MYONAL TABLET 50 mg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

EPERISONE HCl

Доступно од:

DKSH SINGAPORE PTE. LTD.

АТЦ код:

M03BX09

Дозирање:

50 mg

Фармацеутски облик:

TABLET, SUGAR COATED

Састав:

EPERISONE HCl 50 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

BUSHU PHARMACEUTICALS LTD.

Статус ауторизације:

ACTIVE

Датум одобрења:

1991-06-21

Информативни летак

Caution : Use only as directed by a physician. 

【COMPOSITION】 
Each white, sugar-coated tablet
contains 50 mg of eperisone hydrochloride. 

【PRODUCT DESCRIPTION】 
Brand 
name 
Dosage form 
and 
identification 
code 
Appearance 
Description 
Face 
Reverse 
Lateral 
MYONAL 
Tablets 
50mg 
Sugar –coated 
tablets 

White 

Diameter 
Weight 
Thickness 

(mm) 
(mg) 
(mm) 

7.5 
162 
4.2 

【INDICATIONS】 
・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 vascular disorder, subacute myelo-optico 
neuropathy (SMON) and other encephalomyelopathies 

【DOSAGE AND ADMINISTRATION】 
The usual adult dosage for oral
use is 3 tablets (150 mg of eperisone hydrochloride) 
daily in three divided doses after meals. 
The dosage may be adjusted depending on the patient’s age and symptoms. 

【CONTRAINDICATIONS】 
(MYONAL is contraindicated in the following patients.) 
Patients with a history of hypersensitivity to any ingredients of MYONAL. 

【PRECAUTIONS】 
1.  CAREFUL ADMINISTRATION (MYONAL SHOULD BE ADMINISTERED WITH
CARE IN THE 
FOLLOWING PATIENTS.) 
(1)  Patients with a history of drug hypersensitivity 
(2)  Patients with hepatic function disorder 
[MYONAL may aggravate hepatic function.] 
2.  IMPORTANT PRECAUTIONS 
Weakness, light-headedness, sleepiness or other symptoms may occur. In the event 
of such 

Карактеристике производа

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