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ACTIQ 200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance(s): FENTANYL / FENTANYL CITRATE

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ACTIQ PATIENT INFO LFLT GB - 400-33-10321.19

Package leaflet: Information
n
for the user
ACTIQ® 200 micrograms compressed
c
lozenge with integral oromucosal
m
applicator
ACTIQ® 400 micrograms compressed
c
lozenge with integral oromucosal
m
applicator
ACTIQ® 600 micrograms compressed
c
lozenge with integral oromucosal
m
applicator
ACTIQ® 800 micrograms compressed
c
lozenge with integral oromucosal
m
applicator
ACTIQ® 1,200 micrograms compressed lozenge with integral oromucosal applicator
ACTIQ® 1,600 micrograms compressed lozenge with integral oromucosal applicator
Fentanyl
Read all of this leaflet carefully
y before you
start using this medicine because
u it contains
important information for you.
• Ke
Keep
eep this leaflet
leaflet. You may need
d to read it again
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed
c
for you
only. Do not pass it on to others.
e It may harm
them, even if their signs of illness
n
are the
same as yours.
• If you get any side effects, talkk to your doctor
or pharmacist. This includes any
a possible side
effects not listed in this leaflet.
t See section 4.
What is in this leaflet
1. What ACTIQ is and what it is used for
2. What you need to know before
e you use ACTIQ
3. How to use ACTIQ
4. Possible side effects
5. How to store ACTIQ
6. Contents of the pack and other
e information

1. What ACTIQ is and whatt it is used for
ACTIQ contains the active substance
a
fentanyl
which is a strong pain
w
pain-relieving
relieving medicine
m
known
as an opioid. The ACTIQ unit comes
m as a lozenge
on a stick.
• It is used to treat breakthrough
g pain in adults
and adolescents aged 16 years
r and above
with cancer who are already taking
t
other
opioid pain medicines for their
e persistent
(around-the-clock) cancer pain. Breakthrough
pain is additional sudden pain
n that occurs
suddenly in spite of your having taken your
usual opioid pain-relieving medicines.
e

2. What you need to know
w before you
use ACTIQ
Do NOT use ACTIQ:
• if you are not regularly using a prescribed
opioid medicine (e.g. codeine,
e fentanyl,
hydromorphone, morphine, oxycodone,
o
pethidine), every day on a regular
g
schedule,
for at least a week, to control your persistent
pain. If you
p
y have not been using
g these
medicines you must not use A
ACTIQ, because
it may increase the risk that breathing could
become dangerously slow and/or shallow, or
even stop.
• if you are allergic to fentanyl or
o any of the
other ingredients of this medicine (listed in
section 6).
• if you are currently taking monoamine
o
oxidase (MAO) inhibitors (medicines
d
for
severe depression) or have taken them
in the past 2 weeks (see section
o 2 under
Serotonin syndrome).
• if you have severe breathing problems
r
or severe
lung problems where you have
e an obstruction.
• if you suffer from short-term pain
p
(e.g.
pain from injuries, surgery, headaches
e
or
migraines) other than breakthrough
h
pain.

Do not use ACTIQ if any of the
e above apply to
you. If you are not sure, talk to
o your doctor or
pharmacist before using ACTIQ.
I
Warnings and precautions
Keep using the opioid pain medicine
m
you take for
your persistent (around-the-clock)
c
cancer pain
during your ACTIQ treatment.
Talk to your doctor or pharmacist
a
before using
ACTIQ if:
• Your other opioid pain medicine
e
for your
persistent (around-the-clock)
c cancer pain is
not stabilised yet.
• You have any illness that affects
a
your
breathing (such as asthma, wheezing, or
shortness of breath).
• You have a head injury or have had any loss of
consciousness.
• You have problems with your
o heart especially
slow heart rate.
• You have liver or kidney problems
r
- this will
affect how your system breaks
e
down
the medicine.
• You have low blood pressure
u due to a low
amount of fluid in your circulation.
c
• You have diabetes.
• You are over 65 years old - you may need
a lower dose and any dose
e increase will be
reviewed very carefully by your doctor.
• You have a history of alcoholism
h
or any drug
abuse or dependence.
• You have ever developed adrenal
a
insufficiency with opioid use,
u a condition in
which the adrenal glands do
d not produce
enough hormones (see section
c
4 under
serious side effects).
• You drink alcohol; please refer
r
to section
ACTIQ with food, drink and
d alcohol.
Serotonin syndrome
y
Talk to your doctor before using
i ACTIQ if you
use antidepressants or antipsychotics
y
(selective
serotonin reuptake inhibitors [SSRIs], serotonin
norepinephrine reuptake inhibitors
n
i
[SNRIs],
monoamine oxidase (MAO) inhibitors;
n
see
section 2 under Do not use ACTIQ
C
and Other
medicines and ACTIQ).
The use of these medicines with
w ACTIQ can
lead to a serotonin syndrome
e a potentially lifethreatening condition (see section 2 under Other
medicines and ACTIQ).
Serious allergic
g reactions
((anaphylaxis,
p y
, hypersensitivity)
yp
y)
y
Serious allergic reactions have
e been reported with
fentanyl (see section 4 under SSerious side effects),
early symptoms can be difficulty in breathing or
dizziness, swelling of the tongue, lip or throat.

