AUROFENA 100 mcg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. AuroFena, 100 micrograms, buccal tablets
3. AuroFena, 200 micrograms, buccal tablets
4. AuroFena, 400 micrograms, buccal tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is AuroFena and what is it used for
6. Important information before taking AuroFena
   1. When not to take AuroFena:
   2. Warnings and precautions
   3. Accidental ingestion of AuroFena
   4. Children and adolescents
   5. AuroFena and other medicines
   6. Using AuroFena with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. AuroFena contains sorbitol
7. How to take AuroFena
   1. Dosage and frequency of administration
   2. Method of administration
   3. Using the medicine
   4. Taking a higher dose of AuroFena than prescribed
   5. Missing a dose of AuroFena
   6. Stopping treatment with AuroFena
8. Possible side effects
   1. Serious side effects
   2. AuroFena, like other fentanyl-containing medicines, can cause very serious breathing difficulties that can lead to death. If the patient experiences excessive drowsiness and (or) slow and (or) shallow breathing, they or their caregiver should immediately contact their doctor and
   3. Other side effects
   4. Reporting side effects
9. How to store AuroFena
   1. The pain-relieving substance in AuroFena is very strong and can be life-threatening if taken accidentally by a child. This medicine must be stored in a place that is invisible and inaccessible to children.
10. Contents of the packaging and other information
    1. What AuroFena contains
    2. What AuroFena looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder:
    5. Manufacturer:
    6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: information for the user

AuroFena, 100 micrograms, buccal tablets

AuroFena, 200 micrograms, buccal tablets

AuroFena, 400 micrograms, buccal tablets

Fentanyl

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is AuroFena and what is it 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 packaging and other information

1. What is AuroFena and what is it used for

The active substance of AuroFena is fentanyl citrate. AuroFena is a pain-relieving medicine, an opioid used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines to control their persistent (chronic) cancer pain.

2. Important information before taking AuroFena

When not to take AuroFena:

• if the patient has not been taking a prescribed opioid pain medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) for at least one week to regularly control chronic pain, as directed by the doctor. If the patient has not taken these medicines, they must nottake AuroFena, as this medicine may increase the risk of dangerous release and (or) shallow breathing, and even stop it.
• if the patient is allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking a medicine containing sodium oxybate.
• if the patient has serious breathing problems or obstructive pulmonary disease.
• if the patient has short-term pain other than breakthrough pain.

Warnings and precautions

Before starting treatment with AuroFena, the patient should talk to their doctor or pharmacist.

• The patient should continue to take their opioid pain medicine to control their persistent (chronic) cancer pain while taking AuroFena.
• The patient should not take other fentanyl medicines that were previously prescribed to treat breakthrough pain while taking AuroFena. If they still have these medicines, they should consult a pharmacist to dispose of them properly.
• The medicine should be stored in a safe and protected place where others cannot access it (see section 5 "How to store AuroFena").
• If the patient experiences any of the following symptoms, they should talk to their doctor or pharmacist before starting treatment with AuroFena:

The patient should consult their doctor if, DURINGtreatment with AuroFena:

• they experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of pain medicine prescribed by the doctor.
• they experience several of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure. 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.
• they have breathing difficulties during sleep: AuroFena may cause sleep-related breathing difficulties, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, they should contact their doctor. The doctor may consider reducing the dose.

Long-term use and tolerance

This medicine contains fentanyl, which is an opioid. Repeated use of opioid pain medicines can lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, which is known as tolerance to the medicine). During treatment with AuroFena, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia.

• The patient or someone in their family has previously abused or been dependent on alcohol, prescription drugs, or illegal substances (addiction);
• The patient smokes tobacco;
• The patient has previously experienced mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If the patient experiences any of the following symptoms while taking AuroFena, it may indicate addiction or compulsive use.

• The patient needs to take the medicine for a longer period than prescribed by the doctor.
• The patient needs to take a higher dose than prescribed.
• The patient uses the medicine for reasons other than those for which the doctor prescribed it, such as "to calm down" or "to fall asleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has been unable to do so.
• After stopping the medicine, the patient feels unwell (e.g., experiences nausea, vomiting, diarrhea, anxiety, tremors, and excessive sweating), and their condition improves when they take the medicine again (withdrawal symptoms).

