OMNEXEL 400 Microgram Tablet Prolonged Release

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

TAMSULOSIN HYDROCHLORIDE

제공처:

Profind Wholesale Ltd

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

복용량:

400 Microgram

약제 형태:

Tablet Prolonged Release

처방전 유형:

Product subject to prescription which may be renewed (B)

승인 상태:

Withdrawn

승인 날짜:

2013-03-05

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omnexel 400 microgram Prolonged Release Tablets, Film-coated.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release film-coated tablet contains 0.4 mg tamsulosin hydrochloride.
Excipients:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, Prolonged Release Tablets
(Oral Controlled Absorption System)
_Product imported from the Netherlands:_
Approximately 9 mm in diameter, round, bi-convex, yellow, film-coated tablets, debossed with the code ‘04’. 
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
Oral use.
One tablet daily.
Omnexel can be taken independently of food.
The tablet must be swallowed whole and not be crunched or chewed as this interferes with the prolonged release of the
active substance.
No dose adjustment is warranted in renal impairment.
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3,
Contraindications).
There is no relevant indication for use of Omnexel in children.
4.3 CONTRAINDICATIONS
Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioedema or to any of the excipients.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other 1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment
with Omnexel, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness,
weakness), the patient should sit or lie down until the symptoms have disappeared.
Before therapy with Omnexel is initiated, the patient should b