ZABCARE 5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SOLIFENACIN SUCCINATE

Available from:

Heaton k.s. Na Pankraci 14, 140 00 Praha 4, Czech Republic

ATC code:

G04BD08

INN (International Name):

SOLIFENACIN SUCCINATE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SOLIFENACIN SUCCINATE 5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2019-08-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Zabcare 5 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 side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zabcare is and what it is used for
2.
What you need to know before you take Zabcare
3.
How to take Zabcare
4.
Possible side effects
5.
How to store Zabcare
6.
Contents of the pack and other information
1.
WHAT ZABCARE IS AND WHAT IT IS USED FOR
The active substance of Zabcare belongs to the group called
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.
Zabcare 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZABCARE
DO NOT TAKE ZABCARE
–
if you are unable 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 myasthenia gravis, which
can cause an extreme
weakness of certain muscles.
–
if you suffer from increased pressure in the eyes, with gradual loss
of eye sight (glaucoma).
–
if you are allergic to solifenacin or any of the other i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zabcare 5 mg film-coated tablets
Zabcare 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zabcare 5 mg film-coated tablet contains 5 mg solifenacin
succinate, equivalent to 3.8 mg
solifenacin.
Each Zabcare 10 mg film-coated tablet contains 10 mg solifenacin
succinate, equivalent to
7.5 mg solifenacin.
Excipient(s) with known effect:
Excipients: lactose monohydrate 107.5 mg 102.5 mg in one tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Each 5 mg tablet is a round, light-yellow tablet of diameter
approximately 8 mm debossed with “390”
on one side of the tablet.
Each 10 mg tablet is a round, light-pink tablet of diameter
approximately 8 mm debossed with “391”
on one side of the tablet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zabcare is indicated in adults for 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
The recommended dose is 5 mg solifenacin succinate once daily. If
needed, the dose may be
increased to 10 mg solifenacin succinate once daily.
Special Populations
_Elderly_
No dosage adjustment is necessary for patients of the elderly
population.
_Renal impairment_
No dosage 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).
_Hepatic impairment_
No dosage 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).
_Patients treated with potent inhibitors of cytochrome P450 3A4 _
The maximum dose of Zabcare should b