Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I taking ABSTRAL?
ABSTRAL contains the active ingredient fentanyl (as citrate). ABSTRAL is a strong
pain medicine used to treat breakthrough cancer pain in adults who are already receiving
an effective maintenance dose of opioid therapy for their underlying cancer pain.
For more information, see Section
1. Why am I taking ABSTRAL? in the full CMI.
2. What should I know before I take ABSTRAL?
Do not take if you have ever had an allergic reaction to fentanyl or any of the ingredients
listed at the end of the CMI. Talk to your doctor if you have any other medical conditions,
take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take ABSTRAL? in the full CMI.
3. What if I am taking other medicines?
4. How do I take ABSTRAL?
ABSTRAL sublingual tablet is placed under your tongue until dissolved. Do not suck,
chew or swallow the tablet
Do not eat or drink anything until the tablet is completely dissolved. If needed,
you can moisten your mouth by rinsing it with water before placing the tablet under
your tongue.
5. What should I know while taking ABSTRAL?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking ABSTRAL
Carefully follow your doctor's instructions on how much ABSTRAL to take for each breakthrough
pain episode, especially when you first start taking ABSTRAL or change the dose
Talk to your doctor or pharmacist if your pain does not improve.
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Things you should not do
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Do not take ABSTRAL for other types of pain (e.g. post-operative pain, headache, migraine)
Do not take ABSTRAL unless you have already been receiving opioid maintenance therapy
for cancer-related pain for at least one week, because it may increase the risk of
experiencing severe breathing difficulties
Do not take ABSTRAL if you have any lung conditions or breathing difficulties unless
your doctor tells you to.
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Driving or using machines
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Do not drive or operate machinery while taking ABSTRAL as it can cause dizziness,
drowsiness or blurred vision.
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Drinking alcohol
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Do not consume alcohol while taking ABSTRAL, as dizziness and drowsiness may become
worse.
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Looking after your medicine
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Keep your medicine in a cool dry place below 25°C
Keep your medicine where children cannot reach it.
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6. Are there any side effects?
The most common side effects of ABSTRAL are nausea, drowsiness and vomiting. Tell
your doctor or pharmacist immediately or go to Emergency Department at your nearest
hospital if you experience shortness of breath, wheezing or difficulty breathing,
fast or slow heartbeat, dizziness or light-headedness, unusual or extreme mood swings,
blurred vision, swelling of the face, lips, tongue or other parts of the body, or
skin rashes.
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WARNING:
Limitations of use
ABSTRAL should only be taken when your doctor decides that other treatment options
are not able to effectively manage your pain or you cannot tolerate them.
Hazardous and harmful use
ABSTRAL poses risks of abuse, misuse and addiction which can lead to overdose and
death. Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
ABSTRAL can cause life-threatening or fatal breathing problems (slow, shallow, unusual
or no breathing) even when taken as recommended. These problems can occur at any time
during use, but the risk is higher when first starting ABSTRAL and after a dose increase,
if you are older, or have an existing problem with your lungs. Your doctor will monitor
you and change the dose as appropriate.
Use of other medicines or alcohol while taking ABSTRAL
Taking ABSTRAL with other medicines that can make you feel drowsy such as sleeping
tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants,
antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol
may result in severe drowsiness, decreased awareness, breathing problems, coma and
death. Your doctor will minimise the dose and duration of use, and monitor you for
signs and symptoms of breathing difficulties and sedation. You must not drink alcohol
while taking ABSTRAL.
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Active ingredient: fentanyl (as citrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ABSTRAL.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking ABSTRAL.
Where to find information in this leaflet:
1. Why am I taking ABSTRAL?
ABSTRAL contains the active ingredient fentanyl (as citrate).
ABSTRAL belongs to a group of strong pain relieving medicines called opioid analgesics,
and works by blocking the sensation of pain.
ABSTRAL is used to treat breakthrough pain in adults with cancer who are already receiving
an effective maintenance dose of opioid therapy to control their persistent cancer
pain. Breakthrough pain is a short episode of sudden intense pain despite well controlled
persistent cancer pain.
