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"   What is it used for?  Relieving breakthrough pain in people taking regular opioid painkillers for long-term, ongoing, severe pain due to cancer.    How does it work? Abstral sublingual tablets contain the active ingredient fentanyl, which is a type of medicine called an opioid analgesic. The opioids are a group of very strong painkillers that are related to morphine. Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.  Fentanyl mimics the action of natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.  People with long-term, ongoing, severe pain, such as the pain caused by cancer, are given opioid medicines as painkillers. However, occasionally the pain can become worse despite taking these strong painkillers. This is known as &amp;#039;breakthrough&amp;#039; pain. Abstral sublingual tablets are used to relieve this breakthrough pain in people already receiving opioid painkillers on a regular basis. Abstral sublingual tablets should be allowed to dissolve underneath the tongue. This allows the fentanyl to be rapidly absorbed into the bloodstream through the rich supply of blood vessels found in this area, and provide rapid relief from pain. The tablets should not be chewed, sucked or swallowed, as this would make them less effective.    How do I take it?  Abstral tablets are taken on an as needed basis to relieve breakthrough pain. It is very important to follow the instructions given by your doctor. Check with your doctor or pharmacist if you are not sure about anything. Abstral sublingual tablets should be allowed to dissolve underneath the tongue. The tablet should not be chewed, sucked or swallowed.  If you have a dry mouth, have a drink of water before placing the tablet under your tongue. You should not eat or drink anything until the tablet has completely dissolved. You should not use Abstral more than four times in one day. If your previous dose of Abstral is not relieving pain as well, or if you have more than four episodes of breakthrough pain in a day, you should tell your doctor as your pain management may need to be reviewed. You should not change your doses of Abstral or your other pain medicines on your own. This needs to be done by your doctor so that your pain and any side effects of the medicines can be monitored.    Warning!  This medicine may cause drowsiness and dizziness and can affect your ability to concentrate. This could affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure you can do so safely.  You should avoid drinking alcohol while taking this medicine as it is likely to increase the chance of you feeling drowsy or dizzy.  From March 2015 a new &amp;#039;drug driving&amp;#039; law comes into force, which makes it an offence to drive with certain drugs or prescription medicines above specified limits in your body. Fentanyl is in the same class of medicines as some of the medicines on the list, which means it may be an offence to drive while you are taking this medicine. The new law will allow police to use roadside drug tests to check for the presence of the prohibited drugs in a driver&amp;#039;s saliva. There are very low limits for illegal drugs, but higher limits for prescribed medicines. This means most people taking fentanyl as prescribed will not be breaking the law, provided they are not driving dangerously. If you test positive for one of the medicines there is a medical defence if you are taking it as prescribed, as long as your driving is not impaired. If you are taking a high dose of fentanyl it may therefore be sensible to carry your prescription with you if you feel you are safe to drive, in case you are asked to take a test by the police. You should not drive if you think this medicine affects your ability to drive safely, for example if it makes you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision. If you are driving dangerously while taking this medicine you will be breaking the law. This medicine has severe side effects in an overdose. Do not exceed the dose prescribed by your doctor. If you become very sleepy or have slow and/or shallow breathing after taking this medicine, you or your carer should contact your doctor immediately and call for emergency help. You should not use Abstral tablets in combination with any other fentanyl medicine prescribed for breakthrough pain. If this medicine is used for prolonged periods of time, the body can become tolerant to it and it may become less effective at relieving pain. This means that with time, higher doses may be needed to control pain. With prolonged use the body may also become dependent on opioids. As a result, withdrawal symptoms can occur if all opioid painkillers are stopped suddenly. If you no longer need to use Abstral tablets but are still taking other opioids, the Abstral tablets can be stopped suddenly. However, if all opioids are to be stopped, it may be necessary to reduce treatment gradually to avoid withdrawal symptoms. Abstral tablets contain a dose of medicine that can be fatal to children. Keep your tablets well out of sight and reach of children.  Fentanyl is a controlled drug. If you are planning to travel abroad with it you should check its legal status in the countries you are travelling through and to. There are legal limits on how much of this medicine you can take abroad with you. If you need to take more than this limit you will have to apply to the Home Office for a licence before you travel. Even if you don&amp;#039;t need a licence, if you are taking this medicine abroad it is always a good idea to carry a letter from your doctor that confirms your need for the medicine. You should always carry the medicine in correctly labelled packaging, as dispensed by the pharmacy.     Not to be used in  People who are NOT already taking opioid painkillers. People with very slow, shallow breathing (severe respiratory depression). Severe obstructive lung conditions such as severe chronic obstructive pulmonary disease (COPD). People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days.  The safety and effectiveness of Abstral tablets have not been established in children and adolescents under 18 years old. They are not recommended for this age group.  This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.   Use with caution in  People with inflammation or open wounds inside the mouth.  Elderly people. Weak or debilitated people. People with decreased kidney or liver function. People with lung disease such as asthma or chronic obstructive pulmonary disease (COPD). People with a condition called myasthenia gravis, which involves abnormal muscle weakness. People with a head injury or raised pressure in the brain (intracranial pressure).  People with reduced levels of consciousness. People with a brain tumour. People with a history of convulsions (fits), eg epilepsy. People with chronic constipation, inflammatory or obstructive bowel disease. People with a slow abnormal heart rhythm (bradyarrhythmia). People with low blood pressure (hypotension). People with low levels of fluid in the body. People with a history of drug dependence. Men with an enlarged prostate gland.    Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.  The safety of this medicine for use during pregnancy has not been established. If used for long periods during pregnancy it may cause breathing problems and withdrawal symptoms in the baby at birth. It is not recommended for use in pregnancy, particularly during the third trimester and during labour, unless considered essential by your doctor. Seek medical advice from your doctor.  This medicine passes into breast milk and carries a risk of the medicine causing drowsiness and breathing problems in a nursing infant. The manufacturer states that this medicine should only be used during breastfeeding if the benefits to both mother and infant outweigh any risks of the medicine to the nursing infant. If your doctor says you can breastfeed while using this medicine, the infant should be monitored for signs of drowsiness and breathing problems. Seek further medical advice from your doctor.     Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.   Very common (affect more than 1 in 10 people)   Feeling sick.    Common (affect between 1 in 10 and 1 in 100 people)  Vomiting.  Constipation. Dizziness. Sleepiness.  Headache. Dry or sore mouth. Sweating.  Fatigue. Feeling short of breath.    Uncommon (affect between 1 in 100 and 1 in 1000 people)  Feeling weak or generally unwell. Loss of appetite. Disturbance in sense of taste or smell. Loss of sensation (numbness). Mouth, gum or lip ulcers. Sore throat or throat tightness. Stomach pain or discomfort, indigestion. Feeling confused or disorientated. Problems with concentration. Feeling of well-being, optimism and cheerfulness (euphoria). Depression, paranoia or anxiety. Mood swings. Difficulty sleeping (insomnia). Tremor. Blurred vision. Skin reactions such as rash and itching.  Fast or slow heart rate (tachycardia or bradycardia). Low blood pressure (hypotension). Pain or stiffness in the joints. Difficulty getting an erection (erectile dysfunction).    Unknown frequency  Slow, shallow breathing. Difficulty passing urine. Convulsions (fits). Hallucinations.  The side effects listed above may not include all of the side effects reported by the medicine&amp;#039;s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it\u2019s necessary they&amp;#039;ll report it for you. You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard.   How can this medicine affect other medicines? It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.  This medicine should not be taken by people who are taking a monoamine oxidase inhibitor antidepressant (MAOI), for example the antidepressants phenelzine, tranylcypromine or isocarboxazid, or by people who have taken one of these medicines in the last 14 days.  There may be an increased risk of side effects such as drowsiness, sedation, low blood pressure and slow, shallow breathing, if this medicine is used with other medicines that have a sedative effect on the central nervous system. These include the following:   antipsychotics, eg haloperidol  barbiturates, eg phenobarbital, amobarbital   benzodiazepines, eg diazepam, temazepam  general anaesthetics  muscle relaxants, eg baclofen   other opioid painkillers, eg morphine, codeine   sedating antihistamines, eg chlorphenamine, hydroxyzine  sleeping tablets, eg zopiclone   tricyclic antidepressants, eg amitriptyline.  The following medicines can decrease the breakdown of fentanyl by the liver and so could increase the risk of fentanyl side effects:   aprepitant and fosaprepitant (in the first two weeks of combined use, after this the aprepitant could reduce the blood level of fentanyl and make it less effective) azole antifungals such as ketoconazole, itraconazole, fluconazole, posaconazole or voriconazole  cimetidine crizotinib macrolide antibiotics such as clarithromycin, erythromycin or telithromycin  protease inhibitors for HIV, eg ritonavir.  You should let your doctor know if you experience any signs of increased fentanyl side effects if you are prescribed one of the above medicines, for example, trouble breathing or shallow breathing, tiredness, difficulty thinking, walking or talking normally, or feeling faint, dizzy or confused. Your doctor may need to decrease your dose of fentanyl. The following medicines may increase the breakdown of fentanyl by the liver and as a result your doctor may need to increase your fentanyl dose if you are prescribed one of these:  carbamazepine fosphenytoin phenytoin rifampicin the herbal remedy St John&amp;#039;s wort (avoid taking this remedy while you are taking fentanyl unless your doctor or pharmacist have advised that it is OK).  There may be an increased risk of a rare but potentially serious side effect known as the &amp;#039;serotonin syndrome&amp;#039; if fentanyl is used in combination with medicines that increase the levels or activity of serotonin in the nervous system. These include the following:  selective serotonin reuptake inhibitor antidepressants (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine or sertraline  serotonin noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine or duloxetine.  If you are taking any of these medicines you should let your doctor know if you experience symptoms such as confusion, agitation, tremor, muscle twitching, shivering, sweating, racing heartbeat or diarrhoea after taking Abstral tablets.  Fentanyl may oppose the effects of the following medicines on the gut:   domperidone   metoclopramide.  The following medicines will oppose the painkilling effect of fentanyl:  buprenorphine nalmefene naltrexone  pentazocine.    Other medicines containing the same active ingredient   Actiq lozenges. Breakyl films.  Durogesic Dtrans patches.  Effentora tablets. Fencino patches. Fentalis patches. Fentanyl injection.  Instanyl nasal spray. Matrifen patches. Mezolar patches. Opiodur patches.  Osmanil patches.  PecFent nasal spray. Recivit sublingual tablets. Sublimaze injection.  Tilofyl patches. Victanyl patches.    Further reading For background information about our medicine factsheets, including the references used to produce them, click here. Last updated 24.02.2015 "^^<http://www.w3.org/2001/XMLSchema#string>
<http://www.netdoctor.co.uk/medicines/cancer/a8647/abstral-tablets-fentanyl/>