Palgesic Retard 150 mg prolonged-release tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Palgesic retard 25 mg prolonged-release tablets EFG
Palgesic retard 50 mg prolonged-release tablets EFG
Palgesic retard 100 mg prolonged-release tablets EFG
Palgesic retard 150 mg prolonged-release tablets EFG
Palgesic retard 200 mg prolonged-release tablets EFG
Palgesic retard 250 mg prolonged-release tablets EFG
tapentadol
Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Palgesic retard is and what it is used for
- What you need to know before taking Palgesic retard
- How to take Palgesic retard
- Possible side effects
- How to store Palgesic retard
- Contents of the pack and other information
1. What Palgesic retard is and what it is used for
Tapentadol – the active substance in Palgesic retard – is a potent analgesic belonging to the opioid class.
Tapentadol is used for the treatment of severe chronic pain in adults, which can only be adequately managed with an opioid analgesic.
2. What you need to know before taking Palgesic retard
Do not take Palgesic retard
- if you are allergic to tapentadol or to any of the other ingredients of this medicine (listed in section 6),
- if you have asthma or if your breathing is slow or shallow to dangerous levels [respiratory depression; hypercapnia (higher than normal concentration of carbon dioxide in the blood)],
- if you have a condition in which the intestine does not function properly (intestinal paralysis),
- if you have consumed alcohol, sleeping pills, other painkillers, or other psychotropic medicines (medicines affecting mood and emotions) in high doses (see section "Other medicines and tapentadol").
Warnings and precautions
Talk to your doctor or pharmacist before starting tapentadol:
- if your breathing is slow or shallow,
- if you have increased intracranial pressure or altered consciousness up to and including coma,
- if you have had a head injury or brain tumors,
- if you have liver or kidney disease (see section “How to take Palgesic retard”),
- if you have a disease of the pancreas (such as pancreatitis) or of the bile ducts,
- if you are taking medicines known as mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of µ-opioid receptors (e.g., buprenorphine),
if you are prone to epilepsy or seizures, or if you are taking other medicines known to increase the risk of seizures, as the risk of such seizures may increase.
Tolerance, dependence, and addiction
This medicine contains tapentadol, which is an opioid. It may cause dependence and/or addiction.
This medicine contains tapentadol, an opioid medicine. Repeated use of opioid analgesics may reduce their effectiveness (you may become accustomed to them, known as tolerance). Repeated use of tapentadol may also lead to dependence and abuse, which could result in potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.
Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often.
The risk of becoming dependent or addicted varies from person to person. You may be at higher risk of becoming dependent or addicted to tapentadol if:
- you or a family member have a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”),
- you are a smoker,
- you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.
If you notice any of the following signs while taking tapentadol, it could be a sign that you have become dependent or addicted:
- you need to take the medicine for longer than recommended by your doctor,
- you need to take higher doses than recommended,
- you may feel that you need to keep taking the medicine even when it is not helping relieve pain,
- you are using the medicine for reasons other than prescribed, for example, “to calm down” or “to help you sleep”,
- you have made repeated unsuccessful attempts to stop or control medicine use,
- you feel unwell when you stop taking the medicine and feel better when you take it again (“withdrawal symptoms”).
If you notice any of these signs, speak with your doctor to discuss the most appropriate treatment strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 “If you stop treatment with tapentadol”).
Tapentadol can cause physical and psychological addiction. If you have a tendency to abuse medicines or are dependent on medicines, you should take these tablets only for short periods and under strict medical supervision.
Sleep-related breathing disorders
Tapentadol may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.
Other medicines and tapentadol
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The risk of side effects increases if you are taking medicines that may provoke seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tapentadol at the same time as these medicines. Your doctor will tell you whether tapentadol is suitable for you.
Concomitant use of tapentadol and sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquilizers [e.g., barbiturates] or analgesics such as opioids, morphine, and codeine [also as a cough medicine], antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes tapentadol with sedative medicines, your dose and duration of concomitant treatment should be limited.
Concomitant use of opioids and medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and may be potentially fatal.
Inform your doctor if you are taking gabapentin or pregabalin or any other sedative medicine, and follow your doctor’s dosage recommendations exactly. It may be helpful to inform friends or family members so they are aware of the symptoms mentioned above. Contact your doctor if you experience these symptoms.
If you are taking a type of medicine that affects serotonin levels (e.g., certain medicines for treating depression), talk to your doctor before taking tapentadol, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but potentially life-threatening condition. Symptoms may include rhythmic involuntary muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide further information.
The concomitant administration of tapentadol with other medicines known as mixed µ-opioid receptor agonist/antagonists (e.g., pentazocine, nalbuphine) or partial µ-opioid agonists (e.g., buprenorphine) has not been studied. Tapentadol may be less effective if taken together with one of these medicines. Inform your doctor if you are currently being treated with any of these medicines.
