Skip to Content

UK Edition. Click here for US version.

ACTIQ 600 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance(s): FENTANYL / FENTANYL CITRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
ACTIQ PATIENT INFO LFLT GB - 400-33-10321.18

400-33-10321.18

PACKAGE LEAFLET:
E INFORMATION FOR THE USER

TEXT FREE AREA

Profile Key

ACTIQ® 200 micrograms compressed
o
lozenge with integral oromucosal
o applicator
ACTIQ® 400 micrograms compressed
o
lozenge with integral oromucosal
o applicator
ACTIQ® 600 micrograms compressed
o
lozenge with integral oromucosal
o applicator
ACTIQ® 800 micrograms compressed
o
lozenge with integral oromucosal
o applicator
ACTIQ® 1,200 micrograms compressed
c
lozenge with integral oromucosal
u
applicator
ACTIQ® 1,600 micrograms compressed
c
lozenge with integral oromucosal
u
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 nee
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
u
for
2. What you need to know before
r 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
h pain in adult
patients with cancer who are aalready taking
other opioid pain medicines for
o their persistent
(around-the-clock) cancer pain.
n Breakthrough
pain is additional sudden pain that occurs
suddenly in spite of your having
n taken your
usual opioid pain-relieving medicines.
e
• Do not use ACTIQ if you have not been having
a prescribed opioid medicine for persistent
(around-the-clock) pain regularly
a every day,
for at least a week. This is because
c
if you are
not having such a medicine, using
u
ACTIQ
may increase the chances of your
y
breathing
becoming dangerously slow or
o shallow, or
even stopping.
• Do not use ACTIQ to treat pain from injuries,
surgery, headaches or migraines.
n

2. What
2
Wh t you need
d to
t know
k w before
b f
you
use ACTIQ
Do not use ACTIQ:
• if you are not regularly using a prescribed
opioid medicine (e.g. codeine,, fentanyl,
hydromorphone, morphine, oxycodone,
x
pethidine), every day on a regular
u schedule, for
at least a week, to control yourr persistent pain.
If you have not been using these
e medicines
you must not use ACTIQ, because it may
increase the risk that breathing
g 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 m
monoamineoxidase inhibitor (MAOI) medicines for severe
depression (or have taken tthem in the past
2 weeks)
weeks).
• if you have severe breathing
g problems or severe
lung problems where you h
have an obstruction.
• if you suffer from short-term
r pain other than
breakthrough 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 take antidepressants or
o antipsychotics,
please refer to section using
n other medicines.
ACTIQ contains approximatelyy 2 grams of sugar
and a frequent consumption exposes you to an
increase risk of dental decay that
t
may be serious.
TThus, it is important to continue
n to take good
care of your mouth and teeth
h during treatment
with ACTIQ. If you present such
c serious local
effects consult your doctor.
Children and adolescents
ACTIQ is not recommended for
o children below
16 years of age.
Other medicines and ACTIQ
Q
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
h
pain in
the past. If you still have some
o
of these
fentanyl treatments at home,
m check with your
pharmacist how to dispose
e of them.

Tell your doctor or pharmacist before using
ACTIQ if you are taking orr have recently taken
or might takeany other medicines. 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.
• Anyy medicines that might
g affect how your
y
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, 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..
If you are due to have surgery
g
requiring a
general anaesthetic. The risk
r of side effects
increases if you are taking
g medicines such as
certain antidepressants orr antipsychotics. ACTIQ
may interact with these medicines
m
and you may
experience mental status changes (e.g. agitation,
hallucinations, coma), and
d other effects such as
body temperature above 38 °C, increase in heart
rate, unstable blood pressure,
s
and exaggeration
of reflexes, muscular rigidity, lack of coordination
and/or gastrointestinal symptoms (e.g nausea,
vomiting, diarrhoea). Yourr doctor will tell you
whether ACTIQ is suitable
e for you.
ACTIQ with food, drink and
a alcohol
• ACTIQ may be used before
e
or after meals.
However do not use during
u
meals.
• You may drink some water
a before using ACTIQ
to help moisten your m
mouth. However, do not
drink or eat anything w
while using ACTIQ.
• Do not
ot d
drink g
grapefruit
ape u t ju
juice
ce while
e ta
taking
g
ACTIQ. This is because it may affect the way
your body breaks down
n ACTIQ.
• Do not drink alcohol while
w
using ACTIQ. It can
increase the chances of
o getting dangerous
side effects.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
e
think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist
a
for advice before
taking this medicine.
You should not use ACTIQ
Q during child-birth
because fentanyl may cause
u breathing difficulties
in the new-born child. There
e is also a risk of the
new-born child having withdrawal symptoms
of the medicine if ACTIQ is used for a long time
during pregnancy.

Fentanyl can get into breast milk and may cause
side effects in the breast-fed
a
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.

• The active substance
s
is absorbed through the
lining of your mouth,
m
into the blood system.

Ask your doctor or pharmacist
a
for advice before
taking any medicine, if you are pregnant or
breast-feeding.

While the right dose
o is being found
You should start to
o feel some relief quickly while
you are taking ACTIQ.
T However, while you and the
doctor are finding out the dose that controls your
breakthrough pain,
n you may not get enough pain
relief 30 minutes after
f starting to use one ACTIQ
unit (15 minutes from
o when you finish using the
ACTIQ unit). If this happens, your doctor may
allow you to use a second ACTIQ unit of the same
strength for that same
a
episode of breakthrough
pain. Do not use a second unit unless your doctor
tells you to. Never use more than two units to
treat a single episode
o of breakthrough pain.
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 only the strengths
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

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
taking 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.
The medicine can affect
e your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until
you know how it affects
f
you.
• It is an offence to drive
d
if this medicine affects
your ability to drive.
e
However, you would n
not be committing an
offence if:
• The medicine has b
been prescribed to treat a
medical or dental problem
p
and
• You have taken it according
a
to the
instructions given by
b the prescriber or in the
information provided with the medicine and
• It was not affecting
g your ability to drive safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.
ACTIQ contains glucose
o and sucrose
(types of sugar)
• If you have been told
o by your doctor that you
cannot tolerate or digest
d
some sugars, talk to
your doctor before using ACTIQ.
• Each lozenge contains
a about 2 grams of
glucose. If you have
e diabetes, you need to
take this into account.
u
• The glucose in the lozenge may be harmful to
the teeth. Always make
m
sure you clean your
teeth regularly.

3. How to use ACTIQ
T
Always use this medicine
c
exactly as your doctor
or pharmacist has told
d you. Check with your
doctor or pharmacist if
i you are not sure
sure.
When you first start using
s
ACTIQ, your doctor will
work with you to find the dose that will relieve
your breakthrough pain.
a It is very important that
you use ACTIQ exactlyy as the doctor tells you.
• Do not change doses
e of ACTIQ or your other
pain medicines on yyour own. Change in dose
must be prescribed and checked by your doctor.
• If you are not sure about
a
the right dose
or if you have questions
s
about taking this
medicine, talk to your
o doctor.
How the medicine gets
e into your body
When you place the lozenge
o
in your mouth:
• The lozenge dissolves
v and the active
substance is released.
e It takes around
15 minutes for this to happen.

Version
Valid For 7 Days from 24-Oct-2016

Page

Taking the medicine
n like this allows it to be
absorbed quickly. This means that it relieves your
breakthrough pain
n quickly.

How many units to
t use
Once the right dose
s has been found with your
doctor, use 1 unit ffor 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
y
dose needs to
be changed.
You must tell yourr doctor straight away if you are
using ACTIQ more than four times per day. This
is because he mayy wish to change your medicine
for your persistentt (around-the-clock) pain. When
he has done this, w
when your persistent pain has
been controlled, h
he may need to change your
dose of ACTIQ. Forr the most effective relief, tell
your doctor aboutt your pain and how ACTIQ is
working for you. This
T is so that the dose can be
changed if needed.
d
How to use the medicine
m
Opening the pack
k – each ACTIQ 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 blisterr pack with the printed side
away from you..
• Hold the short ttab end of the blister pack.
• Put scissors close
l s to the
h
end of ACTIQ unit and
cut the long tab
b end
completely off
(as shown).
• Separate the printed
r
backing from the
h blister
pack and pull the
h printed backing completely
off the blister pack.
p
• Remove the ACTIQ
C
unit from the blister
pack and put the
h lozenge in your mouth
straight away.

