Dutasteride / Tamsulosin Alenicum 0.5mg/0.4mg Hard capsules

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Beschikbaar vanaf:

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

ATC-code:

G04CA52

INN (Algemene Internationale Benaming):

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

farmaceutische vorm:

HARD CAPSULE

Samenstelling:

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Prescription-type:

POM

Therapeutisch gebied:

UROLOGICALS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2019-08-22

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUTASTERIDE/TAMSULOSIN ALENICUM 0.5MG/0.4 MG HARD CAPSULES
dutasteride/tamsulosin hydrochloride
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/Tamsulosin Alenicum is and what it is used for
2.
What you need to know before you take Dutasteride/Tamsulosin Alenicum
3.
How to take Dutasteride/Tamsulosin Alenicum
4.
Possible side effects
5.
How to store Dutasteride/Tamsulosin Alenicum
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE/TAMSULOSIN ALENICUM IS AND WHAT IT IS USED FOR
DUTASTERIDE/TAMSULOSIN ALENICUM 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.
Dutasteride/Tamsulosin
Alenicum
is
a
combination
of
two
different
medicines
called
dutasteride and tamsulosin.
Dutasteride
belongs
to
a
group
of
medicines
called
_5-alpha _
_reductase _
_inhibitors_
and
tamsulosin belongs to a group of medicines called
_alpha-blockers_
.
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. Sometimes surgery is
necessary to remove or reduce the size of the prostate gland.

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosin Alenicum 0.5mg/0.4mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
hard
capsule
contains
0.5
mg
dutasteride
and
0.4
mg
tamsulosin
hydrochloride
(equivalent to 0.367 mg tamsulosin).
Excipients with known effect
Each capsule contains lecithin (which may contain soya oil) and sunset
yellow FCF (E 110).
Each capsule contains ≤ 0.1 mg sunset yellow FCF.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Oblong, around 24 mm length, hard capsules with a brown body and an
orange cap.
Each
hard
capsule
contains
tamsulosin
hydrochloride
modified
release
pellets
and
one
dutasteride soft gelatin capsule.
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
_Adults (including elderly) _
The
recommended
dose
of
Dutasteride/Tamsulosin
Alenicum
is
one
capsule
(0.5 mg/ 0.4mg) once daily.
Where appropriate, Dutasteride/Tamsulosin Alenicum may be used to
substitute concomitant
dutasteride and tamsulosin hydrochloride in existing dual therapy to
simplify treatment.
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Where clinically appropriate, direct change from dutasteride or
tamsulosin hydrochloride
monotherapy to Dutasteride/Tamsulosin Alenicum may be considered.
_Renal impairment _
The effect of renal impairment on dutasteride-tamsulosin
pharmacokinetics has not been
studied. No adjustment in dosage is anticipated for patients with
renal impairment (see section
4.4 and 5.2).
_ _
_Hepatic impairment _
The effect of hepatic impairment on dutasteride-tamsulosin
pharmacokinetics has not been
studied so caution should be used in patients with mild to moderate
hepatic impairment (see
section
4.4
an