Fybogel Citrus 3.5 g Granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ispaghula husks

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A06AC; A06AC01

INN (International Name):

Ispaghula husks

Dosage:

3.5 gram(s)

Pharmaceutical form:

Granules

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Bulk-forming laxatives; ispaghula (psylla seeds)

Authorization status:

Marketed

Authorization date:

1975-01-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FYBOGEL CITRUS
3.5G GRANULES
Ispaghula Husk
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However you still
need to take Fybogel Citrus carefully to get the
best results from it.
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 any of the side effects get serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1. What Fybogel Citrus is and what is it used for
2. Before you take Fybogel Citrus
3. How to take Fybogel Citrus
4. Possible side effects
5. How to store Fybogel Citrus
6. Further information
1.WHAT FYBOGEL CITRUS IS AND WHAT IT IS USED FOR
Fybogel Citrus 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 gently
relieves constipation in a natural way, helping to
restore and maintain regularity.
It should be used in the management of patients requiring a high fibre
regimen. It is also recommended to help
maintain a normal bowel function among patients suffering from
irritable bowel syndrome, colostomy or
ileostomy, haemmorhoids (piles), anal fissure, persistent diarrhoea
associated with diverticular disease or
ulcerative colitis.
2.WHAT YOU NEED TO KNOW BEFORE YOU USE FYBOGEL CITRUS
DO NOT USE FYBOGEL CITRUS 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)

You are suffering from muscle weakness of the bowel wall (colonic
atony)

You suffer from phenylketonuria, contains aspartame (E951) a source of

Summary of Product characteristics

Health Products Regulatory Authority
21 January 2021
CRN009ZSF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fybogel Citrus 3.5 g Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose sachet contains 3.5 g ispaghula husk.
Excipient(s) with known effect:
Aspartame (E 951): 16 mg per sachet
Sodium: 6.95 mg (0.302 mmol) per sachet
Total maximum daily dose (MDD) is 13.9 mg (0.604 mmol)
Potassium: 9.76 mg (0.25 mmol) per sachet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules
Semi-transparent buff coloured granules with an odour of orange.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of patients requiring a high-fibre regimen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS: One sachet or two 5 ml spoonfuls
each morning and evening, preferably after meals.
ELDERLY: There is no indication that dosage need be modified for the
elderly.
CHILDREN 6 TO 12 YEARS: Half to one level 5 ml spoonful, depending on
age and size, morning and evening.
CHILDREN UNDER 6 YEARS: To be taken only when prescribed by a doctor.
The usual dose is half to one level 5 ml spoonful,
depending on age and size, morning and evening.
Fybogel Citrus is intended for oral use after suspension in water. The
granules should be stirred into a glass of water and taken
as soon as the effervescence subsides. Concentrated fruit juices or
natural juice may be added to taste.
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 sensitization to the active ingredient.
The last dose should not be taken immediately before going to sleep.
If there have been no bowel movements after 3 days of treatment a
doctor should be consulted. (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 should not be
taken immediately before going to sleep.
The effects start 12-24 hours later.
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