Poltram combo forte

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

1. What Poltram Combo Forte is and what it is used for
2. What you need to know 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 Poltram Combo Forte is and what it is used for

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

2. Information before taking Poltram Combo Forte

When not to take Poltram Combo Forte

• if the patient is allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• in case of acute alcohol intoxication, sedatives, analgesics, opioids, or other psychotropic medicines (used in the treatment of mental disorders);
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors – antidepressants, selegiline used in Parkinson’s disease) or has taken them within the previous 14 days before starting treatment with Poltram Combo Forte;
• if the patient has severe hepatic insufficiency and/or severe renal insufficiency;
• if the patient has epilepsy that is not adequately controlled with prescribed antiepileptic drugs;
• if the patient is drug-dependent;
• during withdrawal syndrome.

Warnings and precautions
Before starting treatment with Poltram Combo Forte, discuss this with your doctor, even if
the following warnings relate to symptoms experienced in the past:

• if the patient is taking other medicines containing paracetamol or tramadol;
• if there are liver disorders or liver disease (including Gilbert’s syndrome), or if the patient notices yellowing of the eyes or skin. This may indicate jaundice or biliary tract disorders;
• if there is alcoholic liver disease without cirrhosis;
• if the patient is concurrently treated with other medicines affecting liver function;
• if the patient has glucose-6-phosphate dehydrogenase deficiency or haemolytic anaemia;
• if the patient is dehydrated or chronically undernourished;
• if there are kidney disorders;
• if there are severe respiratory disorders, such as asthma or severe lung diseases;
• if the patient has epilepsy or has experienced seizures;
• if there has recently been head injury, concussion, or severe headaches associated with vomiting;
• if the patient has depression and is taking antidepressants, because some of them may interact with tramadol (see “Poltram Combo Forte with other medicines”). After taking tramadol alone or in combination with certain antidepressants, there is a small risk of developing so-called serotonin syndrome. If the patient experiences any symptoms of this serious condition, medical advice should be sought immediately (see section 4 “Possible side effects”);
• if the patient is dependent on any drugs, including analgesics such as morphine;
• if the patient has increased sensitivity to opioids;
• if the patient is to undergo anaesthesia. Inform the doctor or dentist about taking Poltram Combo Forte.
• if the patient has reduced glutathione levels (e.g. due to sepsis). Paracetamol use may increase the risk of metabolic acidosis.
• if the patient has severe illnesses, including severe kidney dysfunction or 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). In these situations, severe metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients taking paracetamol regularly over a long period or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Caution is advised in patients with respiratory depression, as well as when used together with other
medicines that depress the central nervous system or when significantly exceeding the recommended doses, as respiratory depression cannot be ruled out in these cases (see section 2 “Poltram
Combo Forte with other medicines”).
Tolerance, dependence, and addiction
This medicine contains tramadol, an opioid medicine. Repeated use of opioids may lead to reduced effectiveness (the patient becomes tolerant to the medicine, known as tolerance). Repeated use of Poltram Combo Forte may also lead to physical and/or psychological dependence, abuse, and addiction, which may result in life-threatening overdose.
The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or addiction may cause the patient to lose control over the dose or frequency of medicine intake.
The risk of dependence or addiction varies among individuals. The risk of dependence on Poltram
Combo Forte 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 or uses nicotine-containing 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 during treatment with Poltram Combo Forte, this may indicate dependence or addiction:

• 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 indicated, 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 your doctor to discuss the best treatment approach, including when and how to discontinue the medicine safely (see section 3 “Discontinuing Poltram Combo Forte”).
Sleep-related breathing disorders
Poltram Combo Forte may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and 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 notices these symptoms, contact a doctor. The doctor may consider reducing the dose.
If any of the following symptoms occur during treatment with Poltram Combo Forte, inform your doctor or pharmacist:

• 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, contact your doctor, who will decide whether hormone replacement is necessary.

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 your 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.
Poltram Combo Forte should not be used in the treatment of opioid dependence, as it does not suppress withdrawal symptoms.
Tolerance and physical and/or psychological dependence may occur even with therapeutic doses.
Withdrawal symptoms similar to those seen after opioid discontinuation may occur even after short-term treatment with therapeutic doses.

Children and adolescents
Poltram Combo Forte is not recommended for children under 12 years of age due to 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 diseases, upper respiratory tract infections or pneumonia, multiple injuries, or after extensive surgical procedures, as tramadol toxicity symptoms may be intensified in these patients.

