SOLIFENACIN VIATRIS 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:

Alphapharm Pty Ltd

Lægemiddelform:

Tablet

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

30, 10 (sample).

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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

Produkt oversigt:

Visual Identification: A yellow film-coated, round, biconvex tablet debossed with M on one side of the tablet and SF over 5 on the other side.; Container Type: Blister Pack; Container Material: PVC/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:

2020-03-19

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
SOLIFENACIN MYLAN
_solifenacin succinate film-coated tablets _
1
NAME OF THE MEDICINE
Solifenacin succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SOLIFENACIN MYLAN tablet contains 5 mg or 10 mg of solifenacin
succinate as the active ingredient.
Excipients with known effect: sugars (as lactose monohydrate) and
traces of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SOLIFENACIN MYLAN 5 mg tablets: A yellow film-coated, round, biconvex
tablet debossed with M on one
side of the tablet and SF over 5 on the other side.
SOLIFENACIN MYLAN 10 mg tablets: A pink film-coated, round, biconvex
tablet debossed with M on one
side of the tablet and SF over 10 on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 MYLAN
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 necessary for patients with mild hepatic
impairment. Patients with moderate hepatic
impairment (Child-Pugh B) should be treated with caution and receive
no more than 5 mg once daily.
SOLIFENACIN MYLAN is contraindicated in patients with severe hepatic
impairment (Child-Pugh C).
Co-medication
The maximum dose of SOLIFENACIN MYLAN sho