Hovid Smood-10 Tablet

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

DOMPERIDONE MALEATE

Dostupno od:

HOVID BERHAD

INN (International ime):

DOMPERIDONE MALEATE

Jedinice u paketu:

98Tablet Tablets; 30 Tablet Tablets; 100 Tablet Tablets; 14Tablet Tablets; 10 Tablet Tablets

Proizveden od:

HOVID BERHAD

Uputa o lijeku

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SMOOD-10 TABLET
Domperidone 10 mg
1
WHAT IS IN THIS LEAFLET
1.
What Smood-10 is used for
2.
How Smood-10 works
3.
Before you use Smood-10
4.
How to use Smood-10
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Smood-
10
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT SMOOD-10 IS USED FOR
Smood-10 is used for the relief of the
symptoms of nausea and vomiting
from various causes (including
chemotherapy, radiotherapy or other
medicines).
HOW SMOOD-10 WORKS
Smood-10 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 SMOOD-10
_- When you must not use it_
You should not use Smood-10 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 Smood-10 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 Smood-10.
_Breast-feeding_
Small amounts of Smood-10 can end
up in the mother’s milk. Breast-
feeding is not recommended for
mothers who are taking Smood-10.
Talk to your doctor if you have any
questions.
_- Before you start to use it_
Before taking Smood-10, you should
let your doctor know if you have
s

Svojstava lijeka

VISMO02-var1
DESCRIPTION
White to off white coloured, film coated tablets plain on both
sides.
COMPOSITION
Each tablet contains Domperidone 10 mg
PHARMACODYNAMICS
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 N-dealkylation.
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 for the relief of the symptoms of
nausea and vomiting. This includes:
•
Nausea and vomiting of functional, organi