POLTRAM 75 mg/650 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Poltram Combo Forte
3. 75 mg + 650 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Poltram Combo Forte and what is it used for
5. Important information before taking Poltram Combo Forte
   1. When not to take Poltram Combo Forte
   2. Warnings and precautions
   3. Children and adolescents
   4. Poltram Combo Forte and other medicines
   5. Important: this medicine contains paracetamol and tramadol. The patient should tell their doctor about taking any other medicines containing paracetamol or tramadol to avoid taking a maximum daily dose greater than recommended.
   6. Poltram Combo Forte with alcohol
   7. Pregnancy and breastfeeding
   8. Breastfeeding
   9. Driving and using machines
   10. Poltram Combo Forte contains 4 mg of lactose in each tablet
   11. Poltram Combo Forte contains sodium
6. How to take Poltram Combo Forte
   1. Method of administration
   2. Taking a higher dose of Poltram Combo Forte than recommended
   3. Missing a dose of Poltram Combo Forte
   4. Stopping Poltram Combo Forte
7. Possible side effects
   1. Zgłaszanie działań niepożądanych
8. How to store Poltram Combo Forte
9. Contents of the pack and other information
   1. What Poltram Combo Forte contains
   2. What Poltram Combo Forte looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Poltram Combo Forte

75 mg + 650 mg, coated tablets

Tramadol hydrochloride + Paracetamol

Read the package leaflet carefully before taking the medicine, 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 medicine 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 Leaflet

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

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

Poltram Combo Forte is a combination of two painkillers, tramadol and paracetamol, which work together to relieve pain.
Poltram Combo Forte is used to treat moderate to severe pain, if in the doctor's opinion it is necessary to use a combination of tramadol and paracetamol.

2. Important information before taking Poltram Combo Forte

When not to take Poltram Combo Forte

• in case of acute alcohol intoxication, sleeping pills, painkillers, opioids or other psychotropic drugs (used to treat mental disorders);
• in withdrawal syndrome.

Warnings and precautions

Before starting treatment with Poltram Combo Forte, discuss it with your doctor, even if the following warnings refer to symptoms that have occurred in the past:

Caution should be exercised in patients with respiratory depression, as well as when using other medicines that depress the central nervous system (CNS) or significantly exceed the recommended doses, as respiratory depression cannot be ruled out in these cases (see section 2 "Poltram Combo Forte and other medicines").
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can lead to the medicine becoming less effective (the patient gets used to the medicine, which is called tolerance). Repeated use of Poltram Combo Forte can 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 or addiction can make it difficult for the patient to control the dose of the medicine they take or how often they take it.
The risk of dependence on Poltram Combo Forte may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, 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

psychiatric.
If any of the following symptoms occur while taking Poltram Combo Forte, it may indicate dependence or addiction:

• the patient needs to take the medicine for a longer period 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, e.g. "to calm down" or "to help fall asleep"
• the patient has made repeated, unsuccessful attempts to stop or control the use of the medicine
• after stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal effects").

If any of these symptoms occur, the patient should discuss the best course of treatment with their doctor, including when to stop the medicine and how to do it safely (see section 3 "Stopping Poltram Combo Forte").
Sleep apnea
Poltram Combo Forte may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen level 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 the patient or another person notices these symptoms, they should contact their doctor. The doctor may consider reducing the dose.
If any of the following symptoms occur while taking Poltram Combo Forte, the patient should tell their 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, the patient should contact their 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, the risk of serious side effects may be higher.
The patient should stop taking the medicine and immediately contact their doctor if they experience any of the following side effects: slow breathing or shallow breathing, feeling of confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.
Poltram Combo Forte should not be used to treat opioid addiction, as it does not alleviate withdrawal symptoms.
Tolerance and physical and/or psychological dependence on the medicine may occur even when using therapeutic doses.
Withdrawal symptoms similar to those after stopping opioids may occur even after using therapeutic doses and in the case of short-term treatment.

