Deratos 0,5 mg zachte capsules

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

DUTASTERIDE

から入手可能:

Regiomedica GmbH

ATCコード:

G04CB02

INN（国際名）:

DUTASTERIDE

医薬品形態:

Capsule, zacht

構図:

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

投与経路:

Oraal gebruik

治療領域:

Dutasteride

製品概要:

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

承認日:

2014-01-20

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
DERATOS 0.5 MG CAPSULES, SOFT
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 Deratos is and what it is used for
2.
What you need to know before you take Deratos
3.
How to take Deratos
4.
Possible side effects
5.
How to store Deratos
6.
Contents of the pack and other information
1. WHAT DERATOS IS AND WHAT IT IS USED FOR
DERATOS 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. Deratos 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.
Deratos 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 DERATOS
DO NOT TA

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Deratos 0.5 mg capsules, soft
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.
Deratos soft 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
Deratos 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 Deratos 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
-
Patients with hyp