fentanyl (as citrate)
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about ABSTRAL.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
ABSTRAL against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What ABSTRAL is used for
The medicine is used to treat breakthrough cancer pain in adult patients with cancer
who are already receiving and are tolerant to (maintenance) opioid therapy for chronic
cancer pain. Breakthrough pain is a transient episode of otherwise controlled chronic
ABSTRAL belongs to a group of medicines called analgesics. It is an opioid analgesic
and it acts by blocking pain and your emotional response to pain.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
This medicine is only available on a prescription from your doctor.
Before you take ABSTRAL
When you must not take it
Do not take ABSTRAL if you have an allergy to:
any medicine containing fentanyl or citrate
any other similar medicines (such as other opioid analgesics)
any of the ingredients listed at the end of this leaflet
if you suffer from short-term pain other than breakthrough pain.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take ABSTRAL for other types of acute pain (e.g. post- operative pain, headache,
Do not take ABSTRAL if you are not already receiving (and are tolerant to) opioid
maintenance therapy for cancer-related pain.
Do not take ABSTRAL if you are suffering from severe respiratory depression or severe
obstructive lung conditions.
Do not give this medicine to anyone younger than 18 years of age.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking ABSTRAL, talk to your doctor or
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
chronic obstructive pulmonary disease
difficulty breathing, wheezing, chronic cough, asthma or other chronic breathing condition
hyperkapnia (too much carbon dioxide in the blood) or other evidence of increased
intracranial pressure, reduced consciousness, coma or brain tumours
bradycardia (slow heart beat) or bradyarrhythmias
liver or kidney problems
low blood pressure
mouth wounds or mucositis (inflammation and ulceration of the mouth or gut lining).
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Fentanyl can get into breast milk and may cause side effects in the breast-fed infant.
Do not use ABSTRAL if you are breastfeeding. You should not start breastfeeding until
at least 5 days after the last dose of ABSTRAL. Your doctor can discuss with you the
risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines may be affected by ABSTRAL, or may affect how well ABSTRAL works. These
some antibiotics (e.g. erythromycin)
some antifungal medicines (e.g. ketoconazole, itraconazole)
some antiviral medicines (e.g. ritonavir)
some medicines used to treat bacterial infections (e.g. rifampicin or rifabutin)
some medicines used to treat convulsions/fits (e.g. carbamazepine, phenobarbital or
other analgesics used to treat pain
antitussives (cough suppressants)
medicines used to help you relax, sleep or relieve anxiety, such as barbiturates,
benzodiazepines and other sedatives, antipsychotic agents, medicines used to treat
some antidepressants e.g. phenelzine, selegiline. Taking ABSTRAL with these medicines
may increase the risk of a potentially life-threatening condition called serotonin
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.
You may need different amounts of your medicine, or you may need to take a different
Your pharmacist or doctor will have more information on medicines to be careful with
or avoid while using this medicine.
How to take ABSTRAL
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water.
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
STEP 2: Place the tablet under your tongue as far back as you can, and let it dissolve
ABSTRAL will dissolve rapidly under the tongue and be absorbed in order to provide
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
STEP 3: Dispose of the empty blister square.
Do not substitute ABSTRAL for any other pain reliever. Use of ABSTRAL without dose
titration and by individuals not already taking regular opioid medication may result
in fatal overdose.
If you do not understand the instructions for use, ask your doctor or pharmacist for
How much to take
The recommended dosage will depend on the level of pain you are experiencing.
When starting ABSTRAL
You must start with the lowest dose tablet (100 microgram). If adequate pain relief
is not achieved within 30 minutes, your doctor may recommend a supplemental (second)
100 mcg tablet.
If your pain is still uncontrolled after the second dose you cannot take another ABSTRAL
tablet for this episode of pain.
If adequate pain relief was not achieved for an earlier episode of breakthrough cancer
pain, your doctor may suggest you take additional tablets or higher strength tablets
for your next episode(s) of breakthrough cancer pain. This is because everyone's pain
is different and finding the right dose for you is important.
Do not take more than two doses of ABSTRAL for each episode of breakthrough cancer
You should wait at least 2 hours before taking ABSTRAL to treat another episode of
breakthrough cancer pain.
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
You must tell your doctor immediately if you are using ABSTRAL more than four times
per day, as the doctor may wish to change your medicine for your chronic cancer pain.