ACTIQ PATIENT INFO LFLT GB - 400-33-10321.18

Using the ACTIQ unit
• Put the lozenge between your
u 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
y finish too
quickly, you will
swallow more of the
medicine and get
less relief from your
breakthrough pain.
• Do not bite, suck or chew the llozenge. This
would mean lower blood levels and less
pain relief than when used as d
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
i l episode
i d off breakthrough
b kth
h pain.
p i
If you use more ACTIQ than you should
The most common side effects of
o using too
much are feeling sleepy, sick or dizzy.
d
• If you begin to feel dizzy, sick, o
or very sleepy
before the lozenge is completely
e dissolved,
take it out of your mouth and ccall another
person in your house to help yyou.
A serious side effect of ACTIQ is sslow and/or
shallow breathing. This can occur
u if your
dose of ACTIQ is too high or if you
o take too
much ACTIQ.
• If this happens, get medical help
straight away.
What to do if a child or adult accidentally
c
takes ACTIQ
If you think someone has accidentally
n
taken
ACTIQ, get medical help straight away. Try to
keep the person awake (by calling
n their name
and shaking their arm or shoulder)
e until
emergency help arrives.
If you forget to use ACTIQ
If you still have the breakthrough
h pain, you
may use ACTIQ as your doctor has
a told you.
If the breakthrough pain has stopped,
p
do not
use ACTIQ until the next breakthrough
h
pain episode.
If you stop using ACTIQ
You should discontinue ACTIQ when
w
you
no longer have any breakthrough pain. You
must however continue to take your
y
usual
opioid pain relieving medicine to
o treat your
persistent cancer pain as advised
d by your
doctor. You may experience withdrawal
h
symptoms similar to the possible
e side effects
of ACTIQ when discontinuing ACTIQ.
C

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

If you experience withdrawal symptoms or if
you are concerned about your
u pain 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 can have side
effects, although not everybody
o gets them. If
you notice any of these, contact
a your doctor.
The most serious side effects are shallow
breathing,
b
reathing, low blood pressu
pressure
re
e and shock.
You or your carer should REMOVE the
ACTIQ unit from your mouth,
t contact
your doctor immediately and call for
emergency help if you experience
e
any of
the following serious side effects
e
– you
may need urgent medical attention:
a
• 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 taking 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
e the ACTIQ unit
from the person’s mouth and keep it out
of the reach of children orr pets until it is
disposed
d
isposed of.
of
• CALL FOR EMERGENCY HELP.
E
• While waiting for emergency
n help, if the
person seems to be breathing
h slowly,
prompt them to breathe every
v 5-10 seconds.
If you feel excessively dizzy, sleepy
s
or
otherwise ill while using ACTIQ,
T use the
handle to remove the lozenge
g and dispose
of it according to the instructions given in
this leaflet (see Section 5). Then
h contact your
doctor for further directions on using ACTIQ.
Very common side effects ((affecting more
than 1 in 10 people)
• Vomiting, nausea/feeling sick,
constipation, stomach (abdominal)
b
pain
• Asthenia (weakness), sleepiness,
dizziness, headaches
• Shortness of breath
Common side effects (affecting
i 1 to 10 people
in
n 100)
• Confusion, anxiety, seeing
g or hearing
things that are not there (hallucinations),
(
depression, mood swingss
• Feeling unwell
• Muscle jerks, feeling of dizziness
z
or
“spinning”, loss of consciousness,
u
sedation, tingling or numbness,
b
difficulty
coordinating movements, increased or
altered sensitivity to touch,
h convulsions (fits)
• Dry mouth, mouth inflammation,
m
tongue
problems (for example, burning
u
sensation
or ulcers), taste alteration
• Wind, abdominal bloating,
g indigestion,
decreased appetite, weight
h loss
• Blurred or double vision
• Sweating, skin rash, itchy skin

