Vellofent

Package leaflet: Information for the patient

Vellofent, 67 micrograms, sublingual tablets
Vellofent, 133 micrograms, sublingual tablets
Vellofent, 267 micrograms, sublingual tablets
Vellofent, 400 micrograms, sublingual tablets
Vellofent, 533 micrograms, sublingual tablets
Vellofent, 800 micrograms, sublingual tablets
fentanyl
Please read the entire leaflet before using this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen, or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Vellofent is and what it is used for

Vellofent contains the active substance fentanyl, which belongs to a group of potent pain-relieving medicines known as opioids.
Vellofent is used to treat breakthrough cancer pain in adult patients who are already being treated with other pain-relieving medicines for chronic (persistent throughout the day) cancer pain.
Breakthrough pain is additional, sudden pain that occurs despite the patient's regular use of opioid pain-relieving medicines.

2. Important information before using Vellofent

When not to use Vellofent

• if the patient is allergic to fentanyl or any of the ingredients of this medicine (listed in section 6);
• if the patient has severe breathing problems or serious lung disease;
• if the patient is currently taking, or has taken within the last 2 weeks, medicines from the group of monoamine oxidase inhibitors (MAO) for severe depression;
• if the patient has not been regularly taking an opioid medicine prescribed by a doctor (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) every day for at least one week to control chronic pain. If the patient has not taken these medicines, Vellofent must not be used,

because this medicine may increase the risk of dangerous slowing and/or shallowing of breathing, or even respiratory arrest;

• if the patient has short-term pain other than breakthrough pain;
• if the patient is currently taking medicines containing sodium oxybate.

Warnings and precautions
Vellofent contains an active substance in an amount that could be fatal to a child, therefore all tablets must always be stored in a place inaccessible and out of sight of children and of persons for whom they have not been prescribed.
Tablets should be stored in a closed container and should not be removed from the blister pack.
The medicine should be stored in a safe and secure place where others cannot access it (for more information, see section 5, "How to store Vellofent").
Talk to your doctor or pharmacist before starting to use Vellofent.
Before starting treatment, the patient should inform the doctor if any of the following conditions are present or have recently occurred, as the doctor must take them into account when prescribing the dose:

• the currently used painkiller for chronic (24-hour) cancer pain is not yet adequately effective;
• any condition that makes breathing difficult (such as asthma, wheezing or shortness of breath);
• head injury;
• heart problems, especially slow heart rate, irregular heartbeat, low blood volume or low blood pressure;
• liver or kidney problems, as these organs are involved in the elimination (metabolism and excretion) of the medicine;
• the patient is taking antidepressant or antipsychotic medicines, see section "Other medicines and Vellofent".

Consult your doctor if, while using Vellofent:

• 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; 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 ever had adrenal insufficiency or sex hormone deficiency (androgen deficiency) while taking opioids.

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). While using Vellofent, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia. Increasing the dose of Vellofent 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 Vellofent is the better option for the patient.

Dependence and compulsive use
This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction.
Repeated use of Vellofent 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 longer duration of use. Dependence or compulsive use may cause the patient to feel a loss of control over how much medicine to take or how often to take it. The patient may feel the need to continue taking the medicine, even if it does not help relieve their pain.

The risk of dependence or compulsive use varies between individuals. The risk of becoming dependent on Vellofent or using it compulsively 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 health conditions.

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

• The patient must take this medicine for longer than recommended by the doctor.
• The patient must take a higher dose than recommended.
• The patient uses this medicine for reasons other than those for which the doctor prescribed it, e.g. "to calm down" or "to be able to sleep".
• The patient has made several unsuccessful attempts to stop or control the use of this medicine.
• After stopping the 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, including when it is appropriate to discontinue treatment and how to safely stop treatment.

Sleep-related breathing disorders
Vellofent 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 someone else notices such symptoms, contact the doctor. The doctor may consider reducing the dose.

Children and adolescents
Vellofent is not indicated for use in children and adolescents under 18 years of age.

