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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tamsulosin hydrochloride

Available from:

IMED Healthcare Ltd.

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:

2009-08-28

Patient Information leaflet

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.
WHAT OMNEXEL IS AND WHAT IT IS USED FOR
The active ingredient in Omnexel is tamsulosin. This is a
selective alpha1A/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
03 March 2023
CRN00DDND
Page 1 of 2
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 0.4mg 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 imported from Poland:_
Approximately 9mm in diameter, round, bi-convex, yellow, film-coated
and debossed with the code ’04’.
4 CLINICAL PARTICULARS
As per PA1241/006/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1241/006/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogol
Magnesium stearate (E470b)
Butylhydroxytoluene (E321)
Colloidal silica anhydrous (E551)
Hypromellose (E464)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium foil blister strips in an overlabelled cardboard carton
containing 30 tablets.
Health Products Regulatory Authority
03 March 2023
CRN00DDND
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/025/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28th August 2009
10 DATE OF REVISION OF THE TEXT
March 2023