Dutasteride/Tamsulosin Adair 0.5mg/0.4mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Available from:

Galenicum Health, S.L.

ATC code:

G04CA52

INN (International Name):

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Pharmaceutical form:

HARD CAPSULE

Composition:

DUTASTERIDE 0.5 milligram(s) ; TAMSULOSIN HYDROCHLORIDE 0.4 milligram(s)

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2019-09-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUTASTERIDE/TAMSULOSIN ADAIR 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 Adair is and what it is used for
2.
What you need to know before you take Dutasteride/Tamsulosin Adair
3.
How to take Dutasteride/Tamsulosin Adair
4.
Possible side effects
5.
How to store Dutasteride/Tamsulosin Adair
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE/TAMSULOSIN ADAIR IS AND WHAT IT IS USED FOR
DUTASTERIDE/TAMSULOSIN ADAIR 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 Adair 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.
Dutasteride lowers the produ

Summary of Product characteristics

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