Submena

Leaflet accompanying 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.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 side 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 control chronic cancer pain, but also require treatment for breakthrough pain.If you are not sure if this applies to you, you should consult your doctor.
Breakthrough pain is additional, sudden pain that occurs despite the regular use of opioid painkillers by the patient.
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 you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• If you have severe breathing difficulties.
• If you do 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 you have not taken these medicines, you should not be given Submena, as it may increase the risk of dangerous slowing and/or shallow breathing or even stopping breathing.
• If you have short-term pain other than breakthrough pain.
• If you are taking medicines containing hydroxyma sodium.

Warnings and precautions

The medicine should be kept in a safe place, out of the reach of unauthorized persons (more information can be found in section 5 "How to store Submena").
Before starting treatment with Submena, you should discuss with your doctor if you 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 can cause severe headache, nausea, vomiting, and blurred vision);
• Mouth sores or inflammation of the mucous membrane (redness and swelling of the inside of the mouth);
• If you are taking antidepressant or antipsychotic medicines, you should read the section "Submena and other medicines";
• If you have ever had adrenal gland problems or hormone deficiencies (androgen deficiency) related to opioid use.

While taking Submena, you should inform your doctor, including your dentist, that you are taking this medicine if:

• A surgical procedure is planned;
• You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to the increased dose of painkiller prescribed by your doctor;
• You experience 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 body gets used to it, known as tolerance to the medicine). You may also become more sensitive to pain while taking Submena. This is called hyperalgesia. Increasing the dose of Submena may help to further reduce pain for a while, but it can also be harmful. If you find that the medicine is becoming less effective, you should consult your doctor. The doctor will decide whether it is better 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 side effects may increase with increasing dose and longer treatment duration.
Dependence can cause you to lose control over the amount of medicine you take or how often you take it. You 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:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs (addiction).
• You are an active smoker.
• You have experienced mood disorders (depression, anxiety disorders, personality disorders) or have been treated by a psychiatrist for another mental illness.

If you experience 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".
• Making repeated unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, you feel unwell (you experience nausea, vomiting, diarrhea, anxiety, shivering, and sweating), and after taking the medicine again, you feel better ("withdrawal effect").

If you notice any of these symptoms, you should consult your doctor to discuss the best treatment method, including when and how to safely stop the medicine.
Respiratory depression during sleep
Submena can cause respiratory depression during sleep, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen level in the blood). Symptoms can include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices such symptoms, you should contact your doctor. The doctor may consider reducing the dose.

Submena and other medicines

You should 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 (other than your regular opioid painkiller).
Some medicines can enhance or reduce the effect of Submena. Therefore, when starting, changing the dose, or stopping the following medicines, you should inform your 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. You should tell your doctor if you 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 can enhance the effect of medicines that cause drowsiness (sedatives):

• Other strong painkillers (opioid medicines, e.g. painkillers and cough suppressants);
• 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 sedatives (such as benzodiazepines) can increase 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 your doctor prescribes Submena with a sedative, the dose and treatment duration should be limited.
You should tell your doctor about all sedatives you are taking and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. If such symptoms occur, you should contact your doctor.
The risk of certain other side effects may increase if you take certain antidepressant or antipsychotic medicines. Submena can interact with these medicines, and you 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 can cause drowsiness. You should not drink alcohol without consulting your doctor, as alcohol can cause increased drowsiness.
You should not drink grapefruit juice while taking Submena, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should consult your doctor or pharmacist before taking this medicine.

Submena should not be used during pregnancy, unless your doctor advises otherwise.
Fentanyl can pass into breast milk and cause side effects in breastfed babies. You should not start breastfeeding until at least 5 days after the last dose of Submena.

Driving and using machines

Submena can impair your mental and/or physical ability to perform potentially hazardous activities, such as driving or operating machinery.
If you experience dizziness, drowsiness, or blurred vision while taking Submena, you 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 it is essentially "sodium-free".

