XYLOPROCT 5/0.275 %w/w Rectal Ointment
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
LIDOCAINE HYDROCORTISONE ACETATE
Available from:
AstraZeneca UK Limited
INN (International Name):
LIDOCAINE HYDROCORTISONE ACETATE
Dosage:
5/0.275 %w/w
Pharmaceutical form:
Rectal Ointment
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2009-03-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0970/056/001
Case No: 2044051
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTRAZENECA UK LIMITED
600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
XYLOPROCT 5%/0.275% W/W RECTAL OINTMENT
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 17/12/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/12/2008_
_CRN 2044051_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xyloproct 5%/0.275% w/w Rectal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 100 g:
Lidocaine 5 g.
Hydrocortisone Acetate 0.275 g.
Also contains: Stearyl alcohol 0.9% w/w and Cetyl alcohol 7.4% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal Ointment
A white to slightly yellowish rectal ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the relief of symptoms associated with such anal and perianal conditions as haemorrhoids, proctitis, fissure in ano,
anal fissure, fistula or pruritus ani or perinei.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To b
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