Forlax 10g Powder for Oral Solution

Country: Malaysia

Language: English

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

Active ingredient:

Macrogol 4,000

Available from:

EP PLUS GROUP SDN. BHD.

INN (International Name):

Macrogol 4,000

Units in package:

10Units Units; 20Units Units

Manufactured by:

BEAUFOUR IPSEN INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FORLAX
® POWDER FOR ORAL SOLUTION
Macrogol 4000 (10g)
__________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What FORLAX
is used for
2.
How FORLAX
works
3.
Before you use FORLAX
4.
How to use FORLAX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
FORLAX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FORLAX IS USED FOR
FORLAX is used for the treatment of
constipation
in
adults
and
children
aged 8 years above and regarded as
temporary
adjunctive
therapy
in
an
appropriate
lifestyle
and
in
dietary
measures.
HOW FORLAX
WORKS
FORLAX
contains
the
active
substance macrogol 4000 and belongs
to a group of medicines called osmotic
laxatives. It works by adding water to
the stools, which helps to overcome
problems caused by very slow bowel
movements.
BEFORE YOU USE FORLAX
-
_When you must not use it _
•
If you have
-
severe
inflammatory
bowel disease (ulcerative
colitis, Crohn’s disease),
-
toxic
mega
colon
(enlarged
large
intestine),
-
digestive perforation or
risk of perforation,
-
painful
abdominal
of
undetermined reason,
-
a
bowel
obstruction
(Ileus)
or
suspect
of
having it
•
If you are hypersensitive to
macrogol
or
to
any
of
the
ingredients in FORLAX.
•
If you are intolerant to sugar
fructose (due to the presence
of sorbitol).
-
_Before you start to use it _
Always
ask
your
doctor
or
pharmacist
before
using
this
product if you have any doubts.
If you are pregnant or trying to
pregnant
or
if
you
are
breastfeeding, seek advices from
your doctor or pharmacist before
taking any medicine.
No
effects
during
pregnancy
or
breastfeeding are anticipated since
systemic exposure to FORLAX is
negligible.
FORLAX
can
be
used
during
pregnancy and breastfeeding.
_ _
-
_Taking other medicines _
FORLAX
may interfere with the
absorption of other medicines if
taken simultaneously. Generally, it
is better to take FORLAX at least 2
hours apar

Summary of Product characteristics

COMPOSITION
Macrogol 4000…………………10.000g per sachet
Excipients with known effect:
Sorbitol (E420) ……………………1.7 mg per sachet
Sulphur dioxide (E220) ………0.12x10
-2
mg per sachet
EXCIPIENTS
Saccharin sodium (E954), orange-grapefruit flavour**
**Composition of the orange-grapefruit flavour
Orange and grapefruit essential oils, concentrated orange
juice,
citral,
acetaldehyde,
linalol,
ethyl
butyrate,
alpha
terpineol, octanal, beta gamma hexenol, maltodextrin, gum
arabic, sorbitol, BHA (E320) and sulphur dioxide (E220).
PRODUCT DESCRIPTION
Powder for oral solution in sachet.
Almost white powder with an odour and taste of orange-
grapefruit.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic
class:
OSMOTIC
LAXATIVE,
ATC
code: A06AD15 (A: digestive system and metabolism).
High molecular weight
(4000)
macrogols are long linear
polymers
which retain water
molecules
by
means
of
hydrogen bonds.
When administered by the oral
route,
they lead to an increase in volume of intestinal fluids.
The volume of unabsorbed intestinal fluid accounts for the
laxative properties of the solution.
PHARMACOKINETIC PROPERTIES
The
pharmacokinetic
data
confirms
that
macrogol
4000 undergoes neither
gastrointestinal
resorption nor
biotransformation following oral ingestion.
PRECLINICAL SAFETY DATA
Toxicological studies in different species of animals did not
reveal any signs of systemic or local gastrointestinal toxicity
of
macrogol
4000.
Macrogol
4000 had no teratogenic
or
mutagenic effect.
Potential
drug interactions studies
performed in rats on some NSAIDs, anticoagulants, gastric
antisecretory agents,
or
on a hypoglycaemic sulfamide
showed that FORLAX did not interfere with gastrointestinal
absorption
of
these
compounds.
No
carcinogenicity
studies have been performed.
THERAPEUTIC INDICATIONS
FORLAX
®
10g is
indicated in symptomatic
treatment
of
constipation in adults and children aged 8 years and
above. An
organic disorder should have been ruled out
before initiation of treatment. FORLAX
®
10g should remain
a te