Solifenacin Teva 5 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Solifenacin succinate

Διαθέσιμο από:

Teva B.V.

Φαρμακολογική κατηγορία (ATC):

G04BD; G04BD08

INN (Διεθνής Όνομα):

Solifenacin succinate

Δοσολογία:

5 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Drugs for urinary frequency and incontinence; solifenacin

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2017-03-31

Φύλλο οδηγιών χρήσης

Solifenacin, DK/H/2188/001-002, 18.01.19
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLIFENACIN TEVA 5 MG FILM-COATED TABLETS
SOLIFENACIN TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Solifenacin Teva
3.
How to take Solifenacin Teva
4.
Possible side effects
5.
How to store Solifenacin Teva
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN TEVA IS AND WHAT IT IS USED FOR
The active substance of Solifenacin Teva 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 Teva is used to treat the symptoms of a condition called
overactive bladder. 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.
Solifenacin, DK/H/2188/001-002, 18.01.19
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIFENACIN TEVA
DO NOT TAKE SOLIFENACIN TEVA

if you are allergic to solifenacin or any of the other ingredients of
this medicine (listed in section
6).

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
m

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
09 November 2020
CRN00C0YJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin Teva 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Solifenacin Teva 5 mg film-coated tablet: Each tablet contains 5 mg
solifenacin succinate, corresponding to 3.8 mg solifenacin.
Excipient with known effect
Each film-coated tablet contains 78.0 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Solifenacin Teva 5 mg film-coated tablet: Light yellow to yellow,
round standard convex, film coated tablet, diameter 8 mm,
debossed with "S5" on one side of the tablet and plain on the other
side of the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as may occur in patients with
overactive bladder syndrome.
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.
_ _
_Paediatric population_
Safety and effectiveness in children have not yet been established.
Therefore, solifenacin succinate should not be used in
children.
_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 (see section 5.2).
_ _
_Patients with hepatic impairment_
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients with moderate hepatic impairment
(Child-Pugh score of 7 to 9) should be treated with caution and
receive no more than 5 mg once daily (see section 5.2).
_ _
_Potent inhibitors of cytochrome P450 3A4_
The maximum dose of solifenacin succinate should be limited to 5 mg
when treated s