Solicare ODT solifenacin succinate 10 mg orodispersible tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

solifenacin succinate, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: lactose monohydrate; sucralose; polacrilin potassium; sodium stearylfumarate; croscarmellose sodium; mannitol; hypromellose; Flavour

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Solicare ODT 10 mg orodispersible tablet is white, round, biconvex tablet.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-09-17

Patient Information leaflet

1
SOLICARE ODT
5 MG AND 10 MG ORODISPERSIBLE 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 ODT.
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 ODT 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 ODT IS USED FOR
SOLICARE ODT 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 ODT 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 ODT for another reason. Ask
your doctor if you have any questions
about why SOLICARE ODT has been
prescribed for you.
SOLICARE ODT is available only with a
doctor's prescription.
There is no evidence that SOLICARE ODT
is addictive.
BEFORE YOU TAKE SOLICARE ODT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SOLICARE ODT 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 ODT IF YOU:
•
suffer from urinary retention
(inability to urinate or empty
your bladder completely)
•
are undergoing haemodialysis
•
have seve

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
SOLICARE ODT
(SOLIFENACIN SUCCINATE) ORODISPERSIBLE TABLETS
1
NAME OF THE MEDICINE
solifenacin succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLICARE ODT 5 mg orodispersible tablets contains 5 mg solifenacin
succinate, corresponding to 3.8
mg solifenacin.
SOLICARE ODT 10 mg orodispersible tablets contains 10 mg solifenacin
succinate, corresponding to
7.5 mg solifenacin.
List of excipients with known effect
lactose monohydrate
Sucralose
For the full list of excipients, see Section 6.1 - LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet, orodispersible.
SOLICARE ODT 5 mg orodispersible tablet is a white, round, biconvex
tablet, debossed with 5 on
one side.
SOLICARE ODT 10 mg orodispersible tablet is a white, round, biconvex
tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SOLICARE ODT 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, SOLICARE ODT should
not be used in children.
2
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. SOLICARE ODT is contraindicated in patients with severe
hepatic impairment (Child-Pugh
C).
Co-medication
The maximum dose of SOLI