Skip to Content

ISOGEL

Active substance(s): ISPAGHULA HUSK

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Isogel

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Isogel contains dried Ispaghula Husk 90% w/w.

3

PHARMACEUTICAL FORM
Small reddish granules

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Isogel is not absorbed from the G.I. tract, but it absorbs water to form a mucilaginous
mass. This results in a purely mechanical stimulus to mass peristalsis without any
purgative effect. It is for this reason that Isogel is not only an effective remedy for
constipation, but is also of value in the treatment of diarrhoea, irritable bowel
syndrome and the management of patients with a colostomy. Isogel is indicated in
habitual constipation, including cases due to spastic colon, dietary insufficiencies and
in patients with haemorrhoids or diabetes. It can be used to normalise the bowel
movement in patients with mucous or ulcerative colitis.
Isogel is of help to patients with a colostomy as the formation of a well-formed, easily
passed stool assists in the maintenance of cleanliness and the establishment of
control.

4.2

Posology and method of administration
Route of administration: oral
The required quantity of Isogel should be stirred briskly into half a glass of water and
swallowed at once. Carbonated water is frequently preferred and may make
swallowing easier.

Adults
2 teaspoonfuls once or twice daily, preferably at mealtimes.
Children
1 teaspoonful once or twice daily preferably at mealtimes.
Elderly
As for adults. Elderly or debilitated patients should be supervised whilst taking
Isogel.
The above dosage is only a general guide and it should be adjusted to suit the needs
of each individual patient.
In diarrhoea the dose, usually 1 teaspoonful, is taken 3 times daily until symptoms
abate.

4.3

Contraindications
None known

4.4

Special warnings and precautions for use
This product contains sodium metabisulphite, which rarely may cause severe
hypersensitivity reactions and bronchospasm.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Fertility, Pregnancy and lactation
No known effects. However, as with all medicines, care should be taken during
pregnancy particularly during the first trimester. No effects in lactation.

4.7

Effects on ability to drive and use machines
No effects

4.8

Undesirable effects
A few cases of inhalation of the mucilaginous mass which forms on allowing
an Isogel/water mixture to stand have been reported. In consequence, it is
important that Isogel should be swallowed immediately after mixing and
elderly or debilitated patients should be supervised whilst taking it.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

4.9

Overdose
As Isogel is not absorbed and it has no purgative action, the problem of overdose does
not arise.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Isogel absorbs water to form a mucilaginous mass. This results in a purely mechanical
stimulus to mass peristalsis without any purgative effect.

5.2

Pharmacokinetic properties
Not applicable, as Isogel is not absorbed.

5.3

Preclinical safety data
None presented.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Erythrosine solution
Sodium Metabisulphite
Phosphoric Acid
Gum mucilage
Purified Water
Gum mucilage: Acacia tears, methyl hydroxybenzoate, propyl hydroxybenzoate,
purified water.

6.2

Incompatibilities
None known

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25°C. Keep the container tightly closed to protect from moisture.

6.5

Nature and contents of container
Cardboard outer cartons with greaseproof liners or polypropylene-polyethylene
laminate sachets containing 150g, 165g, 200g and 300g.

6.6

Special precautions for disposal
Isogel is supplied as granules. The patient should stir the required quantity briskly
into half a glass of water and swallow at once. Carbonated water may make
swallowing easier.

7

MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited

1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ

8

MARKETING AUTHORISATION NUMBER(S)
PL 44893/0032

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/08/2012

10

DATE OF REVISION OF THE TEXT
02/11/2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide