Forlax 4g 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:

20 Sachets

Manufactured by:

BEAUFOUR IPSEN INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FORLAX
® POWDER FOR ORAL SOLUTION
Macrogol 4000 (4 g)
__________________________________________________________________________________________________
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 children from 6 months
to 8 years 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 your child has
-
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 your child is hypersensitive
to macrogol or to any of the
ingredients in FORLAX.
_ _
_ _
_ _
_ _
-
_Before you start to use it _
Always
ask
your
doctor
or
pharmacist
before
using
this
product if you have any doubts.
_ _
_ _
-
_Taking other medicines _
FORLAX
may interfere with the
absorption of other medicines if
taken simultaneously.
_ _
HOW TO USE FORLAX
-
_How much to use _
From 6 months to 1 year: 1 sachet
(4 g) per day.
From 1 to 4 years: 1 to 2 sachets (4
to 8 g) per day.
From 4 to 8 years: 2 to 4 sachets (8
to 16 g) per day.
The content of each sachet must be
dissolved in about 50 ml of water
just before use.
Follow all directions given to you
by
your
doctor
and
pharmacist
carefully. They may differ from the
information
contained
in
this
le

Summary of Product characteristics

PRODUCT NAME
FORLAX
®
4g, powder for oral solution
COMPOSITION
Macrogol 4000 ................................ 4.000g per sachet
Excipients with known effect:
Sorbitol (E420) ..............................0.66 mg per sachet
Sulphur dioxide (E220) ...........4.8 x10
-4
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 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
®
4g did
not interfere with gastrointestinal absorption of these
compounds. No carcinogenicity studies have been
performed.
THERAPEUTIC INDICATIONS
Symptomatic treatment of constipation in children from
6 months to 8 years.
An organic disorder should have been ruled out by the
doctor, especially in t