18-May-2017

Dental decayy
ACTIQ contains approximately 2 grams of sugar
and a frequent consumption exposes you to an
iincrease
ncrease risk of dental de
decay
ecay
c that may be serious
serious.
Thus, it is important to continue to take good
care of your mouth and teeth
e
during treatment
with ACTIQ. If you presentt such serious local
effects consult your doctor.
o
Children and adolescents
t
ACTIQ is not recommended
e for children and
adolescents below 16 years
a of age.
Other medicines and ACTIQ
C
Do not use this medicine and tell your doctor
or pharmacist
• if you are taking other fentanyl treatments
that have been prescribed for your
breakthrough pain in the
t past. If you still have
some of these fentanyll treatments at home,
check with your pharmacist
m
how to dispose
of them.
• if you are using monoamine
a
oxidase (MAO)
inhibitors (medicines for
o severe depression)
or have taken them in the past
p 2 weeks
(see section 2 under Do
o NOT use ACTIQ and
Serotonin syndrome).
Tell your doctor or pharmacist before using
ACTIQ if you are taking orr have recently taken
or might take any other medicines.
m
This includes
medicines obtained without
o a prescription,
including herbal medicines.
e In particular, tell
your doctor or pharmacistt if you are taking any
of the following medicines:
e
• Any medicines which might
m
make you sleepy
- such as sleeping pills,, medicines to treat
anxiety, some medicines
e for allergic reaction
(antihistamines), or tranquillisers.
• Some muscle relaxantss - such as
baclofen, diazepam.
• Any medicines that might
g affect how your
body breaks down ACTIQ
T - such as ritonavir
or other medicines that
a help control HIV
infection, other so-called
e ‘CYP3A4 inhibitors’
such as ketoconazole
ketoconazole, itraconazole
itraconazole,
i
or
fluconazole (used for fungal
u
infections)
and troleandomycin, clarithromycin, or
erythromycin (medicines
n for bacterial
infections) and so-called
e ‘CYP3A4 inducers’
such as rifampin or rifabutin
a
(medicines
for bacterial infections),) carbamazepine,
phenobarbital or phenytoin
n
(medicines used
to treat convulsions/fits).
t
• Certain types of strong
g pain killers,
called partial agonist/antagonists
a
e.g.
buprenorphine, nalbuphine
p
and pentazocine
(medicines for treatment
e of pain). You
could experience symptoms
p
of withdrawal
syndrome (nausea, vomiting,
m
diarrhoea,
anxiety, chills, tremor, and
a sweating) while
using these medicines..

