SOLIFENACIN DR.REDDY's solifenacin succinate 5 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

solifenacin succinate, Quantity: 5 mg (Equivalent: solifenacin, Qty 3.75 mg)

Διαθέσιμο από:

Accelagen Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: magnesium stearate; purified talc; iron oxide yellow; hypromellose; triacetin; titanium dioxide; lactose monohydrate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

10 tablets, 30 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

SOLIFENACIN DR.REDDY's is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Περίληψη προϊόντος:

Visual Identification: Light yellow coloured, round shaped, biconvex film-coated tablet debossed with S5 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-09-29

Φύλλο οδηγιών χρήσης

Solifenacin Dr.Reddy’s v0.2
1
SOLIFENACIN DR.REDDY’S
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SOLIFENACIN DR. REDDY’S?
Solifenacin Dr.Reddy’s is used to treat the symptoms of overactive
bladder.
For more information, see Section 1. Why am I using Solifenacin
Dr.Reddy’s? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SOLIFENACIN DR.REDDY’S?
Do not use if you have ever had an allergic reaction to solifenacin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Solifenacin Dr.Reddy’s? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Solifenacin Dr.Reddy’s and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SOLIFENACIN DR.REDDY’S?
•
The usual dose is 5 to 10 mg of Solifenacin Dr.Reddy’s once a day.
Your doctor will decide the most suitable dose for you.
•
Swallow the tablets with water. Do not crush or chew the tablets.
•
Follow all directions given to you by your doctor carefully.
More instructions can be found in Section 4. How do I use Solifenacin
Dr.Reddy’s? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SOLIFENACIN DR.REDDY’S?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Solifenacin Dr.Reddy’s.
•
Make sure you follow your doctor’s instructions and keep all
appointments.
•
Tell your doctor immediately if you become pregnant while taking
Solifenacin Dr.Reddy’s.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are
taking Solifenacin Dr.Reddy’s.
THINGS YOU
SHOULD NOT DO
�

Αρχείο Π.Χ.Π.

SOLIFENACIN DR.REDDY’S PI Ver 2.0
1
AUSTRALIAN
PRODUCT
INFORMATION
–
SOLIFENACIN
DR.REDDY’S
(SOLIFENACIN
SUCCINATE)
1.
NAME OF THE MEDICINE
Solifenacin succinate
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Solifenacin Dr.Reddy’s 5 mg film-coated tablet: Each tablet contains
5 mg solifenacin
succinate, corresponding to 3.8 mg solifenacin.
Solifenacin Dr.Reddy’s 10 mg film-coated tablet: Each tablet
contains 10 mg solifenacin
succinate, corresponding to 7.5 mg solifenacin.
Excipients with known effect: sugars as lactose (as monohydrate).
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Solifenacin Dr.Reddy’s 5 mg film-coated tablet: Each 5 mg tablet is
a light yellow coloured,
round shaped, biconvex film-coated tablet debossed with ‘S5’ on
one side and plain on other
side.
Solifenacin Dr.Reddy’s 10 mg film-coated tablet: Each 10 mg tablet
is a light pink coloured,
round shaped, biconvex film-coated tablet debossed with ‘S10’ on
one side and plain on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Solifenacin Dr.Reddy’s 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.
SOLIFENACIN DR.REDDY’S PI Ver 2.0
2
_Patients with hepatic impairment _
No dose adjus