VESICARE

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Solifenacin succinate

Dostopno od:

Astellas Pharma Australia Pty Ltd

Razred:

Medicine Registered

Navodilo za uporabo

 
1 

5 MG AND 10 MG FILM-COATED TABLETS

contains the active ingredient 
_solifenacin succinate_

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

READ THIS LEAFLET CAREFULLY 
BEFORE YOU START TAKING THIS 
MEDICINE.  

This leaflet answers some common 
questions about VESICARE. 

It does not contain all of the 
available information.  It does not 
take the place of talking to your 
doctor or pharmacist. 

All medicines have benefits and 
risks.  Your doctor has weighed the 
risks of you taking VESICARE 
against the benefits they expect it 
will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, TALK TO 
YOUR DOCTOR OR PHARMACIST. 

Keep this leaflet with your medicine.  
You may need to read it again. 

WHAT VESICARE IS USED 
FOR 

VESICARE is used to treat 
the 
symptoms of overactive bladder. 
These symptoms include needing to 
rush to the toilet to urinate without 
warning, needing to urinate 
frequently, or wetting yourself 
because you did not get to the toilet 
in time.  

VESICARE belongs to a group of 
medicines called anticholinergic 
medicines. It works by acting on 
specialised cells to reduce the 
activity of your bladder and help 
you control your bladder.  
Your doctor may have prescribed 
VESICARE for another reason. Ask 
your doctor if you have any 
questions about why VESICARE has 
been prescribed for you. 

VESICARE is available only with a 
doctor's prescription. 
There is no evidence that VESICARE 
is addictive. 

BEFORE YOU TAKE 
VESICARE 

WHEN YOU MUST NOT TAKE IT 

DO NOT TAKE VESICARE IF YOU 
ARE ALLERGIC TO MEDICINES 
CONTAINING SOLIFENACIN OR ANY OF 
THE INGREDIENTS LISTED AT THE 
END OF THIS LEAFLET.  Some of the 
symptoms of an allergic reaction 
may include skin rash, itching or 
hives, swelling of the face, lips or 
tongue which may cause difficulty 
in swallowing or breathing, 
wheezing or shor

Lastnosti izdelka

PRODUCT INFORMATION 

VESICARE (SOLIFENACIN 5MG, 10MG FILM-COATED TABLETS) 

NAME OF THE MEDICINE 

Vesicare® 5 mg Tablet 
Vesicare® 10 mg Tablet 

DESCRIPTION 
Vesicare 5 mg film-coated tablet: 
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. 
Vesicare 10 mg film-coated tablet: 
Each tablet contains 10 mg solifenacin
succinate, corresponding to 7.5 mg 
solifenacin. 
Solifenacin
(3R)-1-azabicyclo[2.2.2]oct-3-yl(1S)-1-phenyl-3,4-dihydroisoquinoline-
2(1H)-carboxylate monosuccinate 

The empirical formula is C
23
H
26
N
2
O
2
.C
4
H
6
O
4

The molecular weight is 480.55 
The CAS number is 242478-38-2 

Molecular structure: 

N
O
O
N
O
O
O
H
OH
• 

PHARMACOLOGY 

Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08. 
Mechanism of Action 
Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play 
an
important role in several major cholinergic mediated functions,
including 
contractions of urinary bladder smooth muscle and stimulation
of the salivary 
secretion. 
Vesicare (solifenacin 5mg, 10mg): Product Information  

1 
Pharmacokinetics 
_Absorption _
After intake of Vesicare tablets, maximum  solifenacin plasma
concentrations (C
max
) 
are reached after 3 to 8 hours and at steady state ranged
from 32.3 to 69.9 ng/ml for 
the 5 and 10 mg Vesicare tablets, respectively. The t
max
  is independent of the dose. 
The C
max
 and area under the curve (AUC) increase in proportion to
the dose between 
5 to
40 mg.  Absolute bioavailability is approximately 90%. Food
intake does not 
affect the C
max
 and AUC of solifenacin. 
_Distribution _
The apparent volume of distribution of solifenacin
following intravenous 
administration is about 600 L. Solifenacin is to a
great extent (approximately 98%) 
bound to plasma