DETRUSITOL 1 Milligram Film Coated Tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

TOLTERODINE L-TARTRATE

Inapatikana kutoka:

Pfizer Limited

ATC kanuni:

G04BD07

INN (Jina la Kimataifa):

TOLTERODINE L-TARTRATE

Kipimo:

1 Milligram

Dawa fomu:

Film Coated Tablet

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Drugs for urinary frequency and incontinence

Idhini hali ya:

Authorised

Idhini ya tarehe:

2012-05-04

Taarifa za kipeperushi

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

DETRUSITOL 1 MG & 2 MG FILM-COATED TABLETS 
TOLTERODINE TARTRATE 

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 (ulcera

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrusitol 1 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each filmcoated tablet contains tolterodine tartrate 1 mg corresponding to 0.68 mg tolterodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Filmcoated tablets
The filmcoated tablets are white, round and biconvex. The tablet is engraved with arcs above and below the letters TO.
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, Special warnings and_
_precautions for use)_. 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, Pharmacodynamic properties)_.
_Paediatric patients:_
Efficacy of Detrusitol has not been demonstrated in children _(See section 5.1, Pharmacodynamic properties)_.
Therefore, Detrusitol is not recommended for children.
4.3 CONTRAINDICATIONS
Tolterodine is contraindicated in patients with
o
Urinary retention
o
Uncontrolled narrow angle glaucoma
o
Myasthenia gravis
o
Known hypersensitivity to tolterodine or excipients
o
Severe ulcerative colitis
o
Toxic megacolon
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/06/2013_
_CRN 2130371_
_page number: 1_
4.4 SPECIAL WARNINGS AND PREC