Aurofena

Package leaflet: Information for the user

AuroFena, 100 micrograms, buccal tablets
AuroFena, 200 micrograms, buccal tablets
AuroFena, 400 micrograms, buccal tablets
Fentanylum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What AuroFena is and what it is used for
2. What you need to know before using AuroFena
3. How to use AuroFena
4. Possible side effects
5. How to store AuroFena
6. Contents of the pack and other information

1. What AuroFena is and what it is used for

The active substance in AuroFena is fentanyl citrate. AuroFena is an opioid pain-relieving medicine used to treat breakthrough cancer pain in adult patients who are already taking other opioid pain medicines for the management of persistent (constant) pain caused by cancer.
Breakthrough pain is an additional, sudden episode of pain that occurs despite regular treatment with an opioid pain medicine.

2. Important information before using AuroFena

When NOT to use AuroFena:

• if the patient has not been regularly taking an opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) prescribed by a doctor for at least one week to manage chronic pain on a daily basis. If the patient has not taken these medicines, AuroFena must not be used, as this medicine may increase the risk of dangerous slowing and/or weakening of breathing, or even respiratory arrest.
• if the patient is allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• if the patient has serious breathing problems or obstructive lung disease.
• if the patient suffers from short-term pain other than breakthrough pain.
• if the patient is taking a medicine containing sodium hydroxymethylglycinate.

Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with AuroFena.
While being treated with AuroFena, continue taking your prescribed opioid pain medicine for persistent (constant) cancer-related pain.
Do not use other fentanyl-containing medicines previously prescribed for breakthrough pain while using AuroFena. If you still have such medicines, return them to a pharmacist for proper disposal.
Keep the medicine in a safe and secure place inaccessible to others (for more information, see section 5. “How to store AuroFena”).
Talk to your doctor or pharmacist before starting AuroFena if any of the following apply:

• the dose of another opioid medicine used to treat persistent (constant) cancer-related pain has not yet been stabilized
• any condition affecting breathing (e.g. asthma, wheezing or shortness of breath)
• head injury
• very slow heart rate or other heart problems
• liver or kidney problems, as these organs affect how the body processes the medicine
• dehydration or low blood pressure
• age over 65 years – a lower dose may be required, and any dose increase will be closely monitored by the doctor
• heart problems, especially slow heart rate
• the patient is taking benzodiazepines (see section 2 “AuroFena and other medicines”). Concomitant use of benzodiazepines may increase the risk of serious adverse effects, including death.
• the patient is taking antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase inhibitors [MAOIs]; see section 2 “When not to use AuroFena” and “AuroFena and other medicines”). Using these medicines with AuroFena may lead to serotonin syndrome, a potentially life-threatening condition (see section 2 “AuroFena and other medicines”).
• the patient has ever had adrenal insufficiency, a condition in which the adrenal cortex does not produce enough hormones, or sex hormone deficiency (androgen deficiency) during opioid use (see section 4 “Serious adverse reactions”)
• the patient has ever abused or is/was dependent on opioids, other medicines, alcohol or drugs
• alcohol consumption; see section “Using AuroFena with food, drink and alcohol”.

Talk to your doctor DURING treatment with AuroFena if:

• the patient experiences pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of medicine prescribed by the doctor.
• the patient experiences several of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure. The presence of these symptoms together may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• the patient has sleep-related breathing disorders: AuroFena may cause sleep-related breathing problems such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact a doctor. The doctor may consider reducing the dose.

Long-term use and tolerance
This medicine contains fentanyl, which is an opioid medicine. Repeated use of opioid pain medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as drug tolerance). During treatment with AuroFena, the patient’s sensitivity to pain may also increase. This phenomenon is known as hyperalgesia.
Increasing the dose of AuroFena may temporarily further reduce pain intensity, but it may also be harmful. If the patient notices reduced effectiveness of the medicine, they should consult their doctor. The doctor will decide whether increasing the dose or gradually reducing treatment with AuroFena is the better option for the patient.
Dependence and compulsive use

Repeated use of AuroFena may also lead to dependence, abuse, and compulsive use, which may result in life-threatening overdose.
The risk of these adverse effects may increase with higher doses and prolonged duration of use. Dependence or compulsive use may cause the patient to feel a loss of control over how much of the drug to take or how often to take it. The patient may feel a need to continue taking the drug, even if it no longer helps relieve their pain symptoms.