2. What should I know before I take ABSTRAL?
Warnings
Opioids have a potential to cause addiction, even if taken exactly as prescribed.
It is possible that ABSTRAL may become habit forming causing mental and physical dependence.
If abused it may become less able to reduce pain.
Tolerance
As with all other opioid containing products, tolerance to ABSTRAL may develop, which
means that you may need higher doses to control your breakthrough pain.
Dependence and Withdrawal
As with all other opioid containing products, your body may become used to you taking
ABSTRAL. Taking it may result in physical dependence. Physical dependence means that
you may experience withdrawal symptoms if you stop taking opioids suddenly, so it
is important to take these exactly as directed by your doctor.
Continue taking your medicine for as long as you need it or your doctor tells you.
If you stop taking ABSTRAL, you must continue to take your usual opioid pain relieving
medicine to treat your persistent cancer pain as advised by your doctor. When you
stop taking ABSTRAL there should be no noticeable effects but your pain may worsen
and some people may experience some or all of the following withdrawal symptoms:
loss of appetite, nausea, vomiting or diarrhoea
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating.
Do not take ABSTRAL:
1. If you are allergic to fentanyl or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine
2. If you are allergic to any other similar medicines (such as other opioid analgesics)
3. For other types of short-term or acute pain (e.g. post-operative pain, headache, migraine)
4. If you are not already receiving (and are not tolerant to) opioid maintenance therapy
for cancer-related pain
5. If you have any lung conditions or breathing difficulties.
Check with your doctor if you have or have had:
Difficulty breathing, wheezing, chronic cough, asthma or other breathing conditions
such as chronic obstructive pulmonary disease (COPD),
Myasthenia gravis (immune disease that causes muscle weakness)
A brain tumour, increased pressure in your skull, reduced alertness, coma, or head
injury
Heart problems
Liver or kidney problems
Low blood pressure
Mouth wounds or mucositis (inflammation and ulceration of the mouth or gut lining)
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Prolonged
treatment with fentanyl during pregnancy or use during labour can cause breathing
problems, signs of withdrawal, severe harm or life-threatening damage in the newborn.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Fentanyl can
get into breast milk and may cause side effects in the breast-fed infant. You should
not start breastfeeding until at least 5 days after the last dose of ABSTRAL.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with ABSTRAL and affect how it works. These include:
some antibiotics used to treat infections such as erythromycin, rifampicin or rifabutin
some medicines used to treat fungal infections such as ketoconazole and itraconazole
some medicines used to treat HIV infections such as ritonavir
some medicines used to treat convulsions/fits such as gabapentin, pregabalin, carbamazepine,
phenobarbital or phenytoin
other medicines used to treat pain
cough suppressants
medicines used for surgery (anaesthetics) and muscle relaxants
some antihistamines
medicines used to help you relax, sleep, relieve anxiety, depression and mental disorders,
such as barbiturates, benzodiazepines, cannabis
some antidepressants such as phenelzine and selegiline, as these may increase the
risk of a potentially life-threatening condition called serotonin syndrome. Symptoms
of serotonin syndrome include confusion, fast heartbeat, hallucinations, restlessness,
shaking, shivering, sudden jerking of muscles, sweating)
alcohol
certain types of strong pain killers such as buprenorphine, nalbuphine and pentazocine.
You could experience symptoms of withdrawal syndrome (nausea, vomiting, diarrhoea,
anxiety, chills, tremor, and sweating) while using these medicines.
Check with your doctor or pharmacist if you are not sure whether the medicines, vitamins
or supplements you are taking will affect ABSTRAL
4. How do I take ABSTRAL?
Follow all directions given to you by your doctor or pharmacist. They may differ from
the information contained in this leaflet.
If you do not understand the instructions for use, ask your doctor or pharmacist for
help.
How much to take
You must follow your doctor's instructions on how much ABSTRAL to take. Your dose
is the dose that eases your breakthrough pain. This dose is determined by slowly increasing
the ABSTRAL dose as explained below.
