SOLIFENACIN SANDOZ solifenacin succinate 5 mg film-coated tables blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

solifenacin succinate, Quantity: 5 mg (Equivalent: solifenacin, Qty 3.8 mg)

זמין מ:

Sandoz Pty Ltd

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: hypromellose; magnesium stearate; titanium dioxide; iron oxide yellow; pregelatinised maize starch; lactose monohydrate; purified talc; macrogol 6000

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Solifenacin Sandoz is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

leaflet_short:

Visual Identification: Light yellow, round film-coated tablet with debossment 05 on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2020-11-04

עלון מידע

SOLIFENACIN SANDOZ
®
1
SOLIFENACIN
SANDOZ
®
_Solifenacin succinate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
This leaflet answers some common
questions about Solifenacin Sandoz.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Solifenacin
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT SOLIFENACIN
SANDOZ IS USED FOR
Solifenacin Sandoz is used to treat
the symptoms of overactive bladder.
These symptoms include needing to
rush to the toilet to urinate without
warning, needing to urinate
frequently, or wetting yourself
because you did not get to the toilet
in time.
Solifenacin Sandoz belongs to a
group of medicines called
anticholinergic medicines. It works
by acting on specialised cells to
reduce the activity of your bladder
and help you control your bladder.
Your doctor may have prescribed
Solifenacin Sandoz for another
reason. Ask your doctor if you have
any questions about why Solifenacin
Sandoz has been prescribed for you.
Solifenacin Sandoz is available only
with a doctor's prescription.
There is no evidence that Solifenacin
Sandoz is addictive.
BEFORE YOU TAKE
SOLIFENACIN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SOLIFENACIN SANDOZ IF
YOU ARE ALLERGIC TO MEDICINES
CONTAINING SOLIFENACIN OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing,
wheezing or shortness of breath.
DO NOT TAKE SOLIFENACIN SANDOZ IF
YOU:
•
suffer from urinary retention
(inability to urinate or empty your
bladder completely)
•
are unde

מאפייני מוצר

201104-SOLIFENACIN SANDOZ-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
SOLIFENACIN SANDOZ
® (SOLIFENACIN SUCCINATE)
1.
NAME OF THE MEDICINE
Solifenacin succinate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_SOLIFENACIN SANDOZ_
®
_5 mg film-coated tablet: _
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
_SOLIFENACIN SANDOZ_
®
_10 mg film-coated tablet: _
Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5
mg solifenacin.
_Excipient with known effect: _
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
_SOLIFENACIN SANDOZ_
®
_5 mg film-coated tablet: _
Each 5 mg tablet is a round, light-yellow tablet with debossment
“05” on one side.
_SOLIFENACIN SANDOZ_
®
_10 mg film-coated tablet: _
Each 10 mg tablet is a round, light-pink tablet with debossment
“10” on one side and score line
on the other side.
The 10 mg scored tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
SOLIFENACIN SANDOZ
®
is indicated for the treatment of overactive bladder with symptoms
of urge urinary incontinence, urgency or increased urinary frequency.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS, INCLUDING THE ELDERLY _
The recommended dose is 5 mg solifenacin succinate once daily. If
needed, the dose may be
increased to a maximum of 10 mg solifenacin succinate once daily.
_CHILDREN AND ADOLESCENTS _
Safety and effectiveness in children have not yet been established.
Therefore, SOLIFENACIN
SANDOZ
®
should not be used in children.
201104-SOLIFENACIN SANDOZ-pi
Page 2 of 14
METHOD OF ADMINISTRATION
SOLIFENACIN SANDOZ
®
should be taken orally and should be swallowed whole with
liquids. It can be taken with or without food.
DOSAGE ADJUSTMENT IN:

renal impairment
No dose adjustment is necessary for patients with mild to moderate
renal impairment
(creatinine
clearance
>
30
mL/min).
Patients
with
severe
renal
impairment
(creatinine
clearance ≤ 30 mL/min) should