The risk of dependence or compulsive use varies among individuals. The risk of dependence on or compulsive use of AuroFena may be greater if:

• the patient or anyone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur in the patient while using AuroFena, this may indicate dependence or compulsive use:

• The patient needs to take this medicine for longer than prescribed by the doctor.
• The patient needs to take a higher dose than recommended.
• The patient uses this medicine for reasons other than those for which the doctor prescribed it, for example, "to calm down" or "to be able to sleep."
• The patient has made several unsuccessful attempts to stop or control use of this medicine.
• After stopping the use of this medicine, the patient feels unwell (e.g., nausea, vomiting, diarrhoea, anxiety, chills, tremors, and excessive sweating), and feels better when taking the medicine again ("withdrawal effect").

If the patient notices any of these symptoms, they should discuss with their doctor the best treatment strategy for them, including when it is appropriate to discontinue treatment and how to safely stop treatment.
Seek IMMEDIATE medical help if:

• While using AuroFena, the patient experiences symptoms such as difficulty breathing or dizziness, swelling of the tongue, lips, or throat. These may be early signs of a serious allergic reaction (anaphylaxis, hypersensitivity; see section 4 "Serious adverse reactions").

Accidental ingestion of AuroFena
If there is suspicion that someone has accidentally ingested AuroFena, medical help should be sought immediately. The person should be kept awake until emergency help arrives.
A person who has accidentally ingested AuroFena may experience the same adverse effects as described in the section "Use of a higher than recommended dose of AuroFena."

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age.

AuroFena and other medicines
Before starting AuroFena, inform your doctor or pharmacist if the patient is currently taking, has taken recently, or plans to take any of the following medicines:

• Concurrent use of fentanyl and sedative medicines such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered if no other treatment options are possible. However, if the doctor prescribes fentanyl together with sedative medicines, the doctor will limit the dose and duration of concurrent treatment. Inform the doctor about all currently used sedative medicines (such as sleeping pills, anti-anxiety medicines, certain medicines used to treat allergic reactions (antihistamines), or tranquilizers) and strictly follow the dose prescribed by the doctor. It may be helpful to inform friends and family members and make them aware of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact the doctor immediately.

Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see When NOT to use AuroFena:). Treatment with sodium oxybate must be discontinued before starting treatment with AuroFena.

• Certain muscle relaxants – such as baclofen, diazepam (see also section "Warnings and precautions").
• Medicines that may affect how the body processes fentanyl, for example ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines used to control HIV infection) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (for treatment of fungal infections), troleandomycin, clarithromycin, or erythromycin (for treatment of bacterial infections), aprepitant (for treatment of severe nausea), and diltiazem and verapamil (for treatment of high blood pressure and heart diseases).
• Medicines known as monoamine oxidase inhibitors (MAO inhibitors) (used in severe depression), or if they have been taken within the last 2 weeks.
• Certain strong painkillers known as partial agonists/antagonists, e.g., buprenorphine, nalbuphine, and pentazocine (analgesics). When these medicines are used, the patient may experience withdrawal symptoms (nausea, vomiting, diarrhoea, restlessness, chills, tremor, and sweating).
• Certain medicines used to treat neuropathic pain (gabapentin and pregabalin).
• The risk of adverse effects increases if the patient takes medicines such as certain antidepressants or antipsychotics. AuroFena may interact with these medicines, and the patient may experience changes in mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). The doctor will advise the patient whether AuroFena is suitable for them.

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Use of AuroFena with food, drink, and alcohol

• AuroFena may be taken before or after, but not during meals. A small amount of water may be taken before taking AuroFena to moisten the mouth, but do not drink or eat while taking the medicine.
• Do not drink grapefruit juice during treatment with AuroFena, as it may affect how the body processes fentanyl.
• Alcohol must not be consumed during treatment with AuroFena, as it may increase the risk of serious adverse effects, including death.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
AuroFena should not be used during pregnancy unless prescribed by a doctor. If AuroFena is used for a prolonged period during pregnancy, there is also a risk that the newborn may experience withdrawal symptoms, which, if unrecognized and untreated by a doctor, may be life-threatening.
AuroFena should not be used during childbirth, as fentanyl may cause respiratory depression in the newborn.

Breastfeeding
Fentanyl may pass into breast milk and cause side effects in the breastfed infant. AuroFena should not be used in patients who are breastfeeding. Breastfeeding should not be started for at least 5 days after the last dose of AuroFena.

Driving and operating machinery
Ask your doctor whether it is safe to drive or operate mechanical equipment after taking AuroFena. Do not drive a car or operate machinery if drowsiness, dizziness, blurred or double vision, or difficulty concentrating occur. It is important that the patient knows how they react to AuroFena before driving or operating machinery.

AuroFena contains sorbitol
This medicine contains 67.1 mg of sorbitol in each buccal tablet.