Other medicines and Vellofent
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially the following groups of medicines:

• monoamine oxidase inhibitors (MAO) used for severe depression, see above "When not to use Vellofent". Tell your doctor if you have taken such a medicine within the last 2 weeks;
• sleeping pills, anxiolytics, antihistamines, antipsychotics, some muscle relaxants or any other medicines causing drowsiness (sedatives), and some painkillers used for neuropathic pain (gabapentin and pregabalin);
• any medicines that may affect the action of Vellofent (by affecting its elimination from the body), such as:
  • medicines used to control HIV infection (e.g. ritonavir, indinavir, nelfinavir, saquinavir);
  • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole or fluconazole);
  • medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin, telithromycin), including anti-tuberculosis medicines (e.g. rifabutin, rifampicin);
  • medicines used for severe nausea and vomiting (e.g. aprepitant, dronabinol);
  • medicines used to treat high blood pressure or heart conditions (e.g. diltiazem or verapamil);
  • antidepressants (e.g. fluoxetine or St. John's wort);
  • medicines for heartburn and indigestion (e.g. cimetidine);
  • sleeping pills or sedatives (e.g. phenobarbital);
  • medicines used to control seizures and epileptic fits (e.g. carbamazepine, phenytoin, oxcarbazepine);
  • antiviral medicines (e.g. efavirenz, nevirapine);
  • anti-inflammatory or immunosuppressive medicines (e.g. glucocorticosteroids);
  • medicines used to treat diabetes (e.g. pioglitazone);
  • psychostimulants (e.g. modafinil);
• certain types of strong painkillers known as partial agonists/antagonists, e.g. buprenorphine, nalbuphine, and pentazocine (medicines used to treat pain). When taking these medicines, withdrawal symptoms (nausea, vomiting, diarrhoea, restlessness, chills, tremors and sweating) may occur. These medicines may reduce or block the effect of Vellofent;
• the risk of adverse effects increases if the patient takes certain antidepressants or antipsychotics. Vellofent may interact with these medicines, leading to 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, increased reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). The doctor will advise the patient whether Vellofent is suitable for them;
• concurrent use of Vellofent and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concurrent use of Vellofent and sedative medicines should only be considered if no other treatment options are possible. If the doctor prescribes Vellofent together with sedative medicines, they should limit the dose and duration of concurrent treatment. Inform the doctor about all sedative medicines being taken and strictly follow the doctor's instructions. It may be helpful to inform friends or relatives so they are aware of the symptoms mentioned above. If such symptoms occur, contact the doctor;
• concurrent use of medicines containing sodium oxybate and fentanyl is contraindicated (see section "When not to use Vellofent"). Treatment with sodium oxybate must be discontinued before starting treatment with Vellofent.

Vellofent with food, drink and alcohol

• Vellofent may be taken before or after a meal, but not during a meal. A sip of water may be taken before taking Vellofent to moisten the mouth, but do not eat or drink anything while taking the medicine.
• Do not drink grapefruit juice while taking Vellofent, as it may affect the elimination of the medicine from the body.
• Do not drink alcohol while taking Vellofent. This may increase the risk of dangerous adverse effects.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or if planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Do not use Vellofent during pregnancy without consulting your doctor. Do not use Vellofent during childbirth, as fentanyl may cause respiratory depression and withdrawal syndrome in the fetus or newborn.
Fentanyl may pass into breast milk and cause adverse effects in the breastfed infant. Do not use Vellofent in breastfeeding women. Breastfeeding should not be started for at least 5 days after the last dose of Vellofent.

Driving and operating machinery
Talk to your doctor whether it is safe for the patient to drive or operate machinery after taking Vellofent. Do not drive or operate machinery if the patient experiences drowsiness or dizziness, blurred or double vision, or difficulty concentrating. It is important for the patient to understand how their body reacts to Vellofent before deciding to drive or operate machinery.

Vellofent contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Vellofent

Before starting treatment and regularly during therapy, the doctor will discuss with the patient what to expect from using Vellofent, 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).
The tablet should be placed under the tongue (sublingual administration).
This medicine must always be used under the supervision of a doctor or specialist and in accordance with their instructions. If in doubt, consult a doctor or pharmacist.
If the doctor has advised the patient to switch from a previously used medicine to Vellofent, the previous medicine containing fentanyl must not be used simultaneously for breakthrough pain. The previously used fentanyl-containing medicine should be discarded. However, during treatment with Vellofent, the patient should continue taking the opioid painkiller used for chronic (around-the-clock) cancer pain.

