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Intended for UK patients and members of the public

Hydroxychloroquine Tablets

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Hydroxychloroquine Sulfate 200mg Film-coated Tablets

PL Number:
0142/1254
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update:

    IB, B.II.f.1.b.1 – To extend the shelf-life of the finished product packed in PVC/aluminium foil blister, from 2 years to 3 years, based on available real time data. SmPC Section 6.3 affected.

    IB, B.II.f.1.e - To register a change to the stability protocol - to amend post-approval stability protocol by reducing testing schedule at the long term condition and by adding testing at the accelerated condition.

    Section 5 of the PIL has been updated.

    SmPC Sections updated: 6.3 & 10.

  • Description of update:

    IB, B.II.f.1.b.1 – To extend the shelf-life of the finished product packed in PVC/aluminium foil blister, from 2 years to 3 years, based on available real time data. SmPC Section 6.3 affected.

    IB, B.II.f.1.e - To register a change to the stability protocol - to amend post-approval stability protocol by reducing testing schedule at the long term condition and by adding testing at the accelerated condition. Section 5 of the PIL has been updated.

    PIL sections updated: 5 & 6.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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