ENABLEX 7.5MG PROLONGED-RELEASE TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DARIFENACIN HYDROBROMIDE

Boleh didapati daripada:

Aspen Medical Products Malaysia Sdn Bhd

INN (Nama Antarabangsa):

DARIFENACIN HYDROBROMIDE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

ASPEN BAD OLDESLOE GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
1
ENABLEX PROLONGED-RELEASE
TABLETS
Darifenacin hydrobromide (7.5mg, 15mg)
WHAT IS IN THE LEAFLET
1.
What Enablex is used for
2.
How Enablex works
3.
Before you use Enablex
4.
How to use Enablex
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Enablex
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ENABLEX IS USED FOR
Enablex is used to treat the
following symptoms due to a
condition called overactive
bladder:
•
Urgency: a strong need to
urinate right away
•
Urge urinary incontinence:
a strong need to urinate
with leaking or wetting
accidents
•
Frequency: urinating often
HOW ENABLEX WORKS
Enablex contains the active
ingredient called darifenacin
hydrobromide.
Enablex works by relaxing the
bladder smooth muscle and
helps to decrease muscle
spasm. This delays the initial
desire and the urge to urinate.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another
reason.
This medicine is available only
with a doctor's prescription. It
is not addictive.
Enablex is not recommended
for use in children because
there have been no studies of
its effects in this age group.
BEFORE YOU USE ENABLEX
-
_When you must not use it _
Do not take this medicine if
you have an allergy to:
•
darifenacin, the active
ingredient
•
any of the other ingredients
listed at the end of this
leaflet
Do not take Enablex if you
have any of the following
medical conditions:
•
a disorder of eye related to
eye pressure called narrow
angle glaucoma that is not
being controlled with
medicine
•
delayed in stomach
emptying
•
urinary retention
•
abnormal weakness of
certain muscles.
•
severe liver impairment
•
severe inflammation and
ulcer of large intestine
•
a very dilated colon
(megacolon), accompanied
by abdominal bloating
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows

Ciri produk

Enablex ® (Darifenacin)
PRESENTATIONS
Enablex® 7.5mg Prolonged- release Tablets are round, shallow, convex, white tablets and are
identified with “DF” on one side and “7.5” on the other. Each tablet contains 7.5mg of
darifenacin (as hydrobromide).
Enablex® 15mg Prolonged-release Tablets are round, shallow, convex, light -peach -coloured
tablets and are identified with “DF” on one side and “15” on the reverse. Each tablet contains
15mg of darifenacin (as hydrobromide).
THERAPEUTIC INDICATIONS
Enablex is indicated for the treatment of overactive bladder. Symptoms of overactive bladder
include urgency, urge urinary incontinence and frequency.
DOSAGE AND ADMINISTRATION
Adults
The recommended starting dose is 7.5mg daily. For those patients requiring gr eater symptom
relief, the dose may be increased to 15mg daily as early as two weeks after starting therapy,
based on individual response.
Geriatric patients
No dose adjustment is required in elderly patients ( see section CLINICAL
PHARMACOLOGY ).
Paediatri c patients
No studies have been performed in children. Therefore, until more information is available,
Enablex is not recommended for use in children.
Renal impairment
No dose adjustment is required in patients with impaired renal function ( see CLINICAL
P HARMACOLOGY ).
Hepatic impairment
There is a risk of increased exposure in this population ( see section CLINICAL
PHARMACOLOGY ), however, no dose adjustment is required in patients with mild hepatic
impairment (Child Pugh A). The daily dose of Enablex shoul d not exceed 7.5 mg in patients
with moderate hepatic impairment (Child Pugh B). Enablex is not recommended for use in
patients with severe hepatic impairment (Child Pugh C).