Fybogel Orange 3.5 g granules

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Ispaghula husks

Dostępny od:

Reckitt Benckiser Ireland Ltd

Kod ATC:

A06AC; A06AC01

INN (International Nazwa):

Ispaghula husks

Dawkowanie:

3.5 gram(s)

Forma farmaceutyczna:

Granules

Typ recepty:

Product not subject to medical prescription

Dziedzina terapeutyczna:

Bulk-forming laxatives; ispaghula (psylla seeds)

Status autoryzacji:

Marketed

Data autoryzacji:

1993-04-08

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
FYBOGEL ORANGE
3.5 G GRANULES
Ispaghula Husk
READ ALL THIS INFORMATION BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
This medicine is available without prescription. However, you still
need to take Fybogel Orange carefully to get
the best results from it.
Keep this leaflet. You may read it again
Ask your pharmacist if you need more information or advice.
You must contact your doctor if your symptoms worsen or do not
improve.
If any side effects get serious, or you notice any side effects not
listed in this leaflet, please tell you doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Fybogel Orange is and what it is used for
2.
Before you take Fybogel Orange
3.
How to take Fybogel Orange
4.
Possible side effects
5.
How to store Fybogel Orange
6.
Further information
1. WHAT FYBOGEL IS AND WHAT IS IT USED FOR
Fybogel Orange is a high fibre drink containing the active ingredient
Ispaghula Husk. It increases fibre in your diet
helping your digestive system work more efficiently and relieve
constipation, helping to store and maintain
regularity.
It should be used for patients requiring a high fibre regime for use
in the relief of constipation.
2.WHAT YOU NEED TO KNOW BEFORE YOU USE FYBOGEL ORANGE
DO NOT TAKE FYBOGEL IF:

You are allergic to plantago ovata seeds or any of the other
ingredients of this
medicine (see in this section “Warnings and precautions” below)

You are allergic to the active ingredient or any of the excipients
listed in section 6

You are suffering from blockage of the bowel (intestinal obstruction,
faecal impaction)

You are suffering from muscle weakness of the bowel wall (colonic
atony)

The speed in which material moves through your gut has always been
slow (naturally occurring reduced gut
motility).

You are suffering from phenylketonuria, contains aspartame (E951) a
source of phenylalanine

You have a sudden change in bowel habit that lasts more than 2 weeks

You have undiagnosed rectal bleeding and are not able to defecate
f

Charakterystyka produktu

Health Products Regulatory Authority
21 January 2021
CRN009ZSF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fybogel Orange 3.5 g granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose sachet contains 3.5g ispaghula husk.
Excipient(s) with known effect:
Aspartame (E 951): 16 mg per sachet
Sodium: 7.015 mg (0.305 mmol) per sachet
Total maximum daily dose (MDD) is 14.03 mg (0.610 mmol)
Potassium: 9.76 mg (0.25 mmol) per sachet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules
Orange flavoured flaky granules of orange to buff colour which after
dispersion in water form a suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For ahigh-fibre regime indicated for use in the relief of
constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fybogel Orange is intended for oral administration as a suspension in
a full glass of water (See section 4.4). The granules
should be stirred into a glass of water and taken as soon as possible.
Concentrated fruit juices or natural juice may be added to
taste.
Adults and children over 12 years: One sachet or two level 5 ml
spoonfuls of granules to be reconstituted as above each
morning and evening, preferably after meals.
Elderly: There is no indication that dosage needs to be modified for
the elderly.
Children aged 6 to 12 years: Half to one level 5 ml spoonful of
granules, depending on age and size, to be reconstituted as
above, morning and evening.
Children under 6 years: The use in children under 6 years of age is
not recommended (See section 4.4 ‘Special warning and
precautions for use’).
If there have been no bowel movements after 3 days of treatment a
doctor should be consulted. (See section 4.4 ‘Special
warnings and precautions for use’).
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.
The effects start 12-24 hours later.
When preparing the product for administration,