Dutasterid STADA Capsules, Soft 0.5mg

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Germany

Kod ATC:

G04CB02

INN (Nama Antarabangsa):

DUTASTERIDE 0.5 mg

Borang farmaseutikal:

CAPSULE

Komposisi:

DUTASTERIDE 0.5 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

UROLOGICALS

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2015-11-09

Risalah maklumat

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE STADA 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 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 Dutasteride Stada is and what it is used for
2.
What you need to know before you take Dutasteride Stada
3.
How to take Dutasteride Stada
4.
Possible side effects
5.
How to store Dutasteride Stada
6.
Contents of the pack and other information
1. WHAT DUTASTERIDE STADA IS AND WHAT IT IS USED FOR
The active ingredient is dutasteride. It belongs to a group of
medicines called 5-alpha reductase inhibitors.
DUTASTERIDE STADA 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 Stada 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 Stada may also be used with another medicine called
tamsulosin (used to treat t

Ciri produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dutasteride Stada 0.5 mg soft capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.5 mg of dutasteride.
Excipients 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 yelowish 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
Dutasteride Stada 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 older people): _
The recommended dose of Dutasteride Stada 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
section 4.3).
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METHOD OF ADMINISTRATION
The capsules should