Palexia retard

Package leaflet: Information for the patient

Palexia retard, 25 mg, prolonged-release tablets
Tapentadol
Please read this leaflet carefully before taking this medicine, because it contains
important information for you

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

Contents of the leaflet

1. What Palexia retard is and what it is used for
2. What you need to know before taking Palexia retard
3. How to take Palexia retard
4. Possible side effects
5. How to store Palexia retard
6. Contents of the pack and other information

1. What Palexia retard is and what it is used for

Tapentadol – the active substance in Palexia retard – is a pain-relieving medicine belonging to the group of strong opioids. Palexia retard is indicated for the treatment of:

• severe chronic pain in adults, when only opioid treatment can provide adequate pain relief;
• severe chronic pain in children over 6 years of age and adolescents, which can only be adequately managed with opioid medicines.

2. Important information before using Palexia retard

When not to use Palexia retard:

• if the patient is allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• in patients with asthma or dangerously slow and shallow breathing (respiratory depression, increased carbon dioxide levels in the blood),
• in patients with intestinal obstruction,
• in cases of acute alcohol intoxication, hypnotics, analgesics or other psychotropic medicines (medicines affecting mood and emotions) (see "Palexia retard and other medicines").

Warnings and precautions
Before starting treatment with Palexia retard, discuss with your doctor or pharmacist if:

• the patient has slow or shallow breathing,
• the patient has increased intracranial pressure or impaired consciousness up to coma,
• the patient has suffered head injury or has brain tumours,
• the patient has liver or kidney disease (see "How to use Palexia retard"),
• the patient has diseases of the pancreas or biliary tract, including pancreatitis,
• the patient is taking medicines with mixed agonist-antagonist properties at "mu" opioid receptors (e.g. pentazocine, nalbuphine) or medicines that are partial agonists of the "mu" opioid receptor (e.g. buprenorphine),
• the patient has a tendency to seizures or convulsions, or is taking other medicines that increase the risk of seizures and may increase seizure risk.

Tolerance, dependence and abuse
This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid-containing medicines may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to it, known as tolerance). Repeated use of Palexia retard may lead to dependence, addiction and abuse, which may result in life-threatening overdose. The risk of such adverse effects may increase with higher doses and prolonged duration of use. Dependence or addiction may cause the patient to lose control over the amount or frequency of medicine intake. The risk of developing dependence or addiction varies among individuals. Increased risk of addiction or dependence on Palexia retard may apply to individuals in the following situations:

• the patient or anyone in their family has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction"),
• the patient is a tobacco smoker,
• the patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other psychiatric disorders.

If, during treatment with Palexia retard, the patient notices any of the following symptoms, this may indicate the development of dependence or addiction:

• need to take the medicine longer than prescribed by the doctor,
• need to take a higher dose than recommended,
• feeling the need to continue taking the medicine, even if it does not help relieve pain,
• using the medicine for reasons other than recommended, e.g. "to calm down" or "to help fall asleep",
• repeated unsuccessful attempts to stop or control medicine use,
• feeling unwell after stopping the medicine and feeling better after resuming it ("withdrawal effect").

If any of these symptoms are observed, the patient should consult their doctor to discuss the best treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3 Discontinuation of Palexia retard).

Children and adolescents
Children and adolescents with obesity should be closely monitored and the maximum recommended dose should not be exceeded. Palexia retard should not be given to children under 6 years of age.

Sleep-related breathing disorders
Palexia retard may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and hypoxaemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If the patient or another person notices such symptoms, medical advice should be sought. The doctor may consider reducing the dose.