If the patient notices any of these symptoms, they should discuss the best treatment strategy with their doctor, including determining when it is appropriate to stop treatment and how to safely stop the medicine.

The patient should seek IMMEDIATEmedical attention if:

• While taking 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 severe allergic reaction (anaphylaxis, hypersensitivity; see section 4 "Serious side effects").

Accidental ingestion of AuroFena

If it is suspected that someone has accidentally taken AuroFena, medical attention should be sought immediately. The person should be kept awake until the ambulance arrives.

Children and adolescents

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

AuroFena and other medicines

Before starting treatment with AuroFena, the patient should inform their doctor or pharmacist if they are currently taking, have recently taken, or plan to take any of the following medicines:

• Concomitant use of fentanyl and sedative medicines, such as benzodiazepines or similar medicines, increases the risk of sedation, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use can only be considered when other treatment options are not possible. Nevertheless, if the doctor prescribes fentanyl together with sedative medicines, the doctor will limit the dose and duration of concomitant treatment. The patient should inform their doctor about all sedative medicines they are currently taking (such as sleeping pills, anxiolytics, certain anti-allergic medicines (antihistamines), or tranquilizers) and strictly follow the dose prescribed by the doctor.

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

Using AuroFena with food, drink, and alcohol

• AuroFena can be taken before or after, but not during, a meal. Before taking AuroFena, the patient can drink a small amount of water to moisten their mouth, but they should not drink or eat during treatment.
• While taking AuroFena, the patient should not drink grapefruit juice, as it may affect how the body processes fentanyl.
• While taking AuroFena, the patient should not drink alcohol, as it may increase the risk of serious side effects, including death.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The patient should ask their doctor if they can safely drive or operate machinery after taking AuroFena. They should not drive or operate machinery if they experience drowsiness or dizziness, blurred or double vision, or difficulty concentrating.

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 the patient has any doubts, they should consult their doctor or pharmacist.

Dosage and frequency of administration

When starting treatment with AuroFena, the doctor will determine 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, the doctor may prescribe more than one tablet per episode. If breakthrough pain does not resolve within 30 minutes, only one additional AuroFena tablet should be taken during dose titration.

Method of administration

AuroFena buccal tablets are applied to the mucous membrane of the mouth.

Using the medicine

• Open the blister 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 by tearing along the perforation line.
• Bend the single-dose unit along the marked line.
• Remove the foil from the back of the blister to expose the tablet. Do notattempt to push the tablet through the blister, as it may be damaged.

• Remove the tablet from the blister and immediatelyplace the tablet near a molar tooth, between the gum and cheek (as shown in the picture). Sometimes the doctor may recommend placing the tablet under the tongue.
• Do notattempt to crush or divide the tablet.

• Do notchew, suck, or swallow the tablet, as this will result in weaker pain relief than taking the tablet as directed.
• The tablet should remain between the upper gum and cheek until it dissolves. This may take up to 30 minutes. If irritation occurs, the patient can change the position of the tablet on the gum.
• After 30 minutes, if tablet remnants remain in the mouth, the patient can swallow them with a glass of water.

Taking a higher dose of AuroFena than prescribed

• The most common side effects are drowsiness, nausea, or dizziness. If the patient feels strong dizziness or excessive drowsiness before the tablet has completely dissolved, they should immediately rinse their mouth with water and spit out the remaining tablet.
• A serious side effect of fentanyl is slow and (or) shallow breathing. This can occur if the dose of fentanyl is too high or if the patient takes too much AuroFena. In severe cases, symptoms of taking too much AuroFena can lead to coma. If the patient experiences dizziness, excessive drowsiness, or slow and (or) shallow breathing, they should immediately contact their doctor.
• Overdose can also cause brain disorders called toxic leukoencephalopathy.

Missing a dose of AuroFena

If the patient still experiences breakthrough pain, they can take AuroFena as directed by their doctor.

Stopping treatment with AuroFena

The patient should stop taking AuroFena when they no longer experience breakthrough pain. However, they should continue to take their regular opioid pain medicine to control their persistent (chronic) cancer pain as directed by their doctor.

4. Possible side effects

Like all medicines, AuroFena can cause side effects, although not everybody gets them.

Serious side effects

• The most serious side effects are slow and (or) shallow breathing, low blood pressure, and shock.

