Poltram Combo

Leaflet accompanying the packaging: patient information

Poltram Combo

37.5 mg + 325 mg, coated tablets

Tramadol hydrochloride + Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Poltram Combo and what is it used for
• 2. Important information before taking Poltram Combo
• 3. How to take Poltram Combo
• 4. Possible side effects
• 5. How to store Poltram Combo
• 6. Contents of the packaging and other information

1. What is Poltram Combo and what is it used for

Poltram Combo is a combination of two painkillers, tramadol and paracetamol, which work together to relieve pain.
Poltram Combo is used to treat moderate or severe pain, if the doctor considers it necessary to use a combination of tramadol and paracetamol.
Poltram Combo can be used by adults and adolescents from 12 years of age.

2. Important information before taking Poltram Combo

When not to take Poltram Combo

Warnings and precautions

You should discuss with your doctor before taking Poltram Combo if:

• you are taking other medicines containing paracetamol or tramadol
• you have liver disorders or liver disease, or if you notice yellowing of the eyes or skin. This may indicate jaundice or bile duct disorders.
• you have kidney disorders
• you have breathing disorders, such as asthma or severe lung disease
• you have epilepsy or have had seizures
• you have recently had a head injury, shock or severe headaches with or without vomiting
• you have depression and are taking antidepressants, as some of them may interact with tramadol (see "Poltram Combo and other medicines")
• you are addicted to any medicines, including painkillers (used to treat moderate or severe pain), such as morphine
• you are taking painkillers that contain buprenorphine, nalbuphine or pentazocine
• you are to be anesthetized. You should tell your doctor or dentist that you are taking Poltram Combo.

If you have severe illnesses, including severe kidney or liver disorders, 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). In these situations, patients have reported a severe condition called metabolic acidosis (a blood and body fluid disorder) when they took paracetamol at regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of a condition called serotonin syndrome. If you experience any symptoms of this syndrome with a severe course, you should immediately seek medical attention (see section 4 "Possible side effects").
Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can cause the medicine to become less effective (the patient becomes accustomed to the medicine, which is called tolerance). Repeated use of Poltram Combo may also lead to the development of dependence, abuse and addiction, which can result in life-threatening overdose.
The risk of these side effects may increase with dose and duration of use.
Dependence can make it difficult for the patient to control the dose or frequency of use.
The risk of dependence varies from person to person. The risk of dependence on Poltram Combo may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• the patient smokes or uses nicotine products;
• 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 while taking Poltram Combo, it may indicate dependence:
• the patient needs to take the medicine for 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 recommended, such as "to calm down" or "to help fall asleep"
• the patient has made repeated, unsuccessful attempts to stop or control the use

of the medicine

• if the patient stops taking the medicine and feels unwell and feels better after taking it again ("withdrawal effects"). If any of these symptoms occur, you should talk to your doctor to discuss the best course of treatment, including when to stop the medicine and how to do it safely (see section 3 "Stopping Poltram Combo").

Sleep apnea
Poltram Combo may cause sleep apnea, 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 maintaining sleep or excessive daytime sleepiness. If the patient or caregiver observes these symptoms, they should contact a doctor. The doctor may recommend reducing the dose.
If you experience any of the following symptoms while taking Poltram Combo, you should tell your doctor or pharmacist:

• excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, you should contact a doctor who will decide whether the patient needs hormone replacement.

Tramadol is converted in the liver by an enzyme. In some people, there is a certain variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, it is more likely to experience severe side effects.
You should stop taking the medicine and immediately contact a doctor if you experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
If any of the above conditions have occurred in the patient in the past or occur while taking Poltram Combo, you should ensure that the doctor is aware of this. The doctor will decide whether the patient can continue taking this medicine.

Children and adolescents

Use in children with breathing disorders
Tramadol is not recommended for use in children with breathing disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Poltram Combo and other medicines

You should 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.

