Caristenol 4 mg, prolonged-release capsules

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Tolterodine tartrate

Fáanlegur frá:

Accord Healthcare Ireland Ltd.

ATC númer:

G04BD; G04BD07

INN (Alþjóðlegt nafn):

Tolterodine tartrate

Skammtar:

4 milligram(s)

Lyfjaform:

Prolonged-release capsule, hard

Lækningarsvæði:

Drugs for urinary frequency and incontinence; tolterodine

Leyfisstaða:

Not marketed

Leyfisdagur:

2016-06-10

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
Caristenol 2 mg prolonged-release capsules
Caristenol 4 mg prolonged-release capsules
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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Caristenol is and what it is used for
2.
What you need to know before you take Caristenol
3.
How to take Caristenol
4.
Possible side effects
5.
How to store Caristenol
6.
Contents of the pack and other information
1.
WHAT CARISTENOL IS AND WHAT IT IS USED FOR
The active substance in Caristenol is tolterodine.
Tolterodine belongs to a class of medicinal products called
antimuscarinics. Caristenol 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 CARISTENOL
DO NOT TAKE CARISTENOL IF YOU:
-
are allergic (hypersensitive) 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 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).
WARNINGS AND PRECAUTIONS
Tell your doctor b

Vara einkenni

Health Products Regulatory Authority
11 January 2022
CRN00CCL2
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caristenol 4 mg, prolonged-release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains tolterodine tartrate 4 mg
corresponding to 2.74 mg tolterodine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Dark blue /dark blue size ‘3’, approximately 16 mm in length, hard
gelatin capsule with imprinting bar lines on cap and body.
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 population:_
Efficacy of Caristenol has not been demonstrated in children (See
section 5.1). Therefore, Caristenol 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 (see section 6)

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
Health Products Regulatory Authority
11 J