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ACTIQ 200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance(s): FENTANYL / FENTANYL CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIQ® 200 micrograms compressed lozenge with integral oromucosal applicator
ACTIQ® 400 micrograms compressed lozenge with integral oromucosal applicator
ACTIQ® 600 micrograms compressed lozenge with integral oromucosal applicator
ACTIQ® 800 micrograms compressed lozenge with integral oromucosal applicator
ACTIQ® 1200 micrograms compressed lozenge with integral oromucosal applicator
(fentanyl citrate)
Your medicine is called one of the above, however it will be known as Actiq throughout this leaflet. This
product is available in other strengths.



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.
Actiq contains approximately 2 grams of sugar and
a frequent consumption exposes you to an increase
risk of dental decay that may be serious. Thus, it is
important to continue to take good care of your
mouth and teeth during treatment with Actiq. If you
present such serious local effects consult your
doctor.

Other medicines and Actiq

What is in this leaflet
1. What Actiq is and what it is used for
2. What you need to know before you use Actiq
3. How to use Actiq
4. Possible side effects
5. How to store Actiq
6. Contents of the pack and other information

1. WHAT ACTIQ IS AND WHAT IT IS USED
FOR
Actiq contains the active substance fentanyl which
is a strong pain-relieving medicine known as an
opioid.
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
(around-the-clock) cancer pain. Breakthrough
pain is additional sudden pain that occurs
suddenly in spite of your having taken your
usual opioid pain-relieving medicines.
 Do not use Actiq if you have not been having a
prescribed opioid medicine for persistent
(around-the-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.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE ACTIQ
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.
 if you are allergic to fentanyl or any of the other
ingredients of this medicine (listed in Section 6).
 if you are currently taking monoamineoxidase
inhibitor (MAOI) medicines for severe
depression (or have taken them in the past 2
weeks).
 if you have severe breathing problems or severe
lung problems where you have an obstruction.
 if 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.
Warning and precautions
Keep using the opioid pain medicine you take for
your persistent (around-the-clock) cancer pain
during your Actiq treatment.
Talk to your doctor or pharmacist before
using Actiq if:
 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
breath).
 You have a head injury or have had any loss of
consciousness.
 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.

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 account.
 The glucose in the lozenge may be harmful to
the teeth. Always make sure you clean your
teeth regularly.

3. HOW TO USE ACTIQ
Children and adolescents
Actiq is not recommended for children below
16 years of age.

Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
 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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness 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.

Actiq with food, drink and alcohol
 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
effects.

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.
Tell your doctor or pharmacist before using Actiq if
you are taking or have recently taken or might take
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,
diazepam.
 Any medicines that might affect how your body
breaks down Actiq - such as ritonavir or other
medicines that help control HIV infection, 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 rifampin or rifabutin
(medicines for bacterial infections),
carbamazepine, phenobarbital or phenytoin
(medicines used to treat convulsions/fits).
 Certain types of strong pain killers, called partial
agonist/antagonists e.g. buprenorphine,
nalbuphine and pentazocine (medicines for
treatment of pain). You could experience
symptoms of withdrawal syndrome (nausea,
vomiting, diarrhoea, anxiety, chills, tremor, and
sweating) while using these medicines. If you
are due to have surgery requiring a general
anaesthetic.
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 you.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
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 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 infant. Do not use
Actiq if you are breast-feeding. You should not start
breast-feeding until at least 5 days after the last
dose of Actiq.
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
Actiq.
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
if:
 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.

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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.
How the medicine gets into your body
When you place the lozenge in your mouth:
 The lozenge dissolves and the active substance
is released. It takes around 15 minutes for this
to happen.
 The active substance 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
need.
How many units to use
Once the right dose has been found with your
doctor, use 1 unit for an episode of breakthrough
pain.
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.

