Kentera 3.9mg24hours patches

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Ladda ner Bipacksedel (PIL)
09-06-2018
Ladda ner Produktens egenskaper (SPC)
09-06-2018

Aktiva substanser:

Oxybutynin

Tillgänglig från:

Orion Pharma (UK

ATC-kod:

G04BD04

INN (International namn):

Oxybutynin

Dos:

3.9mg/24hour

Läkemedelsform:

Transdermal patch

Administreringssätt:

Transdermal

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 07040200; GTIN: 5024091001215

Bipacksedel

                                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 KENTERA.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
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 gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Kentera is and what it is used for
2.
Before you use Kentera
3.
How to use Kentera
4.
Possible side effects
5.
How to store Kentera
6.
Further 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.
BEFORE YOU USE KENTERA
DO NOT USE KENTERA:
-
If you are hypersensitive (allergic) to oxybutynin or any of the
ingredients of Kentera.
-
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.
TAKE SPECIAL CARE WITH KENTERA:
If you have any of the following:
-
Liver problems
-
Kidney problems
-
Difficulty urinating
-
Intestinal blockage
-
Bloody stools
-
Generalized muscle weakness
-
Painful swallowing
Since treatment with oxybutynin may cause decreased perspiration,
there is an increased risk of fever and
heat stroke if you are exposed to high environmental temperatures.
Kentera is no
                                
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Produktens egenskaper

                                OBJECT 1
KENTERA OXYBUTYNIN TRANSDERMAL PATCH
Summary of Product Characteristics Updated 04-Aug-2014 | Orion Pharma
(UK) Limited
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 a 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
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 recommended dose is one 3.9 mg transdermal patch applied twice
weekly (every 3 to 4 days).
There is no experience in children
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Kentera is contraindicated in patients with urinary retention, severe
gastro-intestinal condition,
myasthenia gravis or narrow-angle glaucoma and in patients who are at
risk for these conditions.
4.4 Special warnings and precautions for use
Kentera should be used with caution in patients with hepatic or renal
impairment. The use of Kentera in
patients with hepatic impairment should be carefully monitored. Other
causes of frequent urination (heart
failure or renal disease) should be assessed before treatment with
Kentera. If urinary tract infection is
present, an appropriate antibacterial therapy should be started.
_Urinary retention: _Anticholinergic products should be administered
with caution to patients with
clini
                                
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