• Serotonergic medicinal
c
products used to treat
depression (antidepressants:
p
such as selective
serotonin reuptake
e inhibitors [SSRIs] and
serotonin norepinephrine
e
reuptake inhibitors
[SNRIs]) or antipsychotics.
c
The use of these
medicines with ACTIQ
T can lead to serotonin
syndrome a potentially
t
life-threatening
condition (see section 2 under Serotonin
syndrome). The symptoms
m
of serotonin
syndrome may include
l
mental status changes
(e.g. agitation, hallucinations,
u
coma), and
other effects such aas body temperature
above 38 °C, increase
a in heart rate, unstable
blood pressure,
p
and
d exaggeration
gg
of reflexes,
muscular rigidity, lack
a of coordination and/
or gastrointestinal symptoms (e.g. nausea,
vomiting, diarrhoea).
a Your doctor will tell you
whether ACTIQ is suitable for you.
If you are due to have surgery requiring a general
anaesthetic speak with
h your doctor or nurse.
ACTIQ with food, drink
n and alcohol
• ACTIQ may be used
d before or after meals.
However do not use
s during meals.
• You may drink some water before using ACTIQ
to help moisten your
u mouth. However, do not
drink or eat anything
n while using ACTIQ.
• Do not drink grapefruit
e
juice while using
ACTIQ. This is because it may affect the way
your body breaks down
d
ACTIQ.
• Do not drink alcohol
o while using ACTIQ. It can
increase the chances
e of getting serious side
effects including death.
e
Pregnancy
g
y and breast-feeding
s
g
If you are pregnant or breast-feeding, think you
may be pregnant or are
r planning to have a baby,
ask your doctor or pharmacist
a
for advice before
using this medicine.
Pregnancy
g
y
ACTIQ should not be u
used during pregnancy
unless you have discussed this with your doctor.
If ACTIQ is used for a long
o time during
pregnancy, there is a risk
r of the new-born child
having withdrawal symptoms
m
which might be
life-threatening if not recognized and treated by
a doctor (see section 4 under Other side effects
with frequency not known).
n
You should not use ACTIQ
C
during child-birth
because fentanyl mayy cause breathing difficulties
in the new-born child..
Breast-feeding
g
Fentanyl can get into breast milk and may cause
side effects in the breast
breast-fed
a fed infant. Do not use
ACTIQ if you are breast-feeding.
s
You should not
start breast-feeding until
n at least 5 days after the
last dose of ACTIQ.
Driving and using machines
a
This medicine may affect
f
you being able to drive
or use any tools or machines.
a
Talk to your doctor
about whether it is safe
f for you to drive, or use
any tools or machiness in the first few hours after
using ACTIQ.
Do not drive or use any
n tools or machines if
you: feel sleepy or dizzy;
z have blurred or double
vision; have difficulty in
i concentrating. It is
important you know how
h
you react to ACTIQ
before driving or using
g any tools or machines.

ACTIQ contains g
glucose and sucrose
(types of sugar)
• If you have been
e told by your doctor that you
cannot tolerate
e or digest some sugars, talk to
your doctor before
f
using ACTIQ.
• Each lozenge contains
o
about 2 grams of
glucose. If you h
have diabetes, you need to
take this into account.
c
• The glucose in the
t lozenge may be harmful to
the teeth. Always make sure you clean your
teeth regularly.

3. How to use ACTIQ
A
Always use this medicine
e
exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist
c if you are not sure.
When you first start using ACTIQ, your doctor will
work with you to ffind the dose that will relieve
your breakthrough
h pain. It is very important that
you use ACTIQ exactly
a
as the doctor tells you.
• Do not change d
doses of ACTIQ or your other
pain medicines o
on your own. Change in dose
must be prescribed
b and checked by your doctor.
• If you are not sure
u about the right dose
or if you have questions
q
about using this
medicine, talk to
t your doctor.
How the medicine
e gets into your body
When you place the
h lozenge in your mouth:
• The lozenge dissolves
s
and the active
substance is released.
l
It takes around
15 minutes for tthis to happen.
• The active substance
s
is absorbed through the
lining of your mouth,
m
into the blood system.
Using the medicine like this allows it to be
absorbed quickly. This means that it relieves your
breakthrough pain
n quickly.
While the right dose
o is being found
You should start to
o feel some relief quickly while
you are using ACTIQ. However, while you and
the doctor are finding
d
out the dose that controls
your breakthrough
h pain, you may not get
enough pain relieff 30 minutes after starting to
use one ACTIQ unit
i (15 minutes from when you
finish using the ACTIQ
C
unit). If this happens, your
doctor may allow you
y to use a second ACTIQ
unit of the same strength
t
for that same episode
of breakthrough pain.
p
Do not use a second
unit unless your doctor
o
tells you to. Never use
more than two units to treat a single episode of
breakthrough pain.
n
While the right dose is being found, you may
need to have more
e than one strength of ACTIQ
units at home. However,
w
, keep
p onlyy the strengths
g
of ACTIQ units you
u need in the house. This is to
stop possible confusion
f
or overdose. Talk to your
pharmacist about how to dispose of any ACTIQ
units you do not need.
n
How many units to
t use
Once the right dose
s has been found with
your doctor, use 1 unit for an episode of
breakthrough pain.
n
Talk to your doctor if your right dose of ACTIQ
does not relieve your
o breakthrough pain for
several episodes o
of breakthrough pain in a row.
Your doctor will decide
e
if your dose needs to
be changed.

