Kentera (previously Oxybutynin Nicobrand)

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

oxybutynin

Dostupné z:

Teva B.V. 

ATC kód:

G04BD04

INN (Medzinárodný Name):

oxybutynin

Terapeutické skupiny:

Urologicals

Terapeutické oblasti:

Urinary Incontinence, Urge

Terapeutické indikácie:

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.

Prehľad produktov:

Revision: 21

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2004-06-15

Príbalový leták

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET: INFORMATION FOR THE USER
KENTERA 3.9 MG / 24 HOURS TRANSDERMAL PATCH
oxybutynin
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 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 Kentera is and what it is used for
2.
What you need to know before you use Kentera
3.
How to use Kentera
4.
Possible side effects
5.
How to store Kentera
6.
Contents of the pack and other information
1.
WHAT KENTERA IS AND WHAT IT IS USED FOR
Kentera is used in adults to control the symptoms of urge incontinence
and/or increased urinary
frequency and urgency.
Kentera works by allowing the bladder to expand and accommodate more
urine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KENTERA
DO NOT USE KENTERA
-
if you are allergic to oxybutynin or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have a rare condition called myasthenia gravis that makes the
muscles in the body
become weak and tire easily.
-
if you experience incomplete bladder emptying during urination, the
use of oxybutynin may
increase this problem. You should discuss this problem with your
doctor before using Kentera.
-
if you have digestion problems caused by reduced emptying of the
stomach after a meal you
should consult your doctor before using Kentera.
-
if you have glaucoma or a family history of glaucoma, tell your
doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Kentera if you have any
of the following.
-
Liver problems
-
Kidney problems
-
Difficulty urinating
-
Intestinal blockage
-
Bloody stools
-
Generaliz

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kentera 3.9 mg / 24 hours transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch contains 36 mg of oxybutynin. The area of the
patch is 39 cm
2
, releasing a
nominal 3.9 mg of oxybutynin per 24 hours.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch
The patch is a clear plastic with an adhesive backing, protected by a
release liner that is to be removed
prior to application.
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 unstable bladder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 3.9 mg transdermal patch applied twice
weekly (every 3 to 4 days).
_Elderly _
Based on clinical trial experience no dose adjustment is considered
necessary in this population.
Nonetheless Kentera should be used with caution in elderly patients,
who may be more sensitive to the
effects of centrally acting anticholinergics and exhibit differences
in pharmacokinetics (see section
4.4).
_Paediatric population _
The safety and efficacy of Kentera in the paediatric population has
not been established. Kentera is not
recommended for use in the paediatric population. Currently available
data are described in section 4.8
but no recommendation on a posology can be made.
Method of administration
The patch should be applied to dry, intact skin on the abdomen, hip,
or buttock immediately after
removal from the protective sachet. A new application site should be
selected with each new patch to
avoid reapplication to the same site within 7 days. The patch must not
be divided or cut into pieces.
Patches that are damaged should not be used.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
3
Kentera is contraindicated in patients with urinary retention, severe
gastro-intestinal