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Package leaflet: Information for the patient

Abstral 100 microgram sublingual tablets
Abstral 200 microgram sublingual tablets
Abstral 300 microgram sublingual tablets
Abstral 400 microgram sublingual tablets
Abstral 600 microgram sublingual tablets
Abstral 800 microgram sublingual tablets

problems with your heart, especially a slow heart rate
low blood pressure
liver or kidney disease, as this may require your doctor to more carefully adjust
your dose
a brain tumour and/or raised intracranial pressure (an increase of pressure in
the brain which causes severe headache, nausea/vomiting and blurred vision)
mouth wounds or mucositis (swelling and redness of the inside of the mouth).

If you take antidepressants or antipsychotics please refer to the section ‘Other
medicines and Abstral’.


When taking Abstral, if you are to have any surgery, inform your doctor or dentist
that you are taking this medicine.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

Other medicines and Abstral
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines (other than your regular opioid pain-relieving medicine).

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.

 his 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 Abstral is and what it is used for
2. What you need to know before you take Abstral
3. How to take Abstral
4. Possible side effects
5. How to store Abstral
6. Contents of the pack and other information

1. What Abstral is and what it is used for

Abstral is a treatment for adults who must already regularly be taking strong
pain-relieving medicine (opioids) for their persistent cancer pain, but require
treatment for their breakthrough pain. If you are not sure, talk to your doctor.
Breakthrough pain is pain which occurs suddenly, even though you have taken or
used your usual opioid pain-relieving medicine.
The active substance in Abstral sublingual tablets is fentanyl. Fentanyl belongs to a
group of strong pain-relieving medicines called opioids.

2. What you need to know before you take Abstral

Do not take Abstral
• if you are allergic to fentanyl or any of the other ingredients of this medicine
(listed in section 6)
• if you have severe breathing problems
• if you suffer from short-term pain other than breakthrough pain
• 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 Abstral because it
may increase the risk that breathing could become dangerously slow and/or
shallow, or even stop.
Warnings and precautions
Talk to your doctor or pharmacist before taking Abstral if you have or have recently
had any of the following, as your doctor will need to take account of these when
prescribing your dose:
• a head injury, because Abstral may cover up the extent of the injury
• breathing problems or suffer from myasthenia gravis (a condition characterised
by muscle weakness)

The following medicines may increase the effects of Abstral:
• certain types of antifungal medicines containing e.g. ketoconazole or itraconazole
(used to treat fungal infections)
• certain types of antibiotic medicines called macrolides, containing
e.g. erythromycin (used to treat infections)
• certain types of antiviral medicines called protease inhibitors, containing
e.g. ritonavir (used to treat infections caused by viruses)
• medicines containing alcohol
• medicines called monoamine-oxidase (MAO) inhibitors, which are used for
severe depression and Parkinson’s disease. Tell your doctor if you have taken
this type of medicine within the last two weeks.
The following medicines may reduce the effects of Abstral:
• 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.
Abstral may add to the effect of medicines that make you feel sleepy, including:
• other strong pain-relieving medicines (opioid-type medicines e.g. for pain
and cough)
• general anaesthetics (used to make you sleep during operations)
• muscle relaxants
• sleeping tablets
• medicines used to treat
- depression
- allergies
- anxiety and psychosis
• medicines containing clonidine (used to treat high blood pressure).
The risk of side effects increases if you are taking medicines such as certain
antidepressants or antipsychotics. Abstral 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 Abstral is suitable for you.
Abstral with food, drink and alcohol
Abstral can make some people feel drowsy. Do not consume alcohol without
consulting your doctor as it might make you feel more drowsy than usual.
Do not drink grapefruit juice while you are prescribed Abstral treatment as it may
increase the side effects of Abstral.
Pregnancy and breast-feeding
You must not use Abstral during pregnancy unless you have been specifically told to
by your doctor.

Fentanyl can get into breast milk and may cause side effects in the breast-fed infant.
Do not use Abstral if you are breast-feeding. You should not start breast-feeding until
at least 5 days after the last dose of Abstral.
Ask your doctor or pharmacist for advice before taking any medicine when pregnant
or breast-feeding.
Driving and using machines
Abstral may impair your mental and/or physical ability to perform potentially
hazardous tasks such as driving or operating machinery.
If you feel dizzy, sleepy or have blurred vision when you take Abstral, do not drive or
use machinery.
Driving in the UK
This 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 this medicine affects you.
It may be an offence to drive if your ability to drive safely is affected by taking this
There is further information for patients who are intending to drive in the UK - go to
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive
while taking this medicine.

3. How to take Abstral

Before taking Abstral for the first time your doctor will explain how Abstral should be
taken to effectively treat your breakthrough pain.
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
This product should ONLY be used by you according to your doctor’s instructions.
It should not be used by anyone else as it could present a SERIOUS risk to their
health, especially in children.
Abstral is a different type of medication from other medicines you may have used
to treat your breakthrough pain. You must always use the dose of Abstral as
prescribed by your doctor – this may be a different dose from that which you have
used with other medicines for breakthrough pain.
Starting Treatment – Finding the most appropriate dose
For Abstral to work successfully, your doctor will need to identify the most
appropriate dose for treating your breakthrough pain. Abstral is available in a range
of strengths. You may need to try different strengths of Abstral over a number of
episodes of breakthrough pain to find the most appropriate dose. Your doctor will
help you do this and will work with you to find the best dose to use.
If you do not get adequate pain relief from one dose your doctor may ask you to take
an extra dose to treat an episode of breakthrough pain. Do not take a second dose
unless your doctor tells you to, as this may result in overdose.
Sometimes your doctor may advise you to take a dose which consists of more than
one tablet at a time. Only do this if directed by your doctor.
Wait at least 2 hours from taking your last dose before treating your next episode of
breakthrough pain with Abstral.
Continuing Treatment - Once you have found the most appropriate dose
Once you and your doctor have found a dose of Abstral that controls your
breakthrough pain you should take this dose no more than four times a day. A dose
of Abstral may consist of more than one tablet.
Wait at least 2 hours from taking your last dose before treating your next episode of
breakthrough pain with Abstral.
If you think that the dose of Abstral that you are using is not controlling your
breakthrough pain satisfactorily tell your doctor, as he may need to adjust your dose.
You must not change your dose of Abstral unless directed by your doctor.

