OMNEXEL 400 Microgram Tablet Prolonged Release

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

TAMSULOSIN HYDROCHLORIDE

Boleh didapati daripada:

Clear Pharmacy

INN (Nama Antarabangsa):

TAMSULOSIN HYDROCHLORIDE

Dos:

400 Microgram

Borang farmaseutikal:

Tablet Prolonged Release

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Status kebenaran:

Authorised

Tarikh kebenaran:

0000-00-00

Ciri produk

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 0.4 mg tamsulosin hydrochloride.
Excipients:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, prolonged release tablet.
(Oral Controlled Absorption System, OCAS).
_Product importedfrom the UK._
Approximately 9 mm in diameter, round, 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).
Paediatric population
There is no relevant indication for use of Omnexel in children.
The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are
described in section 5.1
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 (dizzin