Omnexel, 400 micrograms prolonged release tablets, film-coated

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tamsulosin hydrochloride

Available from:

PCO Manufacturing 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:

2005-11-18

Patient Information leaflet

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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 your
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 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 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 from fainting due to reduced bloo

Summary of Product characteristics

Health Products Regulatory Authority
09 September 2022
CRN00D54J
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 0.4 mg tamsulosin
hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, prolonged release tablet
_Product imported from the Netherlands, Hungary, France, Spain, Greece
and Poland_
Approximately 9 mm 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
_Product imported from France, Spain, Greece, Poland and the
Netherlands:_
Macrogol 7,000,000
Macrogol 8,000
Magnesium stearate (E470b)
Butylhydroxytoluene (E321)
Colloidal anhydrous silica (E551)
Hypromellose (E464)
Iron oxide yellow (E172)
_Product imported from the UK:_
Macrogol
Butylhydroxytoluene
Hypromellose
Magnesium stearate
Yellow iron oxide
_Product imported from Hungary:_
Magnesium stearate
Macrogol 7,000,000
Macrogol 8,000
_Film-coating:_
Opadry yellow O3F22733 (Hypromellose, macrogol 8000, Iron oxide yellow
(E172))
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
09 September 2022
CRN00D54J
Page 2 of 2
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
Do not store above 25 °C
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack containing 30 tablets contained in an overlabelled outer
cardboard carton.
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Busines