When starting ABSTRAL
Your persistent cancer pain must be well controlled on regular opioid pain medicines
before you start ABSTRAL for the breakthrough pain. Do not stop your regular pain
medicines.
You must start with 100 micrograms of ABSTRAL. If adequate pain relief is not achieved
within 30 minutes, your doctor may recommend a supplemental (second) 100 microgram
tablet.
Do not use more than two (2) doses of ABSTRAL for each episode of breakthrough cancer
pain. Wait at least 2 hours before treating another episode of breakthrough pain with
ABSTRAL.
If your pain is not relieved after the second supplemental dose, you cannot take another
ABSTRAL tablet for at least 2 hours. Your doctor may recommend other pain medicines
to relieve this episode of breakthrough pain
If adequate pain relief was not achieved for an earlier episode of breakthrough cancer
pain, your doctor may slowly increase the dose for your next episode(s) of breakthrough
cancer pain until you find a dose that gives you adequate relief and without severe
side effects. This is because everyone's pain is different and finding the right dose
for you is important.
After you have found the right ABSTRAL dose
After you and your doctor have found the dose of ABSTRAL that provides adequate breakthrough
cancer pain relief for you, this is the ongoing dose that you should take for each
episode of breakthrough cancer pain
DO NOT TAKE MORE THAN THE DOSE YOUR DOCTOR HAS RECOMMENDED FOR EACH EPISODE OF BREAKTHROUGH
CANCER PAIN
You must tell your doctor immediately if you are using ABSTRAL more than four times
per day, as your doctor may need to change your regular medicines for the persistent
cancer pain
Your doctor may adjust your ABSTRAL dose whenever changes to your regular pain medications
are made.
Once your persistent pain has been controlled, your doctor may need to change your
dose of ABSTRAL further
Let your doctor know if your ABSTRAL dose is no longer providing pain relief. Your
doctor will decide if your dose needs to be changed.
Do not change doses of ABSTRAL or your other pain medicines on your own.
When to take ABSTRAL
You can take ABSTRAL whenever you have an episode of breakthrough cancer pain; up
to four (4) doses per day. You must wait for at least two (2) hours before treating
another episode of breakthrough pain with ABSTRAL.
You can discontinue ABSTRAL when you no longer have any breakthrough cancer pain,
but you must tell your doctor before you do so. You must also 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 ABSTRAL when discontinuing ABSTRAL. If you experience any withdrawal symptoms
your doctor will evaluate if you need medicine to reduce or eliminate these.
How to take ABSTRAL
If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water
before taking ABSTRAL.
STEP 1: Remove the tablet(s) from the blister pack immediately before use as follows:
Separate one of the blister squares from the pack by tearing along the dotted lines/perforations
(keep the remaining blister squares together)
Peel back the edge of the foil as indicated by the arrow on the coloured strip, and
gently remove the tablet.
Do not try to push ABSTRAL sublingual tablets through the foil top, as this will damage
the tablet.
STEP 2: Place the tablet under your tongue as far back as you can, and let it dissolve completely.
ABSTRAL will dissolve rapidly under the tongue and be absorbed in order to provide
pain relief. It is therefore important that you do not suck, chew or swallow the tablet.
You should not drink or eat anything until the tablet has completely dissolved under
your tongue.
STEP 3: Dispose of the empty blister square.
If you take too much ABSTRAL
If you or someone else receives too much ABSTRAL (overdose) or experiences one or
more of the symptoms below, immediately call triple zero (000) for an ambulance. Keep
the person awake by talking to them or gently shaking them every now and then. You
should follow the above steps even if someone other than you accidentally takes ABSTRAL
that was prescribed for you. If someone takes an overdose they may experience one
or more of the following symptoms:
Slow, unusual or difficult breathing
Drowsiness, dizziness or unconsciousness
Slow or weak heartbeat
Nausea or vomiting
Convulsions or fits.
If you think that you or someone else may have taken too much ABSTRAL, urgent medical
attention may be needed. You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
When seeking medical attention, take this leaflet and remaining medicine with you
to show the doctor. Also tell them about any other medicines or alcohol which have
been taken.
