Detrusitol XL 4mg capsules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Tolterodine tartrate

Disponibil de la:

CST Pharma Ltd

Codul ATC:

G04BD07

INN (nume internaţional):

Tolterodine tartrate

Dozare:

4mg

Forma farmaceutică:

Modified-release capsule

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 07040200; GTIN: 5055946807232

Prospect

DETRUSITOL
® XL 4MG CAPSULES
(tolterodine L-tartrate)
The name of your medicine is Detrusitol XL 4mg Capsules but will be
referred to as Detrusitol XL throughout this 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:
1. What Detrusitol XL is and what it is used for
2. Before you take Detrusitol XL
3. How to take Detrusitol XL
4. Possible side effects
5. How to store Detrusitol XL
6. Further information
1. WHAT DETRUSITOL XL IS AND WHAT IT IS USED FOR
The active substance in Detrusitol XL is tolterodine. Tolterodine
belongs to
a class of medicinal products called antimuscarinics.
Detrusitol XL 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 XL
DO NOT TAKE DETRUSITOL XL IF YOU:
-
are allergic (hypersensitive) to tolterodine or any of the other
ingredients
in Detrusitol XL
-
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 XL
-
If you have difficulties in passing urine and/or a poor stream of
urine
-
If you have a gastro-intestinal disease tha

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Detrusitol XL 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.
Each 4 mg prolonged-release capsule contains a maximum of 123.07 mg of
sucrose.
For a 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 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 XL has not been demonstrated in children (See
section
5.1). Therefore, Detrusitol XL 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
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 impairment (see sections 4.2 and 5.2)
-
Hepatic disease (see sections 4.2 and 5.2)
-
Autonomic