Important: the medicine contains paracetamol and tramadol. You should tell your doctor about taking

any other medicines containing paracetamol or tramadol(including over-the-counter medicines) as you should not exceed the maximum daily doses.
Poltram Combo should not be used at the same time as the following medicines:

• monoamine oxidase inhibitors or within 2 weeks of their discontinuation (see "When not to take Poltram Combo")
• opioids (painkillers), such as morphine and codeine.

It is not recommended to use Poltram Combo at the same time as the following medicines:

• carbamazepine (usually used to treat epilepsy or severe facial pain called trigeminal neuralgia)
• buprenorphine, nalbuphine, pentazocine (painkillers from the opioid group). This may reduce the analgesic effect.

The risk of side effects increases if the following medicines are taken at the same time:

• certain antidepressants - Poltram Combo may interact with them and cause serotonin syndrome (see section 4 "Possible side effects")
• gabapentin or pregabalin for the treatment of epilepsy or pain caused by nerve disorders (neuropathic pain).
• sedatives, sleeping pills, other painkillers, such as morphine or codeine (which also has a cough suppressant effect), baclofen (a muscle relaxant), blood pressure lowering medicines, antidepressants or used in allergies. Drowsiness or a feeling of fainting may occur. If such symptoms occur, you should tell your doctor.
• other medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Poltram Combo at the same time as these medicines. Your doctor should inform you whether Poltram Combo is suitable for you.
• warfarin or phenprocoumon derivatives (used to thin the blood). The effect of these medicines may be disrupted, and bleeding may occur. Any prolonged or unexpected bleeding should be reported to the doctor immediately
• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
• 2).

The effectiveness of Poltram Combo may be impaired if the following medicines are taken at the same time:

• metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting)
• cholestyramine (used to lower cholesterol in the blood)
• ketoconazole or erythromycin (medicines used to treat infections).

Your doctor will tell you which medicines can be safely used with Poltram Combo.
Concomitant use of Poltram Combo and sedatives, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
If, however, your doctor has prescribed Poltram Combo together with sedatives, they should limit the dose and duration of concomitant use.
You should inform your doctor about all sedatives you are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or family members to be aware of the above symptoms. If such symptoms occur, you should contact a doctor.

Poltram Combo with food, drink and alcohol

Poltram Combo may cause drowsiness. Since alcohol can also cause drowsiness, you should not drink alcoholor take other medicines containing alcohol while taking Poltram Combo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
Since Poltram Combo contains tramadol, it should not be used during pregnancy. If you become pregnant while taking Poltram Combo, you should contact your doctor before taking any more tablets.
Tramadol is excreted into breast milk. Therefore, you should not take Poltram Combo more than once while breastfeeding or, if you take Poltram Combo more than once, an alternative is to stop breastfeeding.

Driving and using machines

Poltram Combo may cause drowsiness, dizziness or impaired vision.
You should not drive vehicles, operate machines or perform other activities that require alertness until you know how you react to Poltram Combo.

Poltram Combo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Poltram Combo

This medicine should always be taken as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Poltram Combo, when and how long to take it, when to contact a doctor and when to stop it (see also section 2).
The dose should be adjusted according to the severity of the pain and the individual response of the patient to treatment.
You should use the smallest dose that effectively relieves the pain.
Poltram Combo should be taken for as short a time as possible.
It is not recommended to use in children under 12 years of age.
If your doctor does not prescribe otherwise, the usual dose for adults and adolescents from 12 years of age is 2 tablets. If necessary, you can take additional doses as directed by your doctor. The minimum time between taking additional doses must be 6 hours.
You should not take more than 8 tablets per day.
You should not take the medicine more frequently than directed by your doctor.
Elderly patients
In patients over 75 years of age, the elimination of tramadol from the body may be delayed. In these patients, the doctor may recommend prolonging the time between doses.
Patient with kidney or liver impairment, on dialysis
You should not take Poltram Combo if you have severe liver or kidney impairment. In cases of mild or moderate impairment, the doctor may recommend prolonging the time between doses.

Method of administration

The tablets are taken orally.
The tablets should be swallowed with a sufficient amount of liquid. You should not break or chew the tablets.
If you feel that the effect of the medicine is too strong (e.g., excessive drowsiness or breathing difficulties) or too weak (e.g., incomplete pain relief), you should contact your doctor.

