Dutalan 0.5mg soft capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE

Available from:

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Austria

ATC code:

G04CB02

INN (International Name):

DUTASTERIDE 0.5 mg

Pharmaceutical form:

SOFT CAPSULE

Composition:

DUTASTERIDE 0.5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2016-09-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTALAN 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 Dutalan is and what it is used for
2.
What you need to know before you take Dutalan
3.
How to take Dutalan
4.
Possible side effects
5.
How to store Dutalan
6.
Contents of the pack and other information
1.
WHAT DUTALAN 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 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 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 the
symptoms of an enlarged prostate).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUTAL

Summary of Product characteristics

Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Dutalan 0.5 mg soft capsules
Dutasteride
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 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. 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 swallowed whole and not chewed or opened