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ACTIQ 200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance(s): FENTANYL / FENTANYL CITRATE / 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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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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