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 tabletsEFG

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 this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Tapentadol - the active ingredient in Palgesic retard - is a potent analgesic that belongs to the class of opioids.

Tapentadol is used for the treatment of severe chronic pain in adults, which can only be adequately treated with an opioid analgesic.

Do not take Palgesic retard

Warnings and precautions

Consult your doctor or pharmacist before starting to take tapentadol:

This medication contains tapentadol, which is an opioid medication. Repeated use of opioid analgesics may reduce the effectiveness of the medication (you may become accustomed to it). It may also lead to dependence and abuse, which may result in a potentially fatal overdose. It is essential to inform your doctor if you think you may have developed dependence on tapentadol. Your use (even at therapeutic doses) may cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this medication abruptly.

Tapentadol may cause physical and psychological addiction. If you have a tendency to abuse medications or have medication dependence, you should take these tablets only for short periods of time under strict medical supervision.

Respiratory disorders related to sleep

Tapentadol may cause respiratory disorders related to sleep 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, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Other medications and tapentadol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The risk of side effects increases if you are taking medications that may cause seizures (e.g. certain antidepressants or antipsychotics). The risk of seizures increases if you take tapentadol simultaneously with these medications. Your doctor will tell you if tapentadol is suitable for you.

The concomitant use of tapentadol and sedatives such as benzodiazepines or related medications (certain sleeping pills or tranquilizers [e.g. barbiturates] or painkillers such as opioids, morphine, and codeine [also as a cough medication], antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tapentadol with sedatives, you should limit the dose and duration of concomitant treatment.

The concomitant use of opioids and medications 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, and follow your doctor's dosage recommendations exactly. It may be helpful to inform friends or family members about the symptoms mentioned above. Contact your doctor when you experience these symptoms.

If you are taking a type of medication that affects serotonin levels (e.g. certain medications for depression), speak with your doctor before taking tapentadol, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary muscle contractions, including those that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor may provide additional information.

The concomitant administration of tapentadol with other types of medications called mixed agonist/antagonist µ opioid receptor agonists (e.g. pentazocine, nalbuphine) or partial agonists of the µ opioid receptors (e.g. buprenorphine) has not been studied. Tapentadol may not have the same effectiveness if administered with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

The administration of tapentadol with potent inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary for the elimination of tapentadol from the body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medication. Inform your doctor about all the medications you are taking.

Tapentadol should not be taken with MAO inhibitors (medications for depression). Inform your doctor if you are taking MAO inhibitors or have taken them in the last 14 days.

Taking tapentadol with food, drinks, and alcohol

Do not consume alcohol while taking tapentadol, as some of its adverse effects, such as drowsiness, may increase. Food intake does not affect the effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication:

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during tapentadol treatment. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly cautious at the start of treatment, after a dose change, and when taking it with alcohol or tranquilizers.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose based on the intensity of your pain and your personal sensitivity to pain. Generally, you should take the minimum effective dose to relieve pain.

The tablet can be divided into equal doses.

Adults

The recommended dose is 1 tablet every 12 hours. Do not recommend daily total doses exceeding 500 mg of tapentadol.

Your doctor may prescribe a different dose or a more suitable dosing regimen if necessary. If you think the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.

Older patients

In older patients (over 65 years old), it is usually not necessary to adjust the dose. However, the elimination of tapentadol may be delayed and slower in certain patients of this age group. If this happens to you, your doctor may prescribe a different dosing regimen.

Liver and kidney diseases (hepatic and renal insufficiency)

Patients with severe liver problems should not take these tablets. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. In case of mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

Tapentadol is not indicated in children and adolescents under 18 years old.

How and when to take tapentadol

Tapentadol should be taken orally.

Always take the tablets with a sufficient amount of liquid.

You can take the tablets whole or broken in half through the notch. Do not chew or crush them, as this could lead to an overdose because the active ingredient will be released in your body too quickly.

You can take them on an empty stomach or with meals.

The coating of the tablet may not be fully digested and may appear, apparently unchanged, in the stool. This should not worry you, as the active ingredient of the tablet will have already been absorbed by the body and what you see is only the empty coating.

Instructions for opening the blister pack

This medication is packaged in pre-cut, single-dose safety blisters that are child-resistant. You cannot push the tablet out of the blister. Please follow the following instructions for opening the blister pack:

1. Cut a dose along the pre-cut lines of the blister.

2. Locate the non-sealed area where the pre-cut lines intersect.

3. Pull the non-sealed area to separate the sheet.

For how long should tapentadol be taken

Do not take the tablets for longer than your doctor has indicated.

If you take more tapentadol than you should

After taking very high doses, you may experience some of the following effects:

If any of these things happen, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take tapentadol

If you forget to take a tablet, it is likely that you will feel pain again. Do not take a double dose to compensate for the missed doses, but continue taking the tablets as before.

