SOLIFENACIN AMEDA solifenacin succinate 5 mg film-coated tablets blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

solifenacin succinate, Quantity: 5 mg

Tersedia dari:

Arrow Pharma Pty Ltd

Bentuk farmasi:

Tablet, film coated

Komposisi:

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

Rute administrasi :

Oral

Unit dalam paket:

30 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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

Ringkasan produk:

Visual Identification: Light yellow colored, round, biconvex, film coated tablets, debossed with "EG" on one side and "1" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2019-05-29

Selebaran informasi

Solicare draft v0.2
Page 1 of 4
(solifenacin succinate) tablet, film coated
SOLICARE
5 MG AND 10 MG FILM-COATED TABLETS
_contains the active ingredient 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
Solicare.
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 Solicare
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 SOLICARE IS USED FOR
Solicare 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.
Solicare 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 Solicare for another
reason. Ask your doctor if you
have any questions about why
Solicare has been prescribed for
you.
Solicare is available only with a
doctor's prescription.
There is no evidence that
Solicare is addictive.
BEFORE YOU TAKE SOLICARE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SOLICARE 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 SOLICARE IF YOU:
•
suffer from urinary retention
(inability to urinate or empty
your bladder completely)
•
are undergoing
haemodial

Karakteristik produk

Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION – SOLICARE (SOLIFENACIN
SUCCINATE) TABLET
1
NAME OF THE MEDICINE
Solifenacin succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solicare 5 mg film-coated tablet:
each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Solicare 10 mg film-coated tablet:
each tablet contains 10 mg solifenacin succinate, corresponding to 7.5
mg solifenacin.
List of excipients with known effect: sulfites and lactose
monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solicare 5 mg film-coated tablets: each 5 mg tablet is a light yellow
coloured, round, biconvex, film
coated tablet, debossed with “EG” on one side and “1” on other
side.
Solicare 10 mg film-coated tablets: each 10 mg tablet is a 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
Solicare
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, Solicare should not be
used in children.
Page 2 of 15
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 adjustment is necessary for patients with mild hepatic
impairment. Patients with moderate
hepatic impairment (Child-Pugh B) should be treated with caution and
receive no