Emurason 0,5 mg zachte capsules

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

DUTASTERIDE

Dostupno od:

Regiomedica GmbH

ATC koda:

G04CB02

INN (International ime):

DUTASTERIDE

Farmaceutski oblik:

Capsule, zacht

Sastav:

BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; TITAANDIOXIDE (E 171),

Administracija rute:

Oraal gebruik

Područje terapije:

Dutasteride

Proizvod sažetak:

Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); GELATINE (E 441); GLYCEROL (E 422); GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I; IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); TITAANDIOXIDE (E 171);

Datum autorizacije:

2014-01-20

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMURASON 0,5 MG 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.
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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 Emurason is and what it is used for
2.
What you need to know before you take Emurason
3.
How to take Emurason
4.
Possible side effects
5.
How to store Emurason
6.
Contents of the pack and other information
1. WHAT EMURASON IS AND WHAT IT IS USED FOR
EMURASON 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.
The active ingredient is dutasteride. It belongs to a group of
medicines called 5-alpha reductase
inhibitors.
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. Emurason 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.
Emurason may also be used with another medicine called tamsulosin
(used to treat the symptoms of an
enlarged prostate).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMURASON

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Emurason 0,5 mg zachte capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg dutasteride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Capsule, soft.
Emurason 0.5 mg zachte capsules are light brown, oblong soft-gelatin
capsules without printing,
approximately 19 x 7 mm, containing a clear, slightly yellow to pale
amber, oily liquid.
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
Emurason can be administered alone or in combination with the
alpha-blocker tamsulosin (0.4 mg)
(see sections 4.4, 4.8 and 5.1).
_ _
POSOLOGY
Adults (including elderly):
The recommended dose of Emurason is one capsule (0.5 mg) taken orally
once a day. The capsules
should be swallowed whole and not chewed or opened as contact with the
capsule contents may result
in irritation of the oropharyngeal mucosa. The capsules may be taken
with or without food. 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
elderly.
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).
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 sections 4.4 and 5.2). In
patients with severe hepatic impairment, the use of dutasteride is
contraindicated (see section 4.3).
4.3 CONTRAINDICATIONS
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Pat