Dutasteride/Tamsulosin Hydrochloride 0.5mg/0.4mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

G04CA52

INN (International Name):

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2019-09-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE 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 Hydrochloride 0.5mg/0.4mg hard capsules is
and what it
is used for
2.
What
you
need
to
know
before
you
take
Dutasteride/Tamsulosin
Hydrochloride
0.5mg/0.4mg hard capsules
3.
How to take Dutasteride/Tamsulosin Hydrochloride 0.5mg/0.4mg hard
capsules
4.
Possible side effects
5.
How to store Dutasteride/Tamsulosin Hydrochloride 0.5mg/0.4mg hard
capsules
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE 0.5MG/0.4MG HARD CAPSULES IS
AND
WHAT IT IS USED FOR
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE 0.5MG/0.4MG HARD CAPSULES 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 Hydrochloride 0.5mg/0.4mg hard capsules 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 r

Summary of Product characteristics

Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosin Hydrochloride 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 Hydrochloride
0.5mg/0.4mg hard capsules is
one
capsule
(0.5 mg/ 0.4mg) once daily.
Where appropriate, Dutasteride/Tamsulosin Hydrochloride 0.5mg/0.4mg
hard capsules may be used
to substitute concomitant dutasteride and tamsulosin hydrochloride in
existing dual therapy to
simplify treatment.
Page 2 of 22
Where
clinically
appropriate,
direct
change
from
dutasteride
or
tamsulosin
hydrochloride
monotherapy
to
Dutasteride/Tamsulosin
Hydrochloride
0.5mg/0.4mg
hard
capsules
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 be