Duoride-T 0.5mg0.4mg Capsules

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Disponible depuis:

NOVUGEN PHARMA SDN. BHD.

DCI (Dénomination commune internationale):

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Unités en paquet:

3x10 Capsules; 5x6 Capsules; 1x10 Capsules; 6x10 Capsules; 10x10 Capsules; 50x10 Capsules; 100x10 Capsules

Fabriqué par:

SAG MANUFACTURING, S.L.U

Notice patient

_Consumer Medication Information Leaflet (RiMUP) _
DUORIDE-T 0.5MG/0.4MG CAPSULES
Dutasteride/Tamsulosin Hydrochloride (0.5mg/0.4mg)
1
WHAT IS IN THIS LEAFLET
1.
What Duoride-T is used for
2.
How Duoride-T works
3.
Before you use Duoride-T
4.
How to use Duoride-T
5.
While you are using Duoride-T
6.
Side effects
7.
Storage and Disposal of Duoride-
T
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DUORIDE-T IS USED FOR
Duoride-T is used to treat men with
moderate
to
severe
symptoms
of
benign prostatic hyperplasia (BPH) -
a
non-
cancerous
growth
of
the
prostate gland caused by producing
too much of a hormone called DHT
(dihydrotestosterone).
Duoride-T
reduces
the
risk
of
acute
urinary
retention and the need for surgery in
people
with
moderate
to
severe
symptoms of BPH.
HOW DUORIDE-T WORKS
Duoride-T
capsules
are
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 more 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.
Dutasteride
helps
to
shrink
the
prostate
and
relieve
symptoms,
by
reducing the amount of DHT your
body produces.
Tamsulosin
acts
by
relaxing
the
muscles
in
your
prostate
gland,
making it easier to pass urine, and
improving your symptoms.
BEFORE YOU USE DUORIDE-T
−
_When you must not use it _
Do not take Duoride-T:
•
if you are allergic (hypersensitive)
to dutasteride, tamsulosin or to any
of the other ingredients of Duoride-
T, or to other medicines known as
5-alpha reductase inhibitors.
•
if you are female or age 21 years
and below. This
medicine is
for
adult men only.
If any of these apply to you, don’t
take
Duoride-T
u

Résumé des caractéristiques du produit

DUT-T/S1/PI/L3/M1-04
DUORIDE-T
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE
1. NAME OF THE MEDICINAL PRODUCT
Duoride-T 0.5mg/0.4mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5mg Dutasteride and 0.4mg Tamsulosin
hydrochloride
(equivalent to 0.367mg 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 capsules.
Oblong, around 24mm length, hard capsules with a brown body and orange
cap.
Each hard capsule contains one dutasteride soft gelatin capsule and
tamsulosin
hydrochloride modified release pellets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Duoride-T is indicated as combination therapy for the treatment of
moderate to severe
symptoms of benign prostatic hyperplasia (BPH).
Duoride-T reduces the risk of acute urinary retention and the need for
surgery in
patients with moderate to severe symptoms of BPH.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
PATIENTS >21 YEARS OLD (INCLUDING ELDERLY PATIENTS)
The recommended dose of Duoride-T is one capsule daily (0.5 mg / 0.4
mg).
Duoride-T must always be taken with a glass of water, up to 30 minutes
after a meal. It
must never be taken on an empty stomach. Ideally it should be taken at
the same time
of the day (this means with the same meal).
The capsules should be swallowed whole and not chewed or opened, as
contact with
the capsule contents may result in irritation of the oropharyngeal
mucosa.
SPECIAL DOSAGE INSTRUCTIONS
ELDERLY PATIENTS:
No age-related dose adjustment is required.
RENAL IMPAIRMENT
There is no experience available in patients with renal impairment.
Duoride-T should
therefore be used with caution especially in patients with severe
renal impairment
(creatinine clearance <10ml/ min).
HEPATIC IMPAIRMENT
There is no experience available in patients with hepatic impairment.
Duoride-T should
be used with caution in