Palgotal

Package leaflet: Information for the user

Palgotal, 75 mg + 650 mg, coated tablets
Tramadoli hydrochloridum + Paracetamolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Leaflet contents

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

1. What Palgotal is and what it is used for

Palgotal is an analgesic medicine combining two active substances with pain-relieving properties: tramadol and paracetamol. Palgotal is intended for the treatment of moderate to severe pain, when a doctor considers it necessary to use tramadol and paracetamol in combination.
Palgotal should be used only in adults and adolescents above 12 years of age.

2. Important information before using Palgotal

When not to use Palgotal

• if the patient is allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• in acute intoxication with alcohol, sedatives, painkillers, or psychotropic medicines (medicines affecting mood, emotions, and mental state);
• if the patient is currently taking or has taken within the last 14 days medicines called monoamine oxidase inhibitors (MAOIs). MAO inhibitors are used in the treatment of depression or Parkinson's disease;
• if the patient has severe liver function impairment;
• if the patient suffers from epilepsy that is not adequately controlled by currently prescribed medicines.

Warnings and precautions
Sleep-related breathing disorders
Palgotal may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.

Before starting Palgotal, discuss the following with your doctor or pharmacist:

• if the patient is taking other medicines containing the active substances: paracetamol or tramadol;
• if the patient has liver disease. Yellowing of the eyes and skin may indicate jaundice;
• if the patient has kidney function disorders;
• if the patient has significant breathing difficulties, e.g. bronchial asthma or severe lung diseases;
• if the patient has epilepsy or a history of seizures;
• if the patient has recently suffered a head injury, concussion, or severe headache accompanied by vomiting;
• if the patient is dependent on other painkillers, e.g. morphine;
• if the patient is taking other painkillers containing buprenorphine, nalbuphine, or pentazocine;
• if the patient is to receive anaesthetic medicines. Inform the doctor or dentist about taking Palgotal;
• if the patient suffers from depression and is taking antidepressants, as some of these may interact with tramadol (see "Palgotal with other medicines"). There is a small risk of developing a condition called serotonin syndrome when tramadol is taken together with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, they should seek medical advice immediately (see section 4). If any of these symptoms have occurred in the past or during treatment with Palgotal, inform the doctor.

Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact a doctor, who will decide whether hormone replacement is necessary.

During treatment with Palgotal, inform the doctor immediately if the patient has severe conditions, including severe kidney function disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Severe metabolic acidosis (a blood and body fluid disorder) has been reported in patients taking paracetamol regularly over a long period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Tolerance, dependence, and abuse
This medicine contains tramadol, an opioid medicine. Repeated use of opioids may lead to reduced effectiveness (the patient becomes accustomed to the medicine, known as tolerance). Repeated use of Palgotal may also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged treatment duration.

Dependence may cause the patient to lose control over the dose or frequency of medicine intake.

The risk of dependence varies among individuals. The risk of dependence on Palgotal may be higher if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Palgotal, this may indicate dependence:

• the patient needs to take the medicine longer than prescribed by the doctor;
• the patient needs to take a higher dose than recommended;
• the patient uses the medicine for reasons other than prescribed, e.g. "to calm down" or "to help sleep";
• the patient has made repeated unsuccessful attempts to stop or control medicine use;
• after stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal effects").

If any of these symptoms occur, talk to the doctor to discuss the best treatment approach, including when and how to discontinue Palgotal safely (see section 3, "Discontinuing Palgotal").

It is important to know that:

• Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse reactions are more likely. Discontinue the medicine and contact a doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents
Palgotal is not recommended for children under 12 years of age.
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more severe in these patients.

Palgotal with other medicines
Inform your doctor or pharmacist:

• about all medicines currently or recently taken, and those planned for use. It is especially important to inform the doctor if the patient is taking any other medicine containing paracetamol or tramadol, as Palgotal contains both substances, and care must be taken not to exceed the total maximum daily dose (see section 3);
• if the patient is taking flucloxacillin (an antibiotic), due to the serious risk of a blood and body fluid disorder (called high anion gap metabolic acidosis), which requires urgent treatment (see section 2);
• if the patient is taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).