Taking the medicine
Abstral should be used sublingually. This means that the tablet should be placed
under the tongue where it dissolves rapidly in order to allow fentanyl to be absorbed
across the lining of the mouth. Once absorbed, fentanyl starts to work to relieve pain.
When you get an episode of breakthrough pain, take the dose advised by your
doctor as follows:
• If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water.
• 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 where the arrow is shown and gently remove
the tablet. Do not try to push Abstral sublingual tablets through the foil top, as this
will damage them
• 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 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.
If you take more Abstral than you should
• Remove any remaining tablets from your mouth.
• Tell your carer or another person what has happened.
• You or your carer should immediately contact your doctor, pharmacist or local
hospital and discuss what action to take.
• While waiting for the doctor, keep the person awake by talking to or shaking her/
him now and then.
Symptoms of overdose include:
• extreme drowsiness
• slow, shallow breathing.
If these occur, seek emergency medical help immediately.
If you think someone has taken Abstral by accident seek emergency medical help
If you stop taking Abstral
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.

4. Possible side effects

Like all medicines, Abstral can cause side-effects, although not everybody gets
If you start to feel unusually or extremely sleepy or your breathing becomes
slow or shallow, you or your carer should immediately contact your doctor
or local hospital for emergency help (see also section 3 “If you take more
Abstral than you should”).
Very common side effects (may affect more than 1 in 10 people) include:
• nausea.
Common side effects (may affect up to 1 in 10 people) include:
• dizziness, headache, excessive sleepiness
• breathlessness/shortness of breath
• inflammation inside the mouth, vomiting, constipation, dry mouth
• sweating, weary/tired/lack of energy.

Uncommon side effects (may affect up to 1 in 100 people) include:
• allergic reaction, trembling/shaking, disturbed or blurred vision, fast or slow heart
beat, low blood pressure, memory loss
• depression, suspicious thoughts/ feeling afraid for no reason, feeling confused,
feeling disorientated, feeling anxious/unhappy/restless, feeling unusually happy/
healthy, mood swings
• feeling full all the time, stomach ache, indigestion
• mouth ulcers, problems with tongue, pain in mouth or throat, tightness in throat,
lip or gum ulcers
• loss of appetite, loss of or change in sense of smell/taste
• difficulty sleeping or disturbed sleep, disturbance in attention/easily distracted,
lack of energy/weakness/loss of strength
• abnormality in skin, rash, itchiness, night sweats, decreased sensitivity to touch,
bruising easily
• joint pain or stiffness, stiffness in muscles
• drug withdrawal symptoms, (may manifest by the occurrence of the following
side effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating),
accidental overdose, in males an inability to get and/or keep an erection, feeling
generally unwell.
Side effects of frequency not known: (frequency cannot be estimated from the
available data)
• swollen tongue, severe breathing problems, fall, flushing, feeling very warm,
diarrhoea, convulsion (fits), swelling of arms or legs, seeing or hearing things that
are not really there (hallucinations), fever.
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 national reporting system listed below. By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517

5. How to store Abstral

The pain-relieving medicine in Abstral is very strong and could be lifethreatening if taken accidentally by a child. Abstral must be kept out of the
sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original blister in order to protect from moisture.

6. Contents of the pack and other information

What Abstral contains
The active substance is fentanyl. One sublingual tablet contains either
100 micrograms fentanyl (as citrate)
200 micrograms fentanyl (as citrate)
300 micrograms fentanyl (as citrate)
400 micrograms fentanyl (as citrate)
600 micrograms fentanyl (as citrate)
800 micrograms fentanyl (as citrate)
The other ingredients are mannitol (E421), silicified microcrystalline cellulose,
croscarmellose sodium and magnesium stearate.
What Abstral looks like and contents of the pack
Abstral is a small white sublingual tablet to be inserted under the tongue. It comes
in a range of different strengths and shapes. Your doctor will prescribe the strength
(shape) and number of tablets suitable for you.
The 100 microgram tablet is a white round tablet
The 200 microgram tablet is a white oval-shaped tablet
The 300 microgram tablet is a white triangle-shaped tablet
The 400 microgram tablet is a white diamond-shaped tablet
The 600 microgram tablet is a white “D”-shaped tablet
The 800 microgram tablet is a white capsule-shaped tablet
Abstral tablets are contained in blisters, available in cartons of 10 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing authorisation holder:
Kyowa Kirin Ltd.
Galabank Business Park
Tel : +44 (0)1896 664000
Fax : +44(0)1896 664001
Aesica Queenborough Ltd.
North Road
ME11 5EL
United Kingdom
This medicinal product is authorised in the Member States of the EEA under
the following names:
Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, UK.
Czech Republic, Estonia, Latvia, Lithuania, Slovak Republic, Romania
This leaflet was last revised in: May 2016

It is recommended to keep Abstral in a locked storage space.
Any unused product should be taken, if possible, to your pharmacist to be disposed
of safely. Do not throw away any medicines via wastewater or household waste.
These measures will help protect the environment.


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.