SOLIFENACIN APOTEX

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

SOLIFENACIN SUCCINATE

Sẵn có từ:

Apotex Europe B.V.

Mã ATC:

G04BD08

INN (Tên quốc tế):

SOLIFENACIN SUCCINATE

Liều dùng:

5 Milligram

Dạng dược phẩm:

Film Coated Tablet

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

solifenacin

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2017-08-18

Tờ rơi thông tin

1
SOLIFENACIN APOTEX 5 MG AND 10 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 2018-03-08
MODULE 1.3.1
Package Leaflet
Replaces : 2016-09-29
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIFENACIN APOTEX 5 MG FILM-COATED TABLET
SOLIFENACIN APOTEX 10 MG FILM-COATED TABLET
solifenacin succinate
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.
WHAT IS IN THIS LEAFLET:
1.
What Solifenacin Apotex is and what it is used for
2.
What you need to know before you take Solifenacin Apotex
3.
How to take Solifenacin Apotex
4.
Possible side effects
5.
How to store Solifenacin Apotex
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN APOTEX IS AND WHAT IT IS USED FOR
The active substance of Solifenacin Apotex 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.
Solifenacin succinate 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 SOLIFENACIN APOTEX
DO NOT TAKE SOLIFENACIN APOTEX
-
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
assoc

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin Apotex 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Excipient with known effect:
Each 5 mg tablet contains 117.52 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Each 5 mg tablet is light yellow coloured, round-shaped, biconvex,
film-coated tablet, engraved with “APO” on one
side and “S 5” on the other 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 solifenacin in children have not yet been
established. Therefore, Solifenacin Apotex 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 solifenacin succinate should be limited to 5 mg
when treated simultaneously with ketoconazole
or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir,
nelfinavir, itraconazole (see Section 4.5).
H
E
A
L
T
H
P
R
O
D
U