Do not use Palgotal together with monoamine oxidase inhibitors (MAO inhibitors) (see section 2, "When not to use Palgotal").

Concomitant use of Palgotal is not recommended with the following medicines:

• Carbamazepine (a medicine used to treat epilepsy or certain types of pain);
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). This may reduce the pain-relieving effect.

The risk of adverse effects increases when Palgotal is used together with:

• Medicines that may cause seizures, such as certain antidepressants, antipsychotics (medicines affecting mental state), or bupropion (used for smoking cessation). The risk of seizures may increase if Palgotal is taken at the same time. The treating doctor will decide whether Palgotal is suitable for the patient;
• Certain antidepressants (such as selective serotonin reuptake inhibitors, SSRIs) and triptans (used to treat migraines). Palgotal may interact with these medicines 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 medicines, or antihistamines. If the patient experiences drowsiness or weakness, contact the doctor;
• Warfarin or phenprocoumon (used to thin the blood). The effectiveness of these medicines may change, potentially leading to bleeding (see section 4). Any prolonged or unexpected bleeding should be reported to the doctor immediately;
• Concomitant use of Palgotal and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and potentially life-threatening outcomes. Therefore, concomitant use should only be considered if no other treatment options are available. If a doctor prescribes Palgotal together with sedatives, the dose and duration of treatment should be minimized. Inform the doctor about all sedative medicines being taken and strictly follow the doctor's dosage instructions. Inform friends and family about the symptoms listed above. If the patient experiences such symptoms, contact the doctor immediately.

The effectiveness of Palgotal may also be altered when taken together with:

• Metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting);
• Cholestyramine (a medicine that lowers blood cholesterol);
• Ketoconazole or erythromycin (medicines used to treat infections).

Palgotal with food, drink, and alcohol
Do not consume alcohol while taking Palgotal, as it may increase drowsiness.

Pregnancy and breastfeeding
Palgotal should not be used in pregnant women or women who are breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Tramadol is excreted in breast milk. Therefore, Palgotal should not be taken more than once during breastfeeding, or if the patient takes Palgotal more than once, breastfeeding should be discontinued.

Driving and operating machinery
Palgotal may cause drowsiness. If the patient feels drowsy while taking Palgotal, they should not drive, operate tools, or machinery.

Palgotal contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is considered "sodium-free".

3. How to use Palgotal

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should contact your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can
expect from using Palgotal, when and for how long it should be taken, when you should
contact your doctor, and when the medicine should be discontinued (see also section 2).
Palgotal should be used for the shortest time possible and no longer than prescribed by your doctor. The dose should
be adjusted according to the intensity of pain and individual sensitivity to pain.
In general, the lowest effective dose for pain relief should be used.

Adults and adolescents aged 12 years and above

• If your doctor has not advised otherwise, the usual initial dose is 1 tablet. If necessary, further doses may be taken according to your doctor's instructions.
• The minimum interval between doses must be at least 6 hours.
• Do not take more than 4 tablets in a single day.
• Tablets may be divided into equal doses. Tablets should be swallowed with sufficient fluid.

If you feel the effect of Palgotal is too strong (e.g. marked drowsiness or difficulty breathing) or too weak (inadequate pain relief), you should contact your doctor.
Children under 12 years of age
Palgotal is not recommended for use in children under 12 years of age.
Elderly patients
In elderly patients (aged 75 years and older), tramadol elimination may be delayed.
In such cases, your doctor may recommend extending the interval between doses.
Patients with severe liver or kidney disease or patients undergoing dialysis
Palgotal should not be used in patients with severe liver and/or kidney disease. If the patient has mild or moderate liver or kidney disease, your doctor may recommend extending the interval between doses.
Taking more than the recommended dose of Palgotal
If you take too much medicine or if a child accidentally ingests this medicine, you should immediately contact a doctor or go to the nearest hospital and inform them of the exact amount taken. You should bring the medicine packaging and the enclosed leaflet with you.
Overdose of paracetamol may cause severe liver failure, which may lead to death.
Missing a dose of Palgotal
If you miss a dose, the pain will likely return.
Do not take a double dose to make up for a missed dose. Continue taking the tablets according to the prescribed schedule.
Stopping the use of Palgotal
If treatment with Palgotal is discontinued, the pain will likely return. Do not stop taking this medicine suddenly without your doctor's advice. If you wish to discontinue the medicine, especially after long-term use, you should discuss this with your doctor. Your doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to reduce the likelihood of withdrawal symptoms (such as: restlessness, anxiety, agitation, panic attacks, hallucinations, unusual sensory sensations (itching, tingling, loss of sensation), tinnitus (ringing in the ears), insomnia, tremor, or gastrointestinal symptoms). If any of these symptoms occur after stopping Palgotal, you should contact your doctor.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects may be serious. You must stop taking Palgotal
and seek immediate medical help if any of the following symptoms occur:

