Dutasteride/Tamsulosin hydrochloride Pinewood 0.5 mg/0.4 mg hard capsules

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Dutasteride; Tamsulosin hydrochloride

Disponibbli minn:

Pinewood Laboratories Ltd

Kodiċi ATC:

G04CA52

INN (Isem Internazzjonali):

Dutasteride; Tamsulosin hydrochloride

Dożaġġ:

0.5 mg/0.4 milligram(s)

Għamla farmaċewtika:

Capsule, hard

Żona terapewtika:

tamsulosin and dutasteride

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2020-10-09

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE PINEWOOD 0.5 MG/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 Pinewood is and what it is
used for
2.
What you need to know before you take Dutasteride/Tamsulosin
hydrochloride Pinewood
3.
How to take Dutasteride/Tamsulosin hydrochloride Pinewood
4.
Possible side effects
5.
How to store Dutasteride/Tamsulosin hydrochloride Pinewood
6.
Contents of the pack and other information
1.
WHAT DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE PINEWOOD IS AND WHAT IT IS
USED FOR
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE PINEWOOD 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 Pinewood 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 t

Karatteristiċi tal-prodott

Health Products Regulatory Authority
28 October 2020
CRN009YNX
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dutasteride/Tamsulosin hydrochloride Pinewood 0.5 mg/0.4 mg 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).
Excipient(s) with known effect
Each capsule contains soya lecithin and propylene glycol
This medicine contains 299.46 mg propylene glycol in each hard capsule
which is equivalent to 4.27 mg/kg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Dutasteride/Tamsulosin hydrochloride Pinewood 0.5 mg/0.4 mg hard
capsules are oblong, hard gelatin capsules, of 24.2 mm x
7.7 mm approx, with brown body and beige cap printed with C001 in
black ink.
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 severesymptoms of BPH.
For information on effects of treatment and patient populations
studied in clinical trials please see section5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly) _
The recommended dose of Dutasteride/Tamsulosin hydrochloride Pinewood
0.5 mg/0.4 mg hard capsules is one capsule (0.5
mg/ 0.4 mg) daily.
Where appropriate, Dutasteride/Tamsulosin hydrochloride Pinewood 0.5
mg/0.4 mg hard capsules 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 hydrochloride Pinewood 0.5 mg/0.4 mg hard
capsules may be considered.
_Renal impairment _
The effect of renal impairment on dutasteride/tamsulo