If you interrupt the treatment with tapentadol

If you interrupt or stop taking the treatment too soon, it is likely that you will feel pain again. If you want to interrupt the treatment, consult your doctor before doing so.

Generally, patients do not experience any adverse effects after interrupting treatment, but in rare cases, people who have taken the tablets for a long time may feel unwell if they stop taking them suddenly.

The symptoms may be:

If you experience any of these symptoms after interrupting treatment, consult your doctor.

You should not stop taking this medication abruptly, unless your doctor tells you to. If your doctor wants you to stop taking these tablets, they will indicate how to do it, which may involve a gradual reduction in dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Important side effects or symptoms to be aware of and what to do if you are affected by them:

This medication may cause allergic reactions. Symptoms may include wheezing (a whistling sound when breathing), difficulty breathing, inflammation of the eyelids, face, or lips, skin rash or itching, especially if it affects the entire body.

Another serious side effect consists of breathing more slowly or more weakly than normal. It occurs mainly in elderly patients or in weakened patients.

If you experience any of these important symptoms, consult your doctor immediately.

Other side effects that may occur:

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

Common(may affect up to 1 in 10 people): decreased appetite, anxiety, depression, difficulty sleeping, nervousness, restlessness, attention disturbances, tremors, muscle tics, hot flashes, shortness of breath, vomiting, diarrhea, poor digestion, itching, increased sweating, skin eruptions, feeling of weakness, fatigue, feeling of change in body temperature, dryness of mucous membranes, accumulation of water in tissues (edema).

Uncommon(may affect up to 1 in 100 people): allergic reaction to medications (including hives, urticarial rash, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), weight loss, disorientation, confusion, excitability (agitation), perception disturbances, sleep disturbances, euphoric mood, depression of consciousness level, memory deterioration, mental deterioration, fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal skin sensations (e.g., tingling, itching), vision disturbances, rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure, abdominal discomfort, hives, delayed urination, frequent urination, sexual dysfunction, withdrawal syndrome from medications (see section “If you interrupt treatment with tapentadol”), feeling of discomfort, irritability.

Rare(may affect up to 1 in 1,000 people): drug dependence, thought disturbances, seizures, feeling of impending fainting, coordination disturbances, slow or shallow breathing to dangerous levels (respiratory depression), gastric emptying disturbances, feeling of intoxication, feeling of relaxation.

Unknown frequency(cannot be estimated from available data): delirium.

In general, the possibility of having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medications for treating depression (affecting neurotransmitters in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, through experience in patients it has not been proven to increase this risk.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit containers and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Palgesic retard

The active principle is tapentadol.

Palgesic retard 25 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 25 mg of tapentadol (in the form of phosphate).

Palgesic retard 50 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 50 mg of tapentadol (in the form of phosphate).

Palgesic retard 100 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 100 mg of tapentadol (in the form of phosphate).

Palgesic retard 150 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 150 mg of tapentadol (in the form of phosphate).

Palgesic retard 200 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 200 mg of tapentadol (in the form of phosphate).

Palgesic retard 250 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 250 mg of tapentadol (in the form of phosphate).

The other components (excipients) are:

iron oxide red (E172) (only for the 25, 100, 150, 200, and 250 mg doses), iron oxide yellow (E172) (only for the 25, 100, and 200 mg doses), iron oxide black (E172) (only for the 25, 100, 150, 200, and 250 mg doses).

Appearance of Palgesic retard and contents of the package

Palgesic retard 25 mg prolonged-release tablets EFG : film-coated tablets, brown in color, oblong, biconvex (5.7 mm x 12.2 mm), with a groove on both sides.

Palgesic retard 50 mg prolonged-release tablets EFG : film-coated tablets, white in color, oblong, biconvex (6.2 mm x 13.2 mm), with a groove on both sides.

Palgesic retard 100 mg prolonged-release tablets EFG : film-coated tablets, yellowish in color, oblong, biconvex (6.7 mm x 14.2 mm), with a groove on both sides.

Palgesic retard 150 mg prolonged-release tablets EFG : film-coated tablets, bright reddish in color, oblong, biconvex (7.2 mm x 15.2 mm), with a groove on both sides.

Palgesic retard 200 mg prolonged-release tablets EFG : film-coated tablets, yellow in color, oblong, biconvex (7.7 mm x 16.2 mm), with a groove on both sides.

Palgesic retard 250 mg prolonged-release tablets EFG : film-coated tablets, brownish reddish in color, oblong, biconvex (8.7 mm x 18.2 mm), with a groove on both sides.

Available in packs of 60 units, packaged in a pre-cut, unit-dose, aluminum-PVC/PE/PVDC blister pack, child-resistant.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

Last review date of this leaflet: August 2023

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )