DETRUSITOL SR 4 Milligram Prolonged Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TOLTERODINE TARTRATE

Available from:

LTT Pharma Limited

INN (International Name):

TOLTERODINE TARTRATE

Dosage:

4 Milligram

Pharmaceutical form:

Prolonged Release Capsules

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PATIENT INFORMATION LEAFLET
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:
What Detrusitol SR is and what it is used for
Before you take Detrusitol SR
How to take Detrusitol SR 
Possible side effects
How to store Detrusitol SR
Further information
WHAT DETRUSITOL SR IS AND WHAT IT IS USED FOR
The active substance in Detrusitol SR is tolterodine. Tolterodine
belongs to a
class of medicinal products called antimuscarinics.
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. 
BEFORE YOU TAKE DETRUSITOL SR
DO NOT TAKE DETRUSITOL SR IF YOU:
* are allergic (hypersensitive) to tolterodine or any of the other
ingredients in Detrusitol SR
* 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 SR
* If you have difficulties in passing urine and/or a poor stream of
urine
* If you have a gastro-intestinal disease that affects the passage
and/or 
digestion of food
* If you suffer from kidney problems (renal insufficiency)
* If you have a liver condition
* If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrusitol SR 4mg Prolonged-release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74 mg tolterodine.
Each 4 mg prolonged-release capsule contains sucrose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release Capsule, Hard
_Product imported from Spain and the UK:_
Blue capsule, with white printing (symbol and 4)
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 the elderly):
The recommended dose is 4 mg once daily except in patients with impaired liver function or severely impaired renal
function (GFR
30 ml/min) for whom the recommended dose is 2 mg once daily _(see sections 4.4 and 5.2). _In case of
troublesome side-effects the dose may be reduced from 4 mg to 2 mg once daily. The prolonged-release capsules can
be taken with or without food and must be swallowed whole.
The effect of treatment should be re-evaluated after 2-3 months _(see section 5.1)._
Paediatric patients:
Efficacy of Detrusitol SR has not been demonstrated in children _(See section 5.1). _Therefore, Detrusitol SR 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
Severe ulcerative colitis
Toxic megacolon
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Print