Fybogel Orange

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISPAGHULA HUSKS

Available from:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC code:

A06AC01

INN (International Name):

ISPAGHULA HUSKS 3.5 g

Pharmaceutical form:

EFFERVESCENT GRANULES

Composition:

ISPAGHULA HUSKS 3.5 g

Prescription type:

OTC

Therapeutic area:

DRUGS FOR CONSTIPATION

Authorization status:

Authorised

Authorization date:

2006-04-24

Patient Information leaflet

Ink sequence to reflect order of Repro trapping
based on luminosity of inks (lightest to darkest)
T R I D E N T   A R T W O R K   P A N E L
CUTTER/PRINT TO CUT 
CODE AREA
Pantone 021
INKS:
ARTIST SIGN: 
QA SIGN: 
_This low resolution colour printout has been produced as a guide only
to _
_colour separation and typographic/graphic content and should not be
used_
_to assess image sharpness/clarity or accurate colour matching. _
CUSTOMER:
Reckitt Benckiser
REF CODE:
RB189226
BRIEF NO:
RB189226/02
DIMENSIONS: 
(VERTICAL X HORIZONTAL)
70(v) x 179(h) mm
ACTION:
B
DATE:
27/03/01
BARCODE MAG:
NA
SUBSTRATE:
Foil with paper laminate
APPLICATION:
Illustrator 8
PRINTER:
Lawson Mardon Flexibles
PRINT PROCESS:
Gravure
TRUNC / BWR:
NA
DESCRIPTION:
Fybogel
Orange Laminate UK
#189226
HOW TO USE FYBOGEL ORANGE:
To mak
o make a pleasant orange high fibre drink briskly stir the 
sachet contents into a glass of cold w
sachet contents into a glass of cold water (approx 
1
/
4
 pint 
 pint 
or 150ml) and dr
or 150ml) and drink straight away, preferably after a meal.
ly after a meal.
DOSAGE:
ADULTS AND CHILDREN OVER 12: one sachet in the mor
 one sachet in the morning 
and one in the evening, or as prescribed by your doctor.
CHILDREN 6 - 12:
CHILDREN 6 - 12: 
1
/
2
 - 1 le
 - 1 level 5ml spoonful, mor
el 5ml spoonful, morning and 
ning and 
evening, depending on age and size.
CHILDREN UNDER 6 Y
CHILDREN UNDER 6 YEARS: to be tak
 to be taken only on medical 
en only on medical 
advice, 
1
/
2
 - 1 le
 - 1 level 5ml spoonful, depending on age and 
el 5ml spoonful, depending on age and 
size, mor
, morning and evening.
Each sachet of Fybogel Or
Each sachet of Fybogel Orange g
ange granules contains:
ules contains: 3.5g of 
Ispaghula Husk BP in a base containing aspar
Ispaghula Husk BP in a base containing aspartame and 
tame and 
potassium bicarbonate
potassium bicarbonate.
KEEP ALL MEDICINES OUT OF THE REAC
EEP ALL MEDICINES OUT OF THE REACH OF CHILDREN. DO NOT 
TAKE MORE FYBOG

Summary of Product characteristics

Page 1 of 4 
SUMMARY  OF  PRODUCT  CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Fybogel Orange. 

2. QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 

A unit dose (one sachet or two level 5 ml spoonfuls) contains 3.5
g ispaghula husk BP. 

3. PHARMACEUTICAL 
FORM 

Effervescent granules. 

4. CLINICAL 
PARTICULARS 

 4.1. 
THERAPEUTIC 
INDICATIONS 

The treatment of patients requiring a high fibre
regime: for example, for the relief of 
constipation, including constipation in pregnancy and
the maintenance of regularity; 
for the management of bowel function in
patients with colostomy, ileostomy, 
haemorrhoids, anal fissure, chronic diarrhoea associated
with diverticular disease, 
irritable bowel syndrome and ulcerative colitis. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Fybogel Orange is intended for oral use as a suspension in
a drink of water.  The 
granules should be stirred into a glass of water
and taken as soon as the 
effervescence subsides, preferably after meals. 

Adults and children over 12 years:      

One sachet or two level 5 ml spoonfuls 
morning and evening. 

Elderly: 
There is no indication that dosage needs to be 
modified for the elderly. 

Children aged 6 to 12 years: 
Half to one level 5 ml spoonful, depending on 
age and size, morning and evening. 

Children under 6 years: 
To be taken only when prescribed by a doctor, half to 
one level 5 ml spoonful depending on age and
size, morning and evening.   

4.3. CONTRAINDICATIONS 

Fybogel Orange is contra-indicated in cases of intestinal
obstruction and colonic 
atony such as senile mega-colon. 

Page 2 of 4 
           4.4. 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

Due to its aspartame content Fybogel Orange should not
be given to pat