mexiletine hcl

This medicine is authorised for use in the European Union.


Namuscla is a medicine used to treat symptoms of myotonia (muscle stiffness) in patients with non-dystrophic myotonic disorders, a group of inherited muscle disorders. Non-dystrophic means no muscle wasting occurs in patients affected by the condition.

Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles are slow to relax after contraction.

Myotonic disorders are rare, and Namuscla was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 November 2014. 

This EPAR was last updated on 22/02/2023

Authorisation details

Product details
Agency product number
Active substance
Mexiletine hydrochloride
International non-proprietary name (INN) or common name
mexiletine hcl
Therapeutic area (MeSH)
Myotonic Disorders
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Lupin Europe GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Hanauer Landstraße 139-143
60314 Frankfurt am Main

Product information

20/02/2023 Namuscla - EMEA/H/C/004584 - IB/0012

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

Assessment history

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