Once your chronic pain has been controlled, your doctor may need to change your dose
of ABSTRAL further.
For best results, let your doctor know about your pain and how ABSTRAL is working
for you so that the dose can be changed if needed.
Do not change doses of ABSTRAL or your other pain medicines on your own.
Contact your doctor if your recommended dose of ABSTRAL does not relieve your breakthrough
cancer pain. Your doctor will decide if your dose needs to be changed.
How long to use it
You can use this medication whenever you have an episode of breakthrough pain.
You should discontinue ABSTRAL 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 ABSTRAL when discontinuing ABSTRAL. 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.
Do not continue to use ABSTRAL if you no longer feel breakthrough cancer pain.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre on 13 11 26 (Australia)
or 0800 764 766 (New Zealand) for advice, or go to Accident and Emergency at the nearest
hospital if you think you or anyone else may have taken too much ABSTRAL. Do this
even if there are no signs of discomfort or poisoning.
While you are using ABSTRAL
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ABSTRAL.
Tell any other doctors, dentists and pharmacists who treat you that you are using
If you are going to have surgery, tell the surgeon or anaesthetist that you are using
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Talk to your pharmacist or doctor if your breakthrough cancer pain does not improve.
Your pharmacist or doctor will assess your condition and decide if you should continue
to take this medicine.
Things you must not do
Do not use ABSTRAL to treat any other complaints unless your pharmacist or doctor
tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
Do not switch from ABSTRAL to other medicines that contain fentanyl without talking
with your doctor.
ABSTRAL is NOT interchangeable with other fentanyl products.
Your doctor will prescribe starting and maintenance doses of ABSTRAL that may be different
than other fentanyl-containing medicines you may have been taking.
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.
ABSTRAL can cause dizziness, drowsiness or blurred vision.
Do not drive or operate machinery while taking ABSTRAL as ABSTRAL can cause dizziness,
drowsiness or blurred vision.
Do not consume alcohol while taking ABSTRAL, as dizziness and drowsiness may become
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
ABSTRAL may be habit forming.
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
These are medical emergencies that can cause death.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ABSTRAL.
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, sometimes they
are serious, most of the time they are not. You may need medical attention if you
get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
sore mouth or mouth ulcers
The above list includes the more common side effects of your medicine. They are usually
mild and short-lived.
Tell your doctor or pharmacist immediately if you notice any of the following:
shortness of breath
fast or slow heart beat
dizziness or light-headedness
unusual or extreme mood swings
The above list includes serious side effects that may require medical attention. Serious
side effects are rare.
If any of the following happen, tell your doctor or pharmacist immediately or go to
Accident and Emergency at your nearest hospital:
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
The above list includes very serious side effects. You may need medical attention
or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using ABSTRAL
Keep your medicine in the original pack until it is time to take it.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store ABSTRAL or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop using this medicine or the expiry date has passed,
please return all unused medicine to your pharmacist as soon as possible.
What it looks like
ABSTRAL 100 microgram tablets are white, round and flat with bevelled edges.
ABSTRAL 200 microgram tablets are white, oval-shaped and flat with bevelled edges.
ABSTRAL 300 microgram tablets are white, arc triangle-shaped and flat with bevelled
ABSTRAL 400 microgram tablets are white, diamond-shaped and flat with bevelled edges.
ABSTRAL 600 microgram tablets are white, "D"-shaped and flat with bevelled edges.
ABSTRAL 800 microgram tablets are white, caplet-shaped and flat with bevelled edges.
ABSTRAL is available in foil blister pack sizes of 10 or 30 tablets.
ABSTRAL contains fentanyl (as citrate) as the active ingredient.
ABSTRAL also contains the following inactive ingredients:
colloidal anhydrous silica
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
ABSTRAL is supplied by:
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Ave
Chatswood NSW 2067
Medical Information: 1800 644 542
A. Menarini New Zealand Pty Ltd
4 Whetu Place
Medical Information: 0800 102 349
Australian Registration Number(s):
100 micrograms: AUST R 193332
200 micrograms: AUST R 193335
300 micrograms: AUST R 228199
400 micrograms: AUST R 193336
600 micrograms: AUST R 228208
800 micrograms: AUST R 228209
This leaflet was revised in March 2018.
For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi