Palgotal

Package Leaflet: Information for the User

Palgotal, 75 mg + 650 mg, Coated Tablets

Tramadol Hydrochloride + Paracetamol

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Package Leaflet

• 1. What is Palgotal and What is it Used For
• 2. Important Information Before Taking Palgotal
• 3. How to Take Palgotal
• 4. Possible Side Effects
• 5. How to Store Palgotal
• 6. Contents of the Package and Other Information

1. What is Palgotal and What is it Used For

Palgotal is a pain reliever that combines two active substances with pain-relieving properties: tramadol and paracetamol. Palgotal is used to treat moderate to severe pain when the doctor considers it necessary to use tramadol and paracetamol in combination.
Palgotal should only be used in adults and adolescents over 12 years of age.

2. Important Information Before Taking Palgotal

When Not to Take Palgotal

• if you are allergic to tramadol, paracetamol, or any of the other ingredients of this medication (listed in section 6);
• in acute alcohol intoxication, sleeping pills, painkillers, or psychotropic medications (mood, emotion, and mental state-affecting medications);
• if you are taking monoamine oxidase inhibitors (MAOIs) or have taken them within the last 14 days before starting treatment with Palgotal. MAOIs are used to treat depression or Parkinson's disease.
• if you have severe liver dysfunction;
• if you have epilepsy that is not adequately controlled by your current medication.

Warnings and Precautions

Respiratory depression during sleep
Palgotal may cause respiratory depression during 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, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, you should contact your doctor. Your doctor may recommend reducing the dose.
Before starting Palgotal, you should discuss the following with your doctor or pharmacist:

• if you are taking other medications containing the active substances paracetamol or tramadol.
• if you have liver disease. Yellowing of the eyes and skin may indicate jaundice.
• if you have kidney problems.
• if you have severe breathing difficulties, such as asthma or severe lung disease.
• if you have epilepsy or have had seizures in the past.
• if you have recently had a head injury, concussion, or severe headache with vomiting.
• if you are addicted to other painkillers, such as morphine.
• if you are taking other painkillers that contain buprenorphine, nalbuphine, or pentazocine.
• if you are to receive an anesthetic. You should inform your doctor or dentist about taking Palgotal.
• if you are taking antidepressants, as some of them may interact with tramadol (see "Palgotal and Other Medications"). After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of serotonin syndrome. If you experience any symptoms of this syndrome, you should seek medical attention immediately (see section 4). If you have experienced any of these symptoms in the past or while taking Palgotal, you should inform your doctor.

Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, you should contact your doctor, who will decide whether you need hormone replacement.
While taking Palgotal, you should immediately inform your doctor if you experience severe diseases, including severe kidney problems or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). There have been reports of a severe condition called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a long time or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Tolerance, Dependence, and Addiction
This medication contains tramadol, which is an opioid. Repeated use of opioids can lead to tolerance (you get used to the medication). Repeated use of Palgotal can also lead to dependence, abuse, and addiction, which can result in life-threatening overdose. The risk of these adverse effects may increase with dose and duration of treatment.
Dependence can make it difficult for you to control the dose or frequency of medication use.
The risk of dependence varies from person to person. The risk of dependence on Palgotal may be higher if:

• you or someone in your family has ever abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction");
• you smoke tobacco;
• you have ever had mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If you experience any of the following symptoms while taking Palgotal, it may indicate dependence:

• you need to take the medication for a longer period than your doctor recommended
• you need to take a higher dose than recommended
• you use the medication for reasons other than recommended, such as "to calm down" or "to help you sleep"
• you have made repeated, unsuccessful attempts to stop or control medication use
• after stopping the medication, you feel unwell and feel better after taking it again ("withdrawal effects").

If you experience any of these symptoms, you should talk to your doctor to discuss the best course of treatment, including when to stop the medication and how to do it safely (see section 3, "Stopping Palgotal").
It is essential to know that:

• Tramadol is converted in the liver by an enzyme. In some people, there is a variation of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of severe adverse effects may be higher. You should stop taking the medication and contact your doctor immediately if you experience any of the following adverse effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting.

Children and Adolescents

Palgotal is not recommendedfor children under 12 years of age.
Use in children with respiratory disorders
Tramadol is not recommended for children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Palgotal and Other Medications

Tell your doctor or pharmacist:

• about all medications you are currently taking or have recently taken, as well as any medications you plan to take. It is especially important to inform your doctor if you are taking any other medication that also contains paracetamolor tramadol, as Palgotal contains both of these substances, and you should be careful not to exceed their total maximum daily dose (see section 3).
• if you are taking flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment (see section 2).
• if you are taking gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain.

