OMNEXEL 400 Microgram Tablet Prolonged Release

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TAMSULOSIN HYDROCHLORIDE

Available from:

B & S Healthcare

ATC code:

G04CA02

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

Dosage:

400 Microgram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

tamsulosin

Authorization status:

Authorised

Authorization date:

2009-04-24

Patient Information leaflet

PATIENT INFORMATION LEAFLET 
OMNEXEL 400MICROGRAMS PROLONGED 
RELEASE TABLETS FILM COATED 
(tamsulosin hydrochloride) 

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 from fainting due to reduced blood pressure 
when changing posture (going to sit or stand up).  

TAKE SPECIAL CARE WITH OMNEXEL  

  Periodic medical examinations are necessary to monitor 
the development of the condition you are being treated 
for.  
  Rarely, fainting can occur during the use of Omnexel, as 
with other medicinal products of this type. At the first 
signs of dizziness or weakness you should sit or lie down 
until they have disapp

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.
Excipients:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, prolonged release tablets.
(Oral Controlled Absorption System, OCAS).
_Product sourced from France:_
Approximately 9 mm in diameter, round, bi-convex, yellow, film-coated and debossed with the code '04'.
4 CLINICAL PARTICULARS
As per PA 1241/006/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 1241/006/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Macrogol 7,000,000
Macrogol 8,000
Magnesium stearate (E470b)
Butylhydroxytoluene (E321)
Colloidal anhydrous silica (E551)
Tablet coat:
Macrogol 8,000
Hypromellose (E464)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on
the market in the country of origin.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/11/2014_
_CRN 2146767_
_page number: 1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package.
This medicinal product does not require any special temperature storage conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium/aluminium foil blister packs containing 30 tablets in an over labelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
B&S Healthcare
Unit 4
Bradfield Road
Ruislip
Middlesex HA4 0NU
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBE