Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Lupin Europe GmbH, Hanauer Landstraße 139-143, 60314, Frankfurt am Main, Germany
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. |
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 Capsule shell: Iron (III) oxide (E172) |
Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.
Not all pack sizes may be marketed.
Lupin Europe GmbH, Hanauer Landstraße 139-143, 60314, Frankfurt am Main, Germany
EU/1/18/1325/001 – 004
Date of first authorisation: 18.12.2018
| Drug | Countries | |
|---|---|---|
| NAMUSCLA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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