Dutasteride/Tamsulosin Uropharm 0.5mg/0.4mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Available from:

Abanta Pharma GmbH Reichsstraße 78, 58840 Plettenberg , Germany

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

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-03-26

Patient Information leaflet

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosin Uropharm 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
Uropharm
is
one
capsule
(0.5 mg/ 0.4mg) once daily.
Where appropriate, Dutasteride/Tamsulosin Uropharm may be used to
substitute concomitant
dutasteride and tamsulosin hydrochloride in existing dual therapy to
simplify treatment.
Page
2
of
21
Where
clinically
appropriate,
direct
change
from
dutasteride
or
tamsulosin
hydrochloride
monotherapy to Dutasteride/Tamsulosin Uropharm 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