Palexia retard and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The risk of adverse effects increases if the patient takes medicines that may cause seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of seizures may increase if the patient is also taking Palexia retard. The doctor will inform the patient whether Palexia retard is suitable for them.
Concomitant use of Palexia retard and sedative medicines, such as benzodiazepines or benzodiazepine-like medicines [e.g. certain sleeping tablets or sedatives (e.g. barbiturates) or analgesics such as opioids, morphine and codeine (also used as cough suppressants), antipsychotics, H1 antihistamines, alcohol], increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use of such medicines should only be considered if no other treatment options are available.
If the doctor prescribes Palexia retard together with sedative medicines, they should limit the dose and duration of concomitant treatment.
Concomitant use of opioids and medicines used to treat epilepsy, neuropathic pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening.
Inform your doctor if you are taking gabapentin or pregabalin or any sedative medicine and strictly follow your doctor's dose recommendations. It may be helpful to inform friends or family members so they are aware of the above-mentioned objective and subjective symptoms. If such symptoms occur, contact your doctor.
If the patient is taking medicines that affect serotonin levels (e.g. certain medicines used to treat depression), they should consult their doctor before taking Palexia, due to the possibility of "serotonin syndrome". Serotonin syndrome is rare but may be life-threatening. Symptoms include: uncontrolled, rhythmic muscle contractions, including eye muscles, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone and body temperature above 38°C. If this occurs, seek medical advice.
Concomitant use of Palexia retard with mixed mu-opioid receptor agonist/antagonist medicines (e.g. pentazocine, nalbuphine) or partial mu-opioid receptor agonists (e.g. buprenorphine) has not been studied. Palexia retard may not work properly if used simultaneously with the above-mentioned groups of medicines.
Inform your doctor immediately if you are currently taking any of the medicines listed above.
Concomitant use of Palexia retard with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St John's wort) of enzymes required for tapentadol elimination from the body may affect tapentadol's action or may cause adverse effects, particularly when starting or stopping their administration. Inform your doctor about all medicines currently taken.
Palexia retard should not be used concomitantly with MAO inhibitors (medicines used to treat depression). Inform your doctor if these medicines have been or are being used within the last 14 days.
The risk of adverse effects may increase if the patient takes Palexia retard together with the following medicines with anticholinergic effects:

• antidepressants,
• medicines used to treat allergies, motion sickness or nausea (antihistamines and antiemetics),
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

Palexia retard with food, drink and alcohol
Do not drink alcohol while taking Palexia retard, as certain adverse effects such as drowsiness may be intensified. The medicine can be taken regardless of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Do not use Palexia retard:

• during pregnancy, unless the doctor decides it is necessary. Long-term use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which may be life-threatening if not recognised and treated by a doctor.
• during childbirth, as it may cause dangerous slowing or shallowing of the newborn's breathing (respiratory depression),
• during breastfeeding, as the medicine may be excreted in breast milk.

Driving and operating machinery
Palexia retard may cause drowsiness, dizziness, blurred vision and affect reaction ability. These symptoms may occur especially at the beginning of Palexia retard treatment, after a dose adjustment recommended by the doctor, or if alcohol or sedative medicines are taken concomitantly. Ask your doctor whether driving and operating machinery are permitted after taking the medicine.

Palexia retard contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking the medicine.

3. How to use Palexia retard

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Palexia retard, when and for how long the medicine should be taken, when to contact the doctor, and when the medicine should be discontinued (see also section "Discontinuation of Palexia retard").

Dosage should be adjusted according to the intensity of pain and individual patient sensitivity. The lowest effective dose that adequately relieves pain should be used.

Adults
The usual starting dose is 50 mg every 12 hours.
The doctor may prescribe a different, more appropriate dose or dosing interval if necessary.
If the effect of the medicine seems too strong or too weak, contact the doctor or pharmacist.

Total daily doses exceeding 500 mg of tapentadol are not recommended.

Elderly patients
Dosage adjustment is usually not necessary in elderly patients (over 65 years of age).
Elimination of the drug may be prolonged in patients in this age group, and therefore the doctor may recommend a different dosing regimen.

Patients with impaired liver or kidney function
Patients with severe impairment of liver function should not use this medicine.
In cases of moderate liver impairment, the doctor will recommend an adjusted dosing regimen.
Patients with mild liver impairment do not require dose adjustment.
Patients with severe kidney impairment should not use this medicine.
Dose adjustment is not required in patients with mild or moderate kidney impairment.

Use in children and adolescents
The dose of Palexia retard in children and adolescents aged 6 years to less than 18 years depends on age and body weight.
The appropriate dose will be determined by the doctor. The total daily dose should not exceed 500 mg, i.e. 250 mg administered every 12 hours.
This medicine should not be used in children and adolescents with impaired kidney or liver function.
Palexia retard should not be used in children under 6 years of age.

Method of administration
Palexia retard should be taken orally.
The tablet should be swallowed whole with sufficient liquid.
The tablet must not be chewed, crushed, or broken, as this may lead to overdose due to rapid release of the drug into the body.
Palexia retard may be taken with or without food.
The empty tablet shell may not be completely digested and may be visible in the stool. This is not a cause for concern, as the active substance has already been absorbed by the body and only the tablet shell remains in the stool.

Duration of treatment
Do not use the tablets longer than recommended by the doctor.

