ACTIQ 400MCG LOZENGE WITH INTEGRAL OROMUCOSAL APPLICATOR

Active substance: FENTANYL CITRATE

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0865/10 Actiq P2.indd ARK

002/003

Profile Name: ACT-EU-PIL1-V4

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Actiq
UK
PIL (FRONT)
ACTIQ PATIENT INFO
LFLT GB
1 (One)
ACT-EU-PIL1-V4 (v4)
Nosco 090340
15 9/32” x 113/4”
29/16” x 215/16”
N/A
Code 128 - 400331032115
400-33-10321.15
SLC
17 Jul 2013

ARK Pharma Graphics Ltd
Crown House Business Centre, Home Gardens,
Dartford, Kent, DA1 1DZ.
Tel +44(0)1322 424656
V2.03.2011

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ACTIQ
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04

Date:

29 Jun 11

400-33-10321.15

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
ACTIQ® 1600 micrograms compressed lozenge with integral oromucosal applicator
Fentanyl




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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 any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
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

1. WHAT ACTIQ IS AND WHAT IT IS
USED FOR
ACTIQ contains the active ingredient 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. BEFORE YOU USE ACTIQ
Do not use ACTIQ if:
• You are allergic (hypersensitive) to
fentanyl or any of the other ingredients of
ACTIQ (listed in Section 6).

• 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.
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 breath).
• You have a head injury or have had any
loss of consciousness.
• You have a very, very 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.
Using other medicines
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,
diazepam.
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 symptoms.
If you are due to have surgery requiring a
general anaesthetic.

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 effects.
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 new-born 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.
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 unless
you have discussed this with your doctor.
Breast-feeding should not be restarted until at
least 48 hours after the last use 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.
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 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
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
ingredient is released. It takes around
15 minutes for this to happen.
• 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
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 (aroundthe-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
Please turn over

0865/10 Actiq P2.indd ARK

Cephalon Job No.:
Iteration No.:

002/003

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Perforation

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2 9/16” x 2 15/16“ (Tolerance ± 1/16”)
ACTIQ
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0865/10
02

Black

Profile Name: ACT-EU-PIL1-V4

04

Date:

29 Jun 11

10% - 48% 13% - 63% 10% Black
Black
Black

Product Name
Market
Component
SLC Component
Description
No. of Colours
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Folded Size:
Barcode
Pharmacode
Material No.
Packaging supp.
Date

Actiq
UK
PIL (BACK)
ACTIQ PATIENT INFO
LFLT GB
1 (One)
ACT-EU-PIL1-V4 (v4)
Nosco 090340
15 9/32” x 113/4”
29/16” x 215/16”
N/A
Code 128 - 400331032115
400-33-10321.15
SLC
17 Jul 2013

ARK Pharma Graphics Ltd
Crown House Business Centre, Home Gardens,
Dartford, Kent, DA1 1DZ.
Tel +44(0)1322 424656
V2.03.2011

Artwork Approval Signature Box
ARK
Site Packaging
Regulatory
EU Legal
Packaging Ctrl.

TEXT SIZE
The Smallest Body
text on this A/W is:

9 pt

The Batch Legends
are:

N/A

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
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.

4. POSSIBLE SIDE EFFECTS
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 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
• Fit, muscle jerks, feeling of dizziness
or "spinning", loss of consciousness,
sedation, tingling or numbness,
difficulty coordinating movements,
increased or altered sensitivity to
touch
• 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
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, inflammtion of the
gum, tooth loss
Whilst using ACTIQ you may experience
irritation, pain and ulcer at the application site
and gum bleeding.

If any of the side effects gets serious, or
if you notice any side effects not listed in
this leaflet, please inform your doctor or
pharmacist.

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 reach and sight
of children.
• Do not use ACTIQ after the expiry date
shown on the package label and the
carton.
• Do not store above 30°C.
• 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.
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.
• 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.

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.
Imprinting ink
Water, de-waxed white shellac, propylene
glycol, blue synthetic coal tar dye E133
What ACTIQ looks like and contents of
the pack
ACTIQ consists of a white to off-white solid
lozenge attached to a handle for oromucosal
application. 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 exists in 6 different strengths: 200,
400, 600, 800, 1200 and 1600 micrograms.
The dosage strength is marked on the
white lozenge, on the handle, on the blister
package and on the carton to ensure that you
are taking the right medicine. Each strength
is associated with a specific colour.
ACTIQ lozenges are supplied in individual
blister packages.
Blister packages are supplied in cartons of 3,
6, 15 or 30 individual ACTIQ units.
Not all pack size may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Teva Pharma B.V.
Computerweg 10
3542DR Utrecht
The Netherlands
Manufacturer
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
This leaflet was last revised in July 2013.
Actiq is a registered trademark of Cephalon,
Inc. or one of its affiliates.

6. FURTHER INFORMATION
What ACTIQ contains:
The active substance is fentanyl. Each
individual lozenge contains either:
• 200 micrograms fentanyl (as citrate),
• 400 micrograms fentanyl (as citrate),
• 600 micrograms fentanyl (as citrate),
• 800 micrograms fentanyl (as citrate),
• 1200 micrograms fentanyl (as citrate),
• 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.

46414-A
0865/10

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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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