Children and adolescents

Poltram Combo Forte should not be given to children under 12 years of age due to the lack of data on safety and efficacy in this age group.
Use in children with respiratory disorders
Tramadol should not be used in children with respiratory disorders, including those with neuromuscular disorders, severe heart or respiratory disease, upper respiratory tract or lung infections, multiple injuries, or after extensive surgical procedures, as the symptoms of tramadol toxicity may be exacerbated in them.

Poltram Combo Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Important: this medicine contains paracetamol and tramadol. The patient should tell their doctor about taking any other medicines containing paracetamol or tramadol to avoid taking a maximum daily dose greater than recommended.

Poltram Combo Forte should not be used at the same time as MAO inhibitors (drugs whose active substance is: isocarboxazid, iproniazid, tranylcypromine, clorgyline, selegiline, moclobemide) and for 14 days after their discontinuation (see "When not to take Poltram Combo Forte").
It is not recommended to use Poltram Combo Forte at the same time as:

• alcohol, including medicines containing alcohol;
• carbamazepine (usually used to treat epilepsy or severe facial pain called trigeminal neuralgia);
• other opioid painkillers, such as buprenorphine, nalbuphine, pentazocine, as their analgesic effect may be weakened.

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

• certain antidepressants - Poltram Combo Forte may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• gabapentin or pregabalin in the treatment of epilepsy or neuropathic pain (nerve pain).
• other medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Poltram Combo Forte at the same time as these medicines. The doctor should inform the patient whether Poltram Combo Forte is suitable for them.
• benzodiazepines, barbiturates, due to the increased risk of respiratory depression, which can be life-threatening.
• sedatives, sleeping pills, other painkillers, such as morphine or codeine (also found in some cough medicines), thalidomide (an anticancer drug), baclofen (a muscle relaxant), blood pressure lowering drugs, antipsychotic, antidepressant, sedative, or allergy medicines. Drowsiness or a feeling of fainting may occur. If such symptoms occur, the patient should tell their doctor.
• warfarin or phenprocoumon derivatives (used to thin the blood). The effect of these medicines may be disrupted, and bleeding may occur. If any prolonged or unexpected bleeding occurs, the patient should immediately inform their doctor.

The effectiveness of Poltram Combo Forte 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);
• ketokonazole or erythromycin (medicines used to combat infections).

The patient should inform their doctor or pharmacist if they are taking:

• 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).

The doctor will decide which medicines can be safely used with Poltram Combo Forte.
Taking Poltram Combo Forte and sedatives, such as benzodiazepines or similar medicines, at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, taking them at the same time should only be considered when other treatment options are not possible.
If the doctor has prescribed Poltram Combo Forte with sedatives, they should limit the dose and duration of concurrent use.
The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Poltram Combo Forte with alcohol

The patient should not drink alcohol or take other medicines containing alcohol while taking Poltram Combo Forte. Alcohol enhances the sedative effect of the medicine, which can lead to respiratory depression. Poltram Combo Forte may cause drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Poltram Combo Forte should not be used during pregnancy and breastfeeding.
Since Poltram Combo Forte contains tramadol, it should not be used during pregnancy. If the patient becomes pregnant while taking the medicine, they should contact their doctor before taking any more tablets.

Breastfeeding

Tramadol is excreted into breast milk. Therefore, the patient should not take Poltram Combo Forte more than once while breastfeeding, or if they have taken it more than once, they should stop breastfeeding.

Driving and using machines

Poltram Combo Forte may cause drowsiness and dizziness.
The patient should not drive or operate machinery while taking this medicine.

