Submena

Leaflet included in the packaging: patient information

Submena, 100 micrograms, sublingual tablets
Submena, 200 micrograms, sublingual tablets
Submena, 400 micrograms, sublingual tablets
Submena, 800 micrograms, sublingual tablets
Fentanyl
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Submena and what is it used for
• 2. Important information before taking Submena
• 3. How to take Submena
• 4. Possible undesirable effects
• 5. How to store Submena
• 6. Contents of the packaging and other information

1. What is Submena and what is it used for

Submena is a medicine intended for adults who already regularly take strong painkillers (opioids)
to treat chronic cancer pain, but also require treatment for breakthrough pain.If the patient is unsure whether this applies to them, they should consult a doctor.
Breakthrough pain is additional, sudden pain that occurs despite the patient's regular intake of opioid painkillers.
The active substance in Submena is fentanyl. Fentanyl belongs to a group of strong painkillers called opioids.

2. Important information before taking Submena

When not to take Submena:

• If the patient is allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe breathing difficulties.
• If the patient does not regularly take a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) every day at regular intervals for at least one week to control chronic pain. If the patient has not taken these medicines, they should not be given Submena, as this may increase the risk of dangerous slowing and/or shallow breathing or even breathing stop.
• If the patient has short-term pain other than breakthrough pain.
• If the patient is taking medicines containing hydroxymethylsodium.

Warnings and precautions

The medicine should be stored in a safe place, inaccessible to unauthorized persons (more information can be found in section 5 "How to store Submena").
Before starting Submena, the patient should discuss with their doctor if they have or have recently had any of the following symptoms, as the doctor will need to take them into account when adjusting the dose:

• Head injury, as Submena may mask the extent of the injury;
• Breathing difficulties or myasthenia gravis (a condition characterized by muscle weakness);
• Heart problems, especially slow heart rate;
• Low blood pressure;
• Liver or kidney disease, as this may require the doctor to exercise special caution when setting the dose;
• Brain tumor and/or increased intracranial pressure (increased pressure in the brain, which causes severe headache, nausea, vomiting, and blurred vision);
• Mouth sores or mucositis (redness and inflammation of the inside of the mouth);
• If the patient is taking antidepressant or antipsychotic medicines, they should read the section "Submena and other medicines";
• If the patient has ever had adrenal insufficiency or hormone deficiency (androgen deficiency) associated with opioid use.

During Submena treatment, the patient should inform their doctor, including their dentist, that they are taking this medicine if:

• A surgical procedure is planned;
• The patient experiences pain or increased sensitivity to pain (hyperalgesia) that does not respond to the increased dose prescribed by the doctor;
• The patient experiences a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms can be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones.

Long-term use and tolerance
This medicine contains fentanyl, which is an opioid medicine. Long-term use of opioid painkillers can cause the medicine to become less effective (the patient becomes accustomed to it, known as tolerance to the medicine). The patient may also become more sensitive to pain while taking Submena. This is a phenomenon known as hyperalgesia. Increasing the dose of Submena may help to further reduce pain for a while, but it can also be harmful. If the patient finds that the medicine is becoming less effective, they should consult their doctor. The doctor will decide whether to increase the dose or gradually decrease the dose of Submena.
Dependence and addiction
This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.
Long-term use of Submena can also lead to dependence, abuse, and addiction, which can result in life-threatening overdose. The risk of these undesirable effects may increase with increasing dose and longer treatment duration.
Dependence can cause the patient to lose control over the amount of medicine taken or the frequency of its intake. The patient may feel compelled to take the medicine, even if it does not help to relieve pain. The risk of dependence and addiction varies from person to person. The risk of dependence may be higher if:

• The patient or any of their family members have abused or been dependent on alcohol, prescription medicines, or illegal drugs (addiction).
• The patient is an active smoker.
• The patient has experienced mood disorders (depression, anxiety disorders, personality disorders) or has been treated by a psychiatrist for another mental illness.

If the patient experiences any of the following symptoms while taking Submena, it may indicate dependence

• Need to take the medicine for longer than prescribed by the doctor.
• Need to take a higher dose than prescribed.
• Taking the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep".
• The patient makes repeated unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, the patient feels unwell (experiences nausea, vomiting, diarrhea, anxiety, shivering, and sweating), and after taking the medicine again, they feel better ("withdrawal effect").

