natgillin/translations-raw huggingface dataset:
Πώς χρησιμοποιείται το Kentera; Η συνιστώµενη δόση του Kentera είναι ένα έµπλαστρο δύο φορές την εβδομάδα (κάθε 3 µε 4 ηµέρες).
The recommended dosage of Kentera is one patch twice a week (every 3 to 4 days).
Το έµπλαστρο θα πρέπει να εφαρµόζεται σε στεγνό, υγιές δέρµα στην κοιλιακή χώρα (στομάχι), το ισχίο ή τον γλουτό αμέσως μετά την αφαίρεσή του από τον προστατευτικό φακελίσκο.
The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Κάθε νέο έµπλαστρο θα πρέπει να εφαρµόζεται σε διαφορετικό σηµείο, ώστε να μη χρησιμοποιείται ξανά το ίδιο σημείο εντός 7 ηµερών.
A new application site should be chosen with each new patch so the same place is not used within 7 days.
Πώς δρα το Kentera; Η δραστική ουσία που περιέχει το Kentera, η οξυβουτυνίνη, είναι ένα αντιχολινεργικό φάρμακο.
The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Αναστέλλει ορισμένους υποδοχείς του σώματος, τους μουσκαρινικούς υποδοχείς M1 και M3, με αποτέλεσμα τη χάλαση των μυών που εξωθούν τα ούρα από την ουροδόχο κύστη.
It blocks some receptors in the body, the muscarinic M1 and M3 receptors, and in the bladder, this causes the muscles that push urine out of the bladder to relax.
Το γεγονός αυτό οδηγεί σε αύξηση της χωρητικότητας της ουροδόχου κύστης και σε αλλαγή του τρόπου σύσπασης των μυών της ουροδόχου κύστης κατά την πλήρωσή της.
This leads to an increase in the capacity of the bladder, and to changes in the way the bladder muscles contract as the bladder fills up.
Με τον τρόπο αυτό, το Kentera αποτρέπει την ανεπιθύμητη ούρηση.
This helps Kentera to prevent unwanted urination.
Η οξυβουτυνίνη διατίθεται με τη μορφή δισκίων για τη θεραπεία της υπερκινητικής ουροδόχου κύστης από τη δεκαετία του 1970.
Oxybutinin has been available as a tablet for the treatment of overactive bladder since the 1970’ s.
Ποιες μελέτες εκπονήθηκαν για το Kentera; Για το Kentera εκπονήθηκαν δύο βασικές μελέτες, στις οποίες συμμετείχαν συνολικά 881 ασθενείς, κυρίως ηλικιωμένες γυναίκες, με υπερκινητική ουροδόχο κύστη.
Kentera has been studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Στη μία μελέτη (520 ασθενείς), πραγματοποιήθηκε σύγκριση του Kentera με εικονικό φάρμακο (εικονική θεραπεία).
In one study (520 patients), Kentera was compared with placebo (dummy treatment), in the second (361 patients), Kentera was compared with tolterodine capsules (another medicine used to treat urge incontinence).
Στη δεύτερη μελέτη (361 ασθενείς), πραγματοποιήθηκε σύγκριση του Kentera με κάψουλες τολτεροδίνης (ένα άλλο φάρμακο που χρησιμοποιείται για τη θεραπεία της επιτακτικού τύπου ακράτειας).
The main measure of effectiveness was the effect of the treatment on the number of incontinence episodes over a 7- or a 3-day period.
Ο κύριος 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Kentera was more effective than placebo: after 12 weeks, the average number of incontinence episodes per week had decreased by 19 (or about 3 per day) with Kentera, against a decrease of 15 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged δείκτης μέτρησης της αποτελεσματικότητας ήταν η επίδραση της θεραπείας στον αριθμό των επεισοδίων ακράτειας σε χρονικό διάστημα 7 ή 3 ημερών.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged episodes in the placebo group.
Το Kentera απεδείχθη το ίδιο αποτελεσματικό με την τολτεροδίνη, καθώς και οι δύο θεραπείες οδήγησαν σε μείωση του αριθμού επεισοδίων κατά 3 επεισόδια περίπου ανά ημέρα.
Kentera was as effective as tolterodine, both treatments decreasing the number of episodes by about 3 per day.
Ποιοι κίνδυνοι συνδέονται με το Kentera; Η πιο συχνή ανεπιθύμητη ενέργεια (εμφανίζεται σε περισσότερους από 1 στους 10 ασθενείς) είναι οι αντιδράσεις στο σημείο εφαρμογής (καθώς και κνησμός γύρω από το σημείο εφαρμογής του εμπλάστρου).
