Reckitt Benckiser Ireland Limited

Fybogel Citrus 3.5 g Effervescent Granules

Each single dose sachet contains 3.5 g ispaghula husk.

Excipients: each sachet contains 0.016g aspartame.

For a full list of excipients, see section 6.1.

Effervescent granules.

Semi-transparent buff coloured granules with an odour of orange.

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

Fybogel Citrus is intended for oral use after suspension in 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 5 ml spoonfuls each morning and evening, preferably after meals.

Elderly: There is no indication that dosage need 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 12 years: To be taken only when prescribed by a doctor. The usual dose is half to one level 5 ml spoonful, depending on age and size, morning and evening.

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

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

Adequate fluid intake should be maintained.

None known.

Fybogel Citrus 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 should 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 of 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 Citrus is physical and does not depend on absorption into the systemic circulation.

No preclinical findings relevant to the prescriber have been reported.

Citric acid anhydrous

Potassium hydrogen carbonate

Sodium hydrogen carbonate

Orange flavour

Aspartame E951

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

Riboflavin sodium phosphate

Saccharin sodium E954

Silica colloidal anhydrous

Polysorbate 80

Not applicable.

2 years.

Do not store above 30°C. Store in the original package in order to protect from moisture.

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

Carton containing 2, 10 and 30 sachets.

Not all pack sizes may be marketed.

No special instructions.

The granules are semi-transparent and buff-coloured with an odour of orange which when added to water form an effervescent suspension.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/9/1.

Date of first authorisation: 27th January 1975

Date of last renewal: 27th January 2010

April 2011