3. How to use AuroFena

This medicine should always be used exactly as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Before starting treatment and regularly during therapy, the doctor will discuss with the patient what
to expect from using AuroFena, when and for how long it should be taken, when to contact the
doctor, and when to stop using the medicine (see also section 2).
Dosage and frequency of administration
When starting AuroFena, the doctor will determine, in consultation with the patient, an appropriate
dose to relieve breakthrough pain. AuroFena should always be used exactly as directed by the
doctor. The initial dose is 100 micrograms. During dose titration, the doctor may recommend taking
more than one tablet during an episode. If breakthrough pain does not subside within 30 minutes,
only one additional tablet of AuroFena should be taken during the dose adjustment period.
Once the appropriate dose has been established by the doctor, the general rule is to take one
tablet per breakthrough pain episode. In the future, pain management may require dose changes.
Higher doses may be necessary. If breakthrough pain does not subside within 30 minutes, one
additional tablet of AuroFena may be taken during subsequent dose adjustment.
If the established dose of AuroFena is insufficient to relieve breakthrough pain, contact the doctor,
who will decide whether the dose should be changed.
At least 4 hours should elapse before administering AuroFena for the treatment of another
breakthrough pain episode.
Inform the doctor immediately if AuroFena is used more than 4 times per day, as this may necessitate
a change in the treatment regimen. The doctor may modify the management of chronic pain. Once
better control of background pain is achieved, the doctor may adjust the dose of AuroFena. If the
doctor suspects increased pain sensitivity (hyperalgesia) related to fentanyl use, a reduction in
fentanyl dose may be considered (see section 2 "Warnings and precautions"). To achieve effective
treatment, the patient should inform the doctor about experienced pain and the effects of AuroFena,
so that the dose can be adjusted if necessary.
Do not change the dose of AuroFena or other pain medications independently. Dose adjustments
must be prescribed and monitored by the doctor.
If you have any questions or uncertainties regarding the use or correct dosage, contact your doctor
again.
Method of administration
AuroFena, buccal tablets, are administered to the oral mucosa.
Once placed in the mouth, the tablet dissolves and the active substance is absorbed into the
bloodstream through the oral mucosa. This method of administration allows for rapid absorption
and effective relief of breakthrough pain.
How to use the medicine

• Open the blister pack only when the patient is ready to take the tablet. The tablet must be taken immediately after removal from the blister.
• Separate the single-dose unit from the rest of the blister pack by tearing along the perforated line.
• Bend the blister unit along the marked line.
• Peel back the foil from the back of the blister to expose the tablet. DO NOT attempt to push the tablet through the blister, as it may become damaged.

• Remove the tablet from the blister and immediately place it near the molar tooth, between the gum and the cheek (as shown in the picture). Sometimes the doctor may recommend placing the tablet under the tongue.
• Do not crush or divide the tablet.

• Do not bite, suck, chew, or swallow the tablet, as this may result in less effective pain relief than when taken as directed.
• The tablet should remain between the upper gum and cheek until it dissolves completely, which may take up to 30 minutes. If irritation occurs, the tablet may be repositioned on the gum.
• After 30 minutes, if remnants of the tablet remain in the mouth, they may be swallowed with a glass of water. Taking more AuroFena than recommended
• The most commonly observed adverse effects are drowsiness, nausea, or dizziness. If the patient experiences severe dizziness or excessive drowsiness before the tablet has completely dissolved, they should immediately rinse their mouth with water and spit out any remaining tablet fragments into a sink or toilet.
• A serious adverse effect of fentanyl is slowed and/or shallow breathing. This may occur if the fentanyl dose is too high or if the patient takes AuroFena in excessive amounts. In severe cases, symptoms of overdose with AuroFena may lead to coma. If dizziness, pronounced drowsiness, or slow or shallow breathing occur, contact the doctor immediately.
• Overdose may also cause brain disorders known as toxic leukoencephalopathy. Missing a dose of AuroFena If breakthrough pain persists, AuroFena may be taken as directed by the doctor. If breakthrough pain has subsided, do not take AuroFena until the next breakthrough pain episode occurs.

Stopping AuroFena
AuroFena should be discontinued when the patient no longer experiences breakthrough pain. However,
continue taking the prescribed opioid pain medication regularly for the treatment of chronic cancer-
related pain, as directed by the doctor. Withdrawal symptoms similar to possible adverse effects of
AuroFena may occur when stopping fentanyl. If withdrawal symptoms occur, or if the patient is
concerned about pain relief, contact the doctor. The doctor will assess whether the patient needs
medication to reduce or eliminate withdrawal symptoms.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any side effects occur, you should contact your doctor.

Serious adverse effects

• The most serious adverse effects are shallow breathing, low blood pressure and shock. AuroFena, like other medicines containing fentanyl, may cause very severe breathing problems which can lead to death. If severe drowsiness and/or shallow breathing occur, the patient or caregiver should immediately contact a doctor and call emergency services.
• Contact your doctor immediately if the patient experiences any of the following symptoms together:
  • Nausea, vomiting, loss of appetite, tiredness, weakness, dizziness and low blood pressure.

