AKM SOLIFENACIN solifenacin succinate 10 mg tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

solifenacin succinate, Quantity: 10 mg

Доступно од:

Pharmacor Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: hypromellose; lactose monohydrate; purified water; maize starch; magnesium stearate; titanium dioxide; macrogol 8000; purified talc; iron oxide red

Пут администрације:

Oral

Јединице у пакету:

10, 30

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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

Резиме производа:

Visual Identification: Light pink, round shaped, film coated tablets debossed with S10 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Registered

Датум одобрења:

2018-04-10

Информативни летак

AKM Solifenacin Ver: 02 1
AKM SOLIFENACIN TABLETS
_Solifenacin succinate_
AKM SOLIFENACIN 5 mg film-coated tablets
AKM SOLIFENACIN 10 mg film-coated tablets
_ _
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
AKM SOLIFENACIN.
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 AKM
SOLIFENACIN 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 AKM
SOLIFENACIN IS USED
FOR
AKM SOLIFENACIN 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.
AKM SOLIFENACIN
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 AKM
SOLIFENACIN for another
reason. Ask your doctor if
you have any questions
about why AKM
SOLIFENACIN has been
prescribed for you.
AKM SOLIFENACIN is
available only with a doctor's
prescription.
There is no evidence that
AKM SOLIFENACIN is
addictive.
BEFORE YOU TAKE AKM
SOLIFENACIN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE AKM
SOLIFENACIN 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 AKM
SOLIFENACIN IF YOU:

suffer from urinary
retention (inability

Карактеристике производа

AKM Solifenacin Ver: 02 1
PRODUCT INFORMATION
AKM SOLIFENACIN TABLETS
(solifenacin succinate)
1. NAME OF THE MEDICINE
Solifenacin succinate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM SOLIFENACIN 5 mg Film-coated Tablet:
Each tablet contains 5 mg solifenacin succinate; corresponding to 3.8
mg solifenacin.
AKM SOLIFENACIN 10 mg Film-coated Tablet:
Each tablet contains 10 mg solifenacin succinate; corresponding to 7.5
mg solifenacin.
Excipient(s) with known effect: lactose monohydrate 107.5 mg (for 5 mg
tablets)
Excipient(s) with known effect: lactose monohydrate 102.5 mg (for 10
mg tablets)
AKM SOLIFENACINFor the full list of excipients, see Section 6.1 List
of excipients
3. PHARMACEUTICAL FORM
Film-coated tablets
Solifenacin succinate 5 mg Film-coated Tablets:
Light yellow round shaped, film coated tablets debossed with "S5" on
one side and plain on
other side.
Solifenacin succinate 10 mg Film-coated Tablets:
Light pink, round shaped, film coated tablets debossed with "S10" on
one side and plain on
other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AKM Solifenacin Ver: 02 2
INDICATIONS
Solifenacin 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
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
should not be used in children.
_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 necessa