Tolterodine 1mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Tolterodine tartrate

Διαθέσιμο από:

Actavis UK Ltd

Φαρμακολογική κατηγορία (ATC):

G04BD07

INN (Διεθνής Όνομα):

Tolterodine tartrate

Δοσολογία:

1mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 07040200; GTIN: 5012617022370

Φύλλο οδηγιών χρήσης

AAAF6277
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TOLTERODINE TARTRATE 1MG
FILM-COATED TABLETS
Tolterodine tartrate
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING 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 TOLTERODINE TARTRATE IS AND WHAT IT IS
USED FOR
2
BEFORE YOU TAKE TOLTERODINE TARTRATE
3
HOW TO TAKE TOLTERODINE TARTRATE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE TOLTERODINE TARTRATE
6
FURTHER INFORMATION
1
WHAT TOLTERODINE TARTRATE IS AND
WHAT IT IS USED FOR
The active substance in Tolterodine Tartrate is
tolterodine. Tolterodine belongs to a class of medicinal
products called antimuscarinics.
Tolterodine Tartrate 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 TOLTERODINE
TARTRATE
DO NOT TAKE TOLTERODINE TARTRATE IF YOU:
• are allergic (hypersensitive) to tolterodine or any of the
other ingredients in Tolterodine Tartrate
• 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 TOLTERODINE TARTRATE
• If you have difficulties in passing urine and/or a poor
stream of urine

Αρχείο Π.Χ.Π.

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