Poltram Combo Forte contains 4 mg of lactose in each tablet

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Poltram Combo Forte 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 Forte

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Poltram Combo Forte, when and how long to take it, when to contact the doctor, and when to stop taking it (see also section 2).
The dose should be adjusted according to the severity of the pain and the patient's individual response to treatment.
The patient should take the smallest dose that effectively relieves the pain.
Poltram Combo Forte should be taken for as short a time as possible.
It is not recommended to use it in children under 12 years of age.
If the doctor does not prescribe otherwise, the usual dose for adults and adolescents over 12 years of age is 1 tablet. If necessary, the patient can take additional doses as directed by the doctor.
The minimum interval between taking additional doses must be 6 hours.
The patient should not take more than 4 tablets per day.
The patient should not take the medicine more frequently than directed by the 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 interval between doses.
Patients with kidney or liver failure
Poltram Combo Forte should not be taken in case of severe liver and/or kidney failure. In case of mild or moderate failure, the doctor may recommend prolonging the time intervals between doses.

Method of administration

The tablets are taken orally.
The tablets should be swallowed with a sufficient amount of liquid. The tablets should not be crushed or chewed.
The tablet can be divided along the break line into equal doses.
If the patient feels that the effect of the medicine is too strong (e.g. excessive drowsiness or breathing difficulties) or too weak (e.g. incomplete pain relief), they should contact their doctor.

Taking a higher dose of Poltram Combo Forte than recommended

If the patient takes too much tramadol, the following symptoms may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, fainting, impaired consciousness up to coma (a state of deep unconsciousness), seizures, breathing difficulties up to respiratory arrest.
Paracetamol overdose can cause severe liver and kidney damage. In such a case, the patient should immediately contact their doctor, even if they feel well. There is a risk of serious liver damage, whose symptoms may appear later.

Missing a dose of Poltram Combo Forte

If the patient misses a dose, the pain will likely return.
The patient should not take a double dose to make up for the missed dose, but should return to taking the medicine as before.

Stopping Poltram Combo Forte

The patient should not suddenly stop taking this medicine without consulting their doctor. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if they have been taking it for a long time.
The doctor will advise 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 the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Poltram Combo Forte can cause side effects, although not everybody gets them.
Very common(occurring in more than 1 in 10 patients)

• nausea;
• dizziness, drowsiness.

Common(occurring in less than 1 in 10 patients)

• vomiting, digestive disorders (constipation, bloating, diarrhea), abdominal pain, dry mouth;
• itching, excessive sweating;
• headache, tremors;
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - a state of unnatural well-being with a tendency to laugh).

Uncommon(occurring in less than 1 in 100 patients)

• rapid heartbeat or increased blood pressure, rapid heartbeat or irregular heartbeat;
• difficulty or pain when urinating, 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 contractions;
• depression, nightmares, hallucinations (seeing, hearing, or feeling things that are not there), memory disorders;
• difficulty swallowing, black stools that may indicate bleeding from the digestive tract;
• chills, hot flashes, chest pain;
• breathing difficulties;
• changes in blood test results used to assess liver function (increased aminotransferase activity).

Rare(occurring in less than 1 in 1,000 patients)

• seizures, difficulty coordinating movements, fainting;
• drug dependence;
• blurred vision;
• speech disorders;
• pupil constriction, pupil dilation.

Very rare(occurring in less than 1 in 10,000 patients)

• drug abuse.

Frequency not known(cannot be estimated from the available data)

• decreased blood sugar levels;
• hiccups.

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

• Feeling of fainting when standing up from a lying or sitting position, slow heartbeat, fainting, syncope.
• Rarely, an allergic reaction, including a rash, sudden swelling of the face and neck, difficulty breathing, or a drop in blood pressure and fainting. If these symptoms occur, the patient should stop taking the medicine and consult a doctor. They should not take the medicine again.
• Rare cases of changes in warfarin activity, including prolonged prothrombin time.
• Rare cases: changes in appetite, muscle weakness, and respiratory depression.
• Different from person to person in terms of severity and type, depending on the duration of treatment, psychiatric disorders, such as mood changes (usually euphoria, occasionally dysphoria), changes in activity (usually decreased, occasionally increased), and changes in cognitive function and sensory sensitivity (e.g. decision-making behavior, perception disorders).

Nasilenie astmy oskrzelowej, chociaż nie ustalono związku przyczynowego.

