Fybogel Mebeverine Granules for Oral Suspension Ispaghula Husk 3.5g Mebeverine Hydrochloride 135mg

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Mebeverine hydrochloride; Ispaghula husks

Dostupné z:

Reckitt Benckiser Ireland Ltd

ATC kód:

A06AC; A06AC51

INN (Medzinárodný Name):

Mebeverine hydrochloride; Ispaghula husks

Dávkovanie:

3.5 g/135 milligram(s)

Forma lieku:

Granules for oral suspension

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Bulk-forming laxatives; ispaghula, combinations

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1986-03-14

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
FYBOGEL MEBEVERINE
GRANULES FOR ORAL SUSPENSION
ISPAGHULA HUSK 3.5G
MEBEVERINE HYDROCHLORIDE 135MG
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Fybogel Mebeverine is and what it is used for
2. What you need to know before you take Fybogel Mebeverine
3. How to take Fybogel Mebeverine
4. Possible side effects
5. How to store Fybogel Mebeverine
6. Contents of the pack and other information
1.WHAT FYBOGEL MEBEVERINE IS AND WHAT IT IS USED FOR
Fybogel Mebeverine contains ispaghula husk, which is a natural plant
material which is high in fibre. Ispaghula
husk increases fibre in your diet helping your digestive system work
more efficiently and gently relieve
constipation in a natural way helping to restore and maintain
regularity. Mebeverine is an antispasmodic drug
which relieves spasms and cramps, which occur in the gut causing pain.
This product is used to relieve symptoms of irritable bowel syndrome.
If you have irritable bowel syndrome, you
are likely to suffer from painful spasms of the gut and irregular
bowel habits. Fybogel Mebeverine is effective in
relaxing the spasms of the gut, relieving pain. At the same time
Fybogel Mebeverine will help you to restore and
maintain bowel regularity.
2.WHAT YOU NEED TO KNOW BEFORE YOU USE FYBOGEL MEBEVERINE
DO NOT TAKE FYBOGEL MEBEVERINE IF YOU
are suffering from a BLOCKAGE OF THE BOWEL (intestinal obstruction or
faecal impaction)
have MUSCLE WEAKNESS OF THE BOWEL WALL (colonic atony)
are ALLERGIC to ispaghula husk or mebeverine (See section 2“Warnings
and precautions) or any
of the other ingredients of this medicine (see section 6)
have chronic c

Súhrn charakteristických

Health Products Regulatory Authority
14 March 2023
CRN00CPMY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fybogel Mebeverine Granules for Oral Suspension Ispaghula Husk 3.5g
Mebeverine Hydrochloride 135mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
ACTIVE INGREDIENT
G/SACHET
Ispaghula husk
Mebeverine hydrochloride
3.5
0.135
Excipient(s) with known effect:
Aspartame: 16 mg per sachet
Sodium: 58.65 mg (2.55 mmol) per sachet
Total maximum daily dose (MDD) is 176.0mg (7.65mmol)
Potassium: 97.6 mg (2.5 mmol) per sachet
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension in a unit dose sachet
Buff-coloured granules and orange-coloured spheroids.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment 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.
ELDERLY: There is no indication that the dose needs to be modified for
the elderly.
Children below 12: The product is not recommended in children under 12
years of age (see Section 4.4).
The product is intended for oral administration as a suspension in
water (See section 4.4 Special Warnings and Precautions for
Use). The product should be stirred into a glass of cold water
(approx. 240 mls) and taken immediately.
The doctor should be consulted if you develop new symptoms, or if your
symptoms worsen, or if symptoms do not improve
after 2 weeks treatment (See section 4.4).
The product should be taken during the day at least ½ to 1 hour
before or after intake of other medicines and the product
should not be taken immediately before going to sleep.
Effects may take several 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.
Health Products Regulatory Auth