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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tamsulosin hydrochloride

Available from:

Astellas Pharma Co. 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:

Marketed

Authorization date:

2005-03-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMNEXEL 400 MICROGRAMS
PROLONGED RELEASE TABLETS (FILM-COATED)
tamsulosin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Omnexel is and what it is used for
2
What you need to know before you take Omnexel
3
How to take Omnexel
4
Possible side effects
5
How to store Omnexel
6
Contents of the pack and other information
1.
W
HAT
O
MNEXEL 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMNEXEL
DO NOT TAKE
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 from fainting due to reduced blood pressure when
changing posture (going

Summary of Product characteristics

Health Products Regulatory Authority
08 February 2023
CRN00DC2R
Page 1 of 6
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).
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.
Health Products Regulatory Authority
08 February 2023
CRN00DC2R
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
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.
Be