The most common side effects (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Άλλες ανεπιθύμητες ενέργειες που αναφέρθηκαν ήταν ερυθρότητα στο σημείο εφαρμογής, ξηροστοµία, δυσκοιλιότητα, διάρροια, στομαχική διαταραχή, κεφαλαλγία ή υπνηλία, ζάλη, θολή όραση και ουρολοίμωξη.
Other side effects reported were redness at the site of application, dry mouth, constipation, diarrhoea, upset stomach, headache, or sleepiness dizziness, blurred vision, and urinary infection.
Ο πλήρης κατάλογος όλων των ανεπιθύμητων ενεργειών που έχουν αναφερθεί κατά τη χρήση του Kentera περιλαμβάνεται στο φύλλο οδηγιών χρήσης.
For the full list of all side effects reported with Kentera, see the Package Leaflet.
Το Kentera δεν πρέπει να χρησιμοποιείται σε άτομα που ενδέχεται να παρουσιάζουν υπερευαισθησία (αλλεργία) στην οξυβουτυνίνη ή σε οποιοδήποτε άλλο συστατικό του φαρμάκου καθώς και σε ασθενείς με κατακράτηση ούρων (δυσκολία στην ούρηση), σοβαρές γαστρεντερικές διαταραχές, μη ελεγχόμενο γλαύκωμα κλειστής γωνίας (αυξημένη ενδοφθάλμια πίεση ακόμη και με θεραπεία) ή βαριά μυασθένεια (ασθένεια των νεύρων που προκαλεί μυϊκή αδυναμία).
Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients, and in patients with urinary retention (difficulty in passing urine), severe gastro- intestinal conditions, uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves causing muscle weakness).
Για ποιους λόγος εγκρίθηκε το Kentera; Η Επιτροπή Φαρμάκων για Ανθρώπινη Χρήση (CHMP) αποφάσισε ότι το Kentera είναι εξίσου αποτελεσματικό με τη χορηγούμενη από του στόματος φαρμακοτεχνική μορφή που κυκλοφορεί ήδη στην αγορά.
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Kentera had been shown to be at the level of the oral presentation, already on the market.
Η επιτροπή αποφάσισε ότι τα οφέλη του Kentera υπερτερούν των κινδύνων για τη συµπτωµατική θεραπεία της επιτακτικού τύπου ακράτειας και/ ή της συχνουρίας και της έπειξης για ούρηση που μπορεί να εμφανιστεί σε ασθενείς με σύνδρομο υπερκινητικής ουροδόχου κύστης.
They decided that Kentera’ s benefits are greater than its risks for the symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Η επιτροπή εισηγήθηκε τη χορήγηση άδειας κυκλοφορίας στο Kentera.
They recommended that Kentera be given marketing authorisation.
Λοιπές πληροφορίες σχετικά με το Kentera:
Other information about Kentera:
Στις 15 Ιουνίου 2004, η Ευρωπαϊκή Επιτροπή χορήγησε άδεια κυκλοφορίας, η οποία ισχύει σε ολόκληρη την Ευρωπαϊκή Ένωση, στην Nicobrand Limited για το Kentera.
The European Commission granted a marketing authorisation valid throughout the European Union for Kentera to Nicobrand Limited on 15 June 2004.
Η πλήρης δημόσια έκθεση αξιολόγησης (EPAR) του Kentera διατίθεται εδώ.
The full EPAR for Kentera is available here.
10- 2006.
This summary was last updated in 10-2006.
Επινοηθείσα ονοµασία
Name
3, 9 mg/ 24ωρο
3.9 mg/ 24 h
Φακελλίσκος (Πολυαιθυλένιο χαµηλής πυκνότητας (LDPE) / χαρτί πολυστρωµατικό
Sachet (LDPE/ paper laminate)
8 διαδερµικά έµπλαστρα
8 transdermal patches
24 διαδερµικά έµπλαστρα
24 transdermal patches
2 διαδερµικά έµπλαστρα
2 transdermal patches
Kentera 3, 9 mg / 24
Kentera 3.9 mg / 24 hours, transdermal patch
OTEXNIKH
PHARMACEUTICAL FORM
4.
Transdermal patch.
4. 1! "
4.
4. 2 # $$$!
CLINICAL PARTICULARS
($) * ++ $'%
4.1 Therapeutic indications
$#
Symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with unstable bladder
3, 9 mg "
4.2 Posology and method of administration
(
A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days.
