Dutasteride Doc Generici 0.5 mg soft capsules

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

DUTASTERIDE

Pieejams no:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

ATĶ kods:

G04CB02

SNN (starptautisko nepatentēto nosaukumu):

DUTASTERIDE 0.5 mg

Zāļu forma:

SOFT CAPSULE

Kompozīcija:

DUTASTERIDE 0.5 mg

Receptes veids:

POM

Ārstniecības joma:

UROLOGICALS

Autorizācija statuss:

Authorised

Autorizācija datums:

2015-03-23

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE DOC GENERICI 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 Doc Generici is and what it is used for
2.
What you need to know before you take Dutasteride Doc Generici
3.
How to take Dutasteride Doc Generici
4.
Possible side effects
5.
How to store Dutasteride Doc Generici
6.
Contents of the pack and other information
1. WHAT DUTASTERIDE DOC GENERICI IS AND WHAT IT IS USED FOR
DUTASTERIDE DOC GENERICI 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 Doc Generici 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 Doc

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dutasteride Doc Generici 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 Doc Generici 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 Doc Generici 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 not chewed or opend as
contact with the capsul