Overdose of Palexia retard
After taking very high doses, the following symptoms may occur:

• pinpoint constriction of the pupils, vomiting, decreased blood pressure, rapid heartbeat, collapse, disturbances of consciousness or coma (deep unconsciousness), seizures, dangerously slow or shallow breathing, or respiratory arrest, which may lead to death. In such cases, seek immediate medical attention!

Missed dose of Palexia retard
If the patient forgets to take the medicine, pain symptoms are likely to return. Do not take a double dose to make up for the missed dose. Resume the usual dosing schedule.

Discontinuation of Palexia retard
If treatment with Palexia retard is interrupted or stopped before the end of the prescribed course, pain symptoms are likely to return. Contact the doctor before stopping the medicine. Generally, no adverse effects are observed after discontinuation of the medicine; however, in rare cases, patients who have been taking the medicine for some time and who stop abruptly may experience general malaise.

The following symptoms may occur:

• restlessness, lacrimation, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils,
• irritability, restlessness, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, respiratory rate, and heart rate.

If any of the above symptoms occur, consult a doctor immediately. Do not stop taking the medicine abruptly unless instructed by the doctor. The doctor will advise the patient on how to discontinue the medicine. Discontinuation may involve gradually reducing the dose.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. In children and adolescents, no additional adverse effects have been observed compared to those occurring in adults.

Important adverse effects or symptoms to watch for, and what to do if they occur:

This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, particularly affecting the whole body.

Another serious adverse effect is excessive slowing and shallowness of breathing. This most commonly occurs in elderly and debilitated patients.

If any of these important adverse effects affect you, contact your doctor immediately.

Other adverse effects that may occur:

Very common (may affect more than 1 in 10 people): nausea, constipation, dizziness, drowsiness, headache.

Common (may affect less than 1 in 10 people): loss of appetite, anxiety, depressive mood, sleep disturbances, restlessness, motor agitation, difficulty concentrating, tremor, muscle cramps, flushing, shortness of breath, vomiting, diarrhoea, indigestion, itching, excessive sweating, rash, feeling of weakness, fatigue, sensation of body temperature changes, dryness of mucous membranes, fluid retention (oedema).

Uncommon (may affect less than 1 in 100 people): allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases difficulty breathing, low blood pressure, collapse or shock), weight loss, disorientation, confusion, agitation, disturbances of perception, unusual dreams, euphoric mood, impaired level of consciousness, memory impairment, psychiatric disturbances, fainting, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g. numbness, prickling), visual disturbances, faster heartbeat, slower heartbeat, palpitations, decreased arterial blood pressure, discomfort in the abdominal cavity, urticaria, difficulty urinating, increased frequency of urination, sexual dysfunction, withdrawal syndrome (see "Stopping Palexia retard"), feeling of abnormality, irritability.

Rare (may affect less than 1 in 1000 people): drug dependence, disturbances in thinking, seizures, feeling of impending fainting, coordination disorders, dangerously slow or shallow breathing (respiratory depression), delayed gastric emptying, sensation of alcohol intoxication, feeling of relaxation.

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

Generally, the likelihood of suicidal thoughts and behaviours is higher in patients with chronic pain. Additionally, medicines used in the treatment of depression (which affect the neurotransmitter system in the brain) may increase this risk, particularly at the beginning of treatment. Although tapentadol also affects neurotransmitters, data obtained from its use in humans have not provided evidence of increased risk.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the 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 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Palexia retard

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
No special precautions for storage of this medicine are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Palexia retard contains

• The active substance is tapentadol. Each tablet contains 25 mg of tapentadol (29.12 mg of tapentadol hydrochloride).
• Other ingredients are:
  Tablet core: hypromellose, silicified microcrystalline cellulose (microcrystalline cellulose, colloidal anhydrous silica), magnesium stearate.
  Tablet coating Opadry II Orange 30C230000: hypromellose, lactose monohydrate, talc, polyethylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Palexia retard looks like and contents of the pack
Palexia retard tablets are light orange-brown, prolonged-release coated tablets, elongated in shape (5.5 mm x 10 mm), marked with the Grünenthal logo on one side and "H9" on the other side.

Pack sizes available on the Polish market: 20, 24, 30, 54 and 60 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium, Croatia, Cyprus, Germany, Greece, Luxembourg, Netherlands, Poland, Portugal, Slovakia, Spain: PALEXIA retard
Denmark, Norway, Sweden: PALEXIA Depot
Ireland, Slovenia, United Kingdom (Northern Ireland): PALEXIA SR
Italy: PALEXIA

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20