Detrusitol 1mg film-coated tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

TOLTERODINE L, TARTRATE

थमां उपलब्ध:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

ए.टी.सी कोड:

G04BD07

INN (इंटरनेशनल नाम):

TOLTERODINE L-TARTRATE 1 mg

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

TOLTERODINE L-TARTRATE 1 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

UROLOGICALS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2005-10-26

सूचना पत्रक

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PACKAGE LEAFLET
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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 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 Detrusitol is and what it is used for
2.
What you need to know before you take Detrusitol
3.
How to take Detrusitol
4.
Possible side effects
5.
How to store Detrusitol
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUSITOL
DO NOT TAKE DETRUSITOL IF YOU
•
are allergic (hypersensitive) to tolterodine or any of the other
ingredients in Detrusitol
(listed in section 6)
•
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).
WARNINGS AND PRECAUTIONS
Talk to your doctor or

उत्पाद विशेषताएं

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SUMMARY OF THE PRODUCT CHARACTERISTICS
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NAME OF THE MEDICINAL PRODUCT
Detrusitol 1 mg film-coated tablets
Detrusitol 2 mg film-coated tablets
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tolterodine tartrate 1 mg or 2 mg
corresponding to 0.68 mg and
1.37 mg tolterodine, respectively
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 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
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
_ _
_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 population _
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 contraindicated in patients with
-
Urinary retention
-
Uncontrolled narrow angle glaucoma
-
Myasthenia gravis
-
Known hypersensitivity to tolterodine or excipients (see section 6)
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Severe ulcerative colitis
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Toxic megacolon
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4.4
SPECIAL WARNINGS AND 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)
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Hepatic disease. (see section 4.2 and 5.2)
-