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TRANSTEC 70 MICROGRAM/H TRANSDERMAL PATCHES

Active substance: BUPRENORPHINE

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Transcript
PAC
CKAGE LE
EAFLET: INFORMA
ATION FO THE U
OR
USER

T
Transte
ec® 35 microg
gram/h T
Transd
dermal P
Patches
Tr
ranstec 52.5 microg

5
gram/h Transd
h
dermal Patche
es
T
Transte
ec® 70 microg
gram/h T
Transd
dermal P
Patches
(bu
uprenorphine)
Th medicin is available using any of th above names bu will be r
his
ne
g
he
ut
referred to as Transtec
o
thr
roughout t following leaflet.
the
.
Re all of this leafle careful before you star using th medic
ead
et
lly
e
rt
his
cine.
Ke this lea
eep
aflet. You may need to read it again.
d
If y have a furthe question ask your doctor or pharma
you
any
er
ns,
acist.
Th medicin has be prescr
his
ne
een
ribed for y
you. Do no pass it o to othe It may harm the
ot
on
ers.
y
em,
even if their symptoms are the s
same as y
yours.
If a of the side eff
any
e
fects gets serious, or if you notice an side eff
ny
fects not listed in this
t
lea
aflet, pleas tell you doctor o pharmac
se
ur
or
cist.
In this leafle
et:
1. What Tra
anstec is a what it is used for
and
d
2. Before yo use Tr
ou
ranstec
3. How to use Transt
tec
4. Possible side effe
ects
5. How to store Tran
nstec
6. Further in
nformatio
on
1. What Tra
anstec is a what it is used for
and
d
Tra
anstec is a analge
an
esic (a pain-relieving medicine intende to reliev modera to severe
g
e)
ed
ve
ate
cancer pain and seve pain th has no respond to other types o painkille Transtec
ere
hat
ot
ded
of
ers.
acts through the skin. When the trans
h
sdermal p
patch is a
applied to the skin the act
o
n,
tive
substance b
buprenorp
phine pass
ses through the sk into th blood. Buprenorphine is an
kin
he
op
pioid (stron pain re
ng
eliever), w
which reduces pain by acting on the ce
entral nerv
vous system
(sp
pecific ner cells in the spina cord an in the b
rve
n
al
nd
brain). The effect of the transd
e
dermal patch
las for up t four day
sts
to
ys.
Tra
anstec is n suitable for the t
not
treatment of acute (
(short-last
ting) pain.
2. Before yo use Tr
ou
ranstec
Do not use Transtec
o
c,
ce
if you are allergic (hypersen
e
nsitive) to the active substanc bupren
e
norphine o any of the
or
other ingr
redients o Transtec
of
c;
e
elievers (opioids);
■ if you are dependent on strong pain re
ou
ffer from a disease in which yo have o may hav great difficulty br
or
ve
reathing
■ if you suff
e
monoamine oxidase (MAO) in
e
e
nhibitors (
(certain medicines u
used to treat
■ if you are taking m
depressio or you have tak this ty of med
on)
u
ken
ype
dicine in the last tw weeks (see "Tak
wo
king
other med
dicines");
ffer from m
myasthenia gravis (a certain ty of sev
a
a
ype
vere musc weakne
cle
ess);
■ if you suff
ffer from d
delirium tre
emens (co
onfusion a tremb
and
bling cause by abs
ed
stinence from
■ if you suf
alcohol fo
ollowing h
habitual ex
xcessive drinking o occurrin during an episo
or
ng
ode of hea
avy
alcohol co
onsumptio
on);
■ if you are pregnant
e
t.
Tra
anstec mu not be used to tr
ust
reat withdr
rawal sym
mptoms in drug-depe
endent persons.


