Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Lupin Europe GmbH, Hanauer Landstraße 139-143, 60314, Frankfurt am Main, Germany
Namuscla 62 mg hard capsules.
Namuscla 83 mg hard capsules.
Namuscla 167 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Namuscla 62 mg hard capsules: Namuscla 62 mg hard capsules are white hard shell gelatin capsules (15 mm) filled with white powder. Namuscla 83 mg hard capsules: Namuscla 83 mg hard capsules are Swedish orange (cap) and white (body) hard shell gelatin capsules (20 mm) filled with white powder. Namuscla 167 mg hard capsules: Namuscla 167 mg hard capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder. |
Namuscla 62 mg hard capsules: Each capsule contains mexiletine hydrochloride corresponding to 62.48 mg mexiletine.
Namuscla 83 mg hard capsules: Each capsule contains mexiletine hydrochloride corresponding to 83.31 mg mexiletine.
Namuscla 167 mg hard capsules: Each capsule contains mexiletine hydrochloride corresponding to 166.62 mg mexiletine.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 (Namuscla 62 mg hard capsules): Titanium dioxide (E171) Capsule shell (Namuscla 83 mg and 167 mg hard capsules): Iron (III) oxide (E172) |
Namuscla hard capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100, 200 or 300 capsules in a carton.
Not all pack sizes may be marketed.
Lupin Europe GmbH, Hanauer Landstraße 139-143, 60314, Frankfurt am Main, Germany
EU/1/18/1325/001 – 014
Date of first authorisation: 18/12/2018
Date of latest renewal: 09/08/2023
| Drug | Countries | |
|---|---|---|
| NAMUSCLA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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