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Active substance(s): FENTANYL CITRATE

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ACTIQ® 1600 micrograms compressed lozenge
with integral oromucosal applicator

Using other medicines

(fentanyl citrate)
The name of your medicine is Actiq 1600 micrograms compressed lozenge with integral oromucosal
applicator however it will be known as Actiq throughout this leaflet. This product is available in other

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Actiq is and what it is used for
2. Before you use Actiq
3. How to use Actiq
4. Possible side effects
5. How to store Actiq
6. Further information

Actiq contains the active ingredient fentanyl which is
a strong pain-relieving medicine known as an
The Actiq unit comes as a lozenge on a stick.
• It is used to treat breakthrough pain in adult
patients with cancer who are already taking other
opioid pain medicines for their persistent (aroundthe-clock) cancer pain. Breakthrough pain is
additional sudden pain that occurs suddenly in
spite of your having taken your usual opioid painrelieving medicines.
• Do not use Actiq if you have not been having a
prescribed opioid medicine for persistent (aroundthe-clock) pain regularly every day, for at least a
week. This is because if you are not having such
a medicine, using Actiq may increase the chances
of your breathing becoming dangerously slow or
shallow, or even stopping.
• Do not use Actiq to treat pain from injuries,
surgery, headaches or migraines.

• You are over 65 years old - you may need a lower
dose and any dose increase will be reviewed very
carefully by your doctor.
• You take antidepressants or antipsychotics,
please refer to section using other medicines

Do not use Actiq if:
• You are not regularly using a prescribed opioid
medicine (e.g codeine, fentanyl, hydromorphone,
morphine, oxycodone, pethidine), every day on a
regular schedule, for at least a week, to control
your persistent pain. If you have not been using
these medicines, you must not use Actiq,
because it may increase the risk that breathing
could become dangerously slow and/or shallow,
or even stop
• You are allergic (hypersensitive) to fentanyl or any
of the other ingredients of Actiq (listed in Section
• You are currently taking monoamineoxidase
inhibitor (MAOI) medicines for severe depression
(or have taken them in the past 2 weeks).
• You have severe breathing problems or severe
lung problems where you have an obstruction.
• You suffer from short-term pain other than
breakthrough pain
Do not use Actiq if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist
before using Actiq.
Take special care with Actiq
Keep using the opioid pain medicine you take for
your persistent (around-the-clock) cancer pain
during your Actiq treatment.
Actiq is not recommended for children below 16
years of age.
If you have any of the following talk to your doctor
or pharmacist before starting Actiq:
• Your other opioid pain medicine for your
persistent (around-the-clock) cancer pain is not
stabilised yet.
• You have any illness that affects your breathing
(such as asthma, wheezing, or shortness of
• You have a head injury or have had any loss of
• You have problems with your heart especially
slow heart rate.
• You have liver or kidney problems – this will affect
how your system breaks down the medicine.
• You have low blood pressure due to a low amount
of fluid in your circulation.
• You have diabetes.

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 past.
If you still have some of these fentanyl treatments
at home, check with your pharmacist how to
dispose of them.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
This includes medicines obtained without a
prescription, including herbal medicines. In
particular, tell your doctor or pharmacist if you are
taking any of the following medicines:
• Any medicines which might make you sleepy such as sleeping pills, medicines to treat anxiety,
some medicines for allergic reaction
(antihistamines), or tranquillisers.
• Some muscle relaxants - such as baclofen,
• Any medicines that might affect how your body
breaks down Actiq - such as ritonavir or other
medicines that help control HIV infection, or other
so-called ‘CYP3A4 inhibitors’ such as
ketoconazole, itraconazole, or fluconazole (used
for fungal infections) and troleandomycin,
clarithromycin, or erythromycin (medicines for
bacterial infections) and so-called 'CYP3A4
inducers' such as rifampicin or rifabutin
(medicines for bacterial infections),
carbamazepine, Phenobarbital or phenytoin
(medicines used to treat convulsions/fits).
• Any medicine which may reduce or reverse the
effect of Actiq – such as naloxone, pentazocine,
buprenorphine. These may lead to withdrawal
• If you are due to have surgery requiring a general
• The risk of side effects increases if you are taking
medicines such as certain antidepressants or
antipsychotics. Actiq may interact with these
medicines and you may experience mental status
changes (e.g. agitation, hallucinations, coma),
and other effects such as body temperature
above 38°C, increase in heart rate, unstable blood
pressure, and exaggeration of reflexes, muscular
rigidity, lack of coordination and/or gastrointestinal
symptoms (e.g nausea, vomiting, diarrhoea). Your
doctor will tell you whether Actiq is suitable for
Using Actiq with food or drink
• Actiq may be used before or after meals.
However do not use during meals.
• You may drink some water before using Actiq to
help moisten your mouth. However, do not drink
or eat anything while using Actiq.
• Do not drink grapefruit juice while taking Actiq.
This is because it may affect the way your body
breaks down Actiq.
• Do not drink alcohol while using Actiq. It can
increase the chances of getting dangerous side

Pregnancy and breast-feeding


You should not use Actiq during pregnancy unless
you have discussed this with your doctor. You
should not use Actiq during child-birth because
fentanyl may cause breathing difficulties in the newborn child. There is also a risk of the new-born
child having withdrawal symptoms of the drug if
Actiq is used for a long time during pregnancy.

