Detrusitol 1mg film-coated tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

TOLTERODINE L, TARTRATE

थमां उपलब्ध:

Pfizer Hellas S.A.

ए.टी.सी कोड:

G04BD07

INN (इंटरनेशनल नाम):

TOLTERODINE L, TARTRATE

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

TOLTERODINE L-TARTRATE 1 milligram(s)

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

UROLOGICALS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2005-10-26

सूचना पत्रक

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUSITOL 1 MG & 2 MG FILM-COATED TABLETS
TOLTERODINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Detrusitol is and what it is used for
2.
Before you take Detrusitol
3.
How to take Detrusitol
4.
Possible side effects
5.
How to store Detrusitol
6.
Further information
1. WHAT DETRUSITOL IS AND WHAT IT IS USED FOR
The active substance in Detrusitol is tolterodine. Tolterodine belongs
to a class of medicinal
products called antimuscarinics.
Detrusitol 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.
2. BEFORE YOU TAKE DETRUSITOL
DO NOT TAKE DETRUSITOL IF YOU:
•
are allergic (hypersensitive) to tolterodine or any of the other
ingredients in
Detrusitol
•
are unable to pass urine from the bladder (urinary retention)
•
have an uncontrolled narrow-angle glaucoma (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 dilatation of the colon).
TAKE SPECIAL CARE WITH DETRUSITOL
•
If you have difficulties in passing urine and/or a poor stream of
urine
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•
If you have a gastro-intestinal disease that affects the passage
and/or digestion of
food
•
If you suff

उत्पाद विशेषताएं

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SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Detrusitol 1 mg film-coated tablets
Detrusitol 2 mg film-coated tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains tolterodine tartrate 1 mg or 2 mg
corresponding to 0.68 mg
and 1.37 mg tolterodine, respectively
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablets
The film-coated tablets are white, round and biconvex. The 1 mg tablet
is engraved with arcs
above and below the letters TO and the 2 mg tablet is engraved with
arcs above and below the
letters DT.
4
C
LINICAL
P
ARTICULARS
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
_Adults (including elderly):_
The recommended dose is 2 mg twice daily except in patients with
impaired liver function or
severely impaired renal function (GFR<30 ml/min) for whom the
recommended dose is 1 mg
twice daily (see section 4.4). In case of troublesome side effects the
dose may be reduced
from 2 mg to 1 mg twice daily.
The effect of treatment should be re-evaluated after 2-3 months (see
section 5.1).
_Paediatric _
_patients_
_: _
Efficacy of Detrusitol has not been demonstrated in children (See
section 5.1). Therefore,
Detrusitol is not recommended for children
.
4.3
CONTRAINDICATIONS
Tolterodine
is contraindicate
d in patients with
-
Urinary retention
-
Uncontrolled narrow angle glaucoma
-
Myasthenia gravis
-
Known hypersensitivity to tolterodine or excipients
-
Severe ulcerative colitis
-
Toxic megacolon
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4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Tolterodine shall be used with caution in patients with
-
Significant bladder outlet obstruction at risk of urinary retention
-
Gastrointestinal obstructive disorders, e.g. pyloric stenosis
-
Renal impairement (see section 4.2)
-
Hepatic disease. (see section 4.2 and 5.2)
-
Autonomic ne