Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR 127-09/19)

Aventis Pharma Limited t/a Sanofi has informed the MHRA that a change to the Patient Information Leaflet concerning possible side effects for Rifadin (rifampicin) 150mg Capsules has not been implemented by the required timeline.

From:
Medicines and Healthcare products Regulatory Agency
Published
16 October 2019
Message type:
Medicines recall/notification
Medical specialty:
General practice and Pharmacy
Issued:
16 October 2019

Company name

Aventis Pharma Limited t/a Sanofi

Product description

Rifadin (rifampicin) 150mg Capsules PL 04425/5915R

Product information

Sanofi has informed us that a change to the Patient Information Leaflet (PIL) for Rifadin (rifampicin) 150mg Capsules PL 04425/5915R has not been implemented by the required timeline. The change concerns:

  • The addition of possible side effect, ‘Acute Generalized Exanthematous Pustulosis (AGEP)’ - a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment
  • The addition of possible side effect, ‘risk of severe bleeding’
  • The addition of Drug-Drug interactions with Hepatitis C drugs, including indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, neviparine, daclatasvir, simeprevir, sofosbuvir and telaprevir

It is important that any patients who notice the symptoms seek immediate medical advice.

  • Batch number: 9G020A
  • Expiry date: 12/2021
  • Pack size: 1 x 100
  • First distributed: 16 October 2019

Advice for healthcare professionals

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 remove the PIL in the pack and provide a copy of the correct version, which can be downloaded from the link below:

https://www.medicines.org.uk/emc/product/6382/pil

Further Information

For medical information enquiries, please contact Sanofi Medical Information, Tel +44 (0) 845 372 7101; email uk-medicalinformation@sanofi.com.

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

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Drug alert: Rifadin (rifampicin) 150mg Capsules

Updates to this page

Published 16 October 2019
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