Dutasteride Pharmacare 0.5mg soft capsules

Pays: Malte

Langue: anglais

Source: Malta Medicines Authority

Ingrédients actifs:

DUTASTERIDE

Disponible depuis:

Pharmacare Srl

Code ATC:

G04CB02

DCI (Dénomination commune internationale):

DUTASTERIDE

forme pharmaceutique:

SOFT CAPSULE

Composition:

DUTASTERIDE 0.5 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

UROLOGICALS

Statut de autorisation:

Authorised

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE PHARMACARE 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 Pharmacare is and what it is used for
2.
What you need to know before you take Dutasteride Pharmacare
3.
How to take Dutasteride Pharmacare
4.
Possible side effects
5.
How to store Dutasteride Pharmacare
6.
Contents of the pack and other information
1. WHAT DUTASTERIDE PHARMACARE 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
PHARMACARE 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 Pharmacare 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 Pharmacare may also be used with anothe

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dutasteride Pharmacare 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 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 Pharmacare 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 Pharmacare 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 sho