• Częstość nieznana: zespół serotoninowy, którego objawami mogą być zmiany stanu psychicznego (np. pobudzenie, halucynacje, śpiączka), a także inne objawy, jak gorączka, przyspieszone tętno, niestabilne ciśnienie krwi, mimowolne skurcze mięśni, sztywność mięśni, brak koordynacji i (lub) objawy ze strony przewodu pokarmowego (np. nudności, wymioty, biegunka) (patrz punkt 2 Informacje ważne przed przyjęciem leku Poltram Combo Forte).

Stosowanie takich leków, jak tramadol, może prowadzić do uzależnienia od leku, co utrudnia
odstawienie leku. Osoby stosujące tramadol przez pewien czas mogą czuć się źle po nagłym
zaprzestaniu leczenia. Mogą być to objawy takie jak: pobudzenie, niepokój, nerwowość i drżenie.
Pacjenci mogą być nadmiernie aktywni, mieć zaburzenia snu, dolegliwości żołądka lub jelit.
Bardzo rzadko mogą wystąpić napady paniki, omamy, niezwykłe odczucia, takie jak świąd skóry,
mrowienie i drętwienie, szum w uszach. Jeśli wystąpią takie działania niepożądane po odstawieniu
leku, należy skontaktować się z lekarzem.
Paracetamol:

• Rzadko może wystąpić nadwrażliwość włącznie z wysypką skórną.
• Zgłaszano bardzo rzadkie przypadki ciężki reakcji skórnych: wysypka z krostami na całym ciele lub nadżerki w jamie ustnej, oczach, narządach płciowych i na skórze albo pękające olbrzymie pęcherze, złuszczanie dużych płatów naskórka, przebiegające z osłabieniem, gorączką i bólami stawowymi.
• Opisywano zaburzenia składu krwi włącznie z trombocytopenią (zmniejszeniem liczby płytek krwi, ze skłonnością do krwawień) i agranulocytozą (zmniejszenie liczby białych krwinek powodujące skłonność do zakażeń), lecz bez udowodnionego związku przyczynowego ze stosowaniem paracetamolu.
• Stosowanie leku Poltram Combo Forte jednocześnie z lekami przeciwzakrzepowymi (np. fenprokumon, warfaryna) może zwiększać ryzyko krwawienia. O każdym nieoczekiwanym lub wydłużonym krwawieniu należy natychmiast poinformować lekarza.
• Poważne schorzenie, które może powodować zakwaszenie krwi (tzw. kwasica metaboliczna), u pacjentów z ciężką chorobą przyjmujących paracetamol (częstość nieznana) (patrz punkt 2).

Zgłaszanie działań niepożądanych

Jeśli wystąpią jakiekolwiek objawy niepożądane, w tym wszelkie objawy niepożądane niewymienione
w tej ulotce, należy powiedzieć o tym lekarzowi lub farmaceucie. Działania niepożądane można
zgłaszać bezpośrednio do Departamentu Monitorowania Niepożądanych Działań Produktów
Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów
Biobójczych
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Strona internetowa: https://smz.ezdrowie.gov.pl
Działania niepożądane można zgłaszać również podmiotowi odpowiedzialnemu.
Dzięki zgłaszaniu działań niepożądanych można będzie zgromadzić więcej informacji na temat
bezpieczeństwa stosowania leku.

5. How to store Poltram Combo Forte

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a safe place, inaccessible to other people. It can cause serious harm and be fatal to people it has not been prescribed for.
There are no special precautions for storing 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, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Poltram Combo Forte contains

• The active substances of the medicine are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• The other ingredients are: tablet core: maize starch, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate. tablet coating: hypromellose (6cP), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin.

What Poltram Combo Forte looks like and contents of the pack

Poltram Combo Forte coated tablets are white or almost white, oblong, biconvex with a break line. The tablet can be divided into equal doses.
The pack contains 10, 20, 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Date of last revision of the leaflet: