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ACTIQ 1600 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance(s): FENTANYL CITRATE / FENTANYL / FENTANYL CITRATE / 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® 1600 micrograms compressed lozenge with
integral oromucosal applicator
(fentanyl citrate)
This product is available as any of the above names but will be referred to as Actiq
throughout this leaflet. Please note that the leaflet also contains information about the other
strength (Actiq® 1200 micrograms compressed lozenge with integral oromucosal
applicator).
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.
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 adults and adolescents aged 16 years and above
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.
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 monoamine oxidase (MAO) inhibitors (medicines for severe
depression) or have taken them in the past 2 weeks (see section 2 under Serotonin
syndrome).
 if you have severe breathing problems or severe lung problems where you have an
obstruction.
 if you suffer from short-term pain (e.g. pain from injuries, surgery, headaches or
migraines) 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.
Warnings 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 have a history of alcoholism or any drug abuse or dependence.
 You have ever developed adrenal insufficiency with opioid use, a condition in which the
adrenal glands do not produce enough hormones (see section 4 under serious side
effects).
 You drink alcohol; please refer to section Actiq with food, drink and alcohol.
Serotonin syndrome
Talk to your doctor before using Actiq if you use antidepressants or antipsychotics
(selective serotonin reuptake inhibitors [SSRIs], serotonin norepinephrine reuptake
inhibitors [SNRIs], monoamine oxidase (MAO) inhibitors; see section 2 under Do not use
Actiq and Other medicines and Actiq).
The use of these medicines with Actiq can lead to a serotonin syndrome a potentially life
threatening condition (see section 2 under Other medicines and Actiq).
Serious allergic reactions
(anaphylaxis, hypersensitivity)
Serious allergic reactions have been reported with fentanyl (see section 4 under Serious
side effects), early symptoms can be difficulty in breathing or dizziness, swelling of the
tongue, lip or throat.
Dental decay
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 and adolescents 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.
 if you are using monoamine oxidase (MAO) inhibitors (medicines for severe depression)
or have taken them in the past 2 weeks (see section 2 under Do NOT use Actiq and
Serotonin syndrome).

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.
 Serotonergic medicinal products used to treat depression (antidepressants: such as
selective serotonin reuptake inhibitors [SSRIs] and serotonin norepinephrine reuptake
inhibitors [SNRIs]) or antipsychotics. The use of these medicines with ACTIQ can lead to
serotonin syndrome a potentially life-threatening condition (see section 2 under
Serotonin syndrome). The symptoms of serotonin syndrome may include 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.
If you are due to have surgery requiring a general anaesthetic speak with your doctor or
nurse.
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 using 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 serious
side effects including death.
Pregnancy and breast-feeding
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 using this medicine.
Pregnancy
Actiq should not be used during pregnancy unless you have discussed this with your
doctor.
If Actiq is used for a long time during pregnancy, there is a risk of the new-born child having
withdrawal symptoms which might be life-threatening if not recognized and treated by a
doctor (see section 4 under Other side effects with frequency not known).
You should not use Actiq during child-birth because fentanyl may cause breathing
difficulties in the new-born child.
Breast-feeding
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.
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 using 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.
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 using 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.
Using 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 using 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-theclock) 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 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 cause side effects, although not everybody gets them. If
you notice any of these, contact your doctor.
Serious side effects
 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 using 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.
 Contact your doctor if you experience a combination of the following symptoms
Nausea, vomiting, loss of appetite, tiredness, weakness, dizziness and low blood
pressure.
Together these symptoms may be a sign of a potentially life-threatening condition called
adrenal insufficiency, a condition in which the adrenal glands do not produce enough
hormones.
 Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in
the newborn which can be life-threatening (see section 2 under Pregnancy and breastfeeding).
Other side effects
Very common: may affect more than 1 in 10 people
 Vomiting, nausea/feeling sick, constipation, stomach (abdominal) pain
 Asthenia (weakness), sleepiness, dizziness, headaches
 Shortness of breath
Common: may affect up to 1 in 10 people
 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: may affect up to 1 in 100 people
 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).
 Lack of sex hormones (androgen deficiency)
Whilst using Actiq you may experience irritation, pain and ulcer at the application site and
gum bleeding.
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.
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. The
expiry date refers to the last day of that month.
 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. Contents of the pack and other 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).
Each Actiq® 800 micrograms compressed lozenge with integral oromucosal applicator
contains 800 micrograms fentanyl (as citrate).
Each Actiq® 1600 micrograms compressed lozenge with integral oromucosal applicator
contains 1600 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 E 1450, confectioner’s sugar (as sucrose and maize
starch), water.
Imprinting ink
Water, de-waxed white shellac, propylene glycol, blue synthetic coal tar dye E 133.
What Actiq looks like and contents of the pack
Actiq® 200 micrograms compressed lozenge with integral oromucosal applicator is a white
to off-white solid lozenge attached to a plastic applicator for oromucosal application. The
lozenge is marked with 'ACTIQ 200' in blue and the applicator handle is marked with a dark
grey band and 'ACTIQ® 200 µg' in black print.
Actiq® 400 micrograms compressed lozenge with integral oromucosal applicator is a white
to off-white solid lozenge attached to a plastic applicator for oromucosal application. The
lozenge is marked with 'ACTIQ 400' in blue and the applicator handle is marked with a dark
blue band and 'ACTIQ® 400 µg' in black print.
Actiq® 600 micrograms compressed lozenge with integral oromucosal applicator is a white
to off-white solid lozenge attached to a plastic applicator for oromucosal application. The
lozenge is marked with 'ACTIQ 600' in blue and the applicator handle is marked with an
orange band and 'ACTIQ® 600 µg' in black print.
Actiq® 800 micrograms compressed lozenge with integral oromucosal applicator is a white
to off-white solid lozenge attached to a plastic applicator for oromucosal application. The
lozenge is marked with 'ACTIQ 800' in blue and the applicator handle is marked with violet
band and 'ACTIQ® 800 µg' in black print.
Actiq® 1600 micrograms compressed lozenge with integral oromucosal applicator is a
white to off-white solid lozenge attached to a plastic applicator for oromucosal application.
The lozenge is marked with 'ACTIQ 1600' in blue and the applicator handle is marked with
a dark red band and 'ACTIQ® 1600 µg' 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 lozenges are supplied in individual blister packages.
Blister packages are supplied in cartons of 3, 15 or 30 individual Actiq units.
PL 15814/1299

Actiq® 200 micrograms compressed lozenge with
integral oromucosal applicator
PL 15814/1300 Actiq® 400 micrograms compressed lozenge with
POM
integral oromucosal applicator
PL 15814/1301 Actiq® 600 micrograms compressed lozenge with
CD
integral oromucosal applicator
PL 15814/1302 Actiq® 800 micrograms compressed lozenge with
integral oromucosal applicator
PL 15814/1303 Actiq® 1600 micrograms compressed lozenge with
integral oromucosal applicator
Actiq is manufactured by Teva Pharmaceuticals B.V. Europe, Swensweg 5, 2031 GA
Haarlem, The Netherlands OR Cephalon France, 5 rue Charles Martigny, 94700 MaisonsAlfort, France.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 05.07.2017.
Actiq is a registered trademark of Cephalon, Inc., or its affiliates.

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

Expand Transcript

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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