Poltram Combo Forte with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Important: this medicine contains paracetamol and tramadol. Inform your doctor about any other medicines containing paracetamol or tramadol to avoid exceeding the maximum recommended daily dose.
Poltram Combo Forte must not be used simultaneously with MAO inhibitors (medicines containing: isocarboxazid, iproniazid, tranylcypromine, phenelzine, selegiline, moclobemide) or within 14 days after discontinuation of such treatment (see section “When not to take Poltram Combo Forte”).
Concomitant use of Poltram Combo Forte is not recommended with:

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

The risk of adverse effects is increased when used concomitantly with:

• certain antidepressants – Poltram Combo Forte may interact with them and cause serotonin syndrome (see section 4 “Possible side effects”);
• gabapentin or pregabalin used in epilepsy or neuropathic pain (nerve-related pain);
• other medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if Poltram Combo Forte is taken with these medicines. The doctor should inform the patient whether Poltram Combo Forte is suitable;
• benzodiazepines or barbiturates, due to increased risk of life-threatening respiratory depression;
• sedatives, hypnotics, other analgesics such as morphine or codeine (also present in some antitussive medicines), thalidomide (an anticancer medicine), baclofen (a muscle relaxant), antihypertensives, antipsychotics, antidepressants, or medicines with sedative effects or used in allergies. Drowsiness or faintness may occur. Inform the doctor if such symptoms occur;
• warfarin derivatives or phenprocoumon (used to thin the blood). The effect of these medicines may be altered, leading to bleeding. Any prolonged or unexpected bleeding should be reported to the doctor immediately.

The effectiveness of Poltram Combo Forte may be reduced when taken concomitantly with:

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

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Your doctor will decide which medicines can be safely used with Poltram Combo Forte.
Concomitant use of Poltram Combo Forte and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if other treatment options are not possible.
If your doctor has prescribed Poltram Combo Forte together with sedative medicines, the dose and duration of concomitant use should be minimized.
Inform your doctor about all sedative medicines you are taking and strictly follow dosing instructions. It may be helpful to inform friends or family members about the symptoms listed above. If such symptoms occur, contact your doctor.

Poltram Combo Forte and alcohol
Do not drink alcohol or take other medicines containing alcohol while taking Poltram Combo Forte. Alcohol enhances the sedative effect of the medicine, which may lead to breathing problems. Poltram Combo Forte may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
Poltram Combo Forte should not be used during pregnancy or breastfeeding.
Since Poltram Combo Forte contains tramadol, it must not be used during pregnancy. If the patient becomes pregnant while taking the medicine, she should contact her doctor before taking further tablets.

Breastfeeding
Tramadol is excreted in breast milk. Therefore, Poltram Combo Forte should not be taken more than once during breastfeeding, or if taken more than once, breastfeeding should be discontinued.

Driving and operating machinery
Poltram Combo Forte may cause drowsiness and dizziness.
Do not drive or operate machinery while taking this medicine.

Poltram Combo Forte contains 4 mg of lactose per tablet
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Poltram Combo Forte contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered “sodium-free”.

3. How to take Poltram Combo Forte

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Poltram Combo Forte, when and for how long it should be taken, when to contact your doctor, and when the medicine should be discontinued (see also section 2).
The dose should be adjusted according to the intensity of pain and the individual patient's response to treatment.
The lowest effective dose that adequately relieves pain should be used.
Poltram Combo Forte should be taken for as short a duration as possible.
It is not recommended for use in children under 12 years of age.
Unless otherwise directed by a doctor, the usual dose for adults and adolescents over 12 years of age is 1 tablet. If necessary, further doses may be taken as directed by the doctor.
The minimum interval between doses must be 6 hours.
Do not take more than 4 tablets per day.
Do not take the medicine more frequently than prescribed by your doctor.

Elderly patients
In patients over 75 years of age, elimination of tramadol from the body may be delayed. In these patients, the doctor may recommend extending the time interval between doses.

Patients with renal impairment and (or) on dialysis or with hepatic impairment
Poltram Combo Forte should not be taken in cases of severe hepatic and (or) renal impairment. In cases of mild or moderate impairment, the doctor may recommend extending the time intervals between doses.

Method of administration
The tablets are for oral use.
Swallow the tablets whole with sufficient liquid. Do not crush or chew the tablets.
The tablet may be divided along the break line into equal doses.

If you feel the