ACTIQ PATIENT INFO LFLT GB - 400-33-10321.19

You must tell your doctor straight
h away if you
are using ACTIQ more than four times
t
per
day. This is because he may wish
h to change
your medicine for your persistent (aroundthe-clock) pain. When he has done
n this, when
your persistent pain has been controlled,
o
he may need to change your dose
s of ACTIQ.
For the most effective relief, tell your
y
doctor
about your pain and how ACTIQ is working
for you. This is so that the dose can
c be
changed if needed.
How to use the medicine
Opening the pack
k – each ACTIQ
Q unit is
sealed in its own blister pack.
• Open the pack when you are ready to use
it. Do not open it in advance.
• Hold the blister pack with the
e printed side
away from you.
• Hold the short tab end
of the blister pack.
• Put scissors close to the
end of ACTIQ unit and
cut the long tab end
completely off
(as shown).
• Separate the printed backing from the
blister pack and pull the printed
t backing
completely off the blister pack.
• Remove the ACTIQ unit from the
t blister
pack and put the lozenge in your
y
mouth
straight away.
Using the ACTIQ unit
• Put the lozenge
g
between your cheek
and gum.
• Using the handle,
keep moving the
lozenge round in your
mouth, especially along
your cheeks. Twirl the handle often.
• To get the most effective relief,
e finish the
lozenge completely
in 15 minutes. If you
finish too quickly, you
will swallow more of
the medicine and get
less relief from your
breakthrough pain.
• Do not bite or chew the lozenge.
n This
would mean lower blood levels
e and less
pain relief than when used as directed.
• If for some reason you are nott finishing
the whole lozenge each time you have
breakthrough pain, talk to your
u doctor.
How often you should use ACTIQ
T
Once a dose is found that effectively controls
your pain, do not use more than four ACTIQ
units each day. If you think you might
m
need
to use more than four ACTIQ units per day,
talk to your doctor straight away.
y
How many ACTIQ units you should
o
use
Do not use more than two units to treat any
single episode of breakthrough pain.
p

If you use more ACTIQ than
n you should
The most common side effects
c of using too
much are feeling sleepy, sickk or dizzy.
• If you begin to feel dizzy, sick,
i or very sleepy
before the lozenge is completely
p
dissolved,
take it out of your mouth aand call another
person in your house to help
e you.
A serious side effect of ACTIQ
Q is slow and/or
shallow breathing. This can occur
o
if your dose
of ACTIQ is too high or if you
u take too
much ACTIQ.
• If this happens, get medical help
straight away.
What to do if a child or adult
u accidentally
takes ACTIQ
If you think someone has accidentally
c
taken
ACTIQ, get medical help straight away. Try to
keep the person awake (by calling
c
their name
and shaking their arm or shoulder)
o
until
emergency help arrives.
If you forget to use ACTIQ
If you still have the breakthrough
o
pain, you
may use ACTIQ as your doctor
o has told you.
If the breakthrough pain hass stopped, do not
use ACTIQ until the next breakthrough
a
pain episode.
If you stop using ACTIQ
You should discontinue ACTIQ when you
no longer have any breakthrough
r
pain. You
must however continue to take
a your usual
opioid pain relieving medicine
n to treat your
persistent cancer pain as advised
v
by your
doctor.
d
octor You may experience withdrawal
symptoms similar to the possible side effects
of ACTIQ when discontinuing
g ACTIQ. If you
experience withdrawal symptoms
p
or if you
are concerned about your pain
a relief you
should contact your doctor. Your
Y
doctor will
evaluate if you need medicine
n to reduce or
eliminate the withdrawal symptoms.
m
If you have any further questions
i
on the use of
this medicine, ask your doctor
o or pharmacist.