3
The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
.
No studies have been performed in children or adolescents, therefore Kentera is not recommended for use in children or adolescents.
$Kentera, #
4.3 Contraindications
#
Hypersensitivity to the active substance or to any other excipients of the transdermal patch.
# "!
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 special precautions for use
$Kentera
Urinary Retention:
!
2 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..
#
Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera:
Parkinson.
Also in conditions such as ulcerative colitis, and intestinal atony.
!
Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease
#,!
Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
!
Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
(
4.5 Interaction with other medicinal products and other forms of interaction
"
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness.
#
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
P 450,
As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with drugs that inhibit this isoenzyme cannot be ruled out.
"
The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e. g. biperiden, levodopa), antihistamines, antipsychotics (e. g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinc antispasmodics, dipyridamole.
Parkinson (..
Oxybutynin may antagonize prokinetic therapies.
3 4. 6 0%
4.6 Pregnancy and lactation
++
Kentera should not to be used during pregnancy unless clearly necessary
5. 3). $
3 Lactation When oxybutynin is used during lactation, a small amount is excreted in the mother’ s milk.
Kentera
4.7 Effects on ability to drive and use machines
.
Oxybutynin may cause drowsiness, blurred vision, dizziness and fatigue, therefore caution is recommended when driving or operating machines.
#
4.8 Undesirable effects
"
Other adverse drug reactions reported were dry mouth (Kentera 8.6%, placebo 5.2%), constipation (Kentera 3.9%, placebo 2%), diarrhea (Kentera 3.2%, placebo 2%), headache (Kentera 3.0%, placebo 2.4%), dizziness (Kentera 2.3%, placebo 1.2%), and blurred vision (Kentera 2.3%, placebo 0.89%).
.
Undesirable effects known to be associated with anticholinergic therapy, but not observed with Kentera during clinical studies are anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, disorientation, poor ability to concentrate, fatigue, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, confusion, anxiety, paranoia, hallucinations, photosensitivity, erectile dysfunction.
#
Reported Adverse Drug Reactions and rate of occurrence:
$* + + '%
Application site reactions
)
All application site reactions -Application site pruritis -Application site erythema -Application site reaction -Application site rash
% $.) 1. 0 +
23.1% 14.3% 5.7% 3.5% 3.0%
#
Very common very common common common common
+ (Kentera 23, 1%,
Infections and infestations:
"
Urinary Tract Upper Respiratory Tract Fungal Eye disorders
7, 6%). '
1.2% 0.2% 0.2%
(Kentera 8, 6%,
common uncommon uncommon
(Kentera 3, 9%,
Vision abnormalities Ear and labyrinth disorders
2%),
2.3%
2%),
common
# (Kentera 3, 0%,
Dizziness Cardiac Disorders
2, 4%),%
2.3%
1, 2%)
common
(Kentera 2, 3%,
Palpitations Vascular disorders
Kentera
uncommon
!
Hot flushes Urticaria Gastrointestinal disorders
- - * "- (- *
uncommon uncommon
# # # #
Dry Mouth Constipation Diarrhea Nausea Abdominal Pain Dyspepsia Abdominal Discomfort Musculoskeletal disorders
14, 3% 5, 7% 3, 5% 3, 0%
8.6% 3.9% 3.2% 2.1% 1.2% 0.4% 0.5%
1, 2% 0, 2% 0, 2%
common common common common common uncommon uncommon
2, 3% 2, 3%
Back Pain
0, 3%
0.8%
4
4 Renal and urinary disorders
8, 6% 3, 9% 3, 2%
Urinary retention Dysuria General disorders
2, 1% 1, 2% 0, 4% 0, 5%
0.3% 0.9%
0, 8% 0, 3% 0, 9%
uncommon uncommon
& 2%
Headache Somnolence Rhinitis Injury
4. 9 $$$!% & '
common common uncommon
,,,!,,
Inflicted Injury
,,,,
0.3%
,,,,!,,
uncommon
, 100 mg! "
4.9 Overdose
13
Both patients recovered fully with symptomatic treatment.
#
Pharmacotherapeutic group: urinary antispasmodic, ATC code:
-
Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
R
Pharmacodynamic effects:
!). + #
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
in vitro,.
Clinical efficacy:
!. $Kentera "#
5 5.2 Pharmacokinetic Properties
# 3!
Absorption Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
4
Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum.
24!
Following the application of Kentera, oxybutynin plasma concentration increases for approximately 24 to 48 hours, reaching average maximum concentrations of 3 to 4ng/ ml.
48
Steady-state conditions are reached during the second application of the transdermal patch.
.
The volume of distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin hydrochloride.
.
Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.
AUC
Also, less than 0.1% of the administered dose is excreted as the metabolite N-desethyloxybutynin.
0, 4 mg/ kg /
5.3 Preclinical Safety Data
,
At a concentration of 0.4 mg/ kg/ day oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in the presence of maternal toxicity.
. $Kentera
Kentera delivers approximately 0.08 mg/ kg/ day.
(no observed adverse effect level - NOAEL)
In the subcutaneous fertility study in rats, while no effects were reported in males, in females, fertility was impaired and a NOAEL (no observed adverse effect level) of 5 mg/ kg was identified.
6
6 PHARMACEUTICAL PARTICULARS
6. 1 - $$
6.1 List of Excipients
& '
The release liner is two overlapped siliconised polyester strips that are peeled off and discarded by the patient prior to applying the patch.
matrix, / "
Backing Film:
7 6. 6 +!) * +
6 Middle layer:
,
Release Liner:
#
6.2 Incompatibilities
. $
Not applicable.
,. $
6.3 Shelf life
"
6.4 Special precautions for storage
,
Store in the original package.
!.!
Do not refrigerate.
#
6.5 Nature and contents of container
#
The transdermal patches are individually contained in LDPE/ paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.
. -
6.6 Instructions for use and handling
7.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
K
Do not expose the patch to the sun.
#
7.
Nicobrand Limited 189 Castleroe Road Coleraine 6 7 BT51 3RP
Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3RP
8. #
8.
8 A.
10.
Nicobrand Limited 189 Castleroe Road, Coleraine BT51 3RP 6 7
DATE OF REVISION OF THE TEXT
8
8 ANNEX II
3
A.
8
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9
Name and address of the manufacturer responsible for batch release
#
Nicobrand Limited 189 Castleroe Road, Coleraine BT51 3RP Northern Ireland
#
B CONDITIONS OF THE MARKETING AUTHORISATION
5
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
) #
Medicinal product subject to medical prescription
+
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
*!
10 ANNEX III
) *
LABELLING AND PACKAGE LEAFLET
11.
11 A.
) 8
CARTON (Containing 8 transdermal patches)
Kentera 3, 9 mg / 24 +
Kentera 3.9 mg / 24 hours transdermal patch Oxybutynin
3
LIST OF EXCIPIENTS
2 -
4.
#
Do not use if seal on sachet is broken
(
Read the package leaflet before use.
#
Keep out of the reach and sight of children.
33;
7.
# () # (
EXPIRY DATE
8.:
Exp.
9 0 {MM /::::}
Date :< MM/YYYY >
#
Store in original package.
#
10.
#
11.
3
Batch No. :< >
#
14.
5
Medicinal product subject to medical prescription
) #
15.
15. # 3
INSTRUCTIONS ON USE
/ $/ 3 $/ 3 $/ 3 / 3 / / $
Sun/ Wed Mon/ Thu Tue/ Fri Wed/ Sat Thu/ Sun Fri/ Mon Sat/ Tue
) 24
CARTON (Containing 24 transdermal patches)
#
For transdermal use only Do not use if seal on sachet is broken.
(
Read package leaflet before use.
# #
6.
33;
8.
#% #
EXPIRY DATE
#
CARTON (Containing 2 transdermal patches)
-
2 transdermal patches
(. &% $)
SACHET (Contains 1 transdermal patch)
Kentera 3, 9 mg / 24
Kentera 3.9 mg / 24 hours transdermal patch Oxybutynin
*
For transdermal use only
"
Read the package leaflet before use.
!
3.
19 8. # 3
BATCH NUMBER
20 # 3
Batch No. :< >
# 5%
5.
- $(& $$, 0 & $+ 1) * + & + & $'%
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
) +. $!% $
Contains 1 transdermal patch.
;! # #
19 B.
(, 0 & $+ & $
PACKAGE LEAFLET
1) * + 2 + 42! ''%.
20 PACKAGE LEAFLET
Kentera
- Keep this leaflet.
3
- If you have further questions, please ask your doctor or your pharmacist.
#
- This medicine has been prescribed for you personally and you should not pass it on to others.
Kentera
It may
6.
harm them even if their symptoms are the same as yours.
5 "9
In this leaflet:
Kentera
Further Information
(. &% $Kentera 3, 9 mg / 24 1
Kentera 3.9 mg / 24 h transdermal patch
.
The active substance is oxybutynin.
(PET/ EVA),
Marketing Authorisation Holder and Manufacturer:
$Kentera.
Kentera is a thin, flexible, translucent transdermal patch that you apply to your skin.
$Kentera # # "
Each pack contains either 2, 8 or 24 patches.
.
Kentera controls the symptoms of urge incontinence and/ or increased urinary frequency and urgency.
$Kentera:
Do not use Kentera:
!
If you have allergies to medical tape or other transdermal patches, consult your doctor before using Kentera.
(
If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem.
21 (
21 If you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
Kentera.
If you have glaucoma or a family history of glaucoma, tell your doctor.
, Kentera,
Take special care with Kentera:
(
If you have any of the following: • Liver disease • Kidney disease • Bladder obstruction • Gastrointestinal obstruction • Ulcerative colitis • Generalized muscle weakness • Inflammation of the oesophagus
$Kentera
Kentera with food and drink:
* + $Kentera.
Oxybutynin may cause drowsiness or blurred vision.
$Kentera
Pregnancy
#
Ask your doctor for advice before taking any medicine.
"
Kentera should not to be used during pregnancy unless clearly necessary
3 &) $! /
Lactation
#
Ask your doctor for advice before taking any medicine
"
It is not known whether oxybutynin is excreted in human milk.
Kentera.
Caution should be exercised when using Kentera when you are breast feeding.
% (.) 1:. +
Driving and using machines:
$
Kentera may cause drowsiness or blurred vision, requiring caution when driving or operating machines.
4:
Taking other medicines:
7+ & 4
Please inform your doctor or pharmacist if you are taking or have recently taken other medicinal products whether prescribed or not.
22 *
22 3.
Kentera "
HOW TO USE KENTERA
(
You should check with your doctor or pharmacist if you are unsure.
3
Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use.
"! #. (%"
Where to Apply
,
Do not apply a patch to the same place on your body for at least 1 week.
Kentera
abdomen
# # #%
hips
Kentera "
buttocks
$$$* 2%
How to Apply
*
Each patch is individually sealed in a protective sachet.
$Kentera:
To apply Kentera:
8 * 1:
Step 1:
$. &% $$!:
Choose a spot for the patch that is:
•
• Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower). • Free of body powder, lotion, and oil. • Free of cuts, rashes or any other skin irritation.
,
Step 2:
). • •
Open the sachet that contains the patch.
:!:!
• Tear open along arrows marked on the right side of the sachet as shown in drawing below. • Do not cut the sachet with scissors, which might damage the patch inside. • Pull the patch out. • Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
23 8 * 3: $$*
23 Step 3:
Objects cannot be created from editing field codes.
Apply one half of the patch to your skin.
8 * 4: $$*
• Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch. • Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
4
Step 4:
•
• Bend the patch back over itself.
3
Bathing, showering, swimming and exercise:
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You should wear each patch all the time until you apply a new one.
- $,
If the patch comes off:
$, $0 &.
The patch is designed to re-stick.
$. &% $"$&%: & *
Very rarely will the patch come off completely.
$. &% $. -
If not, take it off and put a new patch on a new spot.
(3- 4 +.
No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4 days have elapsed.
24
24 How to Remove
1
If irritation persists, please contact your doctor.
$,
Alcohol or other strong solvents may cause skin irritation and should not be used.
%
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems
.!
4.
"Kentera
POSSIBLE SIDE EFFECTS
"Kentera
Like all medicines Kentera can have side effects.
"
Finally, those using Kentera may experience the following uncommon (1 in 1000 persons): upper respiratory tract or fungal infections, palpitations, hot flashes, back pain, urinary retention, difficulty urinating, common cold, and accidental injury.
,
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
KENTERA
STORING KENTERA
1 #%
Keep out of the reach and sight of children.
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Do not refrigerate.
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6.
!
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België/ Belgique/ Belgien
25 België/ Belgique/ Belgien Vigilex B. V.
Nicobrand Limited A Subsidiary of Watson Pharmaceuticals, Inc. = > A C @ F @ (IC J G G E A F E B? @ B D E G H > @ > B B D? K L) Te?.: +44 (0) 28 7086 8733
() Te. :+44 (0)28 7086 8733
Eeská republika Nicobrand Limited A Subsidiary of Watson Pharmaceuticals, Inc.
eská republika Nicobrand Limited A Subsidiary of Watson Pharmaceuticals, Inc.
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España
& Recordati Hellas Pharmaceuticals A. E..: +30 210- 6773822
Recordati Hellas Pharmaceuticals A. E..: +30 210-6773822