Ta specia care wi Transt
ake
al
ith
tec,









if you hav recently drunk a lot of alco
ve
y
ohol;
if you suff from seizures or convulsio (fits)
ffer
r
ons
if your consciousne is distu
ess
urbed (fee
eling light-headed or faint) for an unkno
r
own reason;
e
e
eat
be
of
if you are in a state of shock (cold swe might b a sign o it);
if the pre
essure in your sku is incre
ull
eased (for instance after he
e
ead injury or in br
y
rain
disease), and artific respiration is no possible
cial
ot
e;
if you hav difficult breathin or are t
ve
ty
ng
taking other medicin that m make you breathe
nes
may
more slow or wea
wly
akly (see "
"Taking ot
ther medic
cines");
if your live does no work pr
er
ot
roperly;
if you are inclined t abuse m
e
to
medicines or drugs.

Ple
ease cons your d
sult
doctor if a of the statem
any
ese
ments app to you or were a
ply
applicable to
e
you at any ti
ime in the past.
Als please be aware of the following pr
so,
e
e
recautions
s:
■ Some pe
eople may become dependen on stron pain re
nt
ng
elievers su as Tra
uch
anstec wh
hen
they use them ove a long p
er
period of t
time. They may hav withdra
y
ve
awal effect when th
ts
hey
g
ee
g
c”).
stop using them (se “If you stop using Transtec
■ Fever and external heat may lead to la
d
l
y
arger quantities of b
buprenorp
phine in th blood th
he
han
normal. A
Also, external heat may prev
vent the transderma patch f
al
from sticking properly.
Therefore do not e
e,
expose yo
ourself to external h
heat (e.g. sauna, in
nfra-red lamps, elec
ctric
blankets, hot water bottles) a consu your doctor if you have fever.
r
and
ult
u
■ Transtec should n
not be us
sed in pe
ersons be
elow the a
age of 18 years, because no
8
experienc has so far been g
ce
gained in t
this age g
group.
Ta
aking othe medicines
er
Ple
ease tell y
your docto or pha
or
armacist if you are taking or have rec
f
cently take any other
en
me
edicines, including m
medicines obtained without a prescripti
s
ion.
■ Transtec must not be used together w
with mono
oamine ox
xidase (MA inhibitors (cert
AO)
tain
s
pression), or if you have take this typ of med
en
pe
dicine for the
medicines used to treat dep
last 2 wee
eks.
■ Transtec may mak some people feel drowsy, sick, or fa
ke
aint or make them b
breathe mo
ore
slowly or weakly.
■ These sid effects m
de
may be int
tensified if other medicines tha may pro
f
at
oduce the same effe
ects
are taken at the same time. These o
n
other medicines include other strong p
pain reliev
vers
(opioids), certain sleeping pills, ana
aesthetics, and me
,
edicines u
used to treat cert
tain
psycholog
gical disea
ases such as tranquillizers, anti-depress
sants, and neurolept
tics.
■ If Transte is used together with som medicin
ec
d
r
me
nes, the e
effects of t transd
the
dermal patch
may be in
ncreased.
■ These m
medicines include e.g. cer
rtain anti
i-infectives
s/anti-fung
gals (e.g. containing
erythromy
ycin or ket
toconazole) or HIV medicines (e.g. con
s
ntaining rit
tonavir)
■ If Transte is used together with othe medicin
ec
d
r
er
nes, the e
effects of t
the transd
dermal patch
may be reduced. These m
medicines include certain p
products, e.g. dexa
amethasone;
s
rbamazep
pine, or ph
henytoin) o medicin
or
nes
medicines to treat epilepsy (e.g. containing car
for tuberc
culosis (e.g. rifampic
cin).
Us
sing Trans
stec with food and drink
d
Yo should not drink alcohol while us
ou
k
sing Trans
stec. Alco
ohol may intensify certain side
eff
fects of th transde
he
ermal patc and yo may fe unwell Drinking grapefru juice may
ch
ou
eel
g
uit
m
l.
intensify the effects of Transtec
e
f
c.

