The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

Nytamel 10 mg Film-coated Tablets

Clonmel Healthcare LtdPA0126/117/002

Main Information

Trade NameNytamel 10 mg Film-coated Tablets
Active SubstancesZolpidem tartrate
Dosage FormFilm-coated tablet
Licence HolderClonmel Healthcare Ltd
Licence NumberPA0126/117/002

Group Information

ATC CodeN05CF Benzodiazepine related drugs
N05CF02 zolpidem


License statusAuthorised
Licence Issued22/03/2002
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017.
Marketing StatusMarketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

Generics Information

Interchangeable List CodeIC0135-002-003
Interchangeable List DocumentPDF of Interchangeable List
« Back