MYONAL TABLET 50MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

EPERISONE HYDROCHLORIDE

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

EPERISONE HYDROCHLORIDE

Units in package:

100Tablet Tablets

Manufactured by:

Bushu Pharmaceuticals Ltd. Misato factory

Patient Information leaflet

MYONAL
®
50MG TABLET
Eperisone hydrochloride (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Myonal is used for
2.
How Myonal
works
3.
Before you use Myonal
4.
How to use Myonal
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Myonal
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MYONAL
IS USED FOR
Myonal is intended for:
a)
Improvement
of
myotonic
conditions
(prolonged
contraction
of
muscles)
caused
by
the
following diseases:

Neck-shoulder-arm syndrome

Frozen shoulder

Low back pain
b)
Condition of muscles in a state of
continuous contraction, causing
dysfunction in muscle movement
and increased tendon reflexes. This
is caused by the following diseases:

Brain blood vessel disorders

Arthritis of the neck

Surgical trauma from brain and
spine tumor

Spinal and head injury

Brain disorder that affects the
ability to coordinate body
movements

Degeneration of spinal cord and
brain

Other diseases that affect both the
brain and the spinal cord
HOW MYONAL
WORKS
Myonal
acts
by
relaxing
both
skeletal
muscles and vascular smooth
muscles.
These
reduce
muscular
spasm
and
improve
blood
circulation.
Meanwhile,
Myonal
reduces
pain
associated
with
myotonic
condition
while
facilitates
muscle movement.
BEFORE YOU USE _MYONAL_
-
_When you must not use it _
Do not take Myonal
if you have a history
of hypersensitivity to any ingredients of
Myonal.
_ _
_ _
_Pregnancy and lactation _
Do not take Myonal
if you are pregnant,
trying to get pregnant or think you may
be
pregnant
unless
the
expected
therapeutic
benefits
are
evaluated
to
outweigh the possible risk of treatment.
Do not take Myonal
if you are breast-
feeding.
When
Myonal
must
be
used,
breast
feeding
should
be
discontinued
during treatment.
Myonal
_ _
is not recommended for children.
_ _
-
_Before you start use it _
Consult your doctor before using _Myonal_
if you have

A history of drug hypersensitivity

Hepatic function dis

Summary of Product characteristics

CAUTION: USE ONLY AS DIRECTED BY A PHYSICIAN.
【COMPOSITION】
- For improvement of myotonic symptoms -
_MYONAL_
®
50
mg
_TABLETS _

2. USE DURING LACTATION
It is advisable to avoid the administration of MYONAL to nursing
mothers.
【PHARMACOKINETICS】
BLOOD CONCENTRATION
Eperisone hydrochloride was administered orally to 8 healthy adult
male
volunteers at a single dose of 150 mg/day
note
) for 14 consecutive days and the
plasma
concentration was determined at days 1, 8 and 14. The time to reach
the
peak plasma concentration (t
max
) ranged from 1.6 to 1.9 hr, the peak plasma
concentration (c
max
) was 7.5 to 7.9 ng/mL, elimination half-life (t
1/2
) was 1.6 to
1.8 hr, and the area under the plasma concentration- time curve (AUC)
was 19.7
to 21.1 ng
・
hr/mL. The plasma concentration profiles of eperisone hydrochloride
determined at days 8 and 14 did not significantly vary from those of
the first day.
【EXCIPIENTS】
It contains carnauba wax, carmellose, micro
crystalline cellulose, titanium oxide,
stearic acid, calcium stearate, sucrose, talc, precipitated calcium
carbonate, corn
starch,
white
shellac,
hydroxypropylcellulose,
pullulan,
povidone
K30,
macrogol 6000 and hydrated silicon dioxide as inactive ingredients.
【EXPIRATION DATE】
MYONAL should be used before the expiration date indicated on the
package or
label.
【STORAGE】
MYONAL should be stored below 30°C.
Each white, sugar-coated tablet contains 50 mg of eperisone
hydrochloride.
【PRODUCT DESCRIPTION】
【INDICA
TIONS】
・
Improvement of myotonic conditions caused by the following diseases:
Neck-shoulder-arm syndrome, scapulohumeral periarthritis and low back
pain
・
Spastic paralysis caused by the following diseases
:
Cerebrovascular disorders, spastic
spinal paralysis,
cervical
spondylosis,
sequelae of surgical trauma (including cerebrospinal tumor), sequelae
of
trauma (spinal injury and head injury), amyotrophic lateral sclerosis,
infantile
cerebral palsy, spinocerebellar degeneration, spinal vascu