Dutasteride/Tamsulosinehydrochloride Teva 0,5 mg/0,4 mg, harde capsules

Kraj: Holandia

Język: niderlandzki

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

Składnik aktywny:

DUTASTERIDE 0,5 mg/stuk ; TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

Dostępny od:

Teva B.V. Swensweg 5 2031 GA HAARLEM

Kod ATC:

G04CA52

INN (International Nazwa):

DUTASTERIDE 0,5 mg/stuk ; TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

Forma farmaceutyczna:

Capsule, hard

Skład:

AMMONIA (E 527) ; BUTYLHYDROXYTOLUEEN (E 321) ; CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DIBUTYLSEBACAAT ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LECITHINE, SOYA (E 322) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; PROPYLEENGLYCOLMONOCAPRILAAT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; ZWARTE INKT, AMMONIA (E 527) ; BUTYLHYDROXYTOLUEEN (E 321) ; CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DIBUTYLSEBACAAT ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LECITHINE, SOYA (E 322) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; PROPYLEENGLYCOLMONOCAPRILAAT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; ZWARTE INKT

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Tamsulosin and dutasteride

Data autoryzacji:

1900-01-01

Ulotka dla pacjenta

1
PACKAGE LEAFLET
2
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
DUTASTERIDE/TAMSULOSINEHYDROCHLORIDE 0,5 MG/0,4 MG, HARDE CAPSULES
Dutasteride/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 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 of the 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 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
IS USED TO TREAT MEN WITH AN ENLARGED PROSTATE
(benign prostatic hyperplasia) - a
non-cancerous growth of the prostate gland, caused by producing too
much of a hormone called
dihydrotestosterone.
is a combination of two different medicines called
dutasteride and tamsulosin.
Dutasteride belongs to a group of medicines called 5-alpha reductase
inhibitors and tamsulosin belongs
to a group of medicines called alpha-blockers.
As the prostate grows, it can lead to urinary problems, such as
difficulty in passing urine and a need to
go to the toilet frequently. It can also cause the flow of the urine
to be slower and less forceful. If left
untreated, there is a risk that your urine flow will be completely
blocked (acute urinary retention). This
requires immediate medical treatment. Sometimes surgery is necessary
to remove or reduce the size of
the prostate gland.
Dutasteride lowers the production of a hormone called
dihydrotestosterone, which helps to shrink the
prostate and r

Charakterystyka produktu

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rvg 123562 EU SPC R-001 met NL info-clean
1.
NAAM VAN HET GENEESMIDDEL
Dutasteride/Tamsulosinehydrochloride Teva 0,5 mg/0,4 mg, harde
capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin
hydrochloride (equivalent to
0.367 mg tamsulosin).
Excipients with known effect
Contains 299.46 mg propylene glycol monocaprylate, type II per capsule
and traces of propylene
glycol in the black ink. Also contains less than 1 mmol (23 mg) sodium
per capsule and traces of
lecithin (may contain soya oil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Oblong hard capsules with brown body and beige cap printed with C001
in black ink and
approximately 24 mm in length.
Each hard capsule contains tamsulosin hydrochloride modified release
pellets and one dutasteride soft
gelatin capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in
patients with moderate to severe
symptoms of BPH.
For information on effects of treatment and patient populations
studied in clinical trials please see
section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults (including elderly) _
The recommended dose of is one capsule (0.5 mg/ 0.4
mg) once daily.
Where appropriate, may be used to substitute
concomitant dutasteride and
tamsulosin hydrochloride in existing dual therapy to simplify
treatment.
Where clinically appropriate, direct change from dutasteride or
tamsulosin hydrochloride monotherapy
to may be considered.
_Renal impairment _
The effect of renal impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied. No
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rvg 123562 EU SPC R-001 met NL info-clean
adjustment in dosage is anticipated for patients with renal impairment
(see section 4.4 and 5.2).
_Hepatic impairment _
The effect of hepatic impairment on dutaste