SOLIFENACIN LUPIN solifenacin succinate 10 mg film-coated tablets blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

solifenacin succinate, Quantity: 10 mg

から入手可能:

Generic Health Pty Ltd

医薬品形態:

Tablet, film coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

30 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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

製品概要:

Visual Identification: Light pink colored, round, biconvex, film coated tablets, debossed with "EG" on one side and "2" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Registered

承認日:

2019-05-29

情報リーフレット

CONSUMER MEDICINE INFORMATION
SOLIFENACIN LUPIN
(SOLIFENACIN SUCCINATE) FILM-COATED TABLETS
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
This leaflet answers some
common questions about
Solifenacin Lupin.
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 Lupin 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 LUPIN
IS USED FOR
Solifenacin Lupin 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 Lupin 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 Lupin for
another reason. Ask your doctor
if you have any questions about
why Solifenacin Lupin has been
prescribed for you.
Solifenacin Lupin is available
only with a doctor's prescription.
There is no evidence that
Solifenacin Lupin is addictive.
BEFORE YOU TAKE
SOLIFENACIN LUPIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SOLIFENACIN LUPIN
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 LUPIN
IF YOU:
•
suffer from urinary retention
(inability to urinate or empty
your bladder completely);
•
are undergoing
haemodialysis

製品の特徴

AUSTRALIAN PRODUCT INFORMATION – SOLIFENACIN LUPIN
(SOLIFENACIN SUCCINATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Solifenacin succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solifenacin Lupin 5 mg film-coated tablet:
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Solifenacin Lupin 10 mg film-coated tablet:
Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5
mg solifenacin.
List of excipients with known effect in 5 mg tablets: sulfites and
sugars as lactose.
List of excipients with known effect in 10 mg tablets: sulfites and
lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solifenacin Lupin 5 mg film-coated tablets: Light yellow coloured,
round, biconvex, film-coated tablet,
debossed with “EG” on one side and “1” on other side.
Solifenacin Lupin 10 mg film-coated tablets: Light pink coloured,
round, biconvex, film-coated tablet,
debossed with “EG” on one side and “2” on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solifenacin Lupin is indicated for the treatment of overactive bladder
with symptoms of urge urinary
incontinence, urgency or increased urinary frequency.
4.2 DOSE AND METHOD OF ADMINISTRATION
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 Lupin should
not be used in children.
Solifenacin Lupin v2
Page 2 of 15
(solifenacin succinate) film-coated tablet
SPECIAL POPULATIONS
Patients with 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 be treated with caution and receive no more than 5 mg once
daily.
Patients with Hepatic Impairment
No dose