When you first start using Actiq, your doctor will
work with you to find the dose that will relieve your
breakthrough pain. It is very important that you use
Actiq exactly as the doctor tells you.
• Do not change doses of Actiq or your other pain
medicines on your own. Change in dose must be
prescribed and checked by your doctor.
• If you are not sure about the right dose or if you
have questions about taking this medicine, talk to
your doctor.

Fentanyl can get into breast milk and may cause
side effects in the breast-fed infant. Do not use
Actiq if you are breast-feeding. You should not start
breast-feeding within 48 hours after the last dose of
Ask your doctor or pharmacist for advice before
taking any medicine, if you are pregnant or breastfeeding.
Driving and using machines
This medicine may affect you being able to drive or
use any tools or machines. Talk to your doctor
about whether it is safe for you to drive, or use any
tools or machines in the first few hours after taking
Do not drive or use any tools or machines if you:
feel sleepy or dizzy; have blurred or double vision;
have difficulty in concentrating.
It is important you know how you react to Actiq
before driving or using any tools or machines.
The medicine can affect 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 you.
• It is an offence to drive if this medicine affects
your ability to drive.
However, you would not be committing an offence
• The medicine has been prescribed to treat a
medical or dental problem and
• You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
• It was not affecting 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.
Important information about some of the
ingredients of Actiq
• Actiq contains glucose and sucrose (types of
sugar). If you have been told by your doctor that
you cannot tolerate or digest some sugars, talk to
your doctor before using Actiq.
• Each lozenge contains about 2 grams of glucose.
If you have diabetes, you need to take this into
• The glucose in the lozenge may be harmful to the
teeth. Always make sure you clean your teeth

How the medicine gets into your body
When you place the lozenge in your mouth:
• The lozenge dissolves and the active ingredient is
released. It takes around 15 minutes for this to
• The active ingredient is absorbed through the
lining of your mouth, into the blood system.
Taking the medicine like this allows it to be
absorbed quickly. This means that it relieves your
breakthrough pain quickly.
While the right dose is being found
You should start to feel some relief quickly while
you are taking Actiq. However, while you and the
doctor are finding out the dose that controls your
breakthrough pain, you may not get enough pain
relief 30 minutes after starting to use one Actiq unit
(15 minutes from 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 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 of breakthrough pain.
While the right dose is being found, you may need
to have more than one strength of Actiq units at
home. However, keep only the strengths of Actiq
units you need in the house. This is to stop possible
confusion or overdose. Talk to your pharmacist
about how to dispose of any Actiq units you do not
How many units to use
Once the right dose has been found with your
doctor, use 1 unit for an episode of breakthrough
Talk to your doctor if your right dose of Actiq does
not relieve your breakthrough pain for several
episodes of breakthrough pain in a row. Your doctor
will decide if your dose needs to be changed.
You must tell your doctor straight away if you are
using Actiq more than four times per day. This is
because he may wish to change your medicine for
your persistent (around-the-clock) pain. When he
has done this, when your persistent pain has been
controlled, he may need to change your dose of
Actiq. For the most effective relief, tell your doctor
about your pain and how Actiq is working for you.
This is so that the dose can be changed if needed.
How to use the medicine
Opening the pack – 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.

Please turn over

• Hold the blister pack with the 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
backing completely off the
blister pack.
• Remove the Actiq unit from the blister pack and
put the lozenge in your mouth straight away.
Using the Actiq unit
• Put the lozenge 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, 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, suck or chew the lozenge. This would
mean lower blood levels and less pain relief than
when used as directed.
• If for some reason you are not finishing the whole
lozenge each time you have breakthrough pain,
talk to your doctor.
How often you should use Actiq
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 need to use more than
four Actiq units per day, talk to your doctor straight
How many Actiq units you should use
Do not use more than two units to treat any single
episode of breakthrough pain.
If you use more Actiq than you should
The most common side effects of using too much
are feeling sleepy, sick or dizzy.
• If you begin to feel dizzy, sick, or very sleepy
before the lozenge is completely dissolved, take it
out of your mouth and call another person in your
house to help you.
A serious side effect of Actiq is slow and/or shallow
breathing. This can occur if your dose of Actiq is too
high or if you take too much Actiq.
• If this happens, get medical help straight away.
What to do if a child or adult accidentally takes
If you think someone has accidentally taken Actiq,
get medical help straight away. Try to keep the
person awake (by calling their name and shaking
their arm or shoulder) until emergency help arrives.
If you forget to use Actiq
If you still have the breakthrough pain, you may use
Actiq as your doctor has told you. If the
breakthrough pain has stopped, do not use Actiq
until the next breakthrough pain episode.

