Emselex
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
27-10-2023
Karatteristiċi tal-prodott
(SPC)
27-10-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
24-05-2013
Ingredjent attiv:
darifenacin hydrobromide
Disponibbli minn:
pharmaand GmbH
Kodiċi ATC:
G04BD10
INN (Isem Internazzjonali):
darifenacin hydrobromide
Grupp terapewtiku:
Urologicals, Drugs for urinary frequency and incontinence
Żona terapewtika:
Urinary Incontinence, Urge; Urinary Bladder, Overactive
Indikazzjonijiet terapewtiċi:
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Sommarju tal-prodott:
Revision: 26
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2004-10-22
Fuljett ta 'informazzjoni
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMSELEX 7.5 MG PROLONGED-RELEASE TABLETS
Darifenacin
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. 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 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 Emselex is and what it is used for
2.
What you need to know before you take Emselex
3.
How to take Emselex
4.
Possible side effects
5.
How to store Emselex
6.
Contents of the pack and other information
1.
WHAT EMSELEX IS AND WHAT IT IS USED FOR
HOW EMSELEX WORKS
Emselex reduces the activity of an overactive bladder. This enables
you to wait longer before you go
to the toilet and it increases the amount of urine that your bladder
can hold.
WHAT EMSELEX CAN BE USED FOR
Emselex belongs to a class of medicines which relax the muscles of the
bladder. It is used in adults for
the treatment of the symptoms of overactive bladder conditions - such
as a sudden urge to rush to the
toilet, needing to go to the toilet frequently and/or not getting to
the toilet in time and wetting yourself
(urge incontinence).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMSELEX
DO NOT TAKE EMSELEX:
•
if you are allergic to darifenacin or any of the other ingredients of
this medicine (listed in
section 6).
•
if you suffer from urinary retention (inability to empty your
bladder).
•
if you have gastric retention (problems emptying the contents of the
stomach).
•
if you suffer from uncontrolled narrow-angle glaucoma (high pressure
in the eyes that is not
being adequately treated).
•
if you have myasthenia gravis (a disease marked by unusual tiredness
and weakness of select
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Emselex 7.5 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg of darifenacin (as hydrobromide)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
White round, convex tablet, debossed with “DF” on one side and
“7.5” on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as may
occur in adult patients with overactive bladder syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended starting dose is 7.5 mg daily. After 2 weeks of
starting therapy, patients should be
reassessed. For those patients requiring greater symptom relief, the
dose may be increased to 15 mg
daily, based on individual response.
_Elderly patients (≥ 65 years) _
The recommended starting dose for the elderly is 7.5 mg daily. After 2
weeks of starting therapy,
patients should be reassessed for efficacy and safety.
_ _
For those patients who have an acceptable
tolerability profile but require greater symptom relief, the dose may
be increased to 15 mg daily, based
on individual response (see section 5.2).
_ _
_Paediatric population _
Emselex is not recommended for use in children below 18 years of age
due to a lack of data on safety
and efficacy.
_ _
_Renal impairment _
No dose adjustment is required in patients with impaired renal
function. However, caution should be
exercised when treating this population (see section 5.2).
_Hepatic impairment _
No dose adjustment is required in patients with mild hepatic
impairment (Child Pugh A). However,
there is a risk of increased exposure in this population (see section
5.2).
Patients with moderate hepatic impairment (Child Pugh B) should only
be treated if the benefit
outweighs the risk, and the dose should be restricted to 7.5 mg daily
(see section 5.2). Emselex is
contraindicated in patients
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