Detrusitol SR 4 mg, prolonged-release capsules, hard

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Tolterodine l-tartrate

Inapatikana kutoka:

Pfizer Healthcare Ireland

ATC kanuni:

G04BD; G04BD07

INN (Jina la Kimataifa):

Tolterodine l-tartrate

Kipimo:

4 milligram(s)

Dawa fomu:

Prolonged-release capsule

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Drugs for urinary frequency and incontinence; tolterodine

Idhini hali ya:

Marketed

Idhini ya tarehe:

2001-07-27

Taarifa za kipeperushi

Page 1 of 7
2020-0061583 (S2), 2020-0063755
(O), 2020-0061653, 2020-0063786
PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUSITOL SR 2 MG & 4 MG PROLONGED RELEASE CAPSULES, HARD
TOLTERODINE TARTRATE
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 SR is and what it is used for
2.
What you need to know before you take Detrusitol SR
3.
How to take Detrusitol SR
4.
Possible side effects
5.
How to store Detrusitol SR
6.
Contents of the pack and other information
1. 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.
2. WHAT YOU NEED TO KNOW 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 (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

Tabia za bidhaa

Health Products Regulatory Authority
16 March 2021
CRN009ZCJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrusitol SR 4 mg, prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains tolterodine tartrate 4 mg
corresponding to 2.74 mg tolterodine.
Excipient(s) with known effect
Each 4 mg prolonged-release capsule contains a maximum of 123.07 mg of
sucrose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
The 4 mg prolonged-release capsule is blue 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
troublesomeside-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 POPULATION_
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 (see section 6)

Severe ulcerative colitis

Toxic megacolon
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
16 March 2021
CRN009ZCJ
Page 2 of 8
Tolterodine shall be used with caution in patients with

Significant bladder outlet obstructi