Package leaflet: Information for the patient

Submena, 100 micrograms, orodispersible tablets
Submena, 200 micrograms, orodispersible tablets
Submena, 400 micrograms, orodispersible tablets
Submena, 800 micrograms, orodispersible tablets
Fentanylum
Please read carefully this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Submena is and what it is used for
Important information before taking Submena
How to take Submena
Possible side effects
How to store Submena
Contents of the pack and other information

1. What Submena is and what it is used for
Submena is a medicine intended for adults who are already receiving regular treatment with strong painkillers (opioids) for chronic cancer-related pain, but who also require treatment for breakthrough pain. If you are unsure whether this applies to you, please consult your doctor.
Breakthrough pain is additional, sudden pain that occurs despite continuous treatment with opioid painkillers.
The active substance in Submena orodispersible tablets is fentanyl. Fentanyl belongs to a group of strong painkillers called opioids.

2. Important information before taking Submena
Do not 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 problems.
If you are not already taking a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) regularly every day, at regular intervals, for at least one week to control chronic pain. If you have not taken these medicines, Submena must not be administered, as this may increase the risk of dangerous slowing and/or shallowing of breathing or even respiratory arrest.
If you have short-term pain other than breakthrough pain.
If you are taking medicines containing sodium hydroxymethylcellulose.

Warnings and precautions
Keep this medicine in a safe place, out of the reach of unauthorized persons (more information in section 5 "How to store Submena").
Before starting treatment with Submena, discuss with your doctor if you have or have recently had any of the following conditions, as your doctor will need to consider them when adjusting the dose:

Head injury, as Submena may mask the extent of injury;
Breathing problems or myasthenia gravis (a condition characterized by muscle weakness);
Heart disorders, particularly bradycardia (slow heart rate);
Low blood pressure;
Liver or kidney disease, as this may require special caution from your doctor when determining the dose;
Brain tumour and/or increased intracranial pressure (elevated pressure in the brain causing severe headache, nausea, vomiting, and blurred vision);
Mouth sores or mucosal inflammation (swelling and redness inside the mouth);
If you are taking antidepressants or antipsychotics, please refer to the section "Submena with other medicines";
If you have ever experienced adrenal insufficiency or sex hormone deficiency (androgen deficiency) related to opioid use.

While taking Submena, inform your doctor, including your dentist, if:

Any surgical procedure is planned;
You experience pain or increased pain sensitivity (hyperalgesia) that does not respond to a higher dose of medicine 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 may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.

Long-term use and tolerance
This medicine contains fentanyl, an opioid painkiller. Long-term use of opioid painkillers may result in reduced effectiveness of the medicine (drug tolerance). You may also become more sensitive to pain while taking Submena. This phenomenon is known as hyperalgesia. Increasing the dose of Submena may help relieve pain for a time, but may also be harmful. If you notice that the medicine becomes less effective, please consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the dose of Submena.

Dependence and abuse
This medicine contains fentanyl, an opioid. It may cause dependence and/or abuse. Long-term use of Submena may lead to dependence, misuse, and abuse, potentially resulting in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer treatment duration. Dependence may cause you to lose control over the amount or frequency of medicine intake. You may feel compelled to take the medicine even if it does not help relieve pain. The risk of dependence and abuse varies between individuals. The risk may be higher if:

You or any family member has misused or been dependent on alcohol, prescription medicines, or illegal drugs (addiction).
You are an active tobacco smoker.
You have ever had mood disorders (depression, anxiety disorders, personality disorders) or have been treated by a psychiatrist for another mental illness.

If any of the following symptoms occur while taking Submena, this may indicate dependence:

Needing to take the medicine longer than prescribed by your doctor.
Needing to take a higher dose than recommended.
Taking the medicine for reasons other than prescribed, e.g. "to calm down" or "to help sleep".
Repeated unsuccessful attempts to stop or control medicine use.
Feeling unwell after stopping the medicine (experiencing nausea, vomiting, diarrhoea, anxiety, chills, tremors, and sweating), with improvement in well-being upon re-taking the medicine ("withdrawal effect").

If you notice any of these symptoms, please consult your doctor to discuss the most appropriate treatment approach, including when and how to safely discontinue the medicine.

Breathing problems during sleep
Submena may cause breathing problems during sleep, such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes such symptoms, please contact your doctor. Your doctor may consider reducing the dose.

Submena with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take (other than your regular opioid painkiller).
Some medicines may enhance or weaken the effect of Submena. Therefore, inform your doctor if you start, change the dose, or stop taking any of the following medicines, as dose adjustment of Submena may be necessary:

Certain antifungal medicines, e.g. 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 known as monoamine oxidase inhibitors (MAOIs), used to treat severe depression and Parkinson’s disease. Inform your doctor if you have taken such medicines within the last two weeks.
Certain types of strong painkillers known as partial agonists and/or antagonists, e.g. buprenorphine, nalbuphine, and pentazocine (medicines used to treat pain). When taking these medicines, withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, chills, tremors, and sweating) may occur.

