NAMUSCLA Hard capsule Ref.[8119] Active ingredients: Mexiletine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Lupin Europe GmbH, Hanauer LandstraรŸe 139-143, 60314, Frankfurt am Main, Germany

Product name and form

Namuscla 167 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

Namuscla capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder.

Qualitative and quantitative composition

Each capsule contains mexiletine hydrochloride corresponding to 166.62 mg mexiletine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mexiletine

Mexiletine blocks sodium channels with a stronger potency in situations of excessive burst of action potentials (use-dependent block) and/or prolonged depolarization (voltage-dependent block), as occurring in diseased tissues, rather than on physiological excitability (resting or tonic block). Mexiletine is, therefore, mostly active on muscle fibres subject to repeated discharges (such as skeletal muscles). It improves myotonic symptoms by decreasing muscle stiffness through reduction of the delay of muscle relaxation.

List of Excipients

Capsule content:

Maize starch
Colloidal anhydrous silica
Magnesium stearate

Capsule shell:

Iron (III) oxide (E172)
Titanium dioxide (E171)
Gelatin

Pack sizes and marketing

Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Lupin Europe GmbH, Hanauer LandstraรŸe 139-143, 60314, Frankfurt am Main, Germany

Marketing authorization dates and numbers

EU/1/18/1325/001 – 004

Date of first authorisation: 18.12.2018

Drugs

Drug Countries
NAMUSCLA Austria, Estonia, France, Ireland, Lithuania, Poland, United Kingdom

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