Tolterodine 1mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Tolterodine tartrate

Prieinama:

Accord-UK Ltd

ATC kodas:

G04BD07

INN (Tarptautinis Pavadinimas):

Tolterodine tartrate

Dozė:

1mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 07040200; GTIN: 5055565701232

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOLTERODINE TARTRATE 1 MG FILM-COATED TABLET
TOLTERODINE TARTRATE 2 MG FILM-COATED TABLET
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. Do not pass it on to
others. It may harm them,
even if their symptoms 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 Tolterodine Tartrate is and what it is used for
2.
What you need to know before you take Tolterodine Tartrate
3.
How to take Tolterodine Tartrate
4.
Possible side effects
5.
How to store Tolterodine Tartrate
6.
Contents of pack and other information
1.
WHAT TOLTERODINE TARTRATE IS AND WHAT IT IS USED FOR
The active substance 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 that
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 TARTRATE
DO NOT TAKE TOLTERODINE TARTRATE

If you are allergic (hypersensitive) to tolterodine or any of the
other ingredients in the
medicine

If you are unable to pass urine from the bladder (urinary retention)

If you have uncontrolled narrow angle glaucoma (increase in
intraocular pressure)

If you suffer from myasthenia gravis (excessive weakness of the
muscles)

If you suffer from severe ulcerative colitis (ulceration and
inflammation of the colon)

If you suffer from a toxic megacolon (acute dilatation of the colon).
WARNINGS AND PRECAUTIONS
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Prekės savybės

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