REG0082823
Valid For 7 Days from 24-Oct-2016

• Difficulty passing urine
n
• Accidental injury (forr example, falls)
Uncommon side effects
t (affecting 1 to
10 people in 1,000)
• 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
The following side effects have also been
reported with the use off ACTIQ lozenge but it
is not known how often they may occur:
• Receding gums, inflammation
m
of the gum,
tooth loss, severe breathing
e
problems,
flushing, feeling very warm, diarrhoea,
swelling of arms or legs, fatigue, insomnia,
pyrexia, withdrawal syndrome
y
(may
manifest by the occurrence
r
of the following
side effects nausea, vomiting,
o
diarrhoea,
anxiety, chills, tremor,
r and sweating).
Whilst using ACTIQ you may experience
irritation, pain and ulcerr at the application
site and gum bleeding.
Reporting of side effects
c
If you get any side effects,
t talk to your doctor
or pharmacist. This includes
u
any possible side
effects not listed in this leaflet. You can also
report side effects directly
t via the Yellow Card
SScheme at: www.mhra.gov.uk/yellowcard
www mhra gov
g uk/yellowcard
By reporting side effectss you can help
provide more information
o on the safety of
this medicine.

5. How to store ACTIQ
T
The pain-relieving medicine
d
in ACTIQ is very
strong and could be life-threatening
e
if taken
accidentally by a child. ACTIQ must be kept
out of the sight and reach
a of children.
• Do not use ACTIQ after
t the expiry date
shown on the package
g label and the
carton. The expiry date
a refers to the last
day of that month.
• Do not store above 30
3 °C.
• Always keep ACTIQ in
n its blister package
until you are ready to
o use it. Do not use if
the blister package has
h been damaged or
opened before you are
a ready to use it.
• If you are no longer using
u
ACTIQ, or if you
have unused ACTIQ units
u
in your home,
home
return all unused packs
c to your doctor
or pharmacist.
How to dispose of ACTIQ
T after use
Partially used ACTIQ lozenge
e
may contain
enough medicine to be harmful or lifethreatening to a child.
Even if there is a little orr no medicine left on
the handle, the handle itself must be properly
disposed of as follows:
• If the medicine is totally
a gone, throw the
handle away in a waste
s container that is
out of reach of children
r and 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
p
g g down
the toilet.

6. Contents of the pack and other
information

Marketing Authorisation Holder
and Manufacturer
t
Marketing Authorisation
h
Holder
Teva Pharma B.V.
B
Swensweg 5
2031 GA Haarlem
e
The Netherlands
d
Manufacturer
Teva Pharmaceuticals
e
Europe B.V.
Swensweg 5
2031 GA HAARLEM
R
Netherlands
This leaflet was
a last approved in
September 2015
0

What ACTIQ contains:
a
• The active substance
t
is fentanyl.
Each individual llozenge contains either:
• 200 microgramss fentanyl (as citrate)
• 400 microgramss fentanyl (as citrate)
• 600 microgramss fentanyl (as citrate)
• 800 microgramss fentanyl (as citrate)
• 1,200 micrograms
m fentanyl (as citrate)
• 1,600 micrograms
m fentanyl (as citrate)
• The other ingredients
d
are:
Lozenge:
Dextrates hydrated (equivalent to
approximately 2 grams
a of glucose).
Citric acid, disodium
m phosphate, artificial
berry flavour (maltodextrin,
o
propylene
glycol, artificial flavours
glycol
flavours, and triethylcitrate),
triethylcitrate)
magnesium stearate.
t
Edible glue used to attach
a
the lozenge to
the handle
Modified maize based
s food starch E 1450,
confectioner’s sugar
a (as sucrose and maize
starch), water.
Imprinting ink
Water, de-waxed white
w
shellac, propylene
glycol, blue synthetic
t coal tar dye E 133
What ACTIQ lookss like and contents of
the pack
ACTIQ consists of a white to off-white solid
lozenge attached to
o a handle for oromucosal
application. The lozenge
z
may appear slightly
mottled on storage.
e This is due to slight
changes in the flavouring
o
agent of the
product and does n
not affect how the product
works in any way.
ACTIQ exists in 6 different strengths: 200,
400, 600, 800, 1,200
0 and 1,600 micrograms.
The dosage strength
t is marked on the
white lozenge, on the
t handle, on the blister
package and on the
e carton to ensure that you
are taking the rightt medicine. Each strength
is associated with a specific colour.
ACTIQ lozenges are
e supplied in individual
blister packages.
Blister packages are
e supplied in cartons of 3,
6, 15 or 30 individual ACTIQ units.
Not all pack size may
a be marketed.

H46147
46414-F

Version 6.2

Approved
Page 2 of 3

Expand view ⇕

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.

Hide