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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 4.3, 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Zimovane LS 3.75 mg, 7.5mg film-coated tablets, PL 04425/0625, 0624 MAH: Aventis Pharma Limited (Sanofi). Consequently, the leaflet has been updated. Additional updates have been made to the SmPC and PIL to correct QRD wording, in line with the QRD template (Version 10.3), spelling, punctuation and grammar.

    SmPC Sections updated: 4.3, 4.4, 4.8, 5.1, 5.2 and 10.

  • Description of update: To update sections 4.3, 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Zimovane LS 3.75 mg, 7.5mg film-coated tablets, PL 04425/0625, 0624 MAH: Aventis Pharma Limited (Sanofi). Consequently, the leaflet has been updated. Additional updates have been made to the SmPC and PIL to correct QRD wording, in line with the QRD template (Version 10.3), spelling, punctuation and grammar.

    PIL sections updated: Heading, 2, 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

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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