Dustezor 0.5 mg soft capsules

Pajjiż: Malta

Lingwa: Ingliż

Sors: Malta Medicines Authority

Ingredjent attiv:

DUTASTERIDE

Disponibbli minn:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

Kodiċi ATC:

G04CB02

INN (Isem Internazzjonali):

DUTASTERIDE 0.5 mg

Għamla farmaċewtika:

SOFT CAPSULE

Kompożizzjoni:

DUTASTERIDE 0.5 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

UROLOGICALS

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2016-08-29

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUSTEZOR 0.5 MG SOFT 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, pharmacist or
nurse.
-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 Dustezor is and what it is used for
2.
What you need to know before you take Dustezor
3.
How to take Dustezor
4.
Possible side effects
5.
How to store Dustezor
6.
Contents of the pack and other information
1.
WHAT DUSTEZOR IS AND WHAT IT IS USED FOR
DUTASTERIDE 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.
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.
Dutasteride may also be used with another medicine called tamsulosin
(used to treat thesymptoms of
an enlarged prostate).
2.
WHAT YOU NEED TO KNOW

Karatteristiċi tal-prodott

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1.
NAME OF THE MEDICINAL PRODUCT
Dustezor 0.5 mg soft capsules
Dutasteride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg of dutasteride.
Excipient with known effect
Each capsule contains lecithin (which 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
Dutasteride 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 dutasteride 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 _
_ _
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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 sev