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 all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What AuroFena is and what it is used for
2. Important information before using AuroFena
3. How to take 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 analgesic used to treat breakthrough pain in adult patients with cancer who are already receiving other opioid analgesics for the management of persistent (ongoing) pain caused by cancer.
Breakthrough pain is a sudden episode of pain that occurs despite regular opioid analgesic therapy.

2. Important information before using AuroFena

When NOT to use AuroFena:

• if the patient has not been taking regularly for at least one week an opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) prescribed by a doctor for the regular management of chronic pain, as directed every day. If the patient has not taken these medicines, AuroFena must not be used, because 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 hydroxymate.

Warnings and precautions
Talk to your doctor or pharmacist before starting to use AuroFena.
While being treated with AuroFena, continue taking your prescribed opioid painkiller for the management of persistent (constant) cancer-related pain.
While being treated with AuroFena, do not use any other fentanyl-containing medicines previously prescribed for breakthrough pain. If you still have such medicines, contact your pharmacist for proper disposal.
Keep the medicine in a safe and secure place, out of reach of others (for more information, see section 5. “How to store AuroFena”).
If the patient has any of the following conditions, talk to a doctor or pharmacist before starting AuroFena:

• the dose of another opioid medicine used to treat persistent (constant) cancer-related pain has not yet been stabilised
• 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 needed, and any dose increase will be closely monitored by the doctor
• heart problems, especially a slow heart rate
• the patient is taking benzodiazepines (see section 2 “AuroFena and other medicines”). Taking benzodiazepines may increase the risk of serious adverse effects, including death.
• the patient is taking antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs], serotonin-noradrenaline reuptake inhibitors [SNRIs], monoamine oxidase inhibitors [MAOIs]; see section 2 “When not to use AuroFena” and “AuroFena and other medicines”). Taking 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, alcohol, or other drugs or substances
• alcohol consumption; see section “Using AuroFena with food, drink and alcohol”.

Consult your doctor if DURING treatment with AuroFena:

• 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 simultaneous occurrence of these symptoms may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• the patient has breathing disorders during sleep: AuroFena may cause sleep-related breathing disorders 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 another person 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 painkillers 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 contact their doctor. The doctor will decide whether increasing the dose or gradually reducing the use of AuroFena is the better option for the patient.
Dependence and habitual 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 increasing dose and prolonged duration of use. Dependence or compulsive use may cause the patient to feel a loss of control over how much or how often the medicine should be taken. The patient may feel a need to continue taking the medicine, even if it does not help relieve their pain symptoms.
The risk of dependence or compulsive use varies among individuals. The risk of becoming dependent on AuroFena or of compulsive use may be higher 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 disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

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

• The patient needs to take this medicine for longer than recommended 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, diarrhea, 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 treatment can be safely stopped.
URGENT medical help should be sought immediately 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, immediate medical attention should be sought. The person should be kept conscious until emergency help arrives.
A person who has accidentally ingested AuroFena may experience the same adverse reactions 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 recently taken, 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. For this reason, concurrent use should only be considered if other treatment options are not possible. However, if the doctor prescribes fentanyl together with sedative medicines, the doctor will limit the dose and duration of concurrent treatment. The patient should inform the doctor about all sedative medicines currently being taken (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 objective and subjective 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 (used to treat fungal infections), troleandomycin, clarithromycin, or erythromycin (used to treat bacterial infections), aprepitant (used to treat severe nausea), and diltiazem and verapamil (used to treat high blood pressure and heart diseases).
• Medicines known as monoamine oxidase inhibitors (MAOIs) (used in severe depression), or which have been taken within the last 2 weeks.
• Certain types of strong painkillers known as partial agonists/antagonists, e.g., buprenorphine, nalbuphine, and pentazocine (painkillers). When these medicines are used, the patient may experience withdrawal symptoms (nausea, vomiting, diarrhea, restlessness, chills, tremors, and sweating).
• Certain medicines used to treat neuropathic pain (gabapentin and pregabalin).
• The risk of adverse reactions 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 status (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The doctor will advise the patient whether AuroFena is suitable for them.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Taking 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 administering AuroFena to moisten the mouth, but the patient should not drink or eat while taking the medicine.
• While using AuroFena, grapefruit juice should not be consumed, as it may affect how the body processes fentanyl.
• Alcohol must not be consumed while using AuroFena, as it may increase the risk of serious adverse reactions, including death.

Pregnancy and breastfeeding

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

Pregnancy
AuroFena should not be used during pregnancy unless specifically advised 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 breastfeeding women. Breastfeeding should not be initiated for at least 5 days after the last dose of AuroFena.