If the patient observes any of these symptoms in themselves, they should consult their doctor to discuss the most appropriate treatment method, including when and how to safely stop the medicine.
Respiratory depression during sleep
Submena may cause respiratory depression during sleep, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen level 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 another person observes such symptoms, they should contact their doctor. The doctor may consider reducing the dose.

Submena and other medicines

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 (other than their regular opioid painkiller).
Some medicines may enhance or weaken the effect of Submena. Therefore, when starting, changing the dose, or stopping the following medicines, the patient should inform their doctor, as it may be necessary to adjust the dose of Submena:

• Certain types of antifungal medicines, such as ketoconazole or itraconazole (used to treat fungal infections);
• Certain types of antibiotics called macrolides, containing e.g. erythromycin (used to treat infections);
• Certain antiviral medicines called protease inhibitors, containing e.g. ritonavir (used to treat viral infections);
• Rifampicin or rifabutin (medicines used to treat bacterial infections);
• Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures);
• Herbal medicines containing St. John's Wort (Hypericum perforatum);
• Medicines containing alcohol;
• Medicines called monoamine oxidase inhibitors (MAOIs), which are used to treat severe depression and Parkinson's disease. The patient should inform their doctor if they have taken these types of medicines in the last two weeks.
• Certain types of strong painkillers, called partial agonists and/or antagonists, e.g. buprenorphine, nalbuphine, and pentazocine (medicines used to treat pain). When taking these medicines, withdrawal symptoms may occur (nausea, vomiting, diarrhea, anxiety, shivering, and sweating).

Submena may enhance the effect of medicines that cause drowsiness (sedatives):

• Other strong painkillers (opioid medicines, e.g. painkillers and cough medicines);
• Medicines used for general anesthesia (used to put the patient to sleep before surgery);
• Muscle relaxants;
• Sleeping medicines;
• Medicines used to treat depression; allergies; anxiety disorders (such as benzodiazepines, e.g. diazepam) and psychosis;
• Medicines containing clonidine (used to treat high blood pressure);
• Certain painkillers used for neuralgia (gabapentin and pregabalin).

Taking Submena with medicines that cause drowsiness (sedatives), such as benzodiazepines, increases the risk of drowsiness, breathing difficulties (respiratory depression), sleepiness, and can be life-threatening. Therefore, taking Submena with sedatives should only be considered when other treatment options are not possible.
However, if the doctor prescribes Submena with a sedative, the dose and treatment duration should be limited.
The patient should tell their doctor about all sedatives they are taking and strictly follow their doctor's instructions regarding dosing. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms listed above. If such symptoms occur, the patient should contact their doctor.
The risk of certain other undesirable effects may increase if the patient is taking certain antidepressant or antipsychotic medicines. Submena may interact with these medicines, and the patient may experience changes in mental state (e.g. agitation, hallucinations, sleepiness) and other effects, such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, and lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).

Taking Submena with food, drink, and alcohol

In some people, Submena may cause drowsiness. The patient should not drink alcohol without consulting their doctor, as alcohol may cause increased drowsiness.
The patient should not drink grapefruit juice while taking Submena, as it may increase the undesirable effects of the medicine.

Pregnancy, breastfeeding, and fertility

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.
Submena should not be taken during pregnancy, unless the doctor recommends otherwise.
Fentanyl may pass into breast milk and cause undesirable effects in breastfed babies. The patient should not start breastfeeding until at least 5 days after the last dose of Submena.

Driving and using machines

Submena may impair mental and/or physical ability to perform potentially hazardous activities, such as driving or operating machinery.
If the patient experiences dizziness, drowsiness, or blurred vision while taking Submena, they should not drive or operate machinery.