3. How to take Submena

Before taking Submena for the first time, your doctor will explain how to take it to effectively treat breakthrough pain.
Before starting treatment and regularly during treatment, your doctor will discuss your 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 exactly as prescribed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
This medicine should only be used as directed by your doctor. It should not be used by other people, as it may pose a serious risk to their health, especially in children.
Submena is different from other medicines you may have taken for breakthrough pain. You should always take the dose of Submena prescribed by your doctor– it may be different from the dose you took for other medicines for breakthrough pain.
Starting treatment – finding the right dose for you
To work effectively, your doctor will need to determine the right dose of Submena for you to treat breakthrough pain. Submena is available in different strengths. You may need to try different strengths of Submena over several episodes of breakthrough pain to find the right dose. Working with you, your doctor will help you find the right dose.
If one dose does not provide enough pain relief, your doctor may prescribe an additional dose to treat the episode of breakthrough pain.
You should not take a second dose without your doctor's advice, as this may lead to overdose.
Sometimes your doctor may prescribe a dose that consists of more than one tablet at the same time. This should only be done on the advice of your doctor.
You should wait at least 2 hours after taking the last dose of Submena before taking another dose for breakthrough pain.
Continuing treatment – after finding the right dose for you
After you and your doctor have determined the dose that controls your breakthrough pain, you should not take it more than four times a day. The dose of Submena may consist of more than one tablet.
You should wait at least 2 hours after taking the last dose of Submena before taking another dose for breakthrough pain.
If the chosen dose of Submena is not enough to relieve breakthrough pain, you should contact your doctor, who will decide whether the dose should be changed.
You should not change the dose of Submena without your doctor's explicit advice.
Taking the medicine
Submena should be taken sublingually, which means that the tablet should be placed under the tongue, where it dissolves quickly, allowing the fentanyl to be absorbed through the mucous membrane of the mouth. After absorption, the fentanyl starts to work to relieve pain.

• If you have a dry mouth, you 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 squares of the blister pack from the rest of the packaging by tearing along the perforated line. o Peel off the edge of the foil at the point marked with an arrow and gently remove the tablet. Do not try to push the Submena sublingual tablets through the foil, as this may damage the tablet.
• Place the tablet under your tongue and let it dissolve completely.
• Submena will dissolve quickly under your tongue and be absorbed to relieve pain. Therefore, it is very important not to suck, chew, or swallow the tablets.
• You should not drink or eat anything until the tablet has completely dissolved under your tongue.

Taking a higher dose of Submena than prescribed

• remove any remaining tablet from your mouth;
• tell a caregiver or another person what happened;
• you or your caregiver should immediately contact a doctor, pharmacist, or the nearest hospital to determine what actions to take;
• while waiting for the doctor, you should keep the person awake by talking to them or shaking them from time to time. Symptoms of overdose include
• extreme drowsiness;
• slow, shallow breathing;
• sleepiness.

If you experience such symptoms, you should seek medical help immediately.
Overdose can also cause brain disorders known as toxic leukoencephalopathy.
If you think someone has accidentally taken Submena, you should seek medical help immediately.

Stopping Submena

You should stop taking Submena when breakthrough pain no longer occurs. However, you should continue to take your regular opioid painkiller to treat chronic cancer pain, as directed by your doctor. After stopping Submena, you may experience withdrawal symptoms similar to possible side effects of Submena. If you experience withdrawal symptoms or are concerned about pain relief, you should contact your doctor. The doctor will assess whether you need a medicine to reduce or eliminate withdrawal symptoms.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

If you start to feel unusual or very strong drowsiness or if your breathing becomes slow or shallow, you or your caregiver should immediately contact a doctor or the nearest hospital for help (see also section 3 "Taking a higher dose of Submena than prescribed").

Very common side effects (may affect more than 1 in 10 people):

• nausea.

Common side effects (may affect 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 tiredness and/or lack of energy.

Uncommon side effects (may affect 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 sense of 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 nausea, vomiting, diarrhea, anxiety, shivering, and sweating), accidental overdose, impotence, 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, hallucinations, fever;
• tolerance, dependence on the medicine;
• misuse of the medicine (see section 2);
• reduced or lost consciousness;
• severe rash;
• delirium (symptoms may include a combination of agitation, anxiety, disorientation, confusion, fear, hallucinations, 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 side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the
Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help to gather more information on the safety of this 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 kept out of sight and reach of 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 month stated.
Store in the original packaging to protect from moisture.
There are no special storage temperature requirements for the medicinal product.
The medicine should be kept in a safe place, out of the reach of unauthorized persons.
This medicine can cause serious harm, even death, to individuals who take it accidentally or intentionally, if it has not been prescribed for them by a doctor.
It is recommended to store Submena in a secure, closed place.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 for placement under the tongue. It is available in different strengths and shapes. Your doctor will prescribe the strength (shape) and number of tablets suitable for you.
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, diamond-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 blisters 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, you should contact the 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
biuro@gl-pharma.pl
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