Tolterodine 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tolterodine tartrate

Available from:

Torrent Pharma (UK) Ltd

ATC code:

G04BD07

INN (International Name):

Tolterodine tartrate

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200; GTIN: 5060623371777

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOLTERODINE 1MG & 2MG FILM-COATED TABLETS
Tolterodine tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
WHAT IS IN THIS LEAFLET
1.
What Tolterodine is and what it is used for
2.
What you need to know before you take Tolterodine Film-coated Tablets
3.
How to take Tolterodine Film-coated Tablets
4.
Possible side effects
5.
How to store Tolterodine Film-coated Tablets
6.
Contents of the pack and other information
1. WHAT TOLDERODINE IS AND WHAT IT IS USED FOR
The active substance in Tolterodine Film-coated Tablets is
tolterodine. Tolterodine belongs
to a class of medicinal products called antimuscarinics.
Tolterodine 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 TOLTERODINE FILM-COATED
TABLETS
DO NOT TAKE TOLTERODINE FILM-COATED TABLETS IF YOU
-
are allergic to tolterodine or any of the other ingredients of this
medicine (listed in
section 6)
-
are unable to pass urine from the bladder (urinary retention)
-
have uncontrolled narrow angle glaucoma (increase in intraocular
pressure)
-
suffer from excessive weakness of the muscles (myasthenia gravis)
-
suffer from ulceration and inflammation of the colon (severe
ulcerative colitis)
-
suffer from acute dilatation of the colon (a toxic megacolon).
WARNINGS AND PRECAUTIONS
Take special care with T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tolterodine 1 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tolterodine tartrate 1 mg
corresponding to
0.68 mg tolterodine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Tolterodine 1 mg: White, round, biconvex, 5.5 mm film-coated tablets
marked
with “T1” on one side.
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
Posology
_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 Tolterodine has not been demonstrated in children (See
section
5.1). Therefore, Tolterodine is not recommended for children.
Method of administration
Oral.
4.3
CONTRAINDICATIONS
Tolterodine is contraindicated in patients with
-
Urinary retention
-
Uncontrolled narrow angle glaucoma
-
Myasthenia gravis
-
Hypersensitivity to the active substance or to any of the excipients
listed
in section 6.1
-
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 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 releas