Submena contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Submena

Before taking Submena for the first time, the doctor will explain how to take it to effectively treat breakthrough pain.
Before starting treatment and regularly during treatment, the doctor will discuss the patient's expectations regarding Submena, when and how long to take it, when to contact the doctor, and when to stop the medicine (see also section 2).
This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
This medicine should only be taken as prescribed by the doctor. It should not be taken by other people, as it may pose a serious risk to their health, especially in children.
Submena is different from other medicines the patient may have taken to treat breakthrough pain. The patient should always take the dose of Submena prescribed by their doctor– it may be different from the dose they took for other medicines to treat breakthrough pain.
Starting treatment – finding the right dose for the patient
To work effectively, the doctor will need to determine the right dose of Submena for the patient to treat breakthrough pain. Submena is available in different strengths. There may be a need to try different strengths of Submena over several episodes of breakthrough pain to find the right dose. Working with the patient, the doctor will help find the right dose.
If one dose does not provide sufficient pain relief, the doctor may recommend an additional dose to treat the episode of breakthrough pain.
The patient should not take a second dose without the doctor's recommendation, as this may result in overdose.
Sometimes the doctor may recommend taking a dose that consists of more than one tablet at the same time. This should only be done on the doctor's recommendation.
The patient should wait at least 2 hours after taking the last dose of Submena before taking the next dose to treat breakthrough pain.
Continuing treatment – after finding the right dose for the patient
After the doctor and patient have determined the dose that controls breakthrough pain, the patient should not take it more often than four times a day. The dose of Submena may consist of more than one tablet.
The patient should wait at least 2 hours after taking the last dose of Submena before taking the next dose to treat breakthrough pain.
If the determined dose of Submena is not sufficient to relieve breakthrough pain, the patient should contact their doctor, who will decide whether to change the dose.
The patient should not change the dose of Submena without their doctor's explicit recommendation.
Taking the medicine
Submena should be taken sublingually, which means that the tablet should be placed under the tongue, where it dissolves quickly, allowing fentanyl to be absorbed through the mucous membrane of the mouth. After absorption, fentanyl starts to work to relieve pain.
When the patient experiences an episode of breakthrough pain, they should take the dose prescribed by their doctor in the following way:

• If the patient has a dry mouth, they should take a sip of water to moisten it, and then spit out or swallow the water.
• Take the tablet (tablets) out of the blister pack just before use in the following way: o Separate one of the blister pack squares from the rest of the packaging by tearing along the perforated line. o Peel off the foil at the indicated place and gently remove the tablet. The patient should not try to push the Submena sublingual tablets through the foil, as this may damage the tablet.
• Place the tablet deep under the tongue and allow it to dissolve completely.
• Submena will dissolve quickly under the tongue and be absorbed to relieve pain. Therefore, it is very important not to suck, chew, or swallow the tablets.
• The patient should not drink or eat anything before the tablet has completely dissolved under the tongue.

Taking a higher dose of Submena than recommended

• Remove any remaining tablet from the mouth;
• Inform a caregiver or another person what happened;
• The patient or their caregiver should immediately contact a doctor, pharmacist, or the nearest hospital to determine what actions to take;
• While waiting for the doctor, the patient should be kept awake by talking to them or shaking them from time to time. Symptoms of overdose include
• extreme drowsiness;
• slow, shallow breathing;
• sleepiness.

If such symptoms occur, the patient should immediately seek medical help.
Overdose can also cause brain disorders known as toxic leukoencephalopathy.
If it is suspected that someone has accidentally taken Submena, medical help should be sought immediately.

Stopping Submena treatment

Submena treatment should be stopped when breakthrough pain no longer occurs. However, the patient should continue to take their regular opioid painkiller to treat chronic cancer pain, as prescribed by their doctor. After stopping Submena, the patient may experience withdrawal symptoms similar to the possible undesirable effects of Submena. If withdrawal symptoms occur or the patient is concerned about pain relief, they should contact their doctor. The doctor will assess whether the patient needs a medicine to reduce or eliminate withdrawal symptoms.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Submena can cause undesirable effects, although not everybody gets them.

If the patient starts to feel unusual or very strong drowsiness or if their breathing becomes slow or shallow, the patient or their caregiver should immediately contact a doctor or the local hospital for help (see also section 3

"Taking a higher dose of Submena than recommended").
Very common undesirable effects (may occur in more than 1 in 10 people):

• nausea.

Common undesirable effects (may occur in up to 1 in 10 people):

• dizziness, headache, excessive drowsiness;
• shortness of breath and/or breathing difficulties;
• mouth inflammation, vomiting, constipation, dry mouth;
• sweating, fatigue, and/or weakness and/or lack of energy.

