Namuscla

Држава: Европска Унија

Језик: Енглески

Извор: EMA (European Medicines Agency)

Активни састојак:

Mexiletine hydrochloride

Доступно од:

Lupin Europe GmbH

АТЦ код:

C01BB02

INN (Међународно име):

mexiletine hcl

Терапеутска група:

Cardiac therapy

Терапеутска област:

Myotonic Disorders

Терапеутске индикације:

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

Резиме производа:

Revision: 5

Статус ауторизације:

Authorised

Датум одобрења:

2018-12-18

Информативни летак

Internal Doc Ref: v6.6
22
B. PACKAGE LEAFLET
Internal Doc Ref: v6.6
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NAMUSCLA 167 MG HARD CAPSULES
mexiletine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
There is an
ALERT CARD
distributed with Namuscla, to remind you and medical staff of the risk
of
cardiac arrythmias.
READ THE ALERT CARD IN CONJUNCTION WITH THIS LEAFLET AND KEEP THE CARD
IT WITH
YOU AT ALL TIMES
.
WHAT IS IN THIS LEAFLET
1.
What Namuscla is and what it is used for
2.
What you need to know before you take Namuscla
3.
How to take Namuscla
4.
Possible side effects
5.
How to store Namuscla
6.
Contents of the pack and other information
1.
WHAT NAMUSCLA IS AND WHAT IT IS USED FOR
Namuscla is a medicine that contains the active substance mexiletine.
Namuscla is used to treat the symptoms of myotonia (when muscles relax
slowly and with difficulty
after they are used) in adults with non-dystrophic myotonic disorders,
which are caused by genetic
defects that affect muscle function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAMUSCLA
_ _
DO NOT TAKE NAMUSCLA
-
if you are allergic to mexiletine or to any of the other ingredients
of this medicine (listed in
section 6)
-
if you are allergic to any local anaesthetic
-
if you have had heart attack
-
if your heart does not work well enough
-
if you have certain disorders of the heart rhythm
-
if your heart beats too fast
-
if the blood vessels of your heart are damaged
-
if you also take certain medicines to treat disorders of the heart
rhythm (see Other medicines
and Namuscla

Карактеристике производа

Internal Doc Ref: v6.6
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Internal Doc Ref: v6.6
2
1.
NAME OF THE MEDICINAL PRODUCT
Namuscla 167 mg hard capsules
2.
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.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Namuscla capsules are Swedish orange hard shell gelatin capsules (20
mm) filled with white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Namuscla is indicated for the symptomatic treatment of myotonia in
adult patients with non-
dystrophic myotonic disorders.
_ _
4.2
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
(2 capsules per day). After at least 1 further week of treatment,
based on clinical response, dose can be
further increased to 500 mg daily (3 capsules per day).
Maintenance treatment is between 167 mg – 500 mg daily (1 to 3
capsules per day), according to the
intensity of symptoms and the clinical response, taken regularly
throughout the day.
The dose should not exceed 500 mg/day. Regular reassessment should be
implemented, not to
continue long-term treatment in a patient not responding or not
experiencing benefit of the treatment.
Before starting mexiletine treatment, detailed and careful cardiac
evaluation should be carried out;
throughout treatment with mexiletine, cardiac monitoring needs to be
continued and adapted as a
function of the heart condition of the patient (see contraindications
in section 4.3 and warning in
section 4.4).
_ _
_Patients with cardiac disorders _
In case of modification of the mexiletine dose, or if medicinal
products susceptible to affect cardiac
conduction are co-administered with mexiletine, patients should be
closely monitored by ECG
(especially patients with conduction anomalies) (see