Napralief 250mg Gastro-resistant tablets do not contain the most up to date safety information and should refer to the correct information listed above.

No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information:

For all medical information enquiries, stock control queries and information on this product, please email [email protected] or call +44 0203 598 9603.

For stock control enquiries, please email [email protected] or call +44 01226 704957

Recipients of this Medicines Recall 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

[email protected]

Download document

Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21