ABSTRAL 100 MCG Sublingual tablet

Зміст інструкції

1. Abstral sublingual tablets 100 micrograms, sublingual tablets 200 micrograms, sublingual tablets 300 micrograms, sublingual tablets 400 micrograms, sublingual tablets 600 micrograms, sublingual tablets 800 micrograms
   1. What is Abstral and what is it used for
   2. What you need to know before taking Abstral
   3. How to take Abstral
   4. Possible side effects
   5. How to store Abstral
   6. Contents of the pack and other information

Abstral sublingual tablets 100 micrograms, sublingual tablets 200 micrograms, sublingual tablets 300 micrograms, sublingual tablets 400 micrograms, sublingual tablets 600 micrograms, sublingual tablets 800 micrograms

fentanil

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of 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 is Abstral and what is it used for

Abstral is a treatment intended for adults who already need to regularly take potent
pain medications (opioids)for persistent cancer pain, but who require a
treatment for intense episodic pain. If you have any doubts, consult your doctor.
Intense episodic pain is pain that occurs suddenly, even if you have already taken your
usual opioid pain medication.
The active ingredient in Abstral sublingual tablets is fentanyl. Fentanyl belongs to
a group of potent pain medications called opioids.

2. What you need to know before taking 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 do not regularly use an opioid medicine prescribed by your doctor (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day according to a regular schedule, for at least one week, for the control of persistent pain. If you are not using these medicines you must notuse Abstral because it may increase the risk that your breathing may become slow and/or difficult in a dangerous way, or even stop
• if you suffer from short-term pain other than episodic intense pain
• if you are being treated with medicines that contain sodium oxybate.

Warnings and precautions
Talk to your doctor or pharmacist before taking Abstral if you have or have recently had any of the
following conditions, as your doctor will need to take these into account when prescribing the dose:

• a head injury, as Abstral may mask the extent of the injury
• breathing problems or myasthenia gravis (a condition characterised by muscle weakness)
• if you have heart problems, particularly slow heartbeat
• low blood pressure
• kidney or liver disease, as this may require your doctor to make a more careful dose adjustment
• brain tumour and/or increased intracranial pressure (increased pressure in the brain causing severe headache, nausea/vomiting and blurred vision)
• sores in the mouth or mucositis (swelling and redness inside the mouth)
• if you are taking antidepressants or antipsychotics refer to section “Other medicines and Abstral”
• if you have developed adrenal insufficiency or a lack of sex hormones (androgen deficiency) in the past with the use of opioids

During treatment with Abstral, tell your doctor or dentist that you are taking this
medicine, if

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

It is possible that your doctor may need to monitor you more closely:

• if you or someone in your family has ever abused or been dependent on alcohol, prescription medicines or illicit substances (“addiction”);
• if you smoke;
• if you have ever had mood problems (depression, anxiety or personality disorders) or if you have been treated by a psychiatrist for other mental illnesses. Repeated use of Abstral can lead to dependence and abuse, which can result in a potentially fatal overdose. If you feel you cannot do without Abstral, it is important to consult your doctor.

Sleep-related breathing disorders
Abstral can cause sleep-related breathing disorders such as sleep apnea (pauses in
breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms
may include pauses in breathing during sleep, awakenings at night due to
shortness of breath, difficulty maintaining sleep or excessive daytime sleepiness. If you or
another person notice these symptoms, contact your doctor. The doctor may consider reducing the
dose.
For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Abstral
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines (other than your usual opioid pain medicine).
Some medicines can increase or reduce the effects of Abstral. Therefore, if you start or
stop taking the following medicines, or change their dose, tell your doctor because
they may need to adjust the dose of Abstral:

• some types of antifungal agents containing e.g. ketoconazole or itraconazole (used to treat fungal infections);
• some types of antibiotic medicines used to treat infections (called macrolides, containing e.g. erythromycin);
• some types of antiviral medicines called protease inhibitors containing e.g. ritonavir (used to treat infections caused by viruses);
• rifampicin or rifabutin (medicines used to treat bacterial infections);
• carbamazepine or phenytoin or phenobarbital (medicines used to treat seizures/epileptic fits);
• herbal remedies containing St John's wort ( Hypericum perforatum);
• medicines containing alcohol;
• medicines called monoamine oxidase inhibitors (MAO), which are used for severe depression and Parkinson's disease; tell your doctor if you have taken this type of medicine in the last two weeks.
• Some types of potent painkillers, called partial agonists/antagonists, for example buprenorphine, nalbuphine and pentazocine (medicines for the treatment of pain). In combination with the use of these medicines withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating) may occur.

