Solifenacin

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Solifenacin succinate 5mg

Sẵn có từ:

PSM Healthcare Ltd trading as API Consumer Brands

INN (Tên quốc tế):

Solifenacin succinate 5 mg

Liều dùng:

5 mg

Dạng dược phẩm:

Film coated tablet

Thành phần:

Active: Solifenacin succinate 5mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Maize starch Opadry yellow 03F520046

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Jubilant Generics Limited

Chỉ dẫn điều trị:

Solifenacin film-coated tablets are indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent micturition, and/or urge incontinence.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, Al-PVC - 30 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle and PP cap with induction seal - 100 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle and PP cap with induction seal - 500 tablets - 48 months from date of manufacture stored at or below 25°C

Ngày ủy quyền:

2016-05-06

Tờ rơi thông tin

NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI)
SOLIFENACIN FILM-COATED TABLETS 5 MG AND 10 MG (PHARMACARE®)
Page 1 of 6
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Solifenacin
film-coated tablets 5 mg and 10 mg,
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 SOLIFENACIN FILM-COATED TABLETS ARE 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 SOLIFENACIN FILM-COATED TABLETS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THE PRODUCT 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
NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI)
SOLIFENACIN FILM-COATED TABLETS 5 MG AND 10 MG (PHARMACARE®)
Page 2 of 6
DO NOT TAKE THIS PRODUCT IF YOU:
•
suffer from an inability to urinate or empty your bladd

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
SOLIFENACIN FILM-COATED TABLETS 5 & 10MG (PHARMACARE®)
Page 1 of 10
PRESENTATION
Solifenacin film-coated tablets 5mg:
Each tablet contains 5 mg of solifenacin succinate.
They are light yellow coloured, round, biconvex, film coated tablets,
debossed with ‘D5’ on
the one side and plain on the other side.
Solifenacin film-coated tablets 10mg:
Each tablet contains 10 mg of solifenacin succinate.
They are light pink coloured, round, biconvex, film coated tablets,
debossed with ‘D6’ on
the one side and plain on the other side.
Solifenacin film-coated tablets 5mg are packed in PVC/Aluminium
blisters in 30 tablet packs.
Solifenacin film-coated tablets 10mg are packed in PVC/Aluminium
blisters in 30 tablet packs.
USES
_ACTIONS:_
_ _
PHARMACOTHERAPEUTIC GROUP:
Urinary antispasmodics.
MECHANISM OF ACTION:
Solifenacin is a competitive, specific cholinergic-receptor antagonist
with selectivity for the
urinary bladder over salivary glands _in vivo_.
PHARMACODYNAMIC EFFECTS:
Treatment with Solifenacin film-coated tablets
in doses of 5 mg and 10 mg daily was studied in
several double
blind, randomised, controlled clinical trials in men and women with
overactive
bladder. As
shown in Table 1 (European studies) and 2 (US studies) below, both the
5 mg
and 10 mg
doses of Solifenacin film-coated tablets
produced statistically significant
improvements in the primary and
secondary endpoints compared with placebo. Efficacy was
observed within one week of
starting treatment and stabilises over a period of 12 weeks. A
long-term open label study
demonstrated that efficacy was maintained for at least 12 months.
After 12 weeks of
treatment approximately 50% of patients suffering from incontinence
before
treatment were
free of incontinence episodes, and in addition 35% of patients
achieved a
micturition
frequency of less than 8 micturitions per day. Treatment with
Solifenacin also
showed
benefit on a number of Quality of Life measures, such as general
limitations,
emotions,
symptom severity, severity measures an