Initial phase – Determining the most appropriate dose
To ensure Vellofent is effective, the doctor must determine the most appropriate dose for each episode of breakthrough pain. Sublingual Vellofent tablets are available in different strengths. To determine the most appropriate dose, the patient may, in cooperation with the doctor, take different strengths of sublingual Vellofent tablets during several episodes of breakthrough pain. The doctor will help determine the most suitable tablet strength for the patient.
If the desired analgesic effect is not achieved after taking one tablet, the doctor may instruct the patient to take two tablets to treat an episode of breakthrough pain. A second tablet must not be taken without the doctor's instruction, as this may lead to overdose. The doctor will advise the patient on which strength of tablet to use.
Always use the dose of Vellofent prescribed by the doctor – this dose may differ from the dose of other medicines the patient has used for breakthrough pain.

Maintenance phase – When the most appropriate dose has been established
After the appropriate dose of Vellofent has been determined with the doctor’s help and effectively controls breakthrough pain, it must not be used more than four times a day. The dose of Vellofent may consist of more than one tablet.
If the patient feels that the current dose of Vellofent is insufficient to effectively control breakthrough pain, they should inform the doctor, as dose adjustment may be necessary.
Do not change the dose of Vellofent without consulting the doctor.

How to use the medicine
Vellofent should be administered sublingually. This means the tablet should be placed under the tongue, where it dissolves quickly, allowing fentanyl to be absorbed through the oral mucosa.
When an episode of breakthrough pain occurs, take the dose prescribed by the doctor, following the instructions below:

• If the mouth feels dry, moisten it with a small amount of water. The water may be spat out or swallowed.
• Remove the tablet(s) from the packaging immediately before use.
• Peel off the foil layer of the blister according to the instructions on the blister and gently remove the tablet. Do not push the sublingual Vellofent tablet through the foil layer.
• Place the tablet as deeply under the tongue as possible and allow it to dissolve completely.
• Vellofent will dissolve quickly under the tongue and be absorbed to provide analgesic effect. For this reason, it is important not to suck, chew, or swallow the tablet.
• After 30 minutes – if any undissolved fragments of the tablet remain – they may be swallowed.
• Do not eat or drink until the tablet has completely dissolved under the tongue.

Use of a higher than recommended dose of Vellofent
You should:

• remove any remaining tablet residue from the mouth,
• inform a caregiver or another person about the incident,
• the patient or caregiver should immediately contact a doctor, pharmacist, or the emergency department of the nearest hospital for further instructions.

Symptoms of overdose include: changes in mental status, loss of consciousness, severe drowsiness, slowed and shallow breathing. If these symptoms occur, immediate medical help is required. Overdose may also cause brain disorders known as toxic leukoencephalopathy.

Information for caregivers
While waiting for medical help:

• do not allow the patient to fall asleep – speak to them and gently shake them from time to time,
• ensure the patient has clear airways and is breathing. If the patient suspects someone else has accidentally taken Vellofent, seek immediate medical assistance.

Missed dose of Vellofent
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Vellofent
Treatment with Vellofent should be stopped when breakthrough pain no longer occurs. However, the patient should continue taking their previous opioid painkillers as prescribed by the doctor for ongoing cancer pain. After stopping Vellofent, withdrawal symptoms similar to potential side effects associated with the medicine may occur. If withdrawal symptoms appear or if there are concerns about pain relief, contact the doctor. The doctor will assess whether medications are 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most serious adverse effects are:

• shallow and slowed breathing (not very common, may occur in fewer than 1 in 100 people);
• low or extremely low blood pressure and shock.

If excessive drowsiness and/or the adverse effects listed above occur, Vellofent should be discontinued immediately, and the patient or their caregiver should contact a doctor without delay and seek medical assistance.
In addition, the following adverse effects have been reported:
Very common (may occur in more than 1 in 10 people):

• nausea,
• constipation,
• drowsiness,
• sedation,
• dizziness.

Common (may occur in fewer than 1 in 10 people):

• confusion, anxiety, hallucinations (seeing or hearing things that are not there), disordered thinking,
• weakness,
• headache, muscle tremors, vertigo, loss of consciousness,
• dry mouth, taste disturbances,
• low blood pressure,
• vomiting, abdominal pain, indigestion,
• excessive sweating, itching of the skin,
• falls.

