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Intended for UK patients and members of the public

Zopiclone 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

Zopiclone 3.75mg Tablets

PL Number:
0142/0449
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC, label and leaflet in line with MHRA review to improve communication of risks for dependency-forming medicines. Additionally, an error to section 4.2 of the SmPC has been corrected with a consequential update to section 3 of the leaflet and editorial updates have been made to section 4.4 of the SmPC and leaflet as well as QRD updates to the leaflet.

    Date of approval: 13/01/2026

    SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10

  • Description of update: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC, label and leaflet in line with MHRA review to improve communication of risks for dependency-forming medicines. Additionally, an error to section 4.2 of the SmPC has been corrected with a consequential update to section 3 of the leaflet and editorial updates have been made to section 4.4 of the SmPC and leaflet as well as QRD updates to the leaflet.

    Date of approval: 13/01/2026

    PIL sections updated: Headline, Index, 1, 2, 3, 4, 5 and 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

Zopiclone 7.5mg Tablets

PL Number:
0142/0434
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC, label and leaflet in line with MHRA review to improve communication of risks for dependency-forming medicines. Additionally, an error to section 4.2 of the SmPC has been corrected with a consequential update to section 3 of the leaflet and editorial updates have been made to section 4.4 of the SmPC and leaflet as well as QRD updates to the leaflet.

    Date of approval: 13/01/2026

    SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10

  • Description of update: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC, label and leaflet in line with MHRA review to improve communication of risks for dependency-forming medicines. Additionally, an error to section 4.2 of the SmPC has been corrected with a consequential update to section 3 of the leaflet and editorial updates have been made to section 4.4 of the SmPC and leaflet as well as QRD updates to the leaflet.

    Date of approval: 13/01/2026

    PIL sections updated: Headline, Index, 1, 2, 3, 4, 5 and 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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