Driving and operating machinery
The patient should consult their doctor whether it is safe to drive a car or operate mechanical equipment after taking AuroFena. The patient should not drive a car or operate machinery if they experience drowsiness or dizziness, blurred or double vision, or difficulty concentrating. 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 take AuroFena

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Before starting treatment and regularly during therapy, your doctor will also discuss with you what to
expect from taking AuroFena, when and for how long it should be taken, when to contact the doctor,
and when to discontinue the medicine (see also section 2).
Dosage and frequency of administration
When starting treatment with AuroFena, your doctor will determine, in consultation with you, the
appropriate dose to relieve breakthrough pain. AuroFena should always be taken exactly as
prescribed by the doctor. The initial dose is 100 micrograms. During dose titration, your doctor may
instruct you to take more than one tablet per breakthrough pain episode. If breakthrough pain
does not subside within 30 minutes, only one additional tablet of AuroFena should be taken during
the dose adjustment period.
After 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 adjustments.
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 adjustments.
If the prescribed dose of AuroFena is insufficient to relieve breakthrough pain, contact your doctor,
who will decide whether the dose should be changed.
Wait at least 4 hours before taking AuroFena to treat another episode of breakthrough pain.
Inform your doctor immediately if AuroFena is taken more than 4 times per day, as this may require
a change in the treatment regimen. Your doctor may modify the treatment for chronic pain. Once
better control of background pain is achieved, your doctor may adjust the dose of AuroFena. If your
doctor suspects increased pain sensitivity (hyperalgesia) related to fentanyl use, a reduction in the
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 modified if necessary.
Do not change the dose of AuroFena or other pain medications on your own. Dose adjustments must
be prescribed and monitored by a doctor.
If you have any questions or doubts about how to take the medicine or the 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 medicine is absorbed into the bloodstream
through the oral mucosa. This method of administration allows for rapid absorption and relief of
breakthrough pain.
How to take 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 blister 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 on the back of the blister to expose the tablet. DO NOT attempt to push the tablet through the blister, as it may be damaged.

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

• Do not bite, suck, chew, or swallow the tablet, as this will 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. This may take up to 30 minutes. If irritation occurs, the tablet may be repositioned to another area of the gum.
• After 30 minutes, if any remnants of the tablet remain in the mouth, they may be swallowed with a glass of water. Taking more AuroFena than prescribed
• 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 may lead to coma. If dizziness, pronounced drowsiness, or slow or shallow breathing occur, contact a doctor immediately.
• Overdose may also cause brain disorders known as toxic leukoencephalopathy. Missed 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 episode of breakthrough pain occurs.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them.
If any side effects occur, contact your doctor.
Serious adverse reactions

• The most serious adverse reactions 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 reactions
Very common: may affect more than 1 in 10 people

• dizziness, headache

• nausea, vomiting

• at the site of tablet placement: pain, ulceration, irritation, bleeding, numbness, loss of sensation, redness, swelling or blisters
  Common: may affect 1 to 10 in 100 people

• feeling anxious or confused, depression, insomnia

• taste disturbances, weight loss

• drowsiness, calmness, excessive tiredness, weakness, migraine, numbness, swelling of hands or feet, withdrawal syndrome (may manifest as occurrence of the following adverse reactions: 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 1 to 10 in 1,000 people

• sore throat
• decreased number of platelets (cells that help blood to clot)
• euphoric mood, nervousness, feeling abnormal, tremors or slowing down; seeing or hearing things that are not real (hallucinations), reduced consciousness, mental changes, disorientation, lack of concentration, loss of balance, dizziness, speech problems, ringing in the ears, ear complaints
• blurred or hazy vision, redness of the eyes
• slowed heart rate, sensation of intense heat (hot flushes)
• severe breathing difficulties, sleep apnoea
• one or more of the following oral complaints: 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, feeling cold or hot, difficulty urinating
• malaise
• sudden reddening of the face

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

• thought disorders, movement disorders
• blisters in the mouth, dry mouth, accumulation of pus 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

Not known: 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: restlessness, motor agitation, disorientation, confusion, anxiety, seeing or hearing things that are not real, 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions helps to provide more information on the safety of the medicine.
Adverse reactions 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. This medicine may cause serious harm and can result in death if taken accidentally or intentionally by someone for whom it was not prescribed.
The pain-relieving component in AuroFena is very strong and may 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 outer carton and blister after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
• Do not store above 30ºC. Store in the original packaging to protect from moisture.
• Medicines must not be disposed of via wastewater 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 pack 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, and have the number "1" embossed on one side for AuroFena 100 micrograms, "2" for AuroFena 200 micrograms, and "4" for AuroFena 400 micrograms. Each tablet has a diameter of approximately 10 mm.

Each blister contains 4 buccal tablets. Packs are 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 European Economic Area countries under the following names:
Poland: AuroFena
France: FENTANYL ARROW 100 micrograms, comprimé buccogingival
FENTANYL ARROW 200 micrograms, comprimé buccogingival