Fybogel Mebeverine

1. Name Of The Medicinal Product

Fybogel Mebeverine.

2. Qualitative And Quantitative Composition

A sachet contains 3.5 g ispaghula husk BP and 135 mg mebeverine hydrochloride BP.

3. Pharmaceutical Form

Granules for oral suspension in unit dose sachet.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of irritable bowel syndrome.

4.2 Posology And Method Of Administration

Adults and children over 12: One sachet morning and evening, taken half an hour before meals. A third dose may be taken before the midday meal if necessary.

Children below 12: Not recommended.

The doctor should be consulted if you develop new symptoms, or if your symptoms worsen, or if symptoms do not improve after two weeks treatment.

The contents of one sachet should be stirred into a glass of cold water (150 ml; ¼ pint) and drunk immediately.

There is no indication that the dose need be modified for the elderly.

4.3 Contraindications

Hypersensitivity to any ingredient.

Intestinal obstruction, paralytic ileus, faecal impaction and colonic atony such as senile megacolon.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Patients allergic to peanut or soya should not take this medicine

4.4 Special Warnings And Precautions For Use

Not recommended for children under 12.

Fybogel Mebeverine should not be taken in the dry form. Gastrointestinal obstruction or impaction have been reported with hydrophilic mucilloid preparations when taken with insufficient liquid, contrary to administration instructions.

As the product contains 7 mmol of potassium per sachet, caution should be exercised when potassium supplements or potassium sparing diuretics have been prescribed.

The Patient Information Leaflet shall contain the following wording:

If this is the first time you have had these symptoms, consult your doctor before using Fybogel Mebeverine.

Fybogel Mebeverine may not be the right treatment for you. Do not use it until you have seen a doctor if you:

• Are aged 40 years or over

• Have passed blood from the bowel

• Are feeling sick or vomiting

• Have lost your appetite or lost weight

• Are looking pale and feeling tired

• Are suffering from severe constipation

• Have a fever

• Have recently travelled abroad

• Are or may be pregnant

• Have abnormal vaginal bleeding or discharge

• Have difficulty or pain passing urine

• Have been prescribed diuretic medicine or a potassium supplemented diet

Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after two weeks of treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

In common with most drugs, care should be taken in prescribing during pregnancy.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

Anaphylactic reaction (frequency unknown)

Urticaria (frequency unknown)

Rash (frequency unknown)

Hypersensitivity (frequency unknown)

4.9 Overdose

In the event of overdose, conservative measures should be taken. The patients 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

5.2 Pharmacokinetic Properties

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

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 it acts directly on the muscle of the gastrointestinal tract, rather than as a result of systemic absorption.

5.3 Preclinical Safety Data

No preclinical findings of relevance to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose

Eudragit E100

Talc sterilised Ph Eur

Macrogol

Apocarotenal 10% WS

Citric acid

Potassium hydrogen carbonate

Sodium hydrogen carbonate

Polysorbate 80

Silica colloidal anhydrous

Orange flavour

Saccharin sodium

Beta-Carotene 10% CWS/S

Aspartame

Riboflavine sodium phosphate

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Store below 30°C.

Store in original container.

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

The contents of one sachet should be stirred into a glass of cold water (150 ml; about ¼ pint) and taken immediately.

No Data Held

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

8. Marketing Authorisation Number(S)

PL 00063/0025

9. Date Of First Authorisation/Renewal Of The Authorisation

24^th April 1995 / 18/06/2003

10. Date Of Revision Of The Text

August 2011