FYBOGEL LEMON
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
ISPAGHULA HUSKS
Available from:
Reckitt Benckiser Ireland Ltd
Dosage:
3.5 Grams
Pharmaceutical form:
Granules Effervescent
Authorization date:
2001-09-21
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0979/009/003
Case No: 2032524
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants
to
RECKITT BENCKISER IRELAND LTD
7 RIVERWALK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FYBOGEL LEMON 3.5G EFFERVESCENT GRANULES
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to
the general conditions as may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 06/02/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/04/2007_
_CRN 2032524_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fybogel Lemon 3.5g Effervescent Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 3.5g ispaghula husk.
Also contains 16mg aspartame, per sachet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent granules
Orange to buff-coloured granules with a lemon odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clinical Indication: for the treatment of patients requiring a high fibre regimen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fybogel Lemon is intended for oral administration in a suspension in a drink of water. The granules
should be stirred into a glass of water an
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