Please turn over

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.
 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

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
Actiq
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
You should discontinue Actiq when you no longer
have any breakthrough pain. You must however
continue to take your usual opioid pain relieving
medicine to treat your persistent cancer pain as
advised by your doctor. You may experience
withdrawal symptoms similar to the possible side
effects of Actiq when discontinuing Actiq. If you
experience withdrawal symptoms or if you are
concerned about your pain relief you should contact
your doctor. Your doctor will evaluate if you need
medicine to reduce or eliminate the withdrawal
symptoms.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.

If you use more Actiq than you should

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 steps
IMMEDIATELY:
 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.
 CALL FOR EMERGENCY HELP.
 While waiting for emergency help, if the person
seems to be breathing slowly, prompt them to
breathe every 5-10 seconds.

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.

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.

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
away.
How many Actiq units you should use
Do not use more than two units to treat any single
episode of breakthrough pain.

Very common side effects (affecting more than 1
in 10 people)
 Vomiting, nausea/feeling sick, constipation,
stomach (abdominal) pain
 Asthenia (weakness), sleepiness, dizziness,
headaches
 Shortness of breath
Common side effects (affecting 1 to 10 people in
100)
 Confusion, anxiety, seeing or hearing things that
are not there (hallucinations), depression, mood
swings
 Feeling unwell
 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 alteration
 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)
Uncommon side effects (affecting 1 to 10 people
in 1,000)
 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
Frequency not known
The following side effects have also been reported
with the use of Actiq lozenge 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, fatigue, insomnia, pyrexia, withdrawal
syndrome (may manifest by the occurrence of
the following side effects nausea, vomiting,
diarrhoea, anxiety, chills, tremor, and sweating).
Whilst using Actiq you may experience irritation,
pain and ulcer at the application site and gum
bleeding.

5. HOW TO STORE ACTIQ
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 protective blister until ready for use. 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 above.
 Do not flush partially used lozenge, handles, or
the blister packaging down the toilet.

6. FURTHER INFORMATION
What Actiq contains:
Each Actiq 200 micrograms compressed lozenge
with integral oromucosal applicator contains 200
micrograms fentanyl (as citrate).
Each Actiq 400 micrograms compressed lozenge
with integral oromucosal applicator contains 400
micrograms fentanyl (as citrate).
Each Actiq 600 micrograms compressed lozenge
with integral oromucosal applicator contains 600
micrograms fentanyl (as citrate).

What Actiq looks like and contents of the pack
Actiq 200 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
200' in blue and the handle is marked with a dark
grey band and 'ACTIQ® 200µg' in black print.
Actiq 400 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
400' in blue and the handle is marked with a blue
band and 'ACTIQ® 400µg' in black print.
Actiq 600 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
600' in blue and the handle is marked with a orange
band and 'ACTIQ® 600µg' in black print.
Actiq 800 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
800' in blue and the handle is marked with a purple
band and 'ACTIQ® 800µg' in black print.
Actiq 1200 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
1200' in blue and the handle is marked with a green
band and 'ACTIQ® 1200µg' 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. However, if you
notice any other signs of deterioration, please refer
to your doctor or pharmacist.
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 1EE.
PL 20492/0468

Each Actiq 800 micrograms compressed lozenge
with integral oromucosal applicator contains 800
micrograms fentanyl (as citrate).

PL 20492/0469

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.

Each Actiq 1200 micrograms compressed lozenge
with integral oromucosal applicator contains 1200
micrograms fentanyl (as citrate).

PL 20492/0470

You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

The other ingredients are:
Lozenge:
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, de-waxed white shellac, propylene glycol,
blue synthetic coal tar dye (E133)

PL 20492/0471

PL 20492/0472

POM

Actiq 200 micrograms
compressed lozenge with integral
oromucosal applicator
Actiq 400 micrograms
compressed lozenge with integral
oromucosal applicator
Actiq 600 micrograms
compressed lozenge with integral
oromucosal applicator
Actiq 800 micrograms
compressed lozenge with integral
oromucosal applicator
Actiq 1200 micrograms
compressed lozenge with integral
oromucosal applicator
CD

Date of preparation: 1st July 2016
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.

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