Vesitirim 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Solifenacin succinate

Available from:

Astellas Pharma Co. Limited

ATC code:

G04BD; G04BD08

INN (International Name):

Solifenacin succinate

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for urinary frequency and incontinence; solifenacin

Authorization status:

Marketed

Authorization date:

2004-08-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VESITIRIM 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 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. 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 VESITIRIM
DO NOT TAKE VESITIRIM
- 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 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 t

Summary of Product characteristics

Health Products Regulatory Authority
06 April 2023
CRN00D9W8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vesitirim 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vesitirim 5 mg film-coated tablet:
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Excipient(s) with known effect: lactose monohydrate (107.5 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Vesitirim 5 mg film-coated tablet:
Each 5 mg tablet is a round, light-yellow tablet marked with the
logo and “150” on the same side.
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 Vesitirim in children have not yet been
established. Therefore, Vesitirim 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 Vesitirim should be limited to 5 mg when treated
simultaneously with ketoconazole or therapeutic
doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir,
itraconazole (