Palexia

Package leaflet: Information for the patient

Palexia, 50 mg, coated tablets
Palexia, 75 mg, coated tablets
Palexia, 100 mg, coated tablets
Tapentadol
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Palexia is and what it is used for

Tapentadol – the active substance in Palexia – is an analgesic belonging to the group of strong opioids. Palexia is indicated for the treatment of moderate to severe acute pain in adults, when only an opioid analgesic can provide adequate pain relief.

2. Important information before using Palexia

When not to use Palexia:

• 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 case of acute alcohol, hypnotic, analgesic or other psychotropic drug intoxication (medicines affecting mood and emotions) (see "Palexia with other medicines").

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

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

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 body becomes accustomed to it, known as tolerance). Repeated use of Palexia may lead to dependence, abuse and addiction, 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 abuse may lead to the patient losing control over the amount or frequency of medicine intake. The risk of developing dependence or addiction varies among individuals. Increased risk of developing addiction or dependence on Palexia may occur 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 smoker
• the patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other mental disorders.

If, while taking Palexia, the patient notices any of the following symptoms, this may indicate that dependence or addiction is developing:

• need to take the medicine longer than prescribed by the doctor
• need to take a higher dose than recommended
• feeling that the medicine must be continued, 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 taking it again ("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, Discontinuing Palexia).

Sleep-related breathing disorders
Palexia may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood). Symptoms may include pauses in breathing 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.

Palexia with other medicines

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.
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. Your doctor will inform you whether taking Palexia is appropriate for you.

Concomitant use of Palexia with sedative medicines, such as benzodiazepines or benzodiazepine-like drugs [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, or alcohol, increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma, and may be life-threatening. Therefore, concomitant use of such medicines should only be considered when no other treatment options are available.

If your doctor prescribes Palexia together with sedative medicines, they should reduce 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 dosage instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact your doctor.

If you are taking medicines that affect serotonin levels (e.g. certain medicines used to treat depression), you should consult your doctor before taking Palexia due to the risk of "serotonin syndrome". Serotonin syndrome is rare but potentially life-threatening. Symptoms include uncontrolled, rhythmic muscle contractions, including eye movement muscles, agitation, excessive sweating, tremor, increased reflexes, increased muscle tone and body temperature above 38°C. If this occurs, seek medical advice.

The concomitant use of Palexia with opioid medicines that are mixed agonists/antagonists at the "mu" receptor (e.g. pentazocine, nalbuphine) or partial agonists at the "mu" receptor (e.g. buprenorphine) has not been studied. Palexia may not work properly if used simultaneously with the above-mentioned medicines.

Inform your doctor immediately if you are currently taking any of the medicines listed above.

Concomitant use of Palexia with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's wort) of enzymes necessary for the elimination of tapentadol from the body may affect the action of tapentadol or may cause adverse effects, especially when starting or stopping their administration. Inform your doctor about all medicines you are currently taking.

Palexia must not be used concomitantly with MAO inhibitors (medicines used to treat depression). Inform your doctor if these medicines have been used within the last 14 days.

The risk of adverse effects may increase if the patient takes Palexia 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 mental disorders (antipsychotics or neuroleptics)
• muscle relaxants
• medicines used to treat Parkinson's disease

Palexia with food, drink and alcohol
Do not drink alcohol while taking Palexia, as some adverse effects such as drowsiness may be intensified. The medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine. Do not use Palexia:

• during pregnancy, unless your 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 weakening of the newborn's breathing (respiratory depression),
• during breastfeeding, as the medicine may be excreted in breast milk.

Driving and operating machinery
Palexia may cause drowsiness, dizziness, blurred vision and affect reaction ability.
These symptoms may occur especially at the beginning of Palexia treatment, after a dose adjustment as advised 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 contains lactose
If you have been previously diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

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

3. How to use Palexia

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

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

Adults
The usual starting dose is 50 mg every 4 to 6 hours.
Your doctor may prescribe a different dose or dosing interval, if necessary.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Daily doses exceeding 700 mg of tapentadol on the first day of therapy and daily doses exceeding 600 mg of tapentadol on subsequent days of therapy are not recommended.

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

Patients with impaired liver or kidney function

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

Use in children and adolescents
The use of Palexia is not recommended in children and adolescents under 18 years of age.

