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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 20-Jul-2020 10:59:06

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4, DRUG ALERT, FOR INFORMATION, ASPAR PHARMACEUTICALS LIMITED, IBUPROFEN 200MG AND 400MG TABLETS PACKAGED IN VARIOUS LIVERIES

Broadcast content:

Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs listed are missing some information identified from post-marketing experience that should be documented in Section 3 (How To Take The Tablets) and Section 4 (Possible Side Effects) of the PIL.

Advice for healthcare professionals:

If any of the listed products are supplied and/or dispensed, please ensure that patients are aware of the missing information as highlighted. It is important that any patients who notice the listed symptoms should seek immediate medical advice.

As a general reminder, patients who experience side effects from taking any medicines should be encouraged to report a suspected problem or incident via the Yellow Card scheme (www.mhra.gov.uk/yellowcard) and seek medical advice accordingly.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.



Additional information: NHS England and NHS Improvement Regional Offices: Please cascade this alert to Community Pharmacy contractors.
GP Practices: Please note that this alert is for dispensing GP Practices only.


Alert reference: EL (20)A/30

Attachments:
Cascade to:
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency