Fybogel Mebeverine effervescent granules sachets orange

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ispaghula husk; Mebeverine hydrochloride

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

A06AC51

INN (International Name):

Ispaghula husk; Mebeverine hydrochloride

Dosage:

3.5gram ; 135mg

Pharmaceutical form:

Effervescent granules

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01020000; GTIN: 5000158063044

Patient Information leaflet

Reckitt Benckiser
0008 PL00063/0025 SmPC Update with CCDS RTQ
Round 3
1.3.2 Mock-up - Clean
Fybogel Meberverine 0061786 and 0083916
Page 2

Summary of Product characteristics

OBJECT 1
FYBOGEL MEBEVERINE
Summary of Product Characteristics Updated 25-Jul-2017 | Forum Health
Products Limited
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
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 (see section 4.4).
POSOLOGY
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.
Elderly: There is no indication that the dose need be modified for the
elderly.
Children below 12: Not recommended (see section 4.3).
METHOD OF ADMINISTRATION
The contents of one sachet should be stirred into a glass of cold
water (150 ml minimum) and drunk
immediately.
The product should be taken during the day at least ½ to 1 hour
before or after intake of other medicines
and should not be taken immediately before going to sleep.
Effects may take 12-24 hours.
When preparing the product for administration, it is important to try
to avoid inhaling any of the powder
in order to minimize the risk of sensitisation to the active
ingredient.
4.3 Contraindications
Hypersensitivity to ispaghula husk, mebeverine or to any of the
excipients listed in section 6.1. (See
Section 4.4).
Patients with a sudden change in bowel habit that has persisted more
than two weeks.
Undiagnosed rectal bleeding and failure to defecate following the use
of a laxative.
Patients suffering from abnormal constrictions in the
gastro-intestinal tract, with diseases of the
oesophagus and cardia, potential or existing intestinal blockage
(ileus), paralysis of the intestine or
megacolon.
Patients who have difficulty in swallo