DETRUSITOL SR 2MG EXTENDED RELEASE CAPSULES

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TOLTERODINE L-TARTRATE

Boleh didapati daripada:

UPJOHN (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TOLTERODINE L-TARTRATE

Unit dalam pakej:

30 Capsule Capsules

Dikeluarkan oleh:

Catalent Pharma Solutions, LLC

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DETRUSITOL
®
SR CAPSULES
Tolterodine tartrate (2 mg, 4 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Detrusitol SR is used for
2.
How Detrusitol SR works
3.
Before you use Detrusitol SR
4.
How to use Detrusitol SR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Detrusitol
SR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT DETRUSITOL SR IS USED FOR
Detrusitol SR is used for the treatment of
the symptoms of overactive bladder
syndrome.
If you have overactive bladder syndrome,
you may find that:
- you are unable to control urination;
- you need to rush to the toilet with no
advance warning and/or go to the toilet
frequently.
HOW DETRUSITOL SR WORKS
Detrusitol SR belongs to a class of
medicines called antimuscarinics. It
works by reducing spasm and relaxing
the bladder muscles.
BEFORE YOU USE DETRUSITOL SR
-
_When you must not use it_
Do not take Detrusitol SR if you:
- are allergic (hypersensitive) to
Detrusitol SR or any of the other
ingredients in Detrusitol SR or to
fesoterodine fumarate extended-
release tablets;
- are unable to pass urine from the
bladder (urinary retention);
- suffer from a condition in which the
stomach's ability to empty its
contents is impaired (gastric
retention);
- have uncontrolled narrow-angle
glaucoma (uncontrolled high pressure
in the eyes).
_Pregnancy and lactation_
The safety of Detrusitol SR during
pregnancy has not yet been proven.
It is not known if Detrusitol SR is
excreted in the mother’s breast milk. You
must discuss with your doctor about the
health benefits of breast feeding,
underlying maternal condition, and the
side effects of Detrusitol SR, on your
breastfed baby before taking Detrusitol
SR.
Ask your doctor or pharmacist for advice
before taking any medicine.
-
_Before you start to use it_
Check with your doctor before you use
this medicine:
- if you have serious allergic reaction
which causes difficulty in breathing
or

Ciri produk

Pfizer Confidential
1
PFIZER
DETRUSITOL
® SR
Tolterodine Tartrate
1. NAME OF THE MEDICINAL PRODUCT
DETRUSITOL
®
SR
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DETRUSITOL
®
SR Capsules 2 mg are blue-green with symbol and 2 printed in white
ink.
Each extended release capsule contains tolterodine tartrate 2 mg
equivalent to 1.37 mg tolterodine.
DETRUSITOL
®
SR Capsules 4 mg are blue with symbol and 4 printed in white ink.
Each extended release capsule contains tolterodine tartrate 4 mg
equivalent to 2.74 mg tolterodine.
3. PHARMACEUTICAL FORM
Extended release capsules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
DETRUSITOL
®
SR Capsules are once-daily extended release capsules indicated for the
treatment of
overactive bladder with symptoms of urge urinary incontinence,
urgency, and frequency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of DETRUSITOL
®
SR Capsules is 4 mg once daily with water and swallowed
whole. The dose may be lowered to 2 mg daily based on individual
response and tolerability; however,
limited efficacy data are available for DETRUSITOL
®
SR 2 mg
_[see CLINICAL STUDIES]_
.
4.2.1 DOSAGE ADJUSTMENT IN SPECIFIC POPULATIONS
HEPATIC AND RENAL IMPAIRMENT
For patients with mild to moderate hepatic impairment (Child-Pugh
Class A or B) or severe renal
impairment (CCr 10 - 30 mL/min), the recommended dose of DETRUSITOL
®
SR is 2 mg once daily.
DETRUSITOL
®
SR is not recommended for use in patients with severe hepatic
impairment (Child-
Pugh Class C). Patients with CCr<10 mL/min have not been studied and
use of DETRUSITOL
®
SR in
this population is not recommended
_[see WARNINGS AND PRECAUTIONS and PHARMACOKINETICS _
_IN SPECIAL POPULATIONS]. _
_ _
PEDIATRIC USE
Efficacy in the pediatric population has not been demonstrated.
GERIATRIC USE
No overall differences in safety were observed between the older and
younger patients treated with
tolterodine.
Pfizer Confidential
2
4.2.2 DOSAGE ADJUSTMENT IN PRESENCE OF CONCOMITANT DRUGS
For
patients
who
are
taking
drugs
that
are
poten