MEDIDONE FILM COATED TABLET 10 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DOMPERIDONE MALEATE

Boleh didapati daripada:

ALLPAC SOLUTIONS SDN. BHD.

INN (Nama Antarabangsa):

DOMPERIDONE MALEATE

Unit dalam pakej:

10x10 Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MEDIDONE FILM COATED TABLET 10 MG
Domperidone 10 mg
1
WHAT IS IN THIS LEAFLET
1.
What Medidone is used for
2.
How Medidone works
3.
Before you use Medidone
4.
How to use Medidone
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Medidone
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT MEDIDONE IS USED FOR
Medidone is used for the relief of the
symptoms of nausea and vomiting
from various causes (including
chemotherapy, radiotherapy or other
medicines).
HOW MEDIDONE WORKS
Medidone 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 YOUR USE MEDIDONE
_- When you must not use it_
You should not use Medidone if:
•
You know you are allergic
(hypersensitive) to domperidone
and other ingredients listed at the
end of the leaflet.
•
You suffer from a tumour of the
pituitary gland called
prolactinoma.
•
Have bleeding, ibstruction 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 Medidone an contact your
doctor immediately if you experience
abnormal heartbeat.
_Pregnancy_
If you are pregnant or think you may
be, tell your doctor, who will decide if
you can take Medidone.
_Breast-feeding_
Small amounts of Medidone can end
up in the mother’s milk. Breast-
feeding is not recommended for
mothers who are taking Medidone.
Talk to your doctor if you have any
questions.
_- Before you start to use it_
Before taking Medidone, you should
let your doctor k

Ciri produk

xxx
MEDIDONE FILM COATED TABLET 10MG
VIXXXxx-08
DESCRIPTION
Round, 6.0 mm in diameter, white to off-white coated tablet
with shallow convex faces.
COMPOSITION
Each film-coated tablet contains Domperidone Maleate 12.73
mg, equivalent to Domperidone 10 mg.
ACTIONS AND PHARMACOLOGY
Domperidone
is
a
dopamine
antagonist
with
anti-emetic
properties.
Domperidone does not readily cross the blood-brain barrier. In
domperidone
users,
especially
adults,
extrapyramidal
side
effects are very rare, but domperidone promotes the release of
prolactin from the pituitary. Its anti-emetic effect may be due to a
combination of peripheral (gastrokinetic) effects and antagonism
of dopamine receptors in the chemoreceptor trigger zone, which
lies outside the blood-brain barrier in the area postrema.
PHARMACOKINETICS
ABSORPTION
Domperidone is rapidly absorbed after oral administration, with
peak plasma concentrations occurring at approximately 60
minutes after dosing.
DISTRIBUTION
Domperidone is 91 - 93% bound to plasma proteins.
METABOLISM
Domperidone
undergoes
rapid
and
extensive
hepatic
metabolism by hydroxylation and Ndealkylation.
EXCRETION
Urinary and faecal excretions amount to 31 and 66% of the oral
dose
respectively.
The
proportion
of
the
drug
excreted
unchanged is small (10% of faecal excretion and approximately
1% of urinary excretion).
Special Populations
HEPATIC IMPAIRMENT
In patients with moderate hepatic impairment the unbound
fraction is increased by 25%, and the terminal elimination
half-life is prolonged from 15 to 23 hours. Patients with mild
hepatic impairment have a somewhat lower systemic exposure,
with no change in protein binding or terminal half-life.
RENAL IMPAIRMENT
In patients with severe renal insufficiency (serum creatinine > 6
mg/100 mL, i.e., > 0.6 mmol/L) the half-life of domperidone is
increased from 7.4 to 20.8 hours, but plasma drug levels are
lower than in patients with normal renal function. Very little
unchanged drug (approximately 1%) is excreted via the kidneys.
INDICATIONS
Domperidone is indicated