AuroFena, like other fentanyl-containing medicines, can cause very serious breathing difficulties that can lead to death. If the patient experiences excessive drowsiness and (or) slow and (or) shallow breathing, they or their caregiver should immediately contact their doctor and

call the emergency services.

• The patient or their caregiver should immediately contact their doctor if they experience any of the following symptoms
• Nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure.

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.

Other side effects

Very common:may affect more than 1 in 10 people

• dizziness, headache
• feeling sick, vomiting
• at the site of tablet placement: pain, ulceration, irritation, bleeding, numbness, loss of sensation, redness, or swelling
• Common:may affect up to 1 in 10 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 with the following side effects: nausea, vomiting, diarrhea, anxiety, tremors, and sweating), tremors, falls, chills
• constipation, mouth inflammation, dry mouth, diarrhea, heartburn, loss of appetite, stomach pain, gastrointestinal disorders, indigestion, toothache, thrush
• itching, excessive sweating, rash
• shortness of breath, sore throat
• decreased white blood cell count, decreased red blood cell count, low or high blood pressure, rapid heart rate
• muscle pain, back pain
• fatigue

Uncommon:may affect up to 1 in 100 people

• sore throat
• decreased platelet count
• euphoric mood, nervousness, feeling abnormal, tremors or slowing; seeing or hearing things that do not exist (hallucinations), decreased consciousness, mental changes, drug dependence (addiction), disorientation, lack of concentration, loss of balance, dizziness, speech problems, ringing in the ears, ear problems
• blurred or cloudy vision, red eyes
• slow heart rate, feeling of intense heat (hot flashes)
• severe breathing difficulties, sleep apnea
• one or more of the following oral symptoms: ulceration, loss of sensation, discomfort, abnormal coloration, soft tissue disorders, tongue disorders, pain, blisters, or ulceration of the tongue, gum pain, cracked lips, tooth disorders
• esophageal inflammation, intestinal obstruction, biliary disorders
• cold sweats, facial swelling, general itching, hair loss, muscle tremors, muscle weakness, malaise, chest discomfort, thirst, feeling cold or hot, urination problems
• malaise
• sudden flushing of the face

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

• thought disorders, movement disorders
• blisters in the mouth, dry mouth, accumulation of pus in the mouth mucosa
• testosterone deficiency, abnormal sensation in the eyes, sensation of seeing flashes, brittle nails
• allergic reactions, such as rash, redness, swelling of the lips and face, hives

Unknown:frequency cannot be estimated from the available data

• loss of consciousness, breathing stop, seizures (fits)
• hormone deficiency (androgen deficiency)
• drug dependence (addiction) (see section 2)
• drug abuse (see section 2)
• tolerance to the medicine (see section 2)
• delirium (may manifest with several of the following symptoms: agitation, restlessness, disorientation, confusion, anxiety, seeing or hearing things that do not exist, sleep disturbances, nightmares)
• long-term treatment with fentanyl during pregnancy may cause withdrawal syndrome in the newborn, which can be life-threatening (see section 2)

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

5. How to store AuroFena

The medicine should be stored in a safe and protected place where others cannot access it. It can cause serious harm and lead to death if taken accidentally or intentionally by someone for whom it was not prescribed.

The pain-relieving substance in AuroFena is very strong and can be life-threatening if taken accidentally by a child. This medicine must be stored in a place that is invisible and inaccessible to children.

• Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation "EXP". The expiry date refers to the last day of the month stated.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What AuroFena contains

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

• 100 micrograms of fentanyl (as citrate)
• 200 micrograms of fentanyl (as citrate)
• 400 micrograms of fentanyl (as citrate)
• 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, and have beveled edges, with the number "1" embossed on one side for AuroFena 100 micrograms, "2" for AuroFena 200 micrograms, and "4" for AuroFena 400 micrograms. Each tablet is approximately 10 mm in diameter.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

Manufacturer:

BLUEPHARMA – INDÚSTRIA FARMACÊUTICA, S.A.

• S. Martinho do Bispo 3045-016 Coimbra Portugal

Ardena Pamplona, S.L.

Calle Noáin 1

31110 Noáin, Navarra

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Fentanyl Aurobindo 100, 200, 400, 600, 800 mcg muco-adhesive buccal tablets

Poland

AuroFena

Date of last revision of the leaflet: 04.2025