Uncommon undesirable effects (may occur in up to 1 in 100 people):

• allergic reaction, seizures, and/or shivering, disturbed or blurred vision, rapid or slow heart rate;
• low blood pressure, memory loss;
• depression, suspicion, and/or fear without reason, feeling of confusion, feeling of disorientation, feeling of anxiety and/or unhappiness and/or restlessness, feeling of unusual happiness and/or well-being, mood changes;
• feeling of persistent fullness in the stomach, stomach pain, indigestion;
• mouth ulcers, tongue disorders, mouth or throat pain, throat tightness, lip or tongue ulcers;
• loss of appetite, loss of or change in taste and/or smell;
• difficulty sleeping or sleep disorders, attention disorders and/or easy distraction, lack of energy and/or weakness and/or loss of strength;
• skin disorders, rash, itching, night sweats, decreased sensitivity to touch, easy bruising;
• joint pain or stiffness, muscle stiffness;
• withdrawal symptoms (may include the following undesirable effects:nausea, vomiting, diarrhea, anxiety, shivering, and sweating), accidental overdose, impotence in men, general malaise.

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

• tongue swelling, severe breathing difficulties, falls, sudden flushing of the face, feeling of intense heat, diarrhea, seizures (fits), swelling of the face or limbs, seeing or hearing things that do not exist (hallucinations), fever;
• tolerance, dependence on the medicine;
• medicine abuse (see section 2);
• reduced or lost consciousness;
• spontaneous rash;
• delirium (symptoms may include a combination of agitation, anxiety, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares).

Prolonged use of fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which can be life-threatening (see section 2).

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should inform their doctor or pharmacist. Undesirable effects can be reported directly to the
Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Submena

The Submena painkiller has a very strong effect and can be life-threatening if accidentally ingested by a child. The medicine should be stored in a place that is invisible and inaccessible to children.

Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from moisture.
There are no special instructions for storing the medicinal product at a certain temperature.
The medicine should be stored in a safe place, inaccessible to other people.
This medicine can seriously harm or even kill people who take it accidentally or intentionally if it has not been prescribed to them by a doctor.
It is recommended to store Submena in a secure and locked place.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Submena contains

The active substance is fentanyl. One sublingual tablet contains:
157 micrograms of micronized fentanyl citrate, equivalent to 100 micrograms of fentanyl (Fentanyl).
314 micrograms of micronized fentanyl citrate, equivalent to 200 micrograms of fentanyl (Fentanyl).
628 micrograms of micronized fentanyl citrate, equivalent to 400 micrograms of fentanyl (Fentanyl).
1257 micrograms of micronized fentanyl citrate, equivalent to 800 micrograms of fentanyl (Fentanyl).
Excipients: mannitol, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate.

What Submena looks like and contents of the pack

Submena is a small white sublingual tablet intended to be placed under the tongue. It is available in different strengths and shapes. The doctor will prescribe the strength (shape) and number of tablets suitable for the patient.
Submena, 100 micrograms, sublingual tablet is a white, round tablet with a diameter of 6 mm.
Submena, 200 micrograms, sublingual tablet is a white, oval tablet with dimensions of 7 x 5 mm.
Submena, 400 micrograms, sublingual tablet is a white, rhomboid-shaped tablet with dimensions of 9 x 7 mm.
Submena, 800 micrograms, sublingual tablet is a white, capsule-shaped tablet with dimensions of 10 x 6 mm.
Submena is available in single-dose blister packs with a child-resistant closure, containing 30 x 1 tablet.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

Prasfarma S.L.

• C. Sant Joan 11-15 Manlleu 08560 Barcelona Spain

Kern Pharma S.L.

• C. Venus 72 Poligono Industrial Colon II Terrassa 08228 Barcelona Spain

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
To obtain more detailed information about this medicine, the patient should contact their local representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
[email protected]
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands Submena
Italy Sublifen
Czech Republic Menasu
Slovakia Submena
Bulgaria Sublifen
Poland Submena
Sweden Submena
Denmark Sublifen
Austria Submena

Date of last revision of the leaflet: 30.06.2025