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Missing PIL information

Xonvea 10 mg/10mg GR and gastro-resistant tablets and Rifadin (rifampicin) 150mg capsules

October 17th 2019

Tagged: MHRA alert

By MHRA

The MHRA has advised of missing side effect information from Xonvea 10 mg/10 mg gastro-resistant tablets (doxylamine succinate and pyridoxine hydrochloride)
The affected batches are:

Batch Number Expiry Date Pack Size First Distributed
1510 30 November 2021 1 x 20 25 September 2018
1525 31 December 2021 1 x 20 05 December 2018
1527 31 January 2022 1 x 20 17 December 2018

Possible side effects not present on the patient information leaflet are:

  • hypersensitivity (allergic reactions)
  • feeling anxious, difficulty sleeping (insomnia), nightmares, feeling disorientated
  • headaches or migraines
  • tingling, pricking or numbness of skin
  • restlessness and a need to move constantly
  • problems with eyesight or blurred vision
  • sensation of spinning dizziness
  • difficulty breathing, awareness of heartbeat or increased heart rate
  • full or bloated feeling, stomach pains, constipation or diarrhoea
  • excessive sweating, skin reactions such as itchiness or rash
  • difficulties or pain with passing urine
  • discomfort in the chest
  • general discomfort, feeling irritable

Some class effects are also missing.
Alliance Pharmaceuticals Ltd is in process of updating the PIL and this will be effective on release of all new batches to the market. When dispensing affected access the SmPC, which includes the missing side effects and class effects
Email Alliance Pharmaceuticals medical information with any queries.

There is also missing PIL information for the following batch of Rifadin (rifampicin) 150mg capsules:

Batch Number Expiry Date Pack Size First Distributed
9G020A 12/2021 1 x 100 16 October 2019

The missing information relates to:

  • 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

If any of the above batch numbers are being dispensed, please remove the PIL in the pack and replace with the correct online version.

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