Taking a higher dose of Poltram Combo than recommended

If you have taken too much of the medicine, you should immediately contact a doctor, even if you feel well. There is a risk of serious liver damage, the symptoms of which may appear later.
If you have taken too much tramadol, you may experience: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, fainting, impaired consciousness up to coma, seizures, breathing difficulties up to respiratory arrest.
Paracetamol overdose is dangerous and can cause severe liver and kidney damage.

Missing a dose of Poltram Combo

If you miss a dose, the pain will likely return.
You should not take a double dose to make up for the missed dose. You should simply return to taking the medicine as before.

Stopping Poltram Combo

You should not suddenly stop taking this medicine without your doctor's advice. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you have been taking it for a long time.
Your doctor will advise you when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms). If you suddenly stop taking Poltram Combo, you may feel unwell. You may experience anxiety, agitation, nervousness, insomnia, excessive activity, tremors and/or gastrointestinal disorders.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are classified according to their frequency of occurrence:
Very common (occurring in more than 1 in 10 patients)
Common (occurring in less than 1 in 10 patients)
Uncommon (occurring in less than 1 in 100 patients)
Rare (occurring in less than 1 in 1000 patients)
Very rare (occurring in less than 1 in 10,000 patients)
Frequency not known (cannot be estimated from the available data)

Very common

• nausea
• dizziness, drowsiness. These usually have a mild course.

Common

• vomiting, digestive disorders (constipation, bloating, diarrhea), abdominal pain, dry mouth
• itching, excessive sweating
• headache, tremors
• disorientation, sleep disorders, mood changes (anxiety, nervousness, feeling of agitation).

Uncommon

• increased blood pressure, rapid heartbeat or irregular heartbeat
• difficulty or pain when urinating, presence of protein in the urine
• skin reactions (e.g., rash, hives)
• tingling, numbness or a feeling of pins and needles in the limbs
• ringing in the ears
• involuntary muscle tremors
• depression, nightmares, hallucinations (seeing, hearing or feeling things that are not there)
• memory loss
• difficulty swallowing
• blood in the stool
• tremors
• hot flashes
• chest pain
• breathing difficulties
• increased liver enzyme levels.

Rare

• seizures, coordination disorders, fainting
• dependence
• blurred vision.

Frequency not known

• decreased blood sugar levels
• hiccups.

The following side effects have occurred in patients taking only paracetamol or only tramadol. However, you should tell your doctor about them if they occur while taking Poltram Combo:

• feeling of fainting when standing up from a lying or sitting position, slow heartbeat, fainting, changes in appetite, muscle weakness, slower or shallower breathing, mood changes, changes in activity, changes in sensation, worsening of asthma symptoms.
• in rare cases, a rash indicating an allergic reaction, with sudden swelling of the face and neck, difficulty breathing or low blood pressure and fainting. If these occur, you should stop taking the medicine and consult a doctor. Do not take the medicine again.
• frequency not known: serotonin syndrome, the symptoms of which may include changes in mental state (e.g., agitation, hallucinations, coma) and other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Poltram Combo"); a serious condition that can cause acidification of the blood (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

In rare cases, the use of medicines such as tramadol may lead to dependence, which can cause difficulties in stopping their use.
In patients who have been taking the medicine for some time, rare symptoms of poor well-being may occur after sudden discontinuation of the medicine. These may include symptoms such as: agitation, anxiety, nervousness and tremors. Patients may be overactive, have sleep disorders, gastrointestinal disorders or other symptoms. Very rarely, panic attacks, hallucinations, unusual sensations such as skin itching, tingling and numbness, ringing in the ears may occur. If such side effects occur after stopping the medicine, you should contact your doctor.
In exceptional cases, patients treated with tramadol have experienced changes in blood composition, such as a low platelet count, which can cause nosebleeds and bruising, or a lack of a certain type of white blood cell (agranulocytosis), which can lead to infection, sore throat or fever.
Taking Poltram Combo at the same time as anticoagulant medicines (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. Any unexpected or prolonged bleeding should be reported to the doctor immediately