If you stop using Actiq
Do not stop using Actiq without talking to your
doctor. There are usually no noticeable effects if
you stop using Actiq. Keep taking your usual opioid
medicine to treat your persistent (around-the-clock)
pain as instructed by your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Like all medicines, Actiq can have side effects,
although not everybody gets them. If you notice any
of these, contact your doctor. The most serious
side effects are shallow breathing, low blood
pressure and shock.
You or your carer should REMOVE the Actiq
unit from your mouth, contact your doctor
immediately and call for emergency help if you
experience any of the following serious side
effects - you may need urgent medical attention:
• Becoming very sleepy or having slow and/or
shallow breathing.
• Difficulty in breathing or dizziness, swelling of the
tongue, lip or throat which may be early signs of
serious allergic reaction.
• Note to Carers:
If you see that the patient taking Actiq has slow
and/or shallow breathing or if you have a hard
time waking the person up, take the following
- Using the handle, remove the Actiq unit from the
person’s mouth and keep it out of the reach of
children or pets until it is disposed of.
- While waiting for emergency help, if the person
seems to be breathing slowly, prompt them to
breathe every 5-10 seconds.
If you feel excessively dizzy, sleepy or otherwise ill
while using Actiq, use the handle to remove the
lozenge and dispose of it according to the
instructions given in this leaflet (see Section 5).
Then 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) pain
• Asthenia (weakness), sleepiness, dizziness,
• Shortness of breath
Common side effects (affecting 1 to 10 people in
• Confusion, anxiety, seeing or hearing things that
are not there (hallucinations), depression, mood
• Feeling unwell
• Fit, muscle jerks, feeling of dizziness or
"spinning", loss of consciousness, sedation,
tingling or numbness, difficulty coordinating
movements, increased or altered sensitivity to
touch, convulsions (fits)
• Dry mouth, mouth inflammation, tongue problems
(for example, burning sensation or ulcers), taste
• Wind, abdominal bloating, indigestion, decreased
appetite, weight loss
• Blurred or double vision
• Sweating, skin rash, itchy skin
• Difficulty passing urine

• Accidental injury (for example, falls)
• Malaise
Uncommon side effects (affecting 1 to 10 people
in 1000)
• Tooth decay, paralysis of the gut, mouth ulcers,
gum bleeding
• Coma, slurred speech
• Abnormal dreams, feeling detached, abnormal
thinking, excessive feeling of well being
• Widening of blood vessels
• Hives
The following side effects have also been reported
with the use of Actiq but it is not known how often
they may occur:
• Receding gums, inflammation of the gum, tooth
loss, severe breathing problems, flushing, feeling
very warm, diarrhoea, swelling of arms or legs,
Whilst using Actiq you may experience irritation,
pain and ulcer at the application site and gum
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.

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

What Actiq contains:
Each Actiq 1600 micrograms compressed lozenge
with integral oromucosal applicator contains 1600
micrograms fentanyl (as citrate).
The other ingredients are:
Dextrates hydrated (equivalent to approximately 2
grams of glucose). Citric acid, disodium phosphate,
artificial berry flavour (maltodextrin, propylene
glycol, artificial flavours, and triethylcitrate),
magnesium stearate.
Edible glue used to attach the lozenge to the handle
Modified maize based food starch, confectioner’s
sugar (as sucrose and maize starch), water.
Imprinting ink
Water, dewaxed white shellac, propylene glycol,
blue synthetic coal tar dye (E133)
What Actiq looks like and contents of the pack
Actiq 1600 micrograms compressed lozenge with
integral oromucosal applicator are white to off-white
solid lozenge attached to a handle for oromucosal
application. The lozenge is marked with 'ACTIQ
1600' in blue and the handle is marked with a dark
red band and 'ACTIQ® 1600µg' in black print.
The lozenge may appear slightly mottled on
storage. This is due to slight changes in the
flavouring agent of the product and does not affect
how the product works in any way.
Actiq is supplied in individual blister packages.
Blister packages are supplied in cartons of 3 or 30
individual Actiq units.
Actiq is manufactured by Cephalon France, 5 rue
Charles Martigny, 94700 Maisons-Alfort, France or
Teva Pharmaceuticals B.V Europe, Swensweg 5,
2031 GA Haarlem, The Netherlands and is
procured from within the EU and repackaged in the
UK by the Product Licence holder: CD Pharma Ltd,
Unit 3, Manor Point, Manor Way, Borehamwood,
Herts WD6 1EU.
PL 20492/0474

Actiq 1600 micrograms
compressed lozenge with integral
oromucosal applicator


Date of preparation: 18 September 2015
Actiq is a registered trademark of Cephalon, Inc. or
one of its affiliates.

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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.