Uncommon (may occur in fewer than 1 in 100 people):

• decreased appetite, flatulence, abdominal distension (bloating), dental caries, intestinal obstruction,
• malaise,
• tingling or numbness, difficulty with motor coordination, seizures (fits), coma,
• strange dreams, feeling of detachment, depression, mood changes, states of abnormally elevated well-being,
• severe breathing difficulties,
• blurred or double vision,
• skin rash, increased or altered sensitivity to touch,
• difficulty in passing urine.

Frequency not known (cannot be estimated from available data):

• gingival recession, tooth loss,
• sudden facial flushing,
• sensation of marked warmth,
• diarrhoea,
• swelling of hands or feet,
• fatigue,
• insomnia,
• fever,
• withdrawal syndrome (symptoms may include nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating),
• drug dependence (see section 2),
• drug abuse (see section 2),
• delirium (symptoms may include restlessness, anxiety, disorientation, confusion, fear, hallucinations, sleep disturbances, nightmares),
• tolerance to the medicine (see section 2).

Long-term treatment with fentanyl during pregnancy may cause a withdrawal syndrome in newborns, which may be life-threatening (see section 2).
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 4921301, fax: +48 22 4921309, website:
https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine Vellofent

The active ingredient in Vellofent with pain-relieving action is very potent 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.
Vellofent should be kept in a secure and protected place inaccessible to others. This medicine may cause serious harm and even death in individuals who take it accidentally or intentionally, when it has not been prescribed for them.
Vellofent must be stored in a secure and closed container.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
No special precautions regarding storage temperature are required.
Keep the medicine in its original blister packaging to protect it from light.
Do not store the tablet after removing it from the blister.
Medicines must not be disposed of via the sewage system 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 Vellofent contains
The active substance is fentanyl.
Each sublingual tablet contains 67, 133, 267, 400, 533 or 800 micrograms of fentanyl (as
fentanyl citrate).
Other ingredients are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose,
disodium phosphate anhydrous, hypromellose, polyethylene glycol 6000, magnesium stearate,
Opadry White 59L280000 [hypromellose, maltodextrin, titanium dioxide (E 171), triacetin, polyethylene glycol 8000], Opacode Monogramming Ink S-1-17860 Black [shellac, iron oxide black (E 172)].

What Vellofent looks like and contents of the pack
Vellofent 67 micrograms are white, convex, triangular tablets 5.6 mm in height, printed with "0" in black ink on one side.
Vellofent 133 micrograms are white, convex, triangular tablets 5.6 mm in height, printed with "1" in black ink on one side.
Vellofent 267 micrograms are white, convex, triangular tablets 5.6 mm in height, printed with "2" in black ink on one side.
Vellofent 400 micrograms are white, convex, triangular tablets 5.6 mm in height, printed with "4" in black ink on one side.
Vellofent 533 micrograms are white, convex, triangular tablets 5.6 mm in height, printed with "5" in black ink on one side.
Vellofent 800 micrograms are white, convex, triangular tablets 5.6 mm in height, printed with "8" in black ink on one side.

Vellofent sublingual tablets are packed in child-resistant blisters with a peelable foil layer, made of PA/Aluminium/PVC/Aluminium and PA/Aluminium/PVC/Aluminium/PET foil, in a cardboard box. Each pack contains 3, 4, 15 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
Poland

Manufacturer
ETHYPHARM
Chemin de la Poudrière
76120 Grand Quevilly
France
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A
Via Vecchia del Pinocchio 22
60131 Ancona
Italy

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Sweden: Vellofent
Bulgaria: Vellofent
Czech Republic: Vellofent
Greece: Vellofent
Spain: Avaric
Italy: Vellofent
Poland: Vellofent
Portugal: Vellofent

The package leaflet in an accessible format for blind or partially sighted persons is available at the Marketing Authorisation Holder's address.

Instructions for use of this product are available by scanning the QR code on the outer packaging using a smartphone or other device. The same information is also available at the following URL:
https://qrcode.angelinipharma.pl/sku001/001