Administration of tapentadol together with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John’s wort) of certain enzymes required to eliminate tapentadol from your body may affect the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping such medication. Keep your doctor informed about all medicines you are taking.
Tapentadol must not be taken together with MAO inhibitors (medicines used to treat depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.
If you use tapentadol together with the following medicines that have anticholinergic effects, the risk of side effects may increase:
- medicines used to treat depression,
- medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
- medicines used to treat psychiatric disorders (antipsychotics or neuroleptics),
- muscle relaxants,
- medicines used to treat Parkinson’s disease.
Taking tapentadol with food, drinks, and alcohol
Do not consume alcohol while taking tapentadol, as some of its adverse effects, such as drowsiness, may be increased. Taking food does not affect the action of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take this medicine:
- if you are pregnant, unless instructed by your doctor; if used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor,
- during childbirth, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn,
- during breastfeeding, as it may be excreted in breast milk.
Driving and using machines
Ask your doctor whether you can drive or use machines while being treated with tapentadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel sleepy, dizzy, have blurred vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose change, and when taking tapentadol together with alcohol or tranquilizers.
3. How to take Palgesic retard
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from the use of tapentadol, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "If you stop taking tapentadol").
Your doctor will adjust the dose according to the intensity of your pain and your individual sensitivity to pain. Generally, the lowest effective dose should be used to relieve pain.
The tablet may be divided into equal doses.
Adults
The recommended dose is 1 tablet every 12 hours. Total daily doses exceeding 500 mg of tapentadol are not recommended.
Your doctor may prescribe a different or more suitable dosage regimen if necessary. If you think the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.
Elderly patients
In elderly patients (over 65 years of age), dose adjustment is usually not necessary. However, elimination of tapentadol may be delayed and slower in certain patients in this age group. If this applies to you, your doctor may prescribe a different dosage regimen.
Liver and kidney disease (hepatic and renal impairment)
Patients with severe liver problems must not take these tablets. If you have moderate liver problems, your doctor will prescribe a different dosage regimen. Dose adjustment is not necessary in mild liver problems.
Patients with severe kidney problems must not take these tablets. Dose adjustment is not necessary in mild or moderate kidney problems.
Use in children and adolescents
Tapentadol is not indicated in children and adolescents under 18 years of age.
How and when to take tapentadol
Tapentadol should be taken orally.
Always take the tablets with sufficient liquid.
You may take the tablets whole or split in half along the score line. Do not chew or crush them, as this could lead to overdose because the active substance would be released too quickly into your body.
You may take them on an empty stomach (with an empty stomach) or with food.
The tablet coating may not be completely digested and therefore may appear apparently unchanged in the faeces. This should not concern you, as the active ingredient of the tablet will already have been absorbed by the body, and what you see is only the empty coating.
Instructions for opening the blister pack
This medicine is packaged in child-resistant, single-dose safety blister packs with pre-cut lines. The tablet cannot be pushed out through the blister. Please follow these instructions for opening the blister:
- Cut one dose along the pre-cut lines of the blister.
- Locate the unsealed area where the pre-cut lines intersect.
- Pull at the unsealed area to peel off the foil.
How long to take tapentadol
Do not take the tablets for longer than your doctor has instructed.
If you take more tapentadol than you should
After taking very high doses, you may experience one or more of the following effects:
- very small pupils, vomiting, decreased blood pressure, rapid heartbeat, fainting, altered consciousness or coma (deep loss of consciousness), epileptic seizures, slow or shallow breathing to dangerous levels, or respiratory arrest which can lead to death.
If any of these occur, call a doctor immediately!
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.
If you forget to take tapentadol
If you forget to take a tablet, you may start to feel pain again. Do not take a double dose to make up for missed doses; instead, continue taking the tablets as before.
If you stop taking tapentadol
If you stop or discontinue treatment too early, you may start to feel pain again. If you wish to stop treatment, consult your doctor first.
Generally, patients do not experience any adverse effects after stopping treatment, but rarely, individuals who have taken the tablets for a prolonged period may feel unwell if they stop suddenly.
Symptoms may include:
- restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils,
- irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhoea, and increases in blood pressure, respiratory rate, or heart rate.
If you experience any of these symptoms after stopping treatment, consult your doctor.
You must not stop this medicine abruptly unless your doctor tells you to do so. If your doctor wants you to stop taking these tablets, they will advise you how to do so, which may involve gradually reducing the dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Important adverse effects or symptoms to watch for, and what to do if you experience them:
This medicine may cause allergic reactions. Symptoms may include wheezing (a whistling sound when breathing), difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if affecting the entire body.