regnancy
y
Pr
Th
here is not sufficie experience reg
ent
garding the use of Transtec in pregn
c
nant wom
men.
Th
herefore d not use Transtec if you are pregnant
do
e
t.
As your do
sk
octor or ph
harmacist for advice before ta
e
aking any medicine.
Br
reast-feed
ding
Bu
uprenorph
hine, the active su
ubstance contained in the transdermal patch, inhibits m
d
milk
fo
ormation and passes into the breast mil Therefo do no use Tran
s
lk.
ore,
ot
nstec if yo are breastou
fe
eeding.
As your do
sk
octor or ph
harmacist for advice before ta
e
aking any medicine.
Dr
riving and using machines
d
m
Tr
ranstec m make you feel dizzy or d
may
drowsy or experience blurred or doub vision and
d
ble
af
ffect your reactions to such an extent th you may not rea adequa
n
hat
act
ately or qu
uickly enough
in the event of unexpected or s
t
sudden oc
ccurrences
s.
Th applies particula
his
s
arly
■ at the be
eginning of treatmen
f
nt,
e
ed,
■ when your dosage is change
o
c
other pain reliever,
n
■ when you switch to Transtec from ano
so
her
nes that a on the brain,
act
■ if you als use oth medicin
ol.
■ if you drink alcoho
If you are a
affected, you should not drive or opera machinery whils using T
y
d
e
ate
st
Transtec. T
This
pplies also at the en of treat
o
nd
tment with Transtec Do not d
h
c.
drive or op
perate ma
achinery fo at
or
ap
least 24 hou after th patch h been r
urs
he
has
removed.
iscuss with your doc or pha
ctor
armacist if you are u
f
unsure ab
bout anything.
Di
he
ne
fect your a
ability to dr
rive as it m make you sleep or dizzy
may
e
py
y.
Th medicin can aff
■ Do not drive while taking this medicine until you know ho it affect you.
u
ow
ts
■ It is an offence to drive if this medicine affects y
d
s
e
your ability to drive.
y
r,
uld
ng
nce if:
■ However you wou not be committin an offen
o The medicine has been prescribe to treat a medica or dental problem and
n
ed
al
o You have tak
ken it according to the instru
uctions giv
ven by th prescriber or in the
he
rmation pr
rovided wit the med
th
dicine and
d
infor
o It wa not affe
as
ecting your ability to drive safe
r
ely
alk
r
cist
ure
er
fe
while
Ta to your doctor or pharmac if you are not su whethe it is saf for you to drive w
ta
aking this m
medicine.
3. How to u Trans
use
stec
Tr
ranstec is available in three strength Transt
s
e
e
hs:
tec 35 micrograms transd
s/h
dermal patch,
Tr
ranstec 52 microg
2.5
grams/ h tr
ransderma patch and Transtec 70 mic
al
crograms/h transder
h
rmal
pa
atch.
Th choice of which strength of Transt will su you best will be made by your doc
he
tec
uit
y
ctor.
Du
uring treat
tment you doctor m chang which t
ur
may
ge
transderm patch y use to a smalle or
mal
you
o
er
larger one if necessary.
f
Al
lways use Transtec exactly as your doctor ha told you. You sh
e
c
as
hould che with y
eck
your
do
octor or ph
harmacist if you are not sure.
Th usual d
he
dose is:
Ad
dults
Un
nless your doctor ha told you differently attach on Transtec transder
r
as
y,
ne
rmal patch (as descri
ibed
in detail belo and ch
ow)
hange it aft 4 days at the late For con
ter
est.
nvenience of use, yo can cha
ou
ange
the transder
rmal patch twice a w
h
week at th same d
he
days, e.g. a
always on Monday mornings and
hursday ev
venings. To help you remembe when to change yo transdermal patc you sho
o
u
er
our
ch,
ould
Th
make a note on the calendar o the oute packaging. If you doctor h advise you to t
c
on
er
ur
has
ed
take
ther pain re
elievers in addition t the transdermal p
n
to
patch, strict follow t doctor's instructio
tly
the
ons,
ot
ot
therwise yo will not fully benef from trea
ou
fit
atment with Transtec
c.
Pa
atients under 18 yea of age
ars
e
Tr
ranstec sh
hould not be used in persons below the age of 18 years, b
b
n
e
because n experience
no
ha so far b
as
been gaine in this a group
ed
age
p.
El
lderly patie
ents
No dosage adjustmen is needed for elderly patien
o
nt
nts.
Pa
atients wit kidney disease / d
th
d
dialysis pa
atients
In patients w kidne disease and in dia
with
ey
e
alysis pati
ients, no d
dosage ad
djustment is necessa
ary.
Pa
atients wit liver dis
th
sease
In patients with liver disease, the inte
r
ensity and duration of action of Transtec may be
d
n
y
af
ffected. If t
this applie to you, your docto will che on you more clo
es
or
eck
u
osely.
Method of administr
ration
Be
efore appl
lying the tr
ransderma patch
al
■ Choose an area of skin which
o
is flat, c
clean and hairless on
d
s
your upp body, preferably on
per
y
the ches below th collar-b
st
he
bone
or on the upper pa of the b
e
art
back
(see adja
acent illus
strations). Call
assistanc if you cannot apply
ce
the trans
sdermal patch yours
self.
Chest Ba
ack

