O ProStrakan

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 Fentanyl

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

•    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.

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)

•    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.

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).

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, g 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.    |

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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 medicine.

There is further information for patients who are intending to drive in the UK - go to https://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.

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 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.

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 immediately.

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 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:

•    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

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL-Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie e-mail: medsafety@hpra.ie

5. How to store Abstral

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.

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:

ProStrakan Ltd,

Galabank Business Park Galashiels TD1 1QH UK

Tel:+44 (0)1896 664000 Fax:+44(0)1896 664001

Manufacturer:

Aesica Queenborough Ltd.

North Road

Queenborough

Kent

ME11 5EL United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Abstral:

Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, UK.

Lunaldin:

Czech Republic, Estonia, Latvia, Lithuania, Slovak Republic, Romania This leaflet was last revised in: 2015-07-16

LFT-ABS-GB-002

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