Vezimed 5 mg, film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SOLIFENACIN SUCCINATE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

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:

2017-01-10

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VEZIMED 5 MG, FILM-COATED TABLET
VEZIMED 10 MG, FILM-COATED TABLET
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vezimed is and what it is used for
2.
What you need to know before you take Vezimed
3.
How to take Vezimed
4.
Possible side effects
5.
How to store Vezimed
6.
Contents of the pack and other information
1.
WHAT VEZIMED IS AND WHAT IT IS USED FOR
The active substance of Vezimed 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.
Vezimed 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
VEZIMED
DO NOT TAKE VEZIMED:
•
if you are allergic to the active substance or any of the other
ingredients of this medicine
(listed in section 6).
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•
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 myasthenia gravis, which
can cause an ex

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vezimed 5 mg, film-coated tablet
Vezimed 10 mg, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vezimed 5 mg, film-coated tablet: Each tablet contains 5 mg
solifenacin succinate, corresponding to
3.8 mg solifenacin.
Vezimed 10 mg film-coated tablet: Each tablet contains 10 mg
solifenacin succinate, corresponding to
7.5 mg solifenacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Each 5 mg film-coated tablet is a yellow, round, biconvex film coated
tablet with a diameter of 6mm
Each 10 mg film-coated tablet is a red, round, biconvex film coated
tablet with a diameter of 8mm
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_
The safety and efficacy of solifenacin in children have not yet been
established. Therefore, Vezimed
should not be used in children.
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_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 Vezimed
should be limited to 5 mg when
treated
simultaneously with
ketoco