The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16508/0032.
Abstral Sublingual Tablets
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
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
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.
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:
When taking Abstral, inform your doctor or dentist that you are taking this medicine, if:
Your doctor may need to check you more closely if:
Repeated use of Abstral may lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on Abstral, it is important that you consult your doctor.
Sleep-related breathing disorders
Abstral can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties in maintaining sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
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).
Some medicines may increase or decrease the effects of Abstral. Therefore if you start, change the dose of, or stop therapy with the following medication tell your doctor as they may need to adjust your dose of Abstral:
Abstral may add to the effect of medicines that make you feel sleepy (sedative medicines), including:
Use of Abstral at the same time as medicines that make you feel sleepy (sedative medicines), such as benzodiazepines, increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, use of Abstral together with sedative medicines should only be considered when other treatment options are not possible.
However, if your doctor does prescribe Abstral together with sedative medicines, the dose and duration of treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
The risk of certain other 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 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.
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.
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 medicine.
There is further information for patients who are intending to drive in the UK - go to www.gov.uk/drug-driving-law
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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.
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.
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.
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:
Symptoms of overdose include:
If these occur, seek emergency medical help immediately.
If you think someone has taken Abstral by accident, seek emergency medical help immediately.
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.
There is a risk that you may become addicted to or dependent on these tablets (a need to keep taking the medicines). If you take these for a long time you can become used to the effects and you may need to take higher doses to control your pain.
You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking you tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. If you suddenly stop taking these tablets you may get withdrawal symptoms such as
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
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:
Common side effects (may affect up to 1 in 10 people) include:
Uncommon side effects (may affect up to 1 in 100 people) include:
Side effects of frequency not known: (frequency cannot be estimated from the available data)
Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2).
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 www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
The pain-relieving medicine in Abstral is very strong and could be life-threatening 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.
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.
The active substance is fentanyl. One sublingual tablet contains:
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.
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:
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland).
Czech Republic, Estonia, Latvia, Lithuania, Slovak Republic, Romania
This leaflet was last revised in: 02 September 2022