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ACTIQ 400 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance(s): FENTANYL / FENTANYL CITRATE

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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 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
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).







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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Actiq contains a
• The active substance is fentanyl. Each individual
lozenge contains:
400 micrograms fentanyl (as citrate),
• 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
E1450, confectioner’s sugar (as sucrose and
maize starch), water.

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

Imprinting ink
Water, de-waxed white shellac, propylene
glycol, blue synthetic coal tar dye E133

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:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine

What Actiq looks like and contents of the pack
• A white to off-white compressed powder drug
matrix attached using edible glue to a fracture
resistant radio opaque plastic applicator, marked
with the dosage strength.

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.
• Do not store above 30°C.
• Do not use this medicine after the expiry date
which is stated on the label and carton after
EXP. The expiry date refers to the last day of
that month.
• Always keep Actiq in its blister 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.
• Keep out of the sight and reach of children.



If your medicine becomes discoloured or shows
any signs of deterioration, ask your pharmacist
who will advise you what to do. Medicines
should not be disposed of via water waste or
household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

How to dispose of Actiq after use
Partially used Actiq lozenge may contain enough
medicine to be harmful or lifethreatening 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.

Actiq lozenges are supplied in individual blister
packages.
Blister packages are supplied in cartons of 3
and 30 individual Actiq units.

Manufacturer and Licence Holder
Manufactured by Teva Pharmaceuticals B.V
Europe. Swensweg 5, 2031 GA Haarlem, The
Netherlands and procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18 Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

CD

PL 15184/1666 Actiq 400
micrograms
compressed
lozenge
with integral
oromucosal
applicator

Actiq is a registered trademarks of Anesta LLC.
Leaflet revision date: 18/07/2016

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help

Ref: 1666/180716/1/F
PATIENT INFORMATION LEAFLET
Actiq ® 400 micrograms compressed lozenge with integral
oromucosal applicator

(fentanyl)
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.
Your medicine is called Actiq 400 micrograms
compressed lozenge with integral oromucosal
applicator and will be referred to as Actiq
throughout the rest of this leaflet. Please note that
the leaflet also contains information about other
strengths of the medicine, 200, 400, 600, 800,
1200 and 1600 micrograms
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.
• 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.
Children and adolescents
Actiq is not recommended for children below
16 years of age.
Other medicines and Actiq
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.
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.
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
new-born 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
breast-feeding.
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.

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
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.
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
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.
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
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.
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.
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,
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)

Ref:1637/180716/1/B

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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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