TAMSULAS Prolonged Release Capsules 0.4 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-04-2024
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Active ingredient:
TAMSULOSIN HYDROCHLORIDE
Available from:
Biokanol Pharma GmbH
Dosage:
0.4 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
2007-04-27
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)
PA1304/001/001
Case No: 2045363
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BIOKANOL PHARMA GMBH
KEHLER STRASSE 7, 76437 RASTATT, GERMANY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TAMSULAS 400 MICROGRAMS PROLONGED RELEASE CAPSULES, HARD
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 13/05/2008 until 12/05/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/05/2008_
_CRN 2045363_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamsulas 400 micrograms prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 micrograms of tamsulosin hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Orange no 2 gelatin capsule which contains white or yellowish granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One capsule daily, to be taken after breakfast or after the first meal of the day.
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