Chest
C
Back
If the cho
osen area has hairs cut them off with a pair of sc
s,
m
cissors. D not shave them o
Do
off!
Avoid sk which is red, irrita
kin
s
ated or ha any othe blemish
as
er
hes, for ins
stance lar scars.
rge
The area of skin you choos must b dry and clean. If necessar wash it with cold or
a
y
se
be
d
ry,
t
d
lukewarm water. Do not use soap or other det
m
D
e
r
tergents. A
After a ho bath or shower, w
ot
wait
until your skin is co
ompletely dry and c
cool.
Do not app lotion, cream o ointme to the chosen area. This might prevent y
o
ply
,
or
ent
e
your
tra
ansderma patch fro sticking properly
al
om
g
y.




Ap
pplying the transder
e
rmal patch
h:
Step 1:
Each tran
nsdermal patch is s
sealed in a sachet. Just befo use, open
ore
the sache by tearin at the n
et
ng
notch. Tak out the transderm patch.
ke
mal

Step 2:
The stick side of the transdermal p
ky
f
patch is c
covered w
with a silv
very
protective foil. Car
e
refully pee off half the foil. Try not to touch the
el
.
sticky par of the tra
rt
ansderma patch.
al

S
Step 3:
S
Stick the transderm patch onto the area of s
mal
skin you h
have chos
sen
a remov the rem
and
ve
maining foil.

