FYBOGEL Granules Ref.[27564] Active ingredients: Ispaghula

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

Product name and form

Fybogel.

Pharmaceutical Form

Granules.

Qualitative and quantitative composition

Each single dose sachet contains 3.5g ispaghula husk EP.

Excipients with known effect:

Aspartame (E 951) 16 mg/sachet

Potassium 9.76 mg/Sachet

For the full list of excipients see section 6.1.

Active Ingredient Description
Ispaghula

Ispaghula is particularly rich in alimentary fibres and mucilages. Ispaghula is capable of absorbing up to 40 times its own weight in water. Gut motility and transit rate can be modified by ispaghula through mechanical stimulation of the gut wall as a result of the increase in intestinal bulk by water and the decrease in viscosity of the luminal contents.

List of Excipients

Potassium bicarbonate Ph Eur
Sodium bicarbonate Ph Eur
Citric acid Ph Eur
Riboflavin sodium phosphate Ph Eur
Beta-carotene 10% (E160a) HSE
Aspartame Ph Eur
Saccharin sodium Ph Eur
Polysorbate 80 Ph Eur
Silica, colloidal anhydrous Ph. Eur

Pack sizes and marketing

Sachets of paper/aluminium foil/polythene laminate enclosed in a cardboard outer carton.

Pack size(s): Ten or thirty sachets (pack size printed in bold is currently sold).

Marketing authorization holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

Marketing authorization dates and numbers

PL 00063/0023

15/01/1990 / 09/06/2003

Drugs

Drug Countries
FYBOGEL Ireland, Malta, Turkey, United Kingdom, South Africa

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