Dutasteride/Tamsulosin Sandoz 0.5mg/0.4mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

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:

2019-09-04

Patient Information leaflet

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

Summary of Product characteristics

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