Vesitirim 1 mg/ml oral suspension

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Solifenacin succinate

Tilgjengelig fra:

Astellas Pharma Co. Limited

ATC-kode:

G04BD; G04BD08

INN (International Name):

Solifenacin succinate

Dosering :

1 milligram(s)/millilitre

Legemiddelform:

Oral suspension

Administreringsrute:

oral use

Enheter i pakken:

150 ml

Resept typen:

Product subject to prescription which may be renewed (B)

Produsert av:

Astellas Pharma Europe BV

Terapeutisk gruppe:

Urologicals, Drugs for urinary frequency and incontinence

Terapeutisk område:

Drugs for urinary frequency and incontinence; solifenacin

Indikasjoner:

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

Autorisasjon status:

Marketed

Autorisasjon dato:

2015-10-09

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VESITIRIM 1 MG/ML ORAL SUSPENSION
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 Vesitirim is and what it is used for
2.
What you need to know before you take Vesitirim
3.
How to take Vesitirim
4.
Possible side effects
5.
How to store Vesitirim
6.
Contents of the pack and other information
1.
WHAT VESITIRIM IS AND WHAT IT IS USED FOR
The active substance of Vesitirim 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.
Vesitirim 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.
-
treat a condition called neurogenic detrusor overactivity in children
aged 2 to 18 years.
Neurogenic detrusor overactivity is a condition in which involuntary
bladder contractions occur
due to a condition that you are born with or injury to the nerves,
which control the bladder. If
left untreated, neurogenic detrusor overactivity may lead to damage to
your bladder and/or
kidneys.
Vesitirim is used to increase the amount of urine your bladder can
hold and reduce urine
leakage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VESITIRIM
DO NOT TAKE VES

Preparatomtale

Health Products Regulatory Authority
19 October 2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vesitirim 1 mg/ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vesitirim oral suspension contains 1 mg/ml solifenacin succinate,
equivalent to 0.75 mg/ml solifenacin.
EXCIPIENTS WITH KNOWN EFFECT:
Benzoic acid (E210) 0.015 mg/ml.
Methyl parahydroxybenzoate (E218) 1.6 mg/ml.
Propylene glycol (E1520) 20 mg/ml.
Propyl parahydroxybenzoate (E216) 0.2 mg/ml.
This medicine contains 48.4 mg of alcohol (ethanol) per maximum dose
of 10ml. Ethanol originates from the natural orange
flavour.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
A white to off-white coloured aqueous, homogeneous suspension with an
orange flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Overactive bladder in adults_
Vesitirim oral suspension is indicated for symptomatic treatment of
urge incontinence and/or increased urinary frequency and
urgency as may occur in patients with overactive bladder (OAB)
syndrome.
_Neurogenic detrusor overactivity_
Vesitirim oral suspension is indicated for treatment of neurogenic
detrusor overactivity (NDO) in paediatric patients aged 2 to
18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
OVERACTIVE BLADDER
Adults, including elderly:
The recommended dose is 5 mg (5 ml) solifenacin succinate once daily.
If needed, the dose may be increased to 10 mg (10 ml)
solifenacin succinate once daily.
PAEDIATRIC POPULATION:
The efficacy of Vesitirim in children and adolescents with overactive
bladder has not been established. Therefore, Vesitirim
should not be used for treatment of overactive bladder in children and
adolescents under 18 years of age. Currently available
data are described in section 5.1 and 5.2.
NEUROGENIC DETRUSOR OVERACTIVITY
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Paediatric population (age 2 to 18 years):
The recommended dose of Vesitirim oral suspension i