Do not takePalgotal with monoamine oxidase inhibitors (MAOIs) (see section 2, "When Not to Take Palgotal").
It is not recommended to take Palgotal with the following medications:

• Carbamazepine (a medication used to treat epilepsy or certain types of pain).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). This may lead to a decrease in the pain-relieving effect.

The risk of adverse effects increases when Palgotal is taken with:

• Medications that can cause seizures, such as certain antidepressants, antipsychotics, or bupropion (used to quit smoking). The risk of seizures may increase if you take Palgotal at the same time. Your doctor will decide whether Palgotal is suitable for you.
• Certain antidepressants (such as selective serotonin reuptake inhibitors, SSRIs) and triptans (used to treat migraines). Palgotal may interact with these medications and cause serotonin syndrome (see section 4).
• Sedatives, sleeping pills, or other painkillers, such as morphine and codeine (also as a cough suppressant), baclofen (a muscle relaxant), blood pressure-lowering medications, or allergy medications. If you experience drowsiness or weakness, you should contact your doctor.
• Warfarin or phenprocoumon (used to thin the blood). The effectiveness of these medications may change, which can lead to bleeding (see section 4). Any prolonged or unexpected bleeding should be reported to your doctor immediately.
• The concurrent use of Palgotal and sedatives, such as benzodiazepines or similar medications, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible. If your doctor prescribes Palgotal in combination with sedatives, they should limit the dose and duration of treatment. You should inform your doctor about all sedatives you are taking and strictly follow their dosage recommendations. You should inform your friends and family about the symptoms mentioned above. If you experience any of these symptoms, you should contact your doctor.

The effectiveness of Palgotal may also be affected by the concurrent use of:

• Metoclopramide, domperidone, or ondansetron (medications used to treat nausea and vomiting),
• Cholestyramine (a medication used to lower cholesterol levels in the blood),
• Ketoconazole or erythromycin (antibiotics).

Palgotal with Food, Drink, and Alcohol

You should not drink alcohol while taking Palgotal, as it may cause increased drowsiness.

Pregnancy and Breastfeeding

Palgotal should not be takenduring pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Tramadol is excreted into breast milk. Therefore, you should not take Palgotal more than once while breastfeeding, or if you take it more than once, you should stop breastfeeding.

Driving and Using Machines

Palgotal may cause drowsiness. If you experience drowsiness while taking Palgotal, you should not drive, use tools, or operate machinery.

Palgotal Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to Take Palgotal

This medication should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Palgotal, when and how long to take it, when to contact your doctor, and when to stop it (see also section 2).
Palgotal should be taken for the shortest duration necessaryand not longer than your doctor has prescribed. The dose should be adjusted according to the severity of the pain and individual sensitivity to pain.
Generally, the lowest effective doseshould be used.

Adults and Adolescents Over 12 Years of Age

• If your doctor does not recommend otherwise, the usual starting dose is 1 tablet. If necessary, you can take additional doses, following your doctor's recommendations.
• The minimum interval between doses must be at least 6 hours.
• Do not take more than 4 tablets in a 24-hour period.
• Tablets can be divided into equal doses. Tablets should be swallowed with a sufficient amount of liquid.

If you feel that the effect of Palgotal is too strong (you experience significant drowsiness or breathing difficulties) or too weak (pain relief is insufficient), you should contact your doctor.

Children Under 12 Years of Age

Palgotal is not recommendedfor children under 12 years of age.

Elderly Patients

In elderly patients (75 years of age and older), tramadol elimination may be delayed. In such cases, your doctor may recommend prolonging the time between doses.

Patients with Severe Liver or Kidney Disease or Patients on Dialysis

In patients with severe liver and/or kidney disease, Palgotal should not be taken. If you have mild or moderate liver or kidney disease, your doctor may recommend prolonging the time between doses.

Overdose of Palgotal

If you take too much of this medication or if a child accidentally takes it, you should immediately contact your doctor or go to the nearest hospital and inform them about the exact amount of medication taken. You should bring the medication packaging and leaflet with you.
Overdose of paracetamol can cause severe liver failure, which can be fatal.

Missing a Dose of Palgotal

If you miss a dose, the pain will likely return.
Do not take a double doseto make up for a missed dose. You should continue taking the tablets according to the established schedule.

Stopping Palgotal

If you stop taking Palgotal, the pain will likely return. You should not stop taking this medication suddenly without your doctor's advice. If you want to stop taking Palgotal, you should discuss it with your doctor, especially if you have been taking it for a long time. Your doctor will advise you on when and how to stop taking the medication; this may involve gradually reducing the dose to minimize the risk of adverse effects (such as anxiety, agitation, nervousness, panic attacks, hallucinations, unusual sensations, ringing in the ears, insomnia, tremors, or gastrointestinal symptoms). If you experience any of these symptoms after stopping Palgotal, you should contact your doctor.
If you have any further questions about taking this medication, you should ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Palgotal can cause side effects, although not everybody gets them.