S
Step 4:
Press the transderm patch against y
e
mal
h
your skin with the p
palm of yo
our
hand for a
about 30 s
seconds.
Make sure that the whole tr
e
ransderma patch is in conta with yo
al
s
act
our
s
skin, espe
ecially at th edges.
he
earing the transderm patch
e
mal
We
Yo may we the tra
ou
ear
ansdermal patch for up to 4 d
l
r
days. Prov
vided that you have applied the
t
e
tra
ansdermal patch co
orrectly, there is little risk of i coming off. You m show
it
may
wer, bathe or
e
sw while w
wim
wearing it. However do not e
r,
expose the transder
e
rmal patch to extrem heat (e
h
me
e.g.
sauna baths infra-red lamps, e
s,
d
electric bla
ankets, hot water bo
t
ottles).
ely
that your transderm patch falls off be
mal
efore it ne
eeds chan
nging, do not
In the unlike event t
use the sam transde
me
ermal patc again. Stick a ne one on straight away (se "Changing
ch
ew
n
ee
e
rmal patch below).
h"
the transder
Ch
hanging th transde
he
ermal patch
■ Take the old transd
dermal pat off.
tch
the sticky s
side inwar
rds.
■ Fold it in half with t
away care
efully, out of the rea and s
ach
sight of ch
hildren.
■ Throw it a
ew
ermal patc on a different skin site (as described above). Wait at least
ch
d
■ Stick a ne transde
one week before using the same site a
k
again.
Du
uration of t
treatment
Yo doctor will tell y
our
r
you how lo
ong you m use T
may
Transtec. Do not st
top using Transtec on
your own ac
ccount, be
ecause pain may ret
turn and y may fe unwell (see also "If you stop
you
eel
l
o
tec" below
w).
using Transt
If y have the impression that the effec of the Transtec transderma patch is too weak or
you
t
ct
al
k
too strong, tell your do
o
octor or ph
harmacist.
If y use m
you
more Tran
nstec than you sho
n
ould
If t
this happe
ens there may be signs of a overdo of the substanc bupren
an
ose
e
norphine. An
ce
overdose ma intensif the side effects o bupreno
ay
e
of
orphine su as dro
uch
owsiness, nausea, and
a
fy
vomiting. Yo may get pin-point pupils and breathing may become slow and weak. You
ou
y
e
d
Y
ma also ge cardiova
ay
et
ascular collapse.
As soon as you disco
s
over that y have used more transde
you
ermal patc
ches than you shou
uld,
rem
move the excess tra
ansdermal patches and talk to a doctor or pharm
o
r
macist.
If y forge to use T
you
et
Transtec
If y forget an applic
you
t
cation, stick a new transderm patch on as so as you rememb
mal
oon
u
ber.
Yo will the need t change your routine, e.g if you u
ou
en
to
e
g.
usually ap
pply your transderm
mal
pa
atches on Mondays and Thur
rsdays, bu you forg and do stick on a new transderm
ut
get
on’t
mal
pa
atch until W
Wednesda you wil need to change yo transd
ay,
ll
our
dermal pat
tches on W
Wednesda
ays
and Saturda from t
ays
then on. M
Make a no of the new pair of days o the cale
ote
on
endar on the
outer packaging. If yo are ver late cha
ou
ry
anging you transde
ur
ermal patc pain m return. In
ch,
may
this case ple
ease conta your doctor.
act
Ne
ever apply twice th numbe of tran
y
he
er
nsdermal patches to make up for the forgotten
ap
pplication!
If y stop using Tra
you
anstec
If y interru or finis using Transtec to soon, p
you
upt
sh
oo
pain may re
eturn. If yo wish to stop use on
ou
o
account of u
unpleasant side effe
ects, pleas consult your doct He/she will tell y what can
se
tor.
e
you
c
e
d
be
er
es.
be done and whether you can b treated with othe medicine
So
ome peop may experienc withdra
ple
ce
awal-effec when they hav used strong pain
cts
ve
relievers for a long tim and sto using th
me
op
hem. The risk of hav
ving effec after yo stop using
cts
ou
Tra
anstec is very low. However if you fe agitate anxiou nervou or shak if you are
r,
eel
ed,
us,
us
ky,
a
overactive, h
have diffic
culty sleep
ping or digestion pro
oblems, tell your doc
ctor.
If y have a furthe question on the u of this product, ask your doctor or pharmacis
you
any
er
ns
use
s
st.

orders
Chest and lung diso
Co
ommon:
sho
ortness of breath
Ra
are:
diff
ficulty brea
athing (res
spiratory d
depression
n)
Ve rare:
ery
abn
normally r
rapid breat
thing, hicc
cups
Digestive s
system di
isorders
Ve common:
ery
nau
usea (feeling sick)
Co
ommon:
vom
miting, con
nstipation
Un
ncommon
n:
dry mouth
y
Ra
are:
hea
artburn
Ve rare:
ery
retc
ching
Sk disord
kin
ders (gen
nerally at t site o applicat
the
of
tion)
Ve common:
ery
red
dness, itch
hing
Co
ommon:
skin changes (exanthe
s
ema, gene
erally on re
epeated use), swea
ating
Un
ncommon
n:
ras
sh
Ra
are:
hiv
ves
Ve rare:
ery
pus
stules, sm blisters
mall
s
Ur
rinary sys
stem diso
orders
Un
ncommon
n:
diff
ficulty in passing wa
ater, urine retention (less urine than normal)
Re
eproductive system disorders
ere
Ra
are:
ection diffic
culties
General dis
sorders
Co
oed
ommon:
dema (e.g swelling of the leg tiredne
g.
gs),
ess
Un
ncommon
n:
weariness
Ra
are:
nistration s reactio
site
ons
withdrawal symptoms (see below), admin
che pain
Ve rare:
ery
est
If you notice any of th side eff
e
he
fects listed above, te your do
d
ell
octor as so as possible.
oon
In some ca
ases delay
yed allergic reaction occurre with m
ns
ed
marked sig of infla
gns
ammation In
n.
su a case you shou stop using Trans
uch
e
uld
stec after you have talked to your docto
or.
If you exp
perience swelling of the ha
s
ands, fee ankles face, lips, mout or thr
et,
s,
th,
roat
y
d
owing or b
breathing hives, f
g,
fainting, y
yellowing of
g
which may cause difficulty in swallo
he
nd
also calle jaundic remo the tra
ed
ce),
ove
ansderma patch a
al
and call y
your
th skin an eyes (a
do
octor imm
mediately or seek help at th casualty depar
he
rtment of the neare hospi
est
ital.
Th
hese can be sympt
toms of a very rare serious allergic r
e
s
reaction.
So
ome peop may ha withdrawal sym
ple
ave
mptoms when they have used strong p
pain reliev
vers
fo a long time and stop using them. Th risk of having w
or
s
g
he
withdrawal effects when you s
stop
us
sing Trans
stec is low Howeve if you f
w.
er,
feel agitat
ted, anxious, nervou or shaky, if you are
us
ov
veractive, have diffic
culty sleep
ping or dig
gestion pro
oblems, te your do
ell
octor.
If any of the side effe
e
ects gets s
serious, or if you no
r
otice any s
side effects not men
ntioned in this
ase
ur
or
acist.
leaflet, plea tell you doctor o pharma
Re
eporting of side ef
ffects
If you get any side effects, ta to you doctor, pharmac or nur
alk
ur
cist
rse. This includes any
ossible sid effects not listed in this lea
de
aflet. You c also r
can
report side effects directly via the
e
po
Ye
ellow Card Scheme at: www.mhra.gov.
d
e
.uk/yellow
wcard.
By reporting side ef
y
ffects, you can hel provide more information on the s
u
lp
e
safety of this
medicine.
5. How to s
store Tran
nstec







