TAMSULOSIN TEVA 400 Microgram Capsules Modified Release

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

TAMSULOSIN HYDROCHLORIDE

Tersedia dari:

Teva Pharma B.V.

Kode ATC:

G04CA02

INN (Nama Internasional):

TAMSULOSIN HYDROCHLORIDE

Dosis:

400 Microgram

Bentuk farmasi:

Capsules Modified Release

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

tamsulosin

Status otorisasi:

Authorised

Tanggal Otorisasi:

2016-02-12

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TAMSULOSIN TEVA 400 MICROGRAMS MODIFIED-RELEASE CAPSULES 

(Tamsulosin hydrochloride) 

The name of your medicine is TAMSULOSIN TEVA 400
MICROGRAMS MODIFIED-RELEASE CAPSULES 
which will be referred to as Tamsulosin throughout this leaflet 

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 any 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 Tamsulosin is and what it is used for 
2. What you need to know before you take Tamsulosin 
3. How to take Tamsulosin 
4. Possible side effects 
5. How to store Tamsulosin 
6. Contents of the pack and other information 

1.  
 WHAT TAMSULOSIN IS AND WHAT IT IS USED FOR 
The active ingredient in your capsules, tamsulosin hydrochloride,
belongs to a group of 
medicines known as alpha-IA-adrenoceptor blockers. 

The capsules are used to treat the symptoms of Benign
Prostatic Hyperplasia (BPH) which is 
caused by enlargement of the prostate gland in men which
can cause difficulty in passing urine 
and/or frequent passing of urine. Tamsulosin works
by relaxing muscle around the bladder and 
prostate gland so urine can be passed more easily. 

2.  
 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSULOSIN 

DO NOT TAKE TAMSULOSIN 
-  
If you are allergic (hypersensitive) to
tamsulosin hydrochloride or any of the other 
ingredients of this medicine(listed in section 6). 
-�

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamsulosin Teva 400 micrograms Modified-release Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 0.4 mg of tamsulosin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release capsule, hard.
Orange/olive-green capsule, with a black printed mark ‘TSL 0.4’ and with a black stripe at both ends. 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
One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water
while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect
on the release of the long-acting active ingredient.
No dose adjustment is warranted in renal impairment.
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also section 4.3
Contraindications).
Paediatric population
There is no relevant indication for use of tamsulosin 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, including drug-induced angio-oedema, or to any of the excipients.
Orthostatic hypotension observed earlier (history of orthostatic hypotension).
Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other
1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during
treatment with tamsulosin as a result of which, rarely, syncope