4. Possible side effects
Like all medicines, this medicine
n can cause side
effects, although not everybody
d gets them. If
you notice any of these, contact
a your doctor.
Serious side effects
• The most serious side effects
e are shallow
breathing, low blood pressure
s
and shock
You or your carer should
d REMOVE the
ACTIQ unit from your mouth
A
mouth,
o
contact
your doctor immediately
y and call for
emergency help if you experience
x
any of
the following serious side
d effects – you
may need urgent medical
a attention:
- Becoming very sleepy or having
h
slow and/
or shallow breathing.
- Difficulty in breathing or d
dizziness, swelling
of the tongue, lip or throatt which may be
early signs of serious allergic
g reaction.
Note to Carers:
If you see that the patient using
s
ACTIQ has
slow and/or shallow breathing
n or if you have
a hard time waking the person
o up, take the
following steps IMMEDIATELY:
L

- Using the handle, remove
m
the ACTIQ unit
from the person’s mouth
o
and keep it out
of the reach of children
r or pets until it is
disposed of.
- CALL FOR EMERGENCY
C HELP.
- While waiting for emergency
e
help, if the
person seems to be breathing
r
slowly,
prompt them to breathe
t every 5-10 seconds.
If you feel excessively dizzy,
i
sleepy or
otherwise ill while using
g ACTIQ, use the
handle to remove the lozenge
o
and dispose
of it according to the instructions
s
given in
this leaflet (see Section 5).
5 Then contact your
doctor for further directions
d
direcctions on using ACTIQ.
ACTIQ
• Contact your doctorr if you experience a
combination of the following symptoms
Nausea, vomiting, loss
s of appetite,
tiredness, weakness, dizziness and low
blood pressure
Together these symptoms
p
may be a sign
of a potentially life-threatening
h
condition
called adrenal insufficiency, a condition in
which the adrenal glands
a
do not produce
enough hormones.
• Prolonged treatmentt with fentanyl
during pregnancy may
a cause withdrawal
symptoms in the newborn
w
which can
be life-threatening (see
s section 2 under
Pregnancy and breast-feeding).
s
Other side effects
Very common: may affect
e more than 1 in
10 people
• V
Vomiting, nausea/feeling
Vomiting
e
sick,
sick
constipation, stomach
c (abdominal) pain
• Asthenia (weakness),, sleepiness,
dizziness, headaches
• Shortness of breath
Common: may affect up
p to 1 in 10 people
• Confusion, anxiety, seeing
e
or hearing
things that are not there
h
(hallucinations),
depression, mood swings
w
• Feeling unwell
• Muscle jerks, feeling o
of dizziness or
“spinning”, loss of consciousness,
n
sedation,
tingling or numbness,, difficulty coordinating
movements, increased
d or altered sensitivity
to touch, convulsions (fits)
• Dry mouth, mouth inflammation,
n
tongue
problems (for example,
p burning sensation
or ulcers), taste alteration
a
• Wind, abdominal bloating,
o
indigestion,
decreased appetite, weight
w
loss
• Blurred
l
d or double
d b vision
s
• Sweating, skin rash, itchy skin
• Difficulty passing urine
n
• Accidental injury (forr example, falls)
Uncommon: may affect up to 1 in 100 people
• Tooth decay, paralysis
i of the gut, mouth
ulcers, gum bleeding
g
• Coma, slurred speech
h
• Abnormal dreams, feeling
e
detached,
abnormal thinking, excessive
e
feeling of
well being
• Widening of blood vessels
e
• Hives

Frequency not known
o
The following side effects
e
have also been
reported with the use
u of ACTIQ lozenge but it
is not known how often
o
they may occur:
• Receding gums, inflammation of the gum,
tooth loss, severe
e breathing problems,
flushing, feeling very warm, diarrhoea,
swelling of arms or legs, fatigue, insomnia,
pyrexia, withdrawal
w syndrome (may
manifest by the o
occurrence of the following
side effects nausea, vomiting, diarrhoea,
anxiety, chills, tremor,
e
and sweating).
• Lack of sex hormones (androgen deficiency)

6. Contents of the pack and
other information
o

Whilst using ACTIQ you may experience
irritation, pain and ulcer at the application
site and gum bleeding.
d

L
Lozenge:
Dextrates hydrated
r
(equivalent to
approximately 2 grams of glucose).
Citric acid, disodium
o
phosphate, artificial
berry flavour (maltodextrin,
m
propylene
glycol, artificial flavours, and triethylcitrate),
magnesium stearate.
e

Reporting of side effects
e
If you get any side effects,
e
talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly
d
via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
m
By reporting side effects
f
you can help
provide more information
m
on the safety of
this medicine.

