Dutasteride 0.5mg soft capsules

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

Accord Healthcare Limited

Kod ATC:

G04CB02

INN (Nama Antarabangsa):

DUTASTERIDE

Borang farmaseutikal:

SOFT CAPSULE

Komposisi:

DUTASTERIDE 0.5 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

UROLOGICALS

Status kebenaran:

Authorised

Risalah maklumat

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE 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 capsule is and what it is used for
2.
What you need to know before you take Dutasteride capsules
3.
How to take Dutasteride capsules
4.
Possible side effects
5.
How to store Dutasteride capsules
6.
Contents of the pack and other information
1. WHAT DUTASTERIDE CAPSULE 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 CAPSULE 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 capsule 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 capsules may also be used with another medicine called
tamsulosin (u

Ciri produk

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dutasteride 0.5 mg soft 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
Dutasteride capsules 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 capsule 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 be swa