Solifenacin PharmSol 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SOLIFENACIN SUCCINATE

Available from:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

ATC code:

G04BD08

INN (International Name):

SOLIFENACIN SUCCINATE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SOLIFENACIN SUCCINATE 10 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-10-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIFENACIN PHARMSOL 5 MG FILM-COATED TABLETS
SOLIFENACIN PHARMSOL 10 MG FILM-COATED TABLETS
solifenacin succinate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Solifenacin PharmSol is and what it is used for
2.
What you need to know before you take Solifenacin PharmSol
3.
How to take Solifenacin PharmSol
4.
Possible side effects
5.
How to store Solifenacin PharmSol
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN PHARMSOL IS AND WHAT IT IS USED FOR
The active substance of Solifenacin PharmSol is Solifenacin succinate
and belongs to the group of
anticholinergics. These medicines are used to reduce the activity of
an overactive bladder. This
enables you to wait longer before having to go to the bathroom and
increases the amount of urine that
can be held by your bladder.
Solifenacin PharmSol is used to treat the symptoms of a condition
called overactive bladder in adults.
These symptoms include: having a strong, sudden urge to urinate
without prior warning, having to
urinate frequently or wetting yourself because you could not get to
the bathroom in time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIFENACIN PHARMSOL
DO NOT TAKE SOLIFENACIN PHARMSOL:
-
if you have an inability to pass water or to empty your bladder
completely (urinary retention)
-
if you have a severe stomach or bowel condition (including toxic
megacolon, a complication
associated with ulcerative colitis)
-
if you suffer from the muscle disease called myasthe

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Solifenacin PharmSol 5 mg film-coated tablets
Solifenacin PharmSol 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solifenacin PharmSol 5 mg film-coated tablet: Each tablet contains 5
mg solifenacin
succinate, equivalent to 3.8 mg solifenacin
Solifenacin PharmSol 10 mg film-coated tablet: Each tablet contains 10
mg solifen-
acin succinate, equivalent to 7.5 mg solifenacin
Excipient(s) with known effect:
Each 5 mg tablet contains 54.25 mg of lactose monohydrate
Each 10 mg tablet contains 108.5 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Solifenacin PharmSol 5 mg: light yellow, round, biconvex film-coated
tablets with a
diameter of 5.8 mm
Solifenacin PharmSol 10 mg: light pink, round, biconvex film-coated
tablets with
score line on one side and plain on the other and with a diameter of
7.9 mm. The tab-
let can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Solifenacin PharmSol is indicated for symptomatic treatment of urge
incontinence
and/or increased urinary frequency and urgency as may occur in
patients with overac-
tive bladder syndrome.
Solifenacin PharmSol is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including the elderly _
The recommended dose is 5 mg Solifenacin succinate once daily. If
needed, the dose
may be increased to 10 mg Solifenacin succinate once daily.
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_Paediatric population _
The safety and efficacy of Solifenacin PharmSol film-coated tablets in
children and
adolescents have not yet been established.
Therefore, Solifenacin PharmSol film-coated tablets should not be used
in children
and adolescents.
_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 tre