ENABLEX darifenacin 7.5mg (as hydrobromide) modified release tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

darifenacin hydrobromide, Quantity: 8.929 mg (Equivalent: darifenacin, Qty 7.5 mg)

Dostępny od:

Aspen Pharmacare Australia Pty Ltd

Forma farmaceutyczna:

Tablet, modified release

Skład:

Excipient Ingredients: magnesium stearate; hypromellose; calcium hydrogen phosphate; titanium dioxide; purified talc; macrogol 4000

Droga podania:

Oral

Sztuk w opakowaniu:

14 Tablets, 28 Tablets, 98 Tablets, 56 Tablets, 7 Tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Enablex prolonged-release tablets are indicated for the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency of micturition.

Podsumowanie produktu:

Visual Identification: Round, shallow, convex white tablets with "DF" on one side and "7.5" on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2005-03-16

Ulotka dla pacjenta

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 LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips
and tongue or other parts of the body;
rash itching or hives on the skin.
DO NO

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION
ENABLEX (DARIFENACIN HYDROBROMIDE) MODIFIED RELEASE
TABLET
1
NAME OF THE MEDICINE
Darifenacin hydrobromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Enablex is darifenacin hydrobromide. Enablex
modified-release tablets
contain 7.5 mg or 15 mg darifenacin (as hydrobromide).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Enablex 7.5 mg modified-release tablets are round, shallow, convex,
white tablets with “DF” on one
side and “7.5” on the reverse.
Enablex 15 mg modified-release tablets are round, shallow, convex,
light peach-coloured tablets
with “DF” on one side and “15” on the reverse.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Enablex modified-release tablets are indicated for the treatment of
overactive bladder, with the
symptoms of urgency, urge urinary incontinence or frequency of
micturition.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended starting dose of Enablex modified-release tablets is
7.5 mg once daily. For those
patients requiring greater symptom relief, the dose may be increased
to 15 mg daily, as early as two
weeks after starting therapy, based on individual response.
Enablex modified-release tablets should be taken once daily with
liquid. They may be taken with or
without food, and should be swallowed whole and not chewed, divided or
crushed.
U
SE IN PATIENTS WITH HEPATIC IMPAIRMENT
•
For patients with moderate hepatic impairment (Child Pugh B) or when
co-administered
with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole,
miconazole, nefazodone
and ritonavir), the daily dose of Enablex should not exceed 7.5 mg.
•
Enablex is not recommended for use in patients with severe hepatic
impairment (Child
Pugh C) (see Section 4.4 – Special Warnings and Precautions for
Use).
2
USE IN PATIENTS WITH RENAL IMPAIRMENT
There are no special dosage requirements for patients with renal
impairment.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to the active substance or to