Vesitirim 10 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Solifenacin succinate

제공처:

Astellas Pharma Co. Limited

ATC 코드:

G04BD; G04BD08

INN (International Name):

Solifenacin succinate

복용량:

10 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Drugs for urinary frequency and incontinence; solifenacin

승인 상태:

Marketed

승인 날짜:

2004-08-13

환자 정보 전단

™
10 MG
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 the other
ingredients of this medicine (listed in section 6)
•
if you are undergoing kidney dialysis
•
if you have severe liver disease
•
if you suffer from severe kidney disease or moderate
liver disease AND at the same time are being treated with
medicines that may decrease the removal of Vesitirim from the
body (for example, ketoconazole). Your doctor or pharmacist
will have informed you if this is the case.
Inform your doctor if you have or ever had any of the above
mentioned conditions before treatment with Vesitirim starts.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vesitirim

제품 특성 요약

Health Products Regulatory Authority
06 April 2023
CRN00D9W8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vesitirim 10 mg film-coated tablets
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 (102.5 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Vesitirim 10 mg film-coated tablet:
Each 10 mg tablet is a round, light-pink tablet marked with the
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 limited to 5 mg when treated
simultaneously with ketoconazole or therapeutic
doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir,
itraconazole