Abstral can intensify the effect of medicines that cause drowsiness (sedatives), such as:

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

The concurrent use of Abstral and medicines that cause drowsiness (sedatives), such as
benzodiazepines, increases the risk of drowsiness, breathing difficulties (respiratory depression),
coma and can be life-threatening. For this reason, the concurrent use of Abstral and
sedative medicines should only be considered when other treatment options are not possible.
However, if your doctor prescribes Abstral together with sedative medicines, the dose and duration of
concurrent treatment must be limited by the doctor.
Tell your doctor about all sedative medicines you are taking and carefully follow
the dose recommendations provided by your doctor. It may be helpful to inform friends or relatives about
the signs and symptoms mentioned above. Contact your doctor when these symptoms occur
The risk of some other side effects increases if you are taking certain antidepressants or
antipsychotics. Abstral can interact with these medicines and you may experience changes in mental
status (e.g. agitation, hallucinations, coma) and other effects such as a temperature above
38°C, increased heart rate, unstable blood pressure and exaggeration of
reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea,
vomiting, diarrhoea). Your doctor will tell you if Abstral is suitable for you.

Abstral with food, drinks and alcohol
In some people Abstral can cause drowsiness. Do not drink alcohol without consulting your doctor, as
it may cause you to feel more drowsy than usual.
Do not drink grapefruit juice if you have been prescribed treatment with Abstral, as it may
increase the side effects of Abstral.

Pregnancy and breastfeeding
Do not use Abstral during pregnancy unless explicitly told to do so by your doctor.
Fentanyl can pass into breast milk and cause unwanted effects in the breastfed baby. Do not
take Abstral during breastfeeding. You can only start breastfeeding your baby
at least 5 days after taking the last dose of Abstral.
Ask your doctor or pharmacist for advice before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
Abstral may affect your physical or mental ability to perform potentially
dangerous activities, such as driving or using machines.
If you feel dizzy, drowsy or have blurred vision when taking Abstral, do not drive or use machines.

Abstral contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
‘sodium-free’.

3. How to take Abstral

Before taking Abstral for the first time, your doctor will explain how to take it to effectively treat breakthrough pain. Take this medicine exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist. This product must be used ONLY by you, based on the instructions provided by your doctor. It must not be used by anyone else as it may pose a SERIOUS risk to their health, especially for children. Abstral is different from other medicines you may have used to treat breakthrough pain. You must always use the dose of Abstral prescribed by your doctor–this may be a different dose than the one you used with other medicines for breakthrough pain.

Initial treatment – finding the most suitable doseFor Abstral to work, your doctor needs to identify the most suitable dose for treating your breakthrough pain. Abstral is available in a range of dosages. You may need to try different doses of Abstral over several episodes of breakthrough pain to find the most suitable dose. Your doctor will help you find the best dose to use. If you do not get adequate pain relief from a dose, your doctor may ask you to take an extra dose to treat an episode of breakthrough pain. Do not take a second tablet, unless your doctor tells you that you can, as this could lead to an overdose. It may happen that your doctor advises you to take a dose consisting of more than one tablet at a time. Take this dose only if prescribed by your doctor.Wait at least 2 hours after taking the last dose before treating a new episode of breakthrough pain with Abstral.

Continued treatment – once the most suitable dose has been foundOnce you and your doctor have found a dose of Abstral that can control 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 after taking the last dose before treating a new episode of breakthrough pain with Abstral. If you think that the dose of Abstral you are using does not adequately control your breakthrough pain, tell your doctor, as they may need to adjust your dose. Do not change the dose of Abstral ,unless you have been told to do so by your doctor.

Taking the medicineAbstral must be used sublingually. This means that the tablet must be placed under the tongue, where it dissolves quickly, so that fentanyl can be absorbed through the lining of the mouth. Once absorbed, fentanyl begins to work to provide its pain-relieving effect. When you have an episode of breakthrough pain, take the dose indicated by your doctor, as follows:

• if your mouth is dry, take a sip of water to moisten it. Spit or swallow the water;
• remove one or more tablets from the blister pack immediately before taking them, as follows:
• separate one of the squares of the blister from the pack by cutting along the dotted lines (leaving the remaining squares of the blister intact).
• Peel off the edge of the aluminum layer where the arrow is indicated and gently remove the tablet. Do not try to push the Abstral sublingual tablets through the top layer of aluminum, as this will damage them
• place the tablet under your tongue as far back as possible and allow it to dissolve completely;
• Abstral will dissolve rapidly under the tongue and be absorbed to provide its pain-relieving effect. Therefore, it is important that you do not suck, chew, or swallow the tablet;
• do not drink or eat anything until the tablet has completely dissolved under your tongue.

