DHACTULOSE SYRUP

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

Lactulose

متاح من:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

Lactulose

الوحدات في الحزمة:

200 mL

المصنعة من قبل:

PT Actavis Indonesia

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DHACTULOSE SYRUP
_ _
Lactulose (3.35g/5ml)
1
WHAT IS IN THIS LEAFLET
1.
What
Dhactulose
is
used
for
2.
How Dhactulose work
3.
Before you use Dhactulose
4.
How to take Dhactulose
5.
While
you
are
using
Dhactulose
6.
Side Effects
7.
Storage
and
Disposal
of
Dhactulose
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
DHACTULOSE IS USED FOR
Dhactulose
is
used
to
treat
occasional
or
non-persistent
constipation.
HOW
DHACTULOSE WORK
Dhactulose contains a medicine
called lactulose. This belongs
to a group of medicine called
laxatives,
which
helps
to
facilitate
or
increase
bowel
movements. It makes the stool
softer
and
easier
to
pass,
by
drawing water into the bowel.
BEFORE YOU USE DHACTULOSE
_-When you must not take it _
Do not take Dhactulose if you:
•
are
allergic
(hypersensitive)
to lactulose, and any of the
other ingredients in the syrup.
•
have
a
rare
problem
called
galactosaemia, that affects an
individual's ability to process
the sugar galactose properly.
•
have an intestinal blockage
•
are on a low sugar galactose
diet
_-Before you start to take it _
You
should
check
with
your
doctor
or
pharmacist
before
taking Dhactulose if you:
•
are pregnant or breast-feeding
•
are diabetic
•
have lactose (a type of sugar)
intolerance
If you are not sure if any of the
above
applies
to
you,
talk
to
your
doctor
or
pharmacist
before taking Dhactulose.
_-Taking other medicines _
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines, including medicines
obtained without a prescription.
This includes:
•
Medicines
containing
5-
Aminosalicylate
formulations,
in
which
the
action will be reduced.
HOW TO TAKE IT
_-How much to take _
Orally administered.
Adults:
Initially, 15 to 30ml daily as a
single
dose
(preferably
during
breakfast) or in 2 divided doses.
The
daily
dosage
should
be
adjusted
according
to
your
needs.
Children:
6-12 years: 10ml
1-5 years: 5ml
Under 1 year: 2.5ml.
_-

خصائص المنتج

DHACTULOSE SYRUP
PRODUCT DESCRIPTION:
Clear, viscous liquid, colourless to pale brownish-yellow.
COMPOSITION:
Each 5ml contains Lactulose BP 3.35g.
PHARMACODYNAMICS:
Lactulose is a synthetic disaccharide which is absorbed minimally
from the GI tract, reaching the colon unchanged. It is then broken
down by colonic bacteria into simple organic acids, mainly lactic
acids, which lead to a lowering of pH in the colon and exert a local
osmotic effect. Fluids retained in the colon by osmosis increase and
soften the faecal bulk and hence, stimulate peristalsis. Constipation
is relieved and the physiological rhythm of the colon is restored. It
may take up to 48 hours before an effect is obtained.
PHARMACOKINETICS:
Following oral administration, a small amount (less than 3%)
of the lactulose dose is absorbed from the small intestine. The
absorbed lactulose is not metabolised and subsequently excreted
unchanged in the urine. The unabsorbed lactulose reaches the
colon unchanged where it is metabolised by colonic bacteria to
form lactic acids and small amounts of acetic and formic acids.
INDICATIONS:
Relief of occasional or non-persistent constipation.
DOSAGE:
Oral
Adults:
Initially, 15 to 30ml daily as a single dose (preferably
during breakfast) or in 2 divided doses. The daily dosage
should be adjusted according to the patient’s needs.
Children:
6-12 years : 10ml
1-5 years : 5ml
under 1 year : 2.5ml. To be given 2 times a day.
SIDE EFFECTS:
Abdominal discomfort, flatulence and cramps. Nausea and vomiting
have been reported with high doses. Diarrhoea with excessive loss
of water and electrolytes (particularly potassium) may result from
prolonged use or excessive dosage.
PRECAUTIONS:
Patients with lactose intolerance or in diabetic patients. Consult
your doctor if constipation is not relieved after a few days or
reoccur
after treatment.
2
03.11.2021
MT
16.11.2021
MT
110x175
Actavis Jakarta
9
03.11.2021
1. profile
2.
3.
1. black
2.
3.
4.
5.
6.
AAAN8680 - Dhactulose 134000 mg/200 ml -, PIL, Malaysia
USE IN PREGNANCY:
No evide