Reckitt Benckiser Ireland Limited

Fybogel Mebeverine Granules for Oral Suspension

Ispaghula Husk 3.5 g

Mebeverine hydrochloride 135 mg

Each sachet contains:

Excipients: Aspartame E951, potassium and sodium.

For a full list of excipients, see Section 6.1.

Granules for oral suspension in a unit dose sachet.

Buff-coloured granules and orange-coloured spheroids.

For the treatment of irritable bowel syndrome.

One sachet morning and evening or as directed by the physician.

An additional sachet may be taken before the midday meal if necessary.

The contents of sachet should be stirred into a glass of cold water and drunk immediately.

1. Contraindicated in cases of intestinal obstruction or faecal impaction.

2. Hypersensitivity to ispaghula or mebeverine.

1. This medicinal product contains 2.5 mmol of potassium per dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

2. This medicinal product contains 2.73 mmol of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

3. This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.

4. Adequate fluid intake should be maintained.

Patients receiving antihypertensive medication may need adjustment of dosage during co-treatment with this agent.

The product should not be used during pregnancy unless considered essential by the physician.

None known.

None known.

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 product has been taken without water contrary to the administration instructions.

Ispaghula husk

Ispaghula husk is capable of absorbing up to forty 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 with a consequential softening of the faeces.

Mebeverine hydrochloride

Mebeverine hydrochloride is a musculotropic antispasmodic agent which exerts a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.

Ispaghula husk

Ispaghula husk has a physical mode of action and does not depend upon absorption into the gastrointestinal tract.

Mebeverine hydrochloride

Mebeverine hydrochloride has been shown to be nearly completely absorbed following oral administration, but first-pass metabolism is extensive and plasma levels of unchanged drug are very low. This supports the view that its action is directly on the muscle of the gastrointestinal tract, rather than as a result of systemic absorption.

Ispaghula husk and mebeverine hydrochloride are well-established drug substances with a known safety record. No further data are submitted.

Aspartame (E951)

Sodium hydrogen carbonate

Citric acid

Potassium hydrogen carbonate

Orange flavour

Saccharin sodium

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

Microcrystalline cellulose

Eudragit

Sterilised talc

Macrogol

Apocarotenal

Polysorbate 80

Silica, colloidal anhydrous

Riboflavine sodium phosphate

None known.

Two years.

Store below 30°C. Store in the original package.

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

Cartons containing 2 and 10 sachets.

This product must be mixed with a glass of cold water prior to administration and taken immediately.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/10/1.

Date of first authorisation: 14th March, 1986

Date of last renewal: 14th March, 2006.

September, 2007.