Reckitt Benckiser Ireland Limited

Fybogel Orange 3.5g Effervescent Granules

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

Excipients: Also includes Aspartame (E951) 0.016g per unit dose.

For a full list of excipients, see section 6.1.

Effervescent granules.

Orange flavoured flaky granules of orange to buff colour which after dispersion in water forms an effervescent suspension.

In the management of patients requiring a high-fibre regimen.

Fybogel Orange is intended for oral use after suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as the effervescence subsides. Concentrated fruit juices or natural juice may be added to taste.

Adults and children over 12 years: One sachet or two level 5 ml spoonfuls each morning and evening, preferably after meals.

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

Children 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 5ml spoonful, depending on age and size, morning and evening.

Fybogel Orange is contraindicated in cases of intestinal obstruction and colonic atony.

Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.

Adequate fluid intake should be maintained.

None known.

Fybogel Orange may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.

None.

Flatulence and bloating may be experienced during the first few days of treatment, but diminish during continued treatment.

In the event of overdosage conservative measures should be taken. The patient may notice abdominal discomfort and flatulence, and attention should be paid to maintaining an adequate fluid intake, particularly if the granules have been taken without water contrary to administration instructions.

Ispaghula husk is capable of absorbing up to 40 times its own weight in water in vitro, and part of its activity can be attributed to its action as a simple bulking agent. In addition, colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass and consequent softening of the faeces.

The mode of action of Fybogel Orange is physical and does not depend on absorption into the systemic circulation.

No relevant preclinical findings relevant to the prescriber have been reported.

Potassium bicarbonate

Sodium bicarbonate

Citric acid anhydrous

Beta-carotene 10% CWS/S (E160a) (contains: Beta carotene, All-rac-alpha-tocopherol, Maize oil refined, Maize Starch and Modified food starch)

Riboflavin sodium phosphate

Aspartame E951

Orange Flavour

Saccharin Sodium

colloidal anhydrous silica

Polysorbate 80

Not applicable.

2 years.

Store below 30° C.

Multidose containers: Keep container tightly closed to protect from moisture.

Sachets: Store in the original package to protect from moisture.

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

Carton containing 10 and 30 sachets.

No special requirements.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/9/2

Date of first authorisation: 8th April, 1993

Date of last renewal: 8th April, 2008

May, 2009.