Dutasteride 0,5 mg Teva, zachte capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DUTASTERIDE

Beschikbaar vanaf:

Teva Nederland B.V.

ATC-code:

G04CB02

INN (Algemene Internationale Benaming):

DUTASTERIDE

farmaceutische vorm:

Capsule, zacht

Samenstelling:

BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I ; IJZEROXIDE GEEL (E 172) ; LECITHINE, SOYA (E 322) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Dutasteride

Product samenvatting:

Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); GELATINE (E 441); GLYCEROL (E 422); GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I; IJZEROXIDE GEEL (E 172); LECITHINE, SOYA (E 322); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN;

Autorisatie datum:

2017-01-24

Bijsluiter

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
DUTASTERIDE 0,5 MG TEVA, ZACHTE CAPSULES
Dutasteride
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
The active ingredient is dutasteride. It belongs to a group of
medicines called 5-alpha reductase
inhibitors.
[PRODUCT NAME] 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.
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. In some situations surgery
is necessary to remove or
reduce the size of the prostate gland. Dutasteride lowers the
production of dihydrotestosterone, which
helps to shrink the prostate and relieve the symptoms. This will
reduce the risk of acute urinary
retention and the need for surgery.
[Product name] may also be used with another medicine called
tamsulosin (used to treat the symptoms
of an enlarged prost

Productkenmerken

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1. NAAM VAN HET GENEESMIDDEL
Dutasteride 0,5 mg Teva, zachte capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg of dutasteride.
Excipient with known effect: lecithin (may contain soya oil)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, soft.
The capsules are opaque, yellow, oblong soft gelatin capsules filled
with an oily and yellowish
liquid, without printing.
Soft capsules dimensions are: 19 ± 0.8 mm x 6.9 ± 0.4 mm
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
[Product name] can be administered alone or in combination with the
alpha-blocker tamsulosin
(0.4mg) (see sections 4.4, 4.8 and 5.1).
_Adults (including elderly): _
The recommended dose of [Product name] is one capsule (0.5 mg) taken
orally once a day.
Although an improvement may be observed at an early stage, it can take
up to 6 months before a
response to the treatment can be achieved. No dose adjustment is
necessary in the older people.
SPECIAL POPULATIONS
_Patients with renal impairment _
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied. No
adjustment in dosage is anticipated for patients with renal impairment
(see section 5.2).
_Patients with hepatic impairment _
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied so caution
should be used in patients with mild to moderate hepatic impairment
(see section 4.4 and section
5.2). In patients with severe hepatic impairment, the use of
dutasteride is contraindicated (see
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section 4.3).
Method of administration
The capsules should be swallowed whole and not chewed or opened as
contac