PHARMACOR SOLIFENACIN solifenacin succinate 5 mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

solifenacin succinate, Quantity: 5 mg

Tilgængelig fra:

Pharmacor Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: magnesium stearate; lactose monohydrate; purified water; maize starch; hypromellose; titanium dioxide; purified talc; iron oxide yellow; macrogol 400

Indgivelsesvej:

Oral

Enheder i pakken:

30, 10

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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

Produkt oversigt:

Visual Identification: Light yellow round shaped, film coated tablets debossed with S5 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

Autorisation status:

Registered

Autorisation dato:

2018-04-10

Indlægsseddel

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

Produktets egenskaber

Pharmacor Solifenacin Ver: 02 1
PRODUCT INFORMATION
PHARMACOR SOLIFENACIN TABLETS
(solifenacin succinate)
1. NAME OF THE MEDICINE
Solifenacin succinate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR SOLIFENACIN 5 mg Film-coated Tablet:
Each tablet contains 5 mg solifenacin succinate; corresponding to 3.8
mg solifenacin.
PHARMACOR 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)
For 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
INDICATIONS
Solifenacin is indicated for the treatment of overactive bladder with
symptoms of urge
urinary incontinence, urgency or increased urinary frequency.
Pharmacor Solifenacin Ver: 02 2
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 adjust