Fybogel Mebeverine
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fybogel Mebeverine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A sachet contains 3.5g ispaghula husk BP and 135mg 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 (150ml; A 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.
4.4 Special Warnings and Special 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
• Have acute porphyria
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
Pre-clinical Safety Data
No preclinical findings of relevance to the prescriber have been reported.
6.1 List of excipients
Microcrystalline cellulose
Basic Butylated Methacrylate Copolymer
Talc sterilised Ph Eur
Polyethylene Glycol 6000
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 Instruction for use and handling
The contents of one sachet should be stirred into a glass of cold water (150ml; about / pint) and taken immediately.
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
24/04/1995
10 DATE OF REVISION OF THE TEXT
10/07/2012