If you take more Abstral than you should

• remove any tablets from your mouth
• tell the person who is caring for you or anyone else what has happened
• you or the person who is caring for you should immediately contact your doctor, pharmacist, or local hospital and discuss what action to take
• while waiting for the doctor, the person should be kept awake by talking to or shaking them continuously

The symptoms of an overdose include:

• extreme drowsiness
• slowed and difficult breathing
• coma

In such an event, seek immediate emergency medical treatment. If you think that someone has accidentally taken Abstral, seek immediate emergency medical treatment.

If you stop taking AbstralIf you no longer experience breakthrough pain, you should stop taking Abstral. However, you should continue to take your usual opioid pain medicine for the treatment of persistent cancer pain, following your doctor's instructions. If you stop taking Abstral, you may experience drug withdrawal symptoms similar to the possible side effects of Abstral. Contact your doctor if you develop withdrawal symptoms or have concerns about pain relief. The doctor will assess whether to prescribe you a medicine to reduce or eliminate withdrawal symptoms. If you have any doubts about using 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 if you experience slowed or difficult breathing,
you or the person assisting you must immediately contact your doctor or
local hospital for emergency medical attention (see also paragraph 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
• dyspnea/shortness of breath
• inflammation of the oral mucosa, vomiting, constipation, dry mouth
• sweating, fatigue/tiredness/lack of energy

Uncommon side effects (may affect up to 1 in 100 people) include:

• allergic reaction, tremor/shaking, disturbed or blurred vision, fast or slow heartbeat, low blood pressure, memory loss
• depression, paranoia/unfounded fear, feeling of confusion, disorientation, anxiety/unhappiness/restlessness, unusual feeling of happiness/well-being, mood swings
• feeling of fullness in the stomach, stomach pain, indigestion
• mouth ulcers, tongue problems, pain in the mouth or throat, constriction of the throat, lip or gum ulcers
• loss of appetite, loss or alteration of taste/smell
• difficulty sleeping or disturbed sleep, attention disorders/distractibility, lack of energy/weakness/loss of strength
• skin abnormalities, skin rashes, itching, night sweats, reduced sensitivity to touch, easy bruising
• joint pain or stiffness, muscle stiffness
• drug withdrawal symptoms (may occur if the following side effects appear: nausea, vomiting, diarrhea, anxiety, chills, tremors and sweating), accidental overdose, in men inability to achieve and/or maintain an erection, general feeling of discomfort

Side effects of unknown frequency: (frequency cannot be estimated based on available data)

• swelling of the tongue, severe breathing problems, falls, flushing, feeling very warm, diarrhea, seizures (fits), swelling of the arms or legs, seeing or hearing things that do not exist (hallucinations), fever, drug dependence, drug abuse, reduced level or loss of consciousness and itching and Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares). Prolonged treatment with fentanyl during pregnancy can cause withdrawal symptoms in the newborn, which can have fatal consequences (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Abstral

The pain relief medicine in Abstral is very strong and could be dangerous to life if accidentally
taken by a child. Keep Abstral out of 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 at a temperature above 25°C.
Store in the original blister to protect the medicine from moisture.
It is recommended to store Abstral in a secure storage location, locked up.
Any unused product should be delivered, if possible, to the pharmacist for safe disposal. Do not
dispose of any medicine in wastewater or household waste. This will help protect the
environment.

6. Contents of the pack and other information

What Abstral contains
The active ingredient is fentanyl. One sublingual tablet contains:
100 micrograms of fentanyl (citrate)
200 micrograms of fentanyl (citrate)
300 micrograms of fentanyl (citrate)
400 micrograms of fentanyl (citrate)
600 micrograms of fentanyl (citrate)
800 micrograms of fentanyl (citrate)
The excipients are mannitol (E421), silicified microcrystalline cellulose, sodium croscarmellose and
magnesium stearate.

Description of Abstral and contents of the pack
Abstral is a small, white sublingual tablet, to be placed under the tongue. It is supplied in a
range of different dosages and shapes. Your doctor will prescribe the dosage (the shape) and the number of
tablets that are right for you.
The 100 microgram tablet is white and round in shape
The 200 microgram tablet is white and oval in shape
The 300 microgram tablet is white and triangular in shape
The 400 microgram tablet is white and pentagonal in shape
The 600 microgram tablet is white and “D” shaped
The 800 microgram tablet is white and capsule shaped
Abstral tablets are available in packs of 10 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Grünenthal Italia S.r.l.
Via Vittor Pisani, 16
20124 Milano

Manufacturer:
RECIPHARM LEGANÉS S.L.U.
Calle Severo Ochoa 13
Leganés, 28914 (Madrid)
Spain
Aesica Queenborough Ltd.
North Road
Queenborough
Kent
ME11 5 EL
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Abstral:
Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Italy, Norway, Netherlands, Portugal, United
Kingdom (Northern Ireland), Slovenia, Spain, Sweden.
Lunaldin:
Estonia, Latvia, Lithuania, Czech Republic, Romania, Slovakia.