VESITIRIM 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SOLIFENACIN SUCCINATE

Available from:

LTT Pharma Limited

INN (International Name):

SOLIFENACIN SUCCINATE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

VESITIRIM  10MG, FILM-COATED TABLETS
(solifenacin succinate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
IN THIS LEAFLET:
What Vesitirim is and what it is used for
What you need to know before you take Vesitirim
How to take Vesitirim
Possible side effects
How to store Vesitirim
Contents of the pack and other information
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.
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 the othe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vesitirim 10 mg, film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vesitirim 10 mg film-coated tablet:
Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin.
Excipient(s) with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from the UK_
Each 10 mg tablet is a round, light-pink tablet marked with the company logo and “151”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 limite