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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What AuroFena is and what it is used for
2. Important information before taking 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 analgesic medicine,
an opioid used to treat breakthrough pain in adult patients with cancer who are already
receiving other opioid analgesics 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 analgesic.

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 control chronic pain on a daily basis. 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 hydroxymethylglycinate.

Warnings and precautions
Talk to your doctor or pharmacist before starting to use AuroFena.
While being treated with AuroFena, continue to take your prescribed opioid pain medicine for the treatment of persistent (constant) pain related to cancer.
While being treated with AuroFena, do not use 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 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-norepinephrine 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 lack of sex hormones (androgen deficiency) while taking opioids (see section 4 "Serious adverse reactions").
• the patient has ever abused or is/was addicted to opioids or any other medicine, alcohol or drugs
• alcohol consumption; see section "Taking 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 pain medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as drug tolerance). While using 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 of the medication to take or how often to take it. The patient may feel a need to continue using the medication, 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 higher if:

• the patient or anyone in their family has ever abused or been dependent on alcohol, prescription medications, 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 in the patient during treatment with AuroFena, this may indicate dependence or compulsive use:

• The patient must take this medication longer than prescribed by the doctor.
• The patient must take a higher dose than recommended.
• The patient uses this medication 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 multiple unsuccessful attempts to stop or control use of this medication.
• After stopping use of this medication, the patient feels unwell (e.g., nausea, vomiting, diarrhea, anxiety, chills, tremors, and excessive sweating), and feels better when taking the medication 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 the medication.
IMMEDIATE medical help should be sought if:

• While using AuroFena, the patient develops 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. Efforts should be made to keep the person conscious until emergency medical services arrive.
A person who has accidentally ingested AuroFena may experience the same adverse effects as described under "Use of a higher than recommended dose of AuroFena."

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

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

• Concurrent use of fentanyl and sedative medications 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 other treatment options are not possible. However, if the doctor prescribes fentanyl together with sedative medications, the doctor will limit the dose and duration of concurrent treatment. Inform the doctor about all currently used sedative medications (such as sleeping pills, anti-anxiety medications, certain medications 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 hydroxymethylglycinate and fentanyl is contraindicated (see When NOT to use AuroFena:). Treatment with sodium hydroxymethylglycinate must be discontinued before starting treatment with AuroFena.

• Certain muscle relaxants—such as baclofen, diazepam (see also section "Warnings and precautions").
• Medications that may affect how the body processes fentanyl, for example ritonavir, nelfinavir, amprenavir, and fosamprenavir (medications 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 disease).
• Medications known as monoamine oxidase inhibitors (MAO inhibitors) (used in severe depression), or taken within the last 2 weeks.
• Certain strong painkillers known as partial agonists/antagonists, e.g., buprenorphine, nalbuphine, and pentazocine (analgesics). When taking these medications, the patient may experience withdrawal symptoms (nausea, vomiting, diarrhea, restlessness, chills, tremors, and sweating).
• Certain medications used to treat neuropathic pain (gabapentin and pregabalin).
• The risk of adverse effects increases if the patient takes medications such as certain antidepressants or antipsychotics. AuroFena may interact with these medications, 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, increased 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.

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

Use of AuroFena with food, drink, and alcohol

• AuroFena may be taken before or after, but not during a meal. A small amount of water may be taken before taking AuroFena to moisten the mouth, but drinking or eating should not occur during administration of the medication.
• Grapefruit juice should not be consumed during treatment with AuroFena, as it may affect how the body metabolizes 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, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medication.

Pregnancy
AuroFena should not be used in pregnant patients 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 breastfeeding patients. Breastfeeding should not be initiated for at least 5 days after the last dose of AuroFena.

Driving and operating machinery
Ask your doctor whether it is safe to drive a car 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 their individual response to AuroFena before driving or operating machinery.

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

3. How to use AuroFena

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during therapy, your doctor will discuss with you what to expect from using AuroFena, when and for how long it should be taken, when to contact your doctor, and when to stop using 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 used exactly as prescribed by your doctor. The initial dose is 100 micrograms. During dose titration, your doctor may recommend taking 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.
Once the appropriate dose has been established by your 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, you should contact your doctor, who will decide whether the dose should be changed.
At least 4 hours should elapse before administering AuroFena for another breakthrough pain episode.
You should inform your doctor immediately if AuroFena is used more than 4 times per day, as this may necessitate a change in the treatment regimen. Your doctor may modify the management of 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 fentanyl dose may be considered (see section 2 "Warnings and precautions"). To ensure effective treatment, you should inform your doctor about your pain experience 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 on your own. Dose adjustments must be prescribed and monitored by your doctor.
If you have any questions or uncertainties regarding administration or the correct dose, 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 you are 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 strip 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 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). Occasionally, your doctor may instruct you to place 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 compared to proper administration.
• 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 any remnants of the tablet remain in the mouth, they may be swallowed with a glass of water. Use of a higher than recommended dose of AuroFena
• The most commonly observed adverse effects are drowsiness, nausea, or dizziness. If you experience severe dizziness or excessive drowsiness before the tablet has completely dissolved, you should immediately rinse your 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 AuroFena is taken in excessive amounts. In severe cases, overdose symptoms may lead to coma. If you experience dizziness, worsening drowsiness, or slow or shallow breathing, contact your 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 prescribed by your doctor. If breakthrough pain has subsided, do not take AuroFena until the next breakthrough pain episode occurs.

Discontinuation of AuroFena
You should stop using AuroFena when breakthrough pain no longer occurs. However, you should continue taking your regular opioid pain medication for chronic cancer-related pain as prescribed by your doctor. When discontinuing fentanyl, withdrawal symptoms may occur, which may resemble possible adverse effects of AuroFena. If withdrawal symptoms occur or if you are concerned about pain control, contact your doctor. Your doctor will assess whether you need medication to reduce or eliminate withdrawal symptoms.
If you have any further doubts regarding the use of 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 their caregiver should contact a doctor immediately and call emergency services.
• Contact your doctor immediately if the patient experiences any of the following symptoms together:
  • Nausea, vomiting, loss of appetite, fatigue, 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
• 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, sedation, excessive fatigue, weakness, migraine, numbness, swelling of hands or feet, withdrawal syndrome (which may present with the following adverse effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating), tremor, falls, chills
• constipation, oral 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 of abnormality, tremors or slowing down; seeing or hearing things that do not exist (hallucinations), reduced consciousness, mental changes, disorientation, lack of concentration, loss of balance, dizziness, speech problems, ringing in the ears, ear discomfort
• blurred or disturbed 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 problems: 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 1 to 10 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 sensations, perception of 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 (fits)
• lack of sex hormones (androgen deficiency)
• drug dependence (see section 2)
• drug abuse (see section 2)
• drug tolerance (see section 2)
• delirium (may involve several of the following symptoms occurring together: restlessness, motor agitation, disorientation, confusion, anxiety, seeing or hearing things that do not exist, sleep disturbances, nightmares)
• prolonged fentanyl treatment during pregnancy may cause a potentially life-threatening withdrawal syndrome in newborns (see section 2)
• difficulty swallowing

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for 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 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 secure and protected place, out of reach of others.
It may cause serious harm and lead to death in individuals who take it accidentally or intentionally,
when it has not been prescribed for them.
The pain-relieving ingredient 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 pack following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• Medicines must not be disposed of via sewage systems or household waste bins. 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 consist of 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.
Sokratesa 13D, local 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 microgrammes, comprimé buccogingival
FENTANYL ARROW 200 microgrammes, comprimé buccogingival