• Swelling of the face, lips or throat, difficulty swallowing or breathing, or low blood pressure and fainting. A rash or itching may also occur. These may indicate a severe allergic reaction.
• Any prolonged or unexpected bleeding when Palgotal is taken together with blood-thinning medicines (warfarin or phenprocoumon).
• Severe skin reactions (very rare), including redness, blistering, peeling of the skin, or detachment of skin sheets.

Additionally, the following side effects may occur during treatment with Palgotal:
Very common side effects (may affect more than 1 in 10 people):

• Nausea,
• Dizziness, drowsiness.

Common side effects (may affect up to 1 in 10 people):

• Vomiting, gastrointestinal disturbances (constipation, bloating, diarrhoea), abdominal pain, dry mouth,
• Itching, excessive sweating,
• Headache, tremor,
• Disorientation, sleep disturbances, mood changes (anxiety, nervousness, euphoria - persistent feeling of elevated mood).

Uncommon side effects (may affect up to 1 in 100 people):

• Increased heart rate or blood pressure, disturbances in heart rate and rhythm,
• Difficulty or pain during urination,
• Skin reactions (e.g. rash, urticaria),
• Tingling, numbness or prickling sensations in the limbs, tinnitus (ringing in the ears), involuntary muscle contractions,
• Depression, nightmares, hallucinations (hearing, seeing or feeling things that do not exist in reality), memory impairment,
• Difficulty swallowing, blood in stool,
• Chills, hot flushes, chest pain,
• Breathing difficulties,
• Increased liver enzyme activity,
• Presence of protein in urine (albuminuria).

Rare side effects (may affect up to 1 in 1,000 people):

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

Very rare side effects (may affect up to 1 in 10,000 people):

• Misuse of the medicine.

Unknown frequency (cannot be estimated from available data):

• Low glucose (sugar) levels,
• Hiccups, Serotonin syndrome, which may include changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2).

Additionally, the following side effects have been reported in individuals taking medicines
containing tramadol or paracetamol alone:

• Feeling faint 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 sensory perception.
• Worsening of bronchial asthma.
• Bleeding from the nose or gums, which may result from low platelet count.
• Withdrawal syndrome – a group of symptoms occurring after discontinuation or dose reduction of the medicine, e.g. restlessness, anxiety, agitation, sleep disturbances, increased muscle activity, tremor, gastrointestinal symptoms. Panic attacks, anxiety, hallucinations (hearing, seeing or feeling things that do not exist in reality), loss of skin sensation, tinnitus and unusual symptoms from the central nervous system have been reported very rarely.
• Destruction of red blood cells in patients with a metabolic disorder known as glucose-6-phosphate dehydrogenase deficiency.
• A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis), reported with unknown frequency in patients with severe illness taking paracetamol (see section 2).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects 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 181 C
02-222 Warsaw
Tel.: +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 authorisation holder or its representative in Poland.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Palgotal

Keep Palgotal out of the sight and reach of children.
The medicine should be stored in a safe place inaccessible to others. It may cause serious harm or even be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the cardboard package following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply. Store the medicine in its original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Palgotal contains

• The active substances are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• Excipients: microcrystalline cellulose, povidone K-25, maize starch, pregelatinized 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 pack
Palgotal is a slightly yellowish-brown, oblong, biconvex film-coated tablet with a division line on both sides, measuring 18 x 9 mm, with a radius of 8 mm. The tablet can be divided into equal doses.
Pack sizes: 10, 20, 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
For further information about the medicinal product and its names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00