资料单张
ENABLEX
®
1
ENABLEX
®
_Darifenacin hydrobromide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Enablex.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.ASPENCMI.COM.AU
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Enablex
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ENABLEX IS USED
FOR
Enablex is used to decrease the
urgency and the frequency of
urination.
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 TAKE
ENABLEX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ENABLEX IF YOU HAVE AN
ALLERGY TO DARIFENACIN, THE ACTIVE
INGREDIENT, OR TO ANY OF THE OTHER
INGREDIENTS LIS
阅读完整的文件
产品特点
Enablex (darifenacin hydrobromide) – Product Information
Page 1 of 19
PRODUCT INFORMATION
ENABLEX
®
(DARIFENACIN HYDROBROMIDE)
NAME OF THE MEDICINE
The active ingredient of Enablex is darifenacin hydrobromide.
Chemical
name: _(S)_-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-
diphenylacetamide hydrobromide
Chemical structure:
O
N
Ph
Ph
O
NH
2
.HBr
Molecular formula: C
28
H
30
N
2
O
2
.HBr
Molecular weight: 507.5
CAS registry no. 133099-07-7
DESCRIPTION_ _
Darifenacin hydrobromide is a white to almost white monomorphic
crystalline solid. The
solubility of darifenacin hydrobromide in water is 6.03 mg/mL at 37
o
C, with a resulting pH
of 5.5.
Enablex prolonged-release tablets are available in strengths of 7.5
mg and 15 mg darifenacin
hydrobromide.
EXCIPIENTS
Enablex prolonged-release tablets 7.5 mg: calcium hydrogen phosphate
anhydrous,
hypromellose, magnesium stearate, Opadry White (00F18296).
Enablex prolonged-release tablets 15 mg: calcium hydrogen phosphate
anhydrous,
hypromellose, magnesium stearate, Opadry Yellow (00F12951), Opadry
Red (00F15613).
PHARMACOLOGY_ _
Enablex (darifenacin hydrobromide) – Product Information
Page 2 of 19
PHARMACODYNAMICS
Darifenacin is a selective muscarinic M3 receptor antagonist that
exhibits 9- to 59-fold
selectivity for the human M3 receptor over human muscarinergic M1, M2,
M4 and M5
receptors. The M3 receptor is the major subtype that controls urinary
bladder muscle
contraction.
Cystometric studies performed with darifenacin in patients with
involuntary bladder
contractions showed increased bladder capacity, increased
volume threshold for unstable
contractions and diminished frequency of unstable detrusor
contractions after darifenacin
treatment. These findings are consistent with the clinical
observations of reduced frequency of
incontinence, reduced frequency of micturition, reduced frequency of
urgency and increas
阅读完整的文件
资料单张 