TAMSULOSIN HYDROCHLORIDE 400 Microgram Capsules Modified Release

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

TAMSULOSIN HYDROCHLORIDE

Disponível em:

Kiron Pharmaceutica BV

DCI (Denominação Comum Internacional):

TAMSULOSIN HYDROCHLORIDE

Dosagem:

400 Microgram

Forma farmacêutica:

Capsules Modified Release

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Status de autorização:

Authorised

Data de autorização:

0000-00-00

Folheto informativo - Bula

 
Common Technical Document 
Tamsulosin hydrochloride 0.4 mg 
capsules 
SynthonBV 

page 1/7 

issue date: 10-12-2013 

version: M1.3.1_03.TSL.hcl.mrc.037.05.IE.1620.01.WD.corr 
approved:TK 

1.3.1 
Package Leaflet 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS, MODIFIED-RELEASE CAPSULE, 
HARD 
Tamsulosin hydrochloride 

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 any further questions, ask your doctor
or pharmacist. 

  This medicine has been prescribed for you. 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 Tamsulosin hydrochloride 400 micrograms is and
what it is used for 
2.  Before you take Tamsulosin hydrochloride 400 micrograms 
3.  How to take Tamsulosin hydrochloride 400 micrograms 
4.  Possible side effects 
5.  How to store Tamsulosin hydrochloride 400 micrograms 
6.  Further information 

1.  WHAT TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS IS AND WHAT
IT IS 
USED FOR 

Tamsulosin is an alpha
1A
-adrenoreceptor blocker. It relaxes the muscles in the 
prostate and urinary tract.  

Tamsulosin is prescribed to alleviate urinary symptoms caused by an
enlarged 
prostrate (benign prostatic hyperplasia). By relaxing the muscle it
enables a more 
easily pass of urine and helps urination. 

2.  BEFORE YOU TAKE TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS 

DO NOT TAKE TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS IF YOU: 

Common Technical Document 
Tamsulosin hydrochloride 0.4 mg 
capsules 
SynthonBV 

page 2/7 

issue date: 10-12-2013 

ve

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamsulosin Hydrochloride 400 micrograms Modified-release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains as active ingredient tamsulosin hydrochloride 400 micrograms.
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Orange/olive-green capsule (19.3 x 6.4 mm). The capsules contain white to off-white pellets.
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
Posology
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 tamsulosin in children.
The safety and efficacy of tamsulosine in children < 18 years have not been established. Currently available data are
described in section 5.1.
Method of administration
One capsule daily, to be taken after breakfast or the first meal of the day.
The capsule must be swallowed whole and must not be crunched or chewed, as this interferes with the modified release
of the active ingredient.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, including drug-induced angio-oedema, or to any of the excipients listed in
section 6.1.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/05/2014_
_CRN 2134921_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other
1-adrenoceptors antagonists, a reduction in blood press