OMNEXEL Tablet Prolonged Release 400 Microgram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
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Active ingredient:
TAMSULOSIN HYDROCHLORIDE
Available from:
LTT Pharma Limited
Dosage:
400 Microgram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2011-09-02
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omnexel 400 micrograms prolonged release tablets, film-coated.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release film-coated tablet contains 400 micrograms tamsulosin hydrochloride.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated, prolonged release tablet.
_Product imported from the UK:_
(Oral Controlled Absorption System, OCAS).
Approximately 9mm in diameter, found, bi-convex, yellow, film-coated and 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 be examined
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