Dutasteride/Tamsulosine HCl Sandoz 0,5 mg/0,4 mg, harde capsules

Țară: Țările de Jos

Limbă: olandeză

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

Ingredient activ:

DUTASTERIDE ; TAMSULOSINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; TAMSULOSINE

Disponibil de la:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codul ATC:

G04CA52

INN (nume internaţional):

DUTASTERIDE ; TAMSULOSINEHYDROCHLORIDE COMPOSITION corresponding to ; TAMSULOSIN

Forma farmaceutică:

Capsule, hard

Compoziție:

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

Calea de administrare:

Oraal gebruik

Zonă Terapeutică:

Tamsulosin and dutasteride

Data de autorizare:

2019-09-27

Prospect

Sandoz B.V.
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Dutasteride/Tamsulosine HCl Sandoz 0,5 mg/0,4 mg, harde capsules
RVG 124158
1313-v3
1.3.1.3 Bijsluiter
Februari 2020
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE/TAMSULOSINE HCL SANDOZ 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 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 prostat

Caracteristicilor produsului

Sandoz B.V.
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Dutasteride/Tamsulosine HCl Sandoz 0,5 mg/0,4 mg,
harde capsules RVG 124158
1311-V2
1.3.1.1 Samenvatting van de Productkenmerken
November 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosine HCl Sandoz 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).
Excipient(s) with known effect
Each capsule contains soya lecithin and propylene glycol
This medicine contains 299.46 mg propylene glycol in each hard capsule
which is equivalent to
4,27 mg/kg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
are oblong, hard gelatin capsules, of 21.4 mm x 7.4 mm
approx, with brown
body and orange cap printed with C001 in black ink.
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
Sandoz B.V.
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Dutasteride/Tamsulosine HCl Sandoz 0,5 mg/0,4 mg,
harde capsules RVG 124158
1311-V2
1.3.1.1 Samenvatting van de Productkenmerken
November 2019
_Adults (including elderly) _
The recommended dose of is one capsule (0.5 mg/ 0.4
mg) 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 impairmen