Ispagel Orange

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISPAGHULA HUSKS

Available from:

Boston Healthcare Limited Unit 6, Navigation Court, Calder Park, Wakefield, West Yorkshire WF2 7JB, 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:

Withdrawn

Authorization date:

2006-04-19

Patient Information leaflet

Package Leaflet: Information for the user
ISPAGEL ORANGE
ISPAGHULA HUSK GRANULES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
•  Keep this leaflet. You may need to read it again.
•  Ask your pharmacist if you need more information or advice.
•  If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
•  You must talk to a doctor if you do not feel better or if you
feel worse.
IN THIS LEAFLET:
1. What Ispagel Orange is and what it is used for
2. What you need to know before you take Ispagel Orange
3. How to take Ispagel Orange
4. Possible side effects
5. How to store Ispagel Orange
6. Contents of the pack and other information
1. WHAT ISPAGEL ORANGE IS AND WHAT IT IS USED FOR
The name of your medicine is Ispagel Orange. It contains the active 
ingredient ispaghula husk in the form of granules which, when 
dispersed in water, make an orange flavoured drink.
Ispaghula husk is a type of natural fibre that belongs to a group of 
medicines known as bulk-forming laxatives. It works by increasing
the 
bulk of your stools so encouraging your bowels to move them through 
your digestive system and also helping to regulate their passage.
Ispagel Orange is for the treatment of constipation and to help 
maintain normal bowel function in people with a colostomy or 
ileostomy, diarrhoea associated with diverticular disease, irritable 
bowel syndrome (IBS) or ulcerative colitis. It is also for use by
people 
with haemorrhoids (piles) or anal fissures to make bowel movements 
more regular and easier to pass, and so avoid straining.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
  ISPAGEL ORANGE
DO NOT TAKE ISPAGEL ORANGE IF YOU:
•  are allergic (hypersensitive) to ispaghula husk or any of the
other 
  ingredients of Ispagel Orange (see

Summary of Product characteristics

Page 1 of 3

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
 NAME OF THE MEDICINAL PRODUCT 
Ispagel Orange 

2 
 QUALITATIVE AND QUANTITATIVE COMPOSITION 
Ispaghula Husk granules 3.5g 
For a full list of excipients, see section 6.1. 

3  
PHARMACEUTICAL FORM 
Effervescent Granules for Oral Suspension. 

4  
CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 
For the treatment of constipation, for use in patients with
colostomy, ileostomy, haemorroids, anal 
fissure, chronic diarrhoea associated with diverticular disease,
irritable bowel syndrome, and as 
adunctants in ulcerative colitis. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
FOR CONSTIPATION. 
Adults: One sachet one to three times daily, mixed in at least
150 ml of liquid, followed by 
additional liquid. 
Children 6 – 12 years half the adult dose; children under
6 years consult a physician. Ispagel Orange 
should be taken with an adequate intake of fluid and not
before bedtime. 

4.3 CONTRAINDICATIONS 
Ispagel Orange should not be given to patients with intestinal
obstruction or conditions likely to 
lead to this, abdominal pain, nausea or
vomiting, colonic atony such as senile megacolon, difficulty 
in swallowing, faecal impaction, or known hypersensitivity to
ispaghula. Patients suffering from 
phenylketonurea should not take this product. 

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
If symptoms persist consult your doctor. Due to its
aspartame content Ispagel Orange should not be 
given to patients with phenylketonuria.  
Ispaghula should not be given to patients with natural or
drug induced failure of gut motility. 
Taking this product without adequate fluid may cause it to
swell and block the throat or oesophagus 
and may cause choking. This product should not be taken if
there is difficulty in swallowing. If 
chest pain, vomiting, or difficulty in swallowing or breathing is
experienced