MOTILIUM TABLET 10 mg

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

DOMPERIDONE

Disponible des:

JOHNSON & JOHNSON PTE. LTD.

Codi ATC:

A03FA03

Dosis:

10 mg

formulario farmacéutico:

TABLET, FILM COATED

Composición:

DOMPERIDONE 10 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

JNTL Consumer Health (France) SAS

Estat d'Autorització:

ACTIVE

Data d'autorització:

1989-03-14

Informació per a l'usuari

 
PRODUCT NAME 
MOTILIUM

 (domperidone base) 

DOSAGE FORMS AND STRENGTHS 
One film-coated tablet contains 10 mg domperidone. 
The oral suspension contains 1 mg domperidone per ml. 

For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 
INDICATIONS 
1.  The dyspeptic symptom complex that
is often associated with delayed gastric emptying, 
gastro-oesophageal reflux and oesophagitis: 
•  epigastric sense of fullness, early satiety,
feeling of abdominal distension, upper 
abdominal pain; 
•  bloating, eructation, flatulence; 
•  nausea and vomiting; 
•  heartburn with
or without regurgitations of gastric contents in the mouth. 
2.  Nausea and vomiting of functional, organic,
infectious or dietary origin. 
3.  Nausea and vomiting induced by: 
•  radiotherapy or drug therapy 
•  dopamine agonists (such as L-dopa and bromocriptine) used
in the treatment of 
Parkinson's disease.. 

DOSAGE AND ADMINISTRATION 
It is recommended to take oral MOTILIUM

 before meals. If taken after meals, absorption of the 
drug is somewhat delayed. 

ADULTS AND ADOLESCENTS (OVER 12 YEARS AND WEIGHING 35
KG OR MORE)  
The dose of MOTILIUM
®
 should be the lowest effective dose for the individual
situation 
(typically 30mg/day) and can be increased if necessary to
a maximum daily oral dose of 40mg. 
The initial duration of treatment
is up to four weeks. If treatment exceeds four weeks, patients 
should be reevaluated and the
need for continued treatment reassessed. 

FORMULATION (DOMPERIDONE PER 
UNIT) 
DOSAGE 
MAXIMUM DOSE 
PER DAY 
Film-coated tablets (10 mg/tablet)  1 tablet
three to four times 
per day 
40 mg (4x10mg 
tablet) 
Oral suspension (1 mg/ml) 
10 mL three to four times 
per day 
40 ml (40 ml of 
1mg/ml oral 
suspension) 

Doses above 30mg/day should be used wit

Fitxa tècnica

1
PRODUCT NAME
MOTILIUM

(domperidone base)
DOSAGE FORMS AND STRENGTHS
One film-coated tablet contains 10 mg domperidone.
The oral suspension contains 1 mg domperidone per mL.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
1.
The dyspeptic symptom complex that is often associated with delayed
gastric emptying,
gastro-esophageal reflux and esophagitis:
•
epigastric sense of fullness, early satiety, feeling of abdominal
distension, upper
abdominal pain;
•
bloating, eructation, flatulence;
•
nausea and vomiting;
•
heartburn with or without regurgitations of gastric contents in the
mouth.
2.
Nausea and vomiting of functional, organic, infectious or dietary
origin.
3.
Nausea and vomiting induced by:
•
radiotherapy or drug therapy
•
dopamine agonists (such as L-dopa and bromocriptine) used in the
treatment of
Parkinson's disease.
DOSAGE AND ADMINISTRATION
It is recommended to take oral MOTILIUM

15-30 minutes before meals. If taken after meals,
absorption of the drug is somewhat delayed.
ADULTS AND ADOLESCENTS ≥ 12 YEARS OF AGE AND WEIGHING ≥ 35 KG
The dose of MOTILIUM
®
should be the lowest effective dose for the individual situation
(typically 30mg/day) and can be increased if necessary to a maximum
daily oral dose of 40mg.
Usually, the maximum treatment duration should not exceed one week for
the treatment of acute
nausea and vomiting. If nausea and vomiting persists for longer than
one week, patients should
consult their physician. For other indications, the initial duration
of treatment is up to four weeks.
If treatment exceeds four weeks, patients should be re-evaluated and
the need for continued
treatment reassessed.
FORMULATION (DOMPERIDONE PER
UNIT)
DOSAGE
MAXIMUM DOSE
PER DAY
Film-coated tablets (10 mg/tablet)
1 tablet three to four times
per day
40 mg (4x10mg
tablet)
Oral suspension (1 mg/ml)
10 mL three to four times
per day
40 mg (40 mL of
1mg/mL oral
suspension)
2
Doses above 30mg/day should be used with caution due to potential risk
of arrhythmias
assoc