5. What should I know while taking ABSTRAL?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Tell your doctor or pharmacist if you do not feel well while you are taking ABSTRAL
Call your doctor straight away if:
You become pregnant while taking ABSTRAL
Your breakthrough cancer pain does not improve.
Remind any doctor, dentist or pharmacist you visit that you are taking ABSTRAL. If
you are going to have surgery, tell the surgeon or anaesthetist that you are taking
ABSTRAL.
Things you should not do
Do not take ABSTRAL to treat any other complaints unless your doctor or pharmacist
tells you to
Do not give your medicine to anyone else, even if they have the same condition as
you
Do not give ABSTRAL to anyone younger than 18 years of age
Do not switch from ABSTRAL to other medicines that contain fentanyl without your doctor's
advice as it can result in a fatal overdose. ABSTRAL is NOT interchangeable with other
fentanyl products. Your doctor will prescribe starting and maintenance doses of the
new fentanyl medicine if you are switched
Do not substitute ABSTRAL for any other pain reliever. The use of ABSTRAL without
dose titration or by individuals who have not already been taking regular opioid medication
for at least one week may result in fatal overdose.
Do not take ABSTRAL for short-term pain that you would expect to go away in a few
days, such as: pain from injuries, from doctors' or dentists' visits, surgery or headaches/migraines.
Do not drink grapefruit juice while you are prescribed ABSTRAL treatment as it may
increase the side effects of ABSTRAL.
Things to be careful of
Do not take high doses of ABSTRAL for long periods of time unless your doctor tells
you to
ABSTRAL may be habit forming.
The below medical emergencies can cause death. Get emergency medical help right away
if:
A child accidentally takes ABSTRAL. ABSTRAL can cause an overdose and death in any
child who takes it
An adult who has not been prescribed ABSTRAL takes it
Driving or using machines
Do not drive or operate machinery while taking ABSTRAL as ABSTRAL may cause dizziness,
drowsiness or blurred vision in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not consume alcohol while taking ABSTRAL, as dizziness and drowsiness may become
worse. There is an increased risk of decreased awareness, breathing difficulties,
coma and death if taken at the same time as alcohol.
Looking after your medicine
Keep your medicine where the temperature stays below 25°C
Keep your medicine in the original pack until it is time to take it.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place, away from moisture, heat or sunlight; for example, do
not store it:
In the bathroom or near a sink, or
In the car or on window sills.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or it is out of date, take all
unused medicine to any pharmacy for safe disposal.
6. Are there any side effects?
This medicine helps most people with breakthrough cancer pain, but it may have unwanted
side effects in a few people. All medicines can have side effects. If you do experience
any side effects, most of them are minor and temporary. However, some side effects
may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects. Do not be alarmed by the following
list of side effects. You may not experience any of them.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ABSTRAL contains
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Active ingredient
(main ingredient)
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fentanyl (as citrate)
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Other ingredients
(inactive ingredients)
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mannitol
microcrystalline cellulose
colloidal anhydrous silica
croscarmellose sodium
magnesium stearate
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Do not take ABSTRAL if you are allergic to any of these ingredients. This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
What ABSTRAL looks like
ABSTRAL 100 microgram tablets are white, round and flat with bevelled edges (AUST
R 193332)
ABSTRAL 200 microgram tablets are white, oval-shaped and flat with bevelled edges
(AUST R 193335)
ABSTRAL 300 microgram tablets are white, arc triangle-shaped and flat with bevelled
edges (AUST R 228199)
ABSTRAL 400 microgram tablets are white, diamond-shaped and flat with bevelled edges
(AUST R 193336)
ABSTRAL 600 microgram tablets are white, "D"-shaped and flat with bevelled edges (AUST
R 228208)
ABSTRAL 800 microgram tablets are white, caplet-shaped and flat with bevelled edges
(AUST R 228209)
ABSTRAL is available in foil blister pack sizes of 10 or 30 tablets
Who distributes ABSTRAL
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Ave, Chatswood NSW 2067
Medical Information: 1800 644 542
® = Registered Trademark
This leaflet was prepared in August 2020.
For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi
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