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

Other strong painkillers (opioids, e.g. analgesics and antitussives);
Medicines used for general anaesthesia (to put you to sleep before surgery);
Muscle relaxants;
Sleeping medicines;
Medicines used to treat depression, allergies, anxiety (such as benzodiazepines, e.g. diazepam), and psychosis;
Medicines containing clonidine (used to treat high blood pressure);
Certain painkillers used for nerve pain (gabapentin and pregabalin).

Taking Submena together with medicines that cause drowsiness (sedatives), such as benzodiazepines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, the use of Submena together with sedative medicines should only be considered if no other treatment options are possible. However, if your doctor prescribes Submena together with a sedative, the dose and duration of treatment should be limited.
Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing instructions. It may be helpful to inform friends or family members to watch for the symptoms listed above. If such symptoms occur, contact your doctor.

The risk of certain other adverse effects increases if you take certain antidepressants or antipsychotics together with Submena. Submena 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Your doctor will advise whether Submena is suitable for you.

Taking Submena with food, drink, and alcohol
Submena may cause drowsiness in some people. Do not consume alcohol without consulting your doctor, as alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Submena, as it may worsen side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Submena must not be used during pregnancy unless otherwise advised by your doctor.
Fentanyl may pass into breast milk and cause adverse effects in breastfed infants. Breastfeeding should not be initiated for 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 you experience dizziness, drowsiness, or blurred vision while taking Submena, do not drive or operate machinery.

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

3. How to take Submena

Before taking Submena for the first time, your doctor will explain how to take it effectively to treat breakthrough pain.
Before starting treatment and regularly during treatment, your doctor will discuss your expectations regarding Submena, when and for how long to take it, when to contact your doctor, and when to discontinue the medicine (see also section 2).
This medicine must always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine must be used EXCLUSIVELY as directed by your doctor. It must not be used by other people, as it may pose a SERIOUS health risk, especially to children.
Submena differs from other medicines you may have used previously for breakthrough pain. Always use the dose of Submena prescribed by your doctor – this may differ from doses used with other medicines for breakthrough pain.

Starting treatment – finding the most appropriate dose for you
To ensure Submena works effectively, your doctor will determine the most appropriate dose for treating your breakthrough pain. Submena is available in different strengths. It may be necessary to try different strengths of Submena during several breakthrough pain episodes to find the most suitable dose. Your doctor will work with you to select the appropriate dose.
If one dose does not provide sufficient pain relief, your doctor may recommend an additional dose to manage the breakthrough pain episode.
Do not take a second dose without your doctor’s advice, as this may lead to overdose.
Sometimes your doctor may recommend taking a dose consisting of more than one tablet at the same time.
You must do this ONLY on your doctor’s advice.
Wait at least 2 hours after taking the last dose of Submena before taking another dose for breakthrough pain.

Continuing treatment – after finding the most appropriate dose for you
After you and your doctor have established the dose that controls breakthrough pain, do not take it more than four times per day. The dose of Submena may consist of more than one tablet.
Wait at least 2 hours after taking the last dose of Submena before taking another dose for breakthrough pain.
If the established dose of Submena is not sufficient to relieve breakthrough pain, contact your doctor, who will decide whether the dose should be changed.
Do not change the dose of Submena without explicit instruction from your doctor.

How to take the medicine
Submena must be taken sublingually, meaning the tablet should be placed under the tongue, where it dissolves quickly, allowing fentanyl to be absorbed through the oral mucosa. After absorption, fentanyl begins to exert its pain-relieving effect.
When a breakthrough pain episode occurs, take the dose prescribed by your doctor as follows:

If you have dry mouth, take a sip of water to moisten it, then spit out or swallow the water.
Remove the tablet(s) from the blister pack immediately before use as follows:
o Separate one blister square from the rest of the pack by tearing along the perforation line (keep the remaining squares unopened).
o Peel back the foil edge at the area marked with an arrow and gently remove the tablet. Do not try to push Submena orodispersible tablets through the foil, as this may damage the tablet.
Place the tablet deeply under the tongue and allow it to dissolve completely.
Submena dissolves quickly under the tongue and is absorbed to relieve pain. It is therefore very important not to suck, chew, or swallow the tablets.
Do not eat or drink anything until the tablet has completely dissolved under the tongue.

