MOTILIUM ORAL SUSPENSION 1MG/ML

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

DOMPERIDONE

Sẵn có từ:

JOHNSON & JOHNSON SDN BHD

INN (Tên quốc tế):

DOMPERIDONE

Các đơn vị trong gói:

200ml mL; 100 ml mL

Sản xuất bởi:

JANSSEN PHARMACEUTICA N.V.

Tờ rơi thông tin

MOTILIUM
® TABLET/ ORAL SUSPENSION
Domperidone (10mg, 1mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What MOTILIUM
®
is used for
2.
How MOTILIUM
®
works
3.
Before you use MOTILIUM
®
4.
How to use MOTILIUM
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of MOTILIUM
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
11.
Serial number
WHAT MOTILIUM
® IS USED FOR
MOTILIUM
®
is used for:
•
the relief of the symptoms of nausea
and vomiting from various causes
(including chemotherapy, radiotherapy
or other medicines).
HOW MOTILIUM
®
WORKS
MOTILIUM
®
works by blocking the
action of a chemical messenger in the
brain which causes the feeling of nausea
and vomiting, as well as increasing the
movement or contractions of the stomach
and intestines, allowing food to move
more easily through the stomach.
BEFORE YOU USE MOTILIUM
®
-
_When you must not use it _
You should not use MOTILIUM
®
if:
•
you know you are allergic
(hypersensitive) to domperidone and
other ingredients listed at the end of the
leaflet
•
you suffer from a tumor of the pituitary
gland called prolactinoma
•
have bleeding, obstruction and hole in
the stomach and bowel (e.g. severe
stomach cramps or persistent black
stools)
•
have moderate to severe liver disease
•
have abnormal potassium level, low
magnesium level in the blood
•
have or had heart problems including
heart failure or heart rhythm disorders
including a slow or irregular heartbeat
If in doubt, ask your pharmacist or doctor
for advice.
Stop taking MOTILIUM
®
and contact
your doctor immediately if you experience
abnormal heart beat.
_Pregnancy and lactation _
If you are pregnant or think you may be,
tell your doctor, who will decide if you
can take MOTILIUM
®
.
_ _
_Breast-feeding _
Small amounts of MOTILIUM
®
can end
up in the mother's milk. Breast-feeding is
not recommended for mothers who are
taking MOTILIUM
®
. Talk to your doctor
if you have any questions.
_ _
-
_B

Đặc tính sản phẩm

1
PRODUCT NAME
MOTILIUM Tablet 10mg
MOTILIUM Oral Suspension 1mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSTION
One film-coated tablet contains 10 mg domperidone.
The oral suspension contains 1 mg domperidone per ml.
PHARMACEUTICAL FORM
Film coated tablets.
Oral suspension.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Domperidone is indicated for the relief of the symptoms of nausea and
vomiting.
Nausea and vomiting of functional, organic, infectious or dietary
origin.
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.
1.
Adults and adolescents ≥ 12 years of age and weighing ≥35 kg and
children <12 years of
age and weighing ≥ 35 kg
The dose of MOTILIUM should be the lowest effective dose for the
individual situation
(typically 30 mg/day) and can be increased if necessary to a maximum
daily oral dose of 40
mg.
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
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 (4×10 mg
tablet).
Oral suspension (1 mg/ml)
10 mL three to four
times per day
40 mg (40 mL of
1 mg/mL oral
suspension)
2.
Adults and adolescents (≥ 12 years of age) weighing < 35 kg
The dose of MOTILIUM should be the lowest effective dose. The total
daily dose is dependent
on weight (see table below).
Usually, the maximum treatment duration should not exceed one week for
the treatment of
acute