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

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

• 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 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
• if you suffer from short-term pain other than breakthrough pain
• if you are being treated with medicines containing sodium oxybate

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)
• if you have 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’
• if you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use

When taking Abstral, inform your doctor or dentist that you are taking this medicine, if:

• you are to have any surgery
• you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor
• you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones

Your doctor may need to check you more closely if:

• you or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
• you are a smoker
• you have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses

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:

• 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).
• Rifampin or rifabutin (medicines used to treat bacterial infections).
• Carbamazepine, phenytoin, or phenobarbital (medicines used to treat convulsions/fits).
• Herbal medicines containing St John’s wort (Hypericum perforatum).
• 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.
• 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 (sedative medicines), including:

• other strong pain-relieving medicines (opioid-type medicines e.g. for pain and cough)
• some painkillers for nerve pain (gabapentin and pregabalin)
• general anaesthetics (used to make you sleep during operations)
• muscle relaxants
• sleeping tablets
• medicines used to treat
  • depression
  • allergies
  • anxiety (such as benzodiazepines e.g. diazepam) and psychosis
• medicines containing clonidine (used to treat high blood pressure)

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’.

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:

• 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 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.

• 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
• coma

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

• agitation,
• anxiety,
• palpitations,
• shaking or
• sweating

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 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:

Manufacturer:

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:

Abstral:

Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland).

Lunaldin:

Czech Republic, Estonia, Latvia, Lithuania, Slovak Republic, Romania