Taking more than the recommended dose of Submena

Remove any remaining tablet fragments from the mouth;
Inform a caregiver or another person what has happened;
The patient or caregiver should immediately contact a doctor, pharmacist, or nearest hospital to determine what actions should be taken;
While waiting for medical help, keep the patient awake by talking to them or gently shaking them from time to time. Symptoms of overdose include:
- Extreme drowsiness;
- Slow, shallow breathing;
- Coma.

If such symptoms occur, seek immediate medical help.
Overdose may also cause brain disorders known as toxic leukoencephalopathy.
If someone accidentally takes Submena, seek immediate medical help.

Stopping treatment with Submena
Treatment with Submena should be stopped when breakthrough pain no longer occurs. However, you should continue taking your regular opioid painkiller for chronic cancer pain, as prescribed by your doctor. After stopping Submena, withdrawal symptoms similar to possible side effects of Submena may occur. If withdrawal symptoms occur or if you are concerned about pain relief, contact your doctor. Your doctor will assess whether you need medicine to reduce or eliminate withdrawal symptoms.
If you have any further questions about using this medicine, please consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
If the patient begins to feel unusual or very strong drowsiness or if the patient's breathing becomes slow or shallow, the patient or caregiver should immediately contact a doctor or the local hospital to obtain help (see also section 3 "Taking more Submena than you should").

Very common adverse effects (may occur in more than 1 in 10 people):

nausea.

Common adverse effects (may occur in less than 1 in 10 people):

dizziness, headache, excessive drowsiness;
breathlessness and/or difficulty in breathing;
mouth inflammation, vomiting, constipation, dry mouth;
sweating, fatigue and/or tiredness and/or lack of energy.

Uncommon adverse effects (may occur in less than 1 in 100 people):

allergic reaction, seizures and/or tremors, blurred or double vision, rapid or slowed heartbeat;
low blood pressure, memory loss;
depression, suspiciousness and/or feeling of fear without reason, feeling confused, feeling disoriented, feeling of anxiety and/or unhappiness and/or restlessness, feeling of unusual happiness and/or well-being, mood changes;
feeling of fullness in the abdomen, abdominal pain, indigestion;
mouth ulceration, tongue disorders, mouth or throat pain, throat tightness, ulceration of lips or gums;
loss of appetite, loss of or change in sense of smell and/or taste;
difficulty falling asleep or sleep disturbances, attention disturbances and/or easy distractibility, lack of energy and/or weakness and/or loss of strength;
skin disorders, rash, itching, night sweats, reduced sensitivity to touch, easy bruising;
joint pain or stiffness, muscle stiffness;
withdrawal symptoms (may manifest as occurrence of the following adverse effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating), accidental overdose, in males inability to achieve and/or maintain erection, general malaise.

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

swelling of the tongue, severe breathing problems, falls, sudden facial flushing, feeling of intense heat, diarrhoea, seizures (fits), swelling of arms or legs, seeing or hearing things that are not really there (hallucinations), fever;
tolerance, drug dependence;
drug abuse (see section 2);
decreased level or loss of consciousness;
itchy rash;
delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist in reality, sleep disturbances, nightmares).

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

Reporting of adverse effects
If any adverse effects occur, including any 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,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Submena medicine

Submena pain-relief medicine is very potent and may be life-threatening if accidentally swallowed by a child. The medicine must be stored out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
There are no special storage temperature requirements for this medicinal product.
The medicine should be stored in a secure place inaccessible to unauthorized persons.
This medicine may cause serious harm or even death in individuals who take it accidentally or intentionally when it has not been prescribed by a physician.
It is recommended to store Submena medicine in a secure and closed place.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the package 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
(Fentanylum).
314 micrograms of micronized fentanyl citrate equivalent to 200 micrograms of fentanyl
(Fentanylum).
628 micrograms of micronized fentanyl citrate equivalent to 400 micrograms of fentanyl
(Fentanylum).
1257 micrograms of micronized fentanyl citrate equivalent to 800 micrograms of fentanyl
(Fentanylum).
Excipients: mannitol, microcrystalline cellulose, colloidal anhydrous 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. Your doctor will prescribe the appropriate strength (shape) and number of tablets 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 measuring 7 x 5 mm.
Submena 400 micrograms, sublingual tablet is a white, diamond-shaped tablet measuring 9 x 7 mm.
Submena 800 micrograms, sublingual tablet is a white, capsule-shaped tablet measuring 10 x 6 mm.
Submena is available in single-dose blisters made of PA/Aluminium/PVC/Aluminium/PET foil, with child-resistant packaging, containing 30 x 1 tablet.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Netherlands Submena
Italy Sublifen
Czech Republic Menasu
Slovakia Submena
Bulgaria Sublifen
Poland Submena
Sweden Submena
Denmark Sublifen
Austria Submena