Detrusitol 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tolterodine tartrate

Available from:

Waymade Healthcare Plc

ATC code:

G04BD07

INN (International Name):

Tolterodine tartrate

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200

Patient Information leaflet

DETRUSITOL
® 1 MG TABLETS
DETRUSITOL
® 2 MG TABLETS
(tolterodine L-tartrate)
Your medicine is available using one of the above names but will be
referred to as Detrusitol throughout the 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 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 (ulceration and inflammation of
the
colon)
-
suffer from a toxic megacolon (acute dilatation of the colon).
TAKE SPECIAL CARE WITH DETRUSITOL
-
If you have difficulties in passing urine and/or a poor stream of
urine
-
If you have a gastro-intestinal disease that affects the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Detrusitol 2 mg filmcoated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each filmcoated tablet contains tolterodine L-tartrate 2 mg
corresponding to
1.37 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 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 patients: _
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
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 impairement (see section 4.2)
-
Hepatic disease. (see section 4.2 and 5.2)
-
Autonomic neuropathy
-
Hiatus hernia
-
Risk for decreased gastrointestinal motility
Multiple oral total daily doses of immediate release 4 mg
(therapeutic) and 8 mg
(supratherapeutic) tolterodine have been shown to prolong