CARDURA Tablets 2 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
DOXAZOSIN MESILATE
Available from:
PCO Manufacturing
Dosage:
2 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2000-08-18
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA0465/063/002A
Case No: 2086852
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PCO MANUFACTURING LIMITED
UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CARDURA 2 MG TABLET
the particulars of which are set out in 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 10/08/2010 until 17/09/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/08/2010_
_CRN 2086852_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardura 2 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains doxazosin mesilate equivalent to 2mg doxazosin.
Excipients: includes Lactose
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White oval tablets marked ‘DXP2’ on one side and ‘PFIZER’ on the other.
_Product imported from Greece, Italy and Hungary:_
White, flat bevelled edged tablets with ‘CN2’ and a breakline on one side and ‘PFIZER’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION: Cardura is indicated for treatment of hypertension a
Read the complete document
