Tamsulosine HCl Zentiva 0,4 mg, tabletten met verlengde afgifte

국가: 네덜란드

언어: 네덜란드어

출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

유효 성분:

TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

제공처:

Zentiva a.s. U. Kabelovny 130 10237 PRAGUE (TSJECHIË)

ATC 코드:

G04CA02

INN (International Name):

TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

약제 형태:

Tablet met verlengde afgifte

구성:

CARBOMEER 71G-NF ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K100M (E 464) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551), CARBOMEER 71G-NF ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K15M, K100M (E 464) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551), CARBOMEER 71G-NF ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K100M (E 464) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551),

관리 경로:

Oraal gebruik

치료 영역:

Tamsulosin

제품 요약:

Hulpstoffen: CARBOMEER 71G-NF; CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, type 2208 (Release controlling polymer), K100M (E 464); IJZEROXIDE ROOD (E 172); MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551);

승인 날짜:

1900-01-01

환자 정보 전단

Common Technical Document
Tamsulosin hydrochloride 0.4 mg
Prolonged release tablets
Document number (version): M13.1-03.TSL.hcl.mrt.002.03.core
Page 1 of 6
1.3.1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMSULOSINE HCL ZENTIVA 0,4 MG, TABLETTEN MET VERLENGDE AFGIFTE
tamsulosine 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 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.
IN THIS LEAFLET:
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1
WHAT IS AND WHAT IT IS USED FOR
Tamsulosin relaxes the muscles in the prostate and urinary tract. By
relaxing the muscle tamsulosin
enables a more easily pass of urine and helps urination. In addition,
it diminishes sensations of urge.
Tamsulosin is prescribed in men to alleviate urinary symptoms caused
by an enlarged prostrate (benign
prostatic hyperplasia). These symptoms 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
DO NOT TAKE IF YOU:

are ALLERGIC TO TAMSULOSIN OR ANY OF THE OTHER INGREDIENTS of this
medicine (listed in section 6).
Hypersensitivity may present a sudden local swelling of the soft
tissues of

제품 특성 요약

Common Technical Document
Tamsulosin hydrochloride 0.4 mg
Prolonged release tablets
Document number (version): M13.1-01.TSL.hcl.mrt.002.05.core
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS - CORE
1.
NAME OF THE MEDICINAL PRODUCT
Tamsulosine HCI Zentiva 0,4 mg, tabletten met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 0.400 mg 400 microgram
tamsulosin hydrochloride, equivalent
to 0.367 mg 367 microgram tamsulosin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
White, un-scored, round tablets with a diameter of 9 mm, debossed on
one side with "T9SL” and “0.4”
on the other side.
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
Posology
One tablet daily.
Tamsulosin can be taken independently of food.
Common Technical Document
Tamsulosin hydrochloride 0.4 mg
Prolonged release tablets
Document number (version): M13.1-01.TSL.hcl.mrt.002.05.core
Page 2 of 11
_Renal impairment _
No dose adjustment is warranted in renal impairment.
_ _
_Hepatic 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 tamsulosin in children and adolescents have
not been established. Currently
available data are described in section 5.1.
Method of administration
Oral use.
The tablet must be swallowed whole and not be crunched or chewed as
this interferes with the
prolonged release of the active substance.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance, including drug-induced
angioedema, or to any of the
excipients listed in section 6.1.

A history of orthostatic hypotension.

Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
1
-adre