Another serious adverse effect is abnormally slow or weak breathing. This occurs mostly in elderly or weakened patients.
If you experience any of these serious symptoms, consult your doctor immediately.
Other possible adverse effects:
Very common (may affect more than 1 in 10 people): nausea, constipation, dizziness, drowsiness, headache.
Common (may affect up to 1 in 10 people): loss of appetite, anxiety, depressed mood, difficulty sleeping, nervousness, restlessness, attention disturbances, tremors, muscle tics, hot flushes, shortness of breath, vomiting, diarrhoea, indigestion, itching, increased sweating, skin rashes, feeling of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, fluid accumulation in tissues (oedema).
Uncommon (may affect up to 1 in 100 people): allergic reaction to medicines (including swelling under the skin, urticarial rash, and in severe cases difficulty breathing, low blood pressure, collapse or shock), weight loss, disorientation, confusion, excitability (agitation), disturbances in perception, sleep disturbances, euphoric mood, depression of\ level of consciousness, memory impairment, mental deterioration, fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, itching), visual disturbances, rapid heartbeat, slow heartbeat, palpitations, low blood pressure, abdominal discomfort, rash, delayed urination, frequent urination, sexual dysfunction, drug withdrawal syndrome (see section “If you stop taking tapentadol”), feeling of malaise, irritability.
Rare (may affect up to 1 in 1,000 people): drug dependence, thought disturbance, epileptic seizures, feeling faint, impaired coordination, slow or shallow breathing to dangerous levels (respiratory depression), gastric emptying disturbance, feeling of drunkenness, feeling of relaxation.
Frequency not known (cannot be estimated from available data): delirium.
In general, the likelihood of suicidal thoughts and behaviours increases in patients with chronic pain. In addition, some medicines used to treat depression (which affect the brain's neurotransmitter system) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, clinical experience in patients has not shown that it increases this risk.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Palgesic retard
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at the pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Pack contents and other information
Composition of Palgesic retard
The active substance is tapentadol.
Palgesic retard 25 mg prolonged-release tablets EFG
Each prolonged-release tablet contains 25 mg of tapentadol (as phosphate).
Palgesic retard 50 mg prolonged-release tablets EFG
Each prolonged-release tablet contains 50 mg of tapentadol (as phosphate).
Palgesic retard 100 mg prolonged-release tablets EFG
Each prolonged-release tablet contains 100 mg of tapentadol (as phosphate).
Palgesic retard 150 mg prolonged-release tablets EFG
Each prolonged-release tablet contains 150 mg of tapentadol (as phosphate).
Palgesic retard 200 mg prolonged-release tablets EFG
Each prolonged-release tablet contains 200 mg of tapentadol (as phosphate).
Palgesic retard 250 mg prolonged-release tablets EFG
Each prolonged-release tablet contains 250 mg of tapentadol (as phosphate).
The other components (excipients) are:
- Tablet core: microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate.
- Tablet coating: hypromellose, glycerol, talc, microcrystalline cellulose, titanium dioxide (E 171),
iron oxide red (E172) (only for the 25, 100, 150, 200 and 250 mg strengths), iron oxide yellow (E172) (only for the 25, 100 and 200 mg strengths), iron oxide black (E172) (only for the 25, 100, 150, 200 and 250 mg strengths).
Appearance of Palgesic retard and pack contents
Palgesic retard 25 mg prolonged-release tablets EFG: brown film-coated tablets, oblong, biconvex (5.7 mm x 12.2 mm), with notches on both sides.
Palgesic retard 50 mg prolonged-release tablets EFG: white film-coated tablets, oblong, biconvex (6.2 mm x 13.2 mm), with notches on both sides.
Palgesic retard 100 mg prolonged-release tablets EFG: yellowish film-coated tablets, oblong, biconvex (6.7 mm x 14.2 mm), with notches on both sides.
Palgesic retard 150 mg prolonged-release tablets EFG: bright reddish film-coated tablets, oblong, biconvex (7.2 mm x 15.2 mm), with notches on both sides.
Palgesic retard 200 mg prolonged-release tablets EFG: yellow film-coated tablets, oblong, biconvex (7.7 mm x 16.2 mm), with notches on both sides.
Palgesic retard 250 mg prolonged-release tablets EFG: reddish-brown film-coated tablets, oblong, biconvex (8.7 mm x 18.2 mm), with notches on both sides.
Available in packs of 60 units in child-resistant, pre-scored unit-dose blisters made of aluminum-PVC/PE/PVDC.
Marketing Authorization Holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain
Manufacturer
Develco Pharma GmbH
Grienmatt 27
79650 Schopfheim
Germany
Date of the most recent review of this summary: November 2025
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)