NAMUSCLA Hard capsule (2019)
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Περιεχόμενα
Name of the medicinal product
Namuscla 167 mg hard capsules.
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.
Pharmaceutical form
Hard capsule (capsule). Namuscla capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder.
Therapeutic indications
Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
Posology and method of administration
Posology The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day). After at least 1 week of treatment, based on the clinical response, the daily dose can be increased to 333 mg daily ...
Contraindications
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Hypersensitivity to any local anaesthetic. Ventricular tachyarrhythmia. Complete heart block (i.e. third-degree ...
Special warnings and precautions for use
Cardiac arrhythmogenic effects Mexiletine may induce an arrhythmia or accentuate a pre-existing arrhythmia, either diagnosed or undiagnosed. See also sections 4.3 and 4.5 regarding association with other ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Antiarrhythmics inducing torsades de pointes (class Ia, Ic, III antiarrhythmics) Co-administration of mexiletine and antiarrhythmics inducing torsades de pointes (class Ia: ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of mexiletine in pregnant women. Limited clinical data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta ...
Effects on ability to drive and use machines
Mexiletine may have minor influence on the ability to drive and use machines. Fatigue, confusion, blurred vision may occur following administration of mexiletine (see section 4.8).
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in patients treated with mexiletine are abdominal pain (12%), vertigo (8%) and insomnia (12%). The most serious reported adverse ...
Overdose
Symptoms Fatal outcomes have been reported for acute overdoses at 4.4 g of mexiletine hydrochloride ingestion but survival has also been reported following acute overdose of approximately 4 g of oral mexiletine ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cardiac therapy, antiarrhythmics, class Ib ATC code: C01BB02 Mechanism of action Mexiletine blocks sodium channels with a stronger potency in situations of excessive burst of ...
Pharmacokinetic properties
Absorption Mexiletine is rapidly and almost completely absorbed following oral administration with a bioavailability of about 90% in healthy subjects. Peak plasma concentrations following oral administration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development. The main observed effects in rats and/or ...
List of excipients
<u>Capsule content:</u> Maize starch Colloidal anhydrous silica Magnesium stearate <u>Capsule shell:</u> Iron (III) oxide (E172) Titanium dioxide (E171) Gelatin
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Lupin Europe GmbH, Hanauer Landstraße 139-143, 60314, Frankfurt am Main, Germany
Marketing authorization number(s)
EU/1/18/1325/001 004
Date of first authorization / renewal of the authorization
Date of first authorisation: 18.12.2018
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