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.
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 Expiry Date Pack Size First Distributed
9G020A 12/2021 1 x 100 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.