ALUPENT 10 MG/5ml Syrup
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
ORCIPRENALINE SULFATE
Available from:
Boehringer Ingelheim Limited
INN (International Name):
ORCIPRENALINE SULFATE
Dosage:
10 MG/5ml
Pharmaceutical form:
Syrup
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2010-12-17
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)
PA0007/015/004
Case No: 2066509
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BOEHRINGER INGELHEIM LIMITED
ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ALUPENT SYRUP 10MG/5ML
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 29/10/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/10/2009_
_CRN 2066509_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alupent Syrup 10mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains Orciprenaline sulphate 10 mg.
Excipients: Also includes sodium metabisulphite (E223) 500 micrograms/5ml; methyl parahydroxybenzoate (E218)
14mg/5ml; propyl parahydroxybenzoate (E216) 50 micrograms/5ml and sorbitol solution (70 per cent) (non-
crystallising) (E420) 2.0g/5ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Clear, colourless to slightly yellow, brown syrup with a faint odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ALUPENT is indicated as a bronchodilator in the relief of bronchospasm
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