OMNEXEL 400 Microgram Tablet Prolonged Release
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
21-05-2024
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Virkt innihaldsefni:
TAMSULOSIN HYDROCHLORIDE
Fáanlegur frá:
Profind Wholesale Ltd
INN (Alþjóðlegt nafn):
TAMSULOSIN HYDROCHLORIDE
Skammtar:
400 Microgram
Lyfjaform:
Tablet Prolonged Release
Gerð lyfseðils:
Product subject to prescription which may be renewed (B)
Leyfisstaða:
Withdrawn
Leyfisdagur:
2013-03-05
Vara einkenni
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
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