Reporting side effects

If you experience any side effects, including those 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
Jerozolimskie Avenue 181C
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Poltram Combo

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a safe place, inaccessible to others. It can cause serious harm and be fatal to persons for whom it has not been prescribed.
There are no special storage instructions for the medicine.
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 stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Poltram Combo contains

• The active substances of the medicine are tramadol hydrochloride and paracetamol. One tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other ingredients are: tablet core: cornstarch, maize starch, microcrystalline cellulose, sodium carboxymethylcellulose (Type A), colloidal anhydrous silica, magnesium stearate. tablet coating: hypromellose (6 mPa·s), macrogol 400, titanium dioxide (E171), yellow iron oxide (E172).

What Poltram Combo looks like and contents of the pack

The tablets are light yellow, oblong, biconvex (16.5 mm long).
The tablets are packaged in blisters. One pack contains 10, 20, 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of last revision of the leaflet:February 2025
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Information intended for healthcare professionals only:

Poltram Combo is a combination medicine. Symptoms of overdose may result from the toxic effects of its active substances: tramadol, paracetamol or both components at the same time.
Symptoms of tramadol overdose
The symptoms of tramadol poisoning are essentially similar to the symptoms of poisoning with other central nervous system analgesics. These include: pinpoint pupils, vomiting, circulatory collapse, impaired consciousness up to coma, seizures, respiratory depression up to respiratory arrest.
Symptoms of paracetamol overdose
Overdose is particularly dangerous for small children. Symptoms of paracetamol overdose occurring within the first 24 hours include pallor, nausea, vomiting, loss of appetite and abdominal pain. Liver damage may occur within 12 to 48 hours after overdose. Metabolic disorders and metabolic acidosis may occur. In severe cases, liver failure may progress to encephalopathy, coma and death. Acute kidney failure with acute tubular necrosis may also develop, even in the absence of severe liver damage. There have also been reports of cardiac arrhythmias and pancreatitis.
Liver damage is possible in adults who have taken 7.5-10 g of paracetamol or more.
It is believed that excessive amounts of the toxic metabolite (usually inactivated by glutathione after therapeutic doses of paracetamol) irreversibly bind to liver tissue.
Emergency treatment

• Take the patient to a specialist unit.
• Maintain respiratory and circulatory functions.
• As soon as possible after the overdose, take blood samples to determine the levels of paracetamol and tramadol in the blood and to perform liver function tests.
• Perform liver function tests at the beginning (overdose) and repeat every 24 hours. Usually, an increase in liver enzyme activity (ALT, AST) is observed, which normalizes after 1 or 2 weeks.
• Empty the stomach by inducing vomiting in the patient (if they are conscious) or by performing gastric lavage.
• Use supportive treatment: maintain airway patency and support circulatory function; administer naloxone to reverse respiratory depression; prevent seizures by administering diazepam.
• Tramadol is only minimally removed from the blood by hemodialysis or hemofiltration. Therefore, hemodialysis or hemofiltration should not be used as the only treatment for acute tramadol overdose.

Immediate initiation of treatment is particularly important in case of paracetamol overdose. Despite the lack of significant early symptoms, patients should be taken to the hospital immediately for observation. In all adults and adolescents who have taken approximately 7.5 g or more of paracetamol in the last 4 hours or children who have taken ≥150 mg/kg of paracetamol in the last 4 hours, gastric lavage should be performed. Paracetamol blood levels should be measured no later than 4 hours after the overdose to assess the risk of liver damage (using the paracetamol overdose nomogram). It may be necessary to administer oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to 48 hours after the overdose. Starting intravenous N-acetylcysteine within 8 hours of the overdose provides the greatest benefits.
However, N-acetylcysteine should be administered even if the time since the overdose is longer than 8 hours and continued throughout the treatment period. N-acetylcysteine should be administered immediately if acute overdose is suspected. General supportive treatment measures should be available.