DETRUSITOL TABLET 2MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TOLTERODINE L-TARTRATE

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

TOLTERODINE L-TARTRATE

Unit dalam pakej:

56 Tablets; 28 Tablets; 14 Tablets

Dikeluarkan oleh:

PFIZER ITALIA S.R.L.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DETRUSITOL
®
TABLET
Tolterodine tartrate (2 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Detrusitol is used for
2.
How Detrusitol works
3.
Before you use Detrusitol
4.
How to use Detrusitol
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Detrusitol
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT DETRUSITOL IS USED FOR
Detrusitol is used for the treatment of
overactive bladder.
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 WORKS
Detrusitol belongs to a class of medicines
called antimuscarinics. It works by
reducing spasm and relaxing the bladder
muscles.
BEFORE YOU USE DETRUSITOL
_-_
_When you must not use it_
Do not take Detrusitol if you:
- are allergic (hypersensitive) to
tolterodine or any of the other
ingredients in Detrusitol;
- are unable to pass urine (urinary
retention);
- have an uncontrolled narrow-angle
glaucoma (uncontrolled high pressure
in the eyes with loss of eyesight that
is not being adequately treated);
- suffer from myasthenia gravis
(excessive weakness of the muscles);
- suffer from severe ulcerative colitis
(ulceration and inflammation of the
colon);
- suffer from a toxic megacolon (acute
expansion of the colon).
_Pregnancy and lactation_
The safety of Detrusitol during pregnancy
has not yet been proven. Detrusitol is not
recommended during pregnancy. You
should use Detrusitol only after
discussing the potential benefits and the
potential risks to your unborn child with
your doctor.
It is not known if Detrusitol is excreted in
the mother’s breast milk. Detrusitol
should be avoided during breast feeding.
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 difficulties in passing
urine and/

Ciri produk

Pfizer Confidential
CLD Title
: Tolterodine tartrate (Detrusitol)
CLD Date
: 2147 May January 20212022
Country
: Malaysia
Reference Document
: EU SPC dated 17 February 2021
Reason for change
: Minor administrative changes to remove Pfizer reference PfLEET
2020-0061583 (S2): Update 4.4 “warnings and precautions for
use”
for
information
on
the
excipient
"sodium".
Pfizer Confidential
1
DETRUSITOL
®
Tolterodine Tartrate
1.
NAME OF THE MEDICINAL PRODUCT
Detrusitol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tolterodine tartrate 2 mg
corresponding to 1.37 mg
tolterodine.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The film-coated tablets are white, round and biconvex. The 2 mg tablet
is engraved
with arcs above and below the letters DT.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tolterodine is indicated for the treatment of overactive bladder with
symptoms of
urinary urgency, frequency, or urge incontinence.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the Elderly)
The recommended total daily dose is 4 mg. Dosage with tolterodine
tablets is 2 mg
twice daily. The total daily dose may be reduced to 2 mg, based on
individual
tolerability.
Use in Children
Safety and effectiveness in children have not been established.
Use in Impaired Renal Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1
mg twice daily)
for patients with impaired renal function (see Section 4.4).
Use in Impaired Hepatic Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1
mg twice daily)
for patients with impaired hepatic function (see Section 4.4).
COMMENTED [PC1]:
As per registered with NPRA
Pfizer Confidential
2
Use with Potent CYP3A4 Inhibitors
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1
mg twice daily)
for patients receiving concomitant ketoconazole or other potent CYP3A4
inhibitors
(see Sections 4.4 and 4.5).
4.3 CONTRAINDICATIONS
Tolterodine is contraindicate