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ISOGEL

Active substance(s): ISPAGHULA HUSK

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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 wellformed, 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.

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,
hydroxybenzoate, purified water.

methyl

hydroxybenzoate,

propyl

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 polypropylenepolyethylene laminate sachets containing 150g, 165g, 200g and 300g.

6.6

Special precautions for disposal and other handling
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
Vifor Pharma UK Ltd
1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ

8

MARKETING AUTHORISATION NUMBER(S)
PL 33656/0023

9

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

10

DATE OF REVISION OF THE TEXT
16/08/2012

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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.

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