Method of administration
Palexia tablets should be taken orally.
Swallow the tablet with sufficient liquid.
The medicine may be taken with or without food.

Duration of treatment
Do not take the tablets longer than prescribed by your doctor.

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

• Pinpoint pupils, vomiting, drop in 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
If you forget to take your dose, your pain may return. Do not take a double dose to make up for the missed dose. Resume your regular dosing schedule.

Discontinuation of Palexia
If you stop or interrupt treatment with Palexia before the end of prescribed therapy, your pain is likely to return. Contact your doctor before stopping the medicine. Generally, no adverse effects are observed upon discontinuation of the medicine. However, in rare cases, patients who have been taking the medicine for some time and who stop it abruptly may experience general malaise. The following symptoms may occur:

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

If any of the above symptoms occur, consult your doctor immediately. Do not stop taking the medicine suddenly, unless your doctor advises you to do so. Your doctor will inform you how to discontinue the medicine. Discontinuation may involve gradually reducing the dose.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Important adverse reactions 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 reaction is excessive slowing and shallowing of breathing. This most commonly
occurs in elderly and weakened patients.
If any of these serious adverse reactions affect you, contact your doctor immediately.

Other adverse reactions that may occur:
Very common (may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache.
Common (may affect less than 1 in 10 people): loss of appetite, anxiety, confusion, hallucinations, sleep disturbances,
unusual dreams, tremor, flushing, constipation, diarrhoea, indigestion, dry mouth, itching, excessive sweating, rash,
muscle spasms, feeling of weakness, fatigue, sensation of body temperature changes.
Uncommon (may affect less than 1 in 100 people): low mood, disorientation, agitation (restlessness), nervousness,
motor restlessness, euphoric mood, difficulty concentrating, memory impairment, feeling faint, excessive sedation,
balance disorders, speech disorders, tingling, abnormal skin sensations (e.g. numbness, prickling), muscle spasms,
visual disturbances, rapid heartbeat, palpitations, decreased blood pressure, dangerously slow or shallow breathing
(respiratory depression), reduced blood oxygen saturation, shortness of breath, abdominal discomfort, urticaria,
feeling of heaviness, difficulty urinating, frequent urination, withdrawal syndrome (see "Discontinuation of Palexia treatment"),
fluid retention (oedema), feeling of abnormality, sensation of alcohol intoxication, irritability, feeling of relaxation.
Rare (may affect less than 1 in 1000 people): allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases difficulty breathing, low blood pressure, collapse or shock), disturbances in thinking, seizures, reduced level of consciousness, coordination disorders, slow heartbeat, impaired gastric emptying.
Frequency not known (frequency cannot be estimated from available data): delirium.

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, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data obtained from human use of the medicine have not provided evidence of increased risk.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Palexia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Palexia contains

• The active substance is tapentadol. Palexia 50 mg, film-coated tablets: Each tablet contains 50 mg of tapentadol (as hydrochloride). Palexia 75 mg, film-coated tablets: Each tablet contains 75 mg of tapentadol (as hydrochloride). Palexia 100 mg, film-coated tablets: Each tablet contains 100 mg of tapentadol (as hydrochloride).
• Other ingredients are:

Palexia 50 mg, film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate.
Tablet coating Opadry II white 85F18422: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

Palexia 75 mg, film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate.
Tablet coating Opadry II yellow 85F32072: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

Palexia 100 mg, film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate.
Tablet coating Opadry II pink 85F24141: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Palexia looks like and contents of the pack

Palexia 50 mg, film-coated tablets: White, round film-coated tablets with a diameter of 7 mm, marked with the Grünenthal logo on one side and "H6" on the other side.

Palexia 75 mg, film-coated tablets: Pale yellow, round film-coated tablets with a diameter of 8 mm, marked with the Grünenthal logo on one side and "H7" on the other side.

Palexia 100 mg, film-coated tablets: Light pink, round film-coated tablets with a diameter of 9 mm, marked with the Grünenthal logo on one side and "H8" on the other side.

Palexia film-coated tablets are packed in blisters and cardboard boxes containing 20, 24, 30, 54 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

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

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Germany: Palexia Akutschmerz
Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): PALEXIA