Vesicare

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Solifenacin succinate 10mg;  

Предлага се от:

Seqirus (NZ) Ltd

INN (Международно Name):

Solifenacin succinate 10 mg

дозиране:

10 mg

Лекарствена форма:

Film coated tablet

Композиция:

Active: Solifenacin succinate 10mg   Excipient: Hypromellose Lactose monohydrate Magnesium stearate Maize starch Opadry pink 03F14895

Броя в опаковка:

Blister pack, PVC/Al x 30 tablets, 30 tablets

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Astellas Ireland Co. Limited

Терапевтични показания:

Vesicare is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent micturition, and/or urge incontinence.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, PVC/Al x 30 tablets - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Дата Оторизация:

2005-02-03

Листовка

Vesicare
1
VESICARE
®
5 MG AND 10 MG FILM COATED TABLETS
SOLIFENACIN SUCCINATE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Vesicare.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using this
medicine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VESICARE IS USED FOR
This medicine is used to treat the symptoms of overactive bladder.
These symptoms include
needing to rush to the toilet to urinate without warning, needing to
urinate frequently, or
wetting yourself because you did not get to the toilet in time.
This medicine belongs to a group of medicines called anticholinergic
medicines. It works on
specialised cells to reduce the activity of your bladder and help you
control your bladder.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another purpose.
This medicine is not addictive.
It is available only with a doctor’s prescription.
BEFORE YOU TAKE VESICARE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VESICARE IF YOU HAVE AN ALLERGY TO:
•
any medicine containing solifenacin succinate
•
any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives on the skin
Vesicare
2
DO NOT TAKE VESICARE IF YOU:
•
suffer from an inability to urinate or empty your bladder completely
(urinary retention)
•
have high pressure in the eyes, with gradual loss of eye sight
(uncontrolled glaucoma)
•
have the muscle condition called myasthenia gravis, which can cause
extreme weakness
in certain muscles. Symptoms i

Данни за продукта

VESICARE

_Solifenacin succinate_
Version: 3.0
1
DATA SHEET
1. PRODUCT NAME
VESICARE

Solifenacin succinate, 5 mg and 10 mg film-coated tablets.
2. QUALIATIVE AND QUANTITATIVE COMPOSITION
Each VESICARE
®
5 mg tablet contains 5 mg solifenacin succinate.
Each VESICARE
®
10 mg tablet contains 10 mg solifenacin succinate.
3. PHARMACEUTICAL FORM
VESICARE
®
5 mg tablet: The film-coated tablet is round, light-yellow and marked
with a
triangular logo and “150”.
VESICARE
®
10 mg tablet: The film-coated tablet is round, light-pink and marked
with a
triangular logo and “151”.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VESICARE
®
is indicated for the treatment of unstable bladder with symptoms of
increased
urinary urgency, frequent micturition, and/or urge incontinence.
4.2 DOSE AND METHOD OF ADMINISTRATION
VESICARE
®
should be taken orally and should be swallowed whole with liquids. It
can be
taken with or without food, as is convenient.
ADULTS:
In adults, the recommended dose is 5 mg once daily. If needed, this
can be increased to
10 mg once daily.
CHILDREN:
Safety and effectiveness in children has not yet been established.
Therefore, VESICARE
®
_ _
is
not recommended for use 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 not
more than 5 mg once
daily. Pharmacokinetics in patients undergoing haemodialysis has not
been studied.
PATIENTS WITH HEPATIC IMPAIRMENT:
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients with
moderate hepatic impairment should be treated with caution and receive
not more than 5 mg
once daily. Pharmacokinetics in patients with severe hepatic
impairment has not been
studied.
STRONG INHIBITORS OF CYTOCHROME P450 3A4:
The maximum dose of VESICARE
®
should be limited to 5 mg when treated simultaneously
with ketocon