The occurrence of these symptoms together may indicate a potentially life-threatening condition called adrenal insufficiency. This is a condition in which the adrenal glands do not produce adequate amounts of hormones.

Other adverse effects
Very common: may affect more than 1 in 10 people

• dizziness, headache
• feeling nauseous, vomiting
• at the site of tablet placement: pain, ulceration, irritation, bleeding, numbness, loss of sensation, redness, swelling or blisters

Common: may affect up to 1 in 10 people

• feeling anxious or confused, depression, insomnia
• taste disturbances, weight loss
• drowsiness, sedation, excessive tiredness, weakness, migraine, numbness, swelling of hands or feet, withdrawal syndrome (which may manifest as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating), tremor, falls, chills
• constipation, mouth inflammation, dry mouth, diarrhoea, heartburn, loss of appetite, abdominal pain, stomach discomfort, indigestion, toothache, oral thrush
• itching, excessive sweating, rash
• shortness of breath, sore throat
• decreased number of white blood cells in blood, decreased number of red blood cells, low or high blood pressure, increased heart rate
• muscle pain, back pain
• fatigue

Uncommon: may affect up to 1 in 1,000 people

• sore throat
• decreased number of platelets (cells that help blood to clot)
• euphoric state, nervousness, feeling of abnormality, tremors or slowing down; seeing or hearing things that are not there (hallucinations), reduced consciousness, mental changes, disorientation, lack of concentration, loss of balance, dizziness, speech problems, ringing in the ears, ear discomfort
• blurred or cloudy vision, redness of the eyes
• slowed heart rate, sensation of intense heat (hot flushes)
• serious breathing difficulties, sleep apnoea
• one or more of the following oral conditions: ulceration, loss of sensation, discomfort, abnormal colouration, soft tissue disorders, tongue disorders, pain, blisters or ulceration of the tongue, gum pain, cracked lips, dental disorders
• oesophagitis, intestinal obstruction, biliary disorders
• cold sweats, facial swelling, generalised itching, hair loss, muscle tremor, muscle weakness, malaise, chest discomfort, thirst, sensation of cold or heat, difficulty urinating
• malaise
• sudden reddening of the face

Rare: may affect up to 1 in 10,000 people

• disturbances in thinking, movement disorders
• blisters in the mouth, dry mouth, pus accumulation in the oral mucosa
• lack of testosterone, abnormal eye sensation, sensation of seeing flashes of light, brittle nails
• allergic reactions such as rash, erythema, swelling of the lips and face, urticaria

Unknown frequency: cannot be estimated from the available data

• loss of consciousness, respiratory arrest, seizures (attacks)
• lack of sex hormones (androgen deficiency)
• drug dependence (see section 2)
• drug abuse (see section 2)
• drug tolerance (see section 2)
• delirium (may include several of the following symptoms: agitation, motor restlessness, disorientation, confusion, anxiety, seeing or hearing things that are not there, sleep disturbances, nightmares)
• prolonged fentanyl treatment during pregnancy may cause a potentially life-threatening withdrawal syndrome in the newborn (see section 2)
• difficulty swallowing

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store AuroFena

Keep the medicine in a safe and secure place, out of reach of others.
It may cause serious harm and result in death of a person who takes it accidentally or intentionally,
when it has not been prescribed for them.
The pain-relieving ingredient in AuroFena is very strong and can be life-threatening
if accidentally ingested by a child. This medicine must be stored out of sight and out of reach of children.

• Do not use this medicine after the expiry date stated on the cardboard box and blister pack following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
• Do not store above 30°C. Keep in the original packaging to protect from moisture.
• Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What AuroFena contains
The active substance is fentanyl. Each tablet contains:

• 100 micrograms of fentanyl (as citrate)
• 200 micrograms of fentanyl (as citrate)
• 400 micrograms of fentanyl (as citrate)

The other ingredients are mannitol, sorbitol, citric acid, macrogol 6000, L-arginine, magnesium stearate.

What AuroFena looks like and contents of the pack
The buccal tablets are white, round with bevelled edges, marked on one side with an embossed number: „1” for AuroFena 100 micrograms, „2” for AuroFena 200 micrograms, „4” for AuroFena 400 micrograms. Each tablet has a diameter of approximately 10 mm.

Each blister contains 4 buccal tablets, available in cardboard boxes containing 4 or 28 buccal tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
Poland

Manufacturer:
BLUEPHARMA – INDÚSTRIA FARMACÊUTICA, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: AuroFena
France: FENTANYL ARROW 100 micrograms, comprimé buccogingival
FENTANYL ARROW 200 micrograms, comprimé buccogingival