Vesicare 10mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Solifenacin succinate

Sẵn có từ:

Astellas Pharma Ltd

Mã ATC:

G04BD08

INN (Tên quốc tế):

Solifenacin succinate

Liều dùng:

10mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 07040200; GTIN: 5013346096885

Tờ rơi thông tin

(solifenacin succinate)
1. What Vesicare is and what it is used for
2. What you need to know before you take
Vesicare
3. How to take Vesicare
4. Possible side effects
5. How to store Vesicare
6. Contents of the pack and other information
1. WHAT VESICARE IS AND WHAT IT IS USED FOR
The active substance of Vesicare 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.
Vesicare 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 VESICARE
DO NOT TAKE VESICARE
• 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 Vesicare 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 Vesicare starts.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Vesicare
• if you have troub

Đặc tính sản phẩm

OBJECT 1
VESICARE 5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 13-Dec-2013 | Astellas
Pharma Ltd
1. Name of the medicinal product
Vesicare® 5 mg, film-coated tablet
Vesicare® 10 mg, film-coated tablet
2. Qualitative and quantitative composition
Vesicare 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)
Vesicare 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.
Vesicare 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.
Vesicare 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 Vesicare in children have not yet been
established. Therefore, Vesicare 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 impairme