Some Side Effects Can be Serious. You Should Stop Taking Palgotal and Seek Immediate Medical Attention if You Experience Any of the Following Symptoms:

• Swelling of the face, lips, or throat, difficulty swallowing or breathing, or low blood pressure and fainting. You may also experience a rash or itching. This could be a sign of a severe allergic reaction.
• Any prolonged or unexpected bleeding when taking Palgotal with blood-thinning medications (warfarin or phenprocoumon).
• Severe skin reactions (very rare), including redness, blisters, and peeling of the skin.

In addition, the following side effects may occur during treatment with Palgotal:
Very Common Side Effects(may affect more than 1 in 10 people):

• Nausea (feeling sick),
• Dizziness, drowsiness.

Common Side Effects(may affect up to 1 in 10 people):

• Vomiting, digestive disorders (constipation, bloating, diarrhea), abdominal pain, dry mouth,
• Itching, excessive sweating,
• Headache, tremors,
• Disorientation, sleep disturbances, mood changes (anxiety, nervousness, euphoria - a constant feeling of elevated mood).

Uncommon Side Effects(may affect up to 1 in 100 people):

• Increased heart rate or high blood pressure, heart rhythm disorders,
• Difficulty or pain when urinating,
• Skin reactions (e.g., rash, hives),
• Numbness, tingling, or a feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle contractions,
• Depression, nightmares, hallucinations (hearing, seeing, or feeling things that do not exist in reality), memory problems,
• Difficulty swallowing, blood in the stool,
• Chills, hot flashes, chest pain,
• Breathing difficulties,
• Increased liver enzyme activity,
• Presence of protein in the urine (albumin).

Rare Side Effects(may affect up to 1 in 1,000 people):

• Seizures, uncoordinated movements,
• Dependence,
• Blurred vision,
• Transient loss of consciousness (fainting),
• Acute confusion (delirium),
• Speech disorders,
• Constriction or dilation of the pupils.

Very Rare Side Effects(may affect up to 1 in 10,000 people):

• Medication abuse.

Unknown(frequency cannot be estimated from the available data):

• Low blood sugar levels,
• Hiccups, Serotonin syndrome, whose symptoms may include changes in mental status (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, unstable blood pressure, involuntary muscle contractions, stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2).

In addition, the following side effects have been reported by people taking medications containing only tramadol or paracetamol:

• Fainting when standing up from a lying or sitting position, slow heart rate, fainting.
• Changes in appetite.
• Muscle weakness, slower or shallower breathing.
• Mood changes, changes in activity, changes in sensation.
• Worsening of asthma.
• Nosebleeds or gum bleeding, which may be due to a low platelet count.
• Withdrawal syndrome - a set of symptoms that occur after stopping or reducing the dose of a medication, e.g., agitation, anxiety, nervousness, sleep disturbances, increased muscle activity, tremors, gastrointestinal symptoms. Very rarely, panic attacks, anxiety, hallucinations (hearing, seeing, or feeling things that do not exist in reality), loss of sensation on the skin, ringing and buzzing in the ears, and unusual symptoms from the central nervous system have occurred.
• Destruction of red blood cells in patients with a metabolic disorder called glucose-6-phosphate dehydrogenase deficiency.
• A serious condition that can cause the blood to become more acidic (metabolic acidosis) has been reported with an unknown frequency in patients with severe illness taking paracetamol (see section 2).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Palgotal

Keep the medication out of sight and reach of children.
The medication should be stored in a safe place, inaccessible to others. It can cause serious harm and be fatal to individuals for whom it was not prescribed.
Do not take this medication after the expiration date stated on the carton after EXP.
The expiration date refers to the last day of the month.
There are no special precautions for storage. You should store the medication in its original packaging to protect it from moisture.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Palgotal Contains

• The active substances of Palgotal are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• Excipients: microcrystalline cellulose, povidone K-25, corn starch, pregelatinized corn starch, sodium croscarmellose, magnesium stearate, talc, hypromellose, macrogol 6000, yellow iron oxide (E 172), brown iron oxide (E 172), titanium dioxide (E 171).

What Palgotal Looks Like and Contents of the Package

Palgotal is a light yellow-brown, elongated, biconvex, coated tablet with a dividing line on both sides, measuring 18 x 9 mm, with a radius of 8 mm. The tablet can be divided into equal doses.
Package sizes: 10, 20, 30, 60, or 90 tablets.
Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Zentiva, k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic

For More Information on This Medication and Its Names in the Member States of the European Economic Area, Please Contact the Representative of the Marketing Authorization Holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of Last Revision of the Leaflet:January 2025