Keep out of the sig and re
t
ght
each of chi
ildren.
Do not use after th expiry d
he
date printe on the c
ed
carton or label.
re
age
utions for this produ
uct.
There ar no stora precau
Please d
dispose of the used patches carefully and out o the reac of child
f
d
of
ch
dren, as t
they
will still c
contain some medic
cation.
If the patches be
ecome br
rittle or d
discoloured you sh
d
hould see the ad
ek
dvice of y
your
cist
w
pharmac who will tell you what to do.
Medicine should not be d
es
disposed of via wa
astewater or house
ehold was
ste. Ask y
your
pharmac how to dispose o medicin no lon
cist
o
of
nes
nger requir
red. These measure will help to
e
es
protect th environ
he
nment.

4. Possible side effe
ects

6. Further i
informatio
on

Lik all medicines, Tra
ke
anstec can cause side effects although not ever
n
s,
rybody gets them.
Sid effects are classified as fo
de
ollows:

What is in your patc
W
ch?
Yo patch is called Transtec Each s
our
d
c.
self-adhes
sive patch contains the activ ingredient
h
s
ve
bu
uprenorph
hine.
Tr
ranstec® 3 microg
35
gram/h Tr
ransderma Patch contains 20mg of buprenor
al
rphine with a
re
elease rate of 35 mi
e
icrogram o buprenorphine per hour. T area o the patc contain
of
The
of
ch
ning
the active s
substance is 25 cm2. Each p
e
m
patch is sq
quare skin coloured with roun
n
d
nded corn
ners
nd
d
c
buprenorp
phinum 20
0mg’ in blu ink.
ue
an marked ‘Transtec 35μg/h b
Tr
ranstec® 5
52.5 micro
ogram/h T
Transderm Patch contains 30mg of buprenor
mal
rphine wit a
th
re
elease rate of 52.5 microgram of bupren
e
m
m
norphine p hour. T area of the patc contain
per
The
ch
ning
the active substance is 37.5 cm2. Each patch is rectan
e
ngle shape skin c
ed
coloured w
with
ounded corners and marked ‘T
Transtec 5
52.5μg/h b
buprenorp
phinum 30mg’ in gre ink.
een
ro
Tr
ranstec® 7 microg
70
gram/h Tr
ransderma Patch contains 40mg of buprenor
al
rphine with a
re
elease rate of 70 mi
e
icrogram o buprenorphine per hour. T area o the patc contain
of
The
of
ch
ning
the active s
substance is 50 cm2. Each pa
atch is rect
tangle sha
aped skin coloured with rounded
co
orners and marked ‘Transtec 70μg/h bu
d

uprenorph
hinum 40m in red i
mg’
ink.

Very comm
V
mon:
more than 1 out of 10 persons
m
s
Uncommon
U
n:
more than 1 out of 1000 perso
m
ons
and
a less th 1 out o 100 per
han
of
rsons
very rare:
v
le than 1 out of 10
ess
0,000 pers
sons

Co
ommon:
mo than 1 out of 100 persons
ore
0
s
and less than 1 out of 10 person
d
ns
Ra
are:
mo than 1 out of 100 perso
ore
000
ons
and less than 1 out of 1000 pers
d
sons

Th following side effe
he
ects have been repo
orted:
Im
mmune sys
stem diso
orders
Ve rare:
ery
seri
ious allerg reactions (see be
gic
elow)
Me
etabolism and nutr
m
rition diso
orders
Ra
are:
loss of appeti
s
ite
Ps
sychiatric disorder
c
rs
Un
ncommon:
:
con
nfusion, sle disord restles
eep
der,
ssness
Ra
are:
illus
sions such as hallu
h
ucinations anxiety and nigh
s,
htmares, r
reduced sex
s
driv
ve
Ve rare:
ery
dep
pendence, mood sw
wings
Ne
ervous sy
ystem diso
orders
Co
ommon:
dizz
ziness, he
eadache
Un
ncommon:
:
vari
ious degr
rees of s
sedation (calmness rangin from tiredness to
s),
ng
muz
zziness
Ra
are:
difficulty conc
centrating speech disorder, muzzines disturb
g,
ss,
bed balance,
normal skin sensatio (numb
n
ons
bness, pric
ckling or b
burning sensations)
abn
Ve rare:
ery
mus
scle twitch
hing, taste disorders
e
s
Ey disorde
ye
ers
Ra
are:
Ve rare:
ery

visu disturb
ual
bance, blur
rred vision swollen eyelids
n,
pin-point pup
pils

Ea disorde
ar
ers
Ve rare:
ery

ear pain

He
eart and b
blood circ
culation d
disorders
Un
ncommon:
:
circ
culatory d
disorders (such as low blo
s
ood press
sure or, rarely, ev
ven
circ
culatory co
ollapse)
Ra
are:
hot flushes

Tr
ranstec als contain the follo
so
ns
owing excipients:
(z
z)-octadec-9-en-1-yl oleate, povidone K90, 4-o
oxopentan acid, poly [acr
nic
rylic acid-cobu
utylacrylat
te-co-(2-et
thylhexyl)
acryla
ate-co-viny
ylacetate]
cross-link
ked;
(5:15:75:5),
po
oly(ethylen
neterephth
halate) foil; poly(eth
hyleneterephthalate) tissue.
)
Ea patch last for up to 4 day (96 hours).
ach
p
ys
Tr
ranstec is available in packs o 4, 5 and 10.
of
d
PO
OM
PL No: 15814/0820
L
PL No: 15814/0821
L
PL No: 15814/0822
L

Transtec® 35 microgram/h Trans
5
sdermal P
Patches
2.5
ansdermal Patches
Transtec® 52 microgram/h Tra
0
sdermal P
Patches
Transtec® 70 microgram/h Trans

Th
hese prod
ducts are manufactu
m
ured by Grunenthal GmbH Zi
ieglerstras 6 Aac
sse
chen D-52078
Germany a
and are pr
rocured fr
rom within the EU and repackaged by the Pro
n
oduct Licence
older: O.P
P.D. Labora
atories Ltd Unit 6, Colonial W
d.,
Way, Watf
ford, Herts WD24 4PR.
s
ho
eaflet revis
sion and is
ssue date (Ref.): 05
5.03.2014
Le
Tr
ranstec® i a registe
is
ered Trade Mark of Grünenth GmbH, Germany
f
hal
y.
To request a copy of this leafle in Braille large pr or audio please call 01923 332 796.
o
et
e,
rint
3

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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