5. How to store ACTIQ
The pain-relieving medicine in ACTIQ is very
strong and could b
be life-threatening if taken
accidentally by a child.
h
ACTIQ must be kept
out of the sight and
d reach of children.
• Do not use ACTIQ after the expiry date
shown on the package
a
label and the
carton. The expiry date refers to the last
ccarton
day of that month.
t
• Do not store above
o 30 °C.
• Always keep ACTIQ
T in its blister package
until you are ready
a to use it. Do not use if
the blister package
a has been damaged or
opened before you
y are ready to use it.
• If you are no longer
n
using ACTIQ, or if you
have unused ACTIQ
C
units in your home,
return all unused
d packs to your doctor
or pharmacist.
How to dispose off ACTIQ after use
Partially used ACTIQ
Q lozenge may contain
enough medicine to
o be harmful or lifethreatening to a child.
Even if there is a little
t or no medicine left on
the handle, the handle
n
itself must be properly
disposed of as follows:
o
• If the medicine is totally gone, throw the
handle away in a waste container that is
out off reach
h off cchildren
hild
and
d pets.
• If any medicine remains
r
on the handle,
place the lozenge
g under hot running
water to dissolve
e the remainder and
then throw the handle
h
away in a waste
container that iss out of the reach of
children and pets.
t
• If you do not finish the entire lozenge
and you cannot immediately dissolve the
remaining medicine,
c
put the lozenge out
of the reach of children
c
and pets until
such a time as you
o can dispose of the
partially used lozenge
z
as instructed above.
• Do not flush partially
r
used lozenge,
handles, or the blister
b
packaging down
the toilet.

What ACTIQ contains:
• The active substance
s
is fentanyl.
Each individual
d
lozenge contains either:
• 200 micrograms
r
fentanyl (as citrate)
• 400 micrograms
r
fentanyl (as citrate)
• 600 micrograms
r
fentanyl (as citrate)
• 800 micrograms
r
fentanyl (as citrate)
• 1,200 micrograms
o
fentanyl (as citrate)
• 1,600 micrograms
o
fentanyl (as citrate)
• The other ingredients
n
are:

Edible glue used
d to attach the lozenge to
the handle
Modified maize
e based food starch E 1450,
confectioner’s sugar (as sucrose and maize
starch), water.
Imprinting ink
Water, de-waxed
e white shellac, propylene
glycol, blue synthetic
n
coal tar dye (E 133),
Ammonium hydroxide
y
(E 527) for
pH adjustmentt
What ACTIQ looks
o
like and contents of
the pack
ACTIQ consistss off a white to off-white
fff
solid
lozenge attached
h to a handle for oromucosal
application. The
h lozenge may appear slightly
mottled on storage.
o
This is due to slight
changes in the
e flavouring agent of the
product and does
o not affect how the product
works in any way.
w
ACTIQ exists in
n 6 different strengths: 200,
400, 600, 800, 1,200
1
and 1,600 micrograms.
The dosage strength
r
is marked on the
white lozenge,, on the handle, on the blister
package and on
o the carton to ensure that you
are using the right medicine. Each strength is
associated with
h a specific colour.
ACTIQ lozenges
e are supplied in individual
blister packages.
e
Blister packages
e are supplied in cartons of 3,
6, 15 or 30 individual
i
ACTIQ units.
Not all pack size
z may be marketed.
Marketing Authorisation Holder
Teva Pharma B.V.
B
Swensweg 5
2031 GA Haarlem
e
The Netherlands
d
Manufacturerr
Teva Pharmaceuticals
e
Europe B.V.
Swensweg 5
2031 GA HAARLEM
R
Netherlands
This leaflet was
a last revised in
05/2017

H49282
EBNUK1005b

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0082823
Valid For 7 Days from 18-May-2017

Version 7.2

Approved
Page 2 of 3

18-May-2017

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