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Document: Abstral sublingual tablet ENG PL change

• Abstral sublingual tablet PL
• Abstral sublingual tablet ENG PL

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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

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. Donot pass it on to others. It may harmthem, 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

6. Contents of the pack and other information

1. What Abstral is and what it is used for

Abstralis 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 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Abstralif 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 haveproblems with your heart especially slow heart rate

 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)

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 oritraconazole (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

o depression

o allergies

o anxiety and psychosis

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.

Abstralwith 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 Abstraltreatment 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.

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 Abstralas 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 Abstralto work successfully, your doctor will need to identify the most appropriate dose for treating your breakthrough pain. Abstralis available in a range of strengths. You may need to try different strengths of Abstralover 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 Abstralthat 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

Abstralshould be used sublingually, which 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 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

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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:

• 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 in100 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)

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.

To be completed nationally.

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:

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

Abstraltablets 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 Galashiels TD1 1QH UK

Manufacturer:

Recipharm Stockholm AB Lagervägen 7 136 50 Jordbro Sweden Aesica Queenborough Ltd. North Road Queenborough Kent ME11 5EL United Kingdom Gedeon Richter Plc. Gyömrői út 19-21 1103 Budapest Hungary

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: 2016-07-29