Omnexel, 400 micrograms, prolonged release tablets, film-coated

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tamsulosin hydrochloride

Available from:

Imbat Limited

ATC code:

G04CA; G04CA02

INN (International Name):

Tamsulosin hydrochloride

Dosage:

400 microgram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; tamsulosin

Authorization status:

Authorised

Authorization date:

2007-09-14

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMNEXEL
® 400 MICROGRAMS
PROLONGED RELEASE TABLETS, FILM-COATED (tamsulosin hydrochloride)
Your medicine is available using the name Omnexel
400 micrograms, prolonged-release tablets, film-coated but will
be referred to as Omnexel throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you personally. Do
not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1.
What Omnexel is and what it is used for
2.
Before you take Omnexel
3.
How to take Omnexel
4.
Possible side effects
5.
How to store Omnexel
6.
Further information
1.
WHAT OMNEXEL IS AND WHAT IT IS USED FOR
The active ingredient in Omnexel is tamsulosin. This is a selective
alpha
1A/1D
-adrenoceptor antagonist. It reduces tension of the
smooth muscles in the prostate and the urethra, enabling urine to
pass more readily through the urethra and facilitating urination. In
addition, it diminishes sensations of urge.
Omnexel is used in men for the treatment of the complaints of the
lower urinary tract associated with an enlarged prostatic gland
(benign prostatic hyperplasia). These complaints may include
difficulty urinating (poor stream), dribbling, urgency and having to
urinate frequently at night as well as during the day.
2.
BEFORE YOU TAKE OMNEXEL
DO NOT USE OMNEXEL

if you are allergic (hypersensitive) to tamsulosin or to any of
the other ingredients in Omnexel. Hypersensitivity may
present as sudden local swelling of the soft tissues of the
body (e.g. the throat or tongue), difficult breathing and/or
itching and rash (angioedema).

if you suffer from severe liver problems.

if you suffer fro

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.
(Oral Controlled Absorption System, OCAS).
_Product imported from The Netherlands, Poland, and the United
Kingdom:_
Round, bi-convex, yellow, film-coated and debossed with the code '04'
on one side and plain on the other.
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, 400 micrograms, 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.
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