Dutasteride Galenicum 0.5 mg soft capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

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:

2015-03-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE GALENICUM 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dutasteride Galenicum is and what it is used for
2.
What you need to know before you take Dutasteride Galenicum
3.
How to take Dutasteride Galenicum
4.
Possible side effects
5.
How to store Dutasteride Galenicum
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE GALENICUM IS AND WHAT IT IS USED FOR
Dutasteride Galenicum 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 Galenicum 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 Galenicum may also be used with another

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dutasteride Galenicum 0.5 mg soft capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 0.5 mg dutasteride.
Excipient with known effect:
Each soft capsule contains lecithin (which may contain soya oil)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, soft.
The soft 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 Galenicum 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 Galenicum 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 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
section 4.4 and section 5.2). In patients
with severe hepatic impairment, the use of dutasteride is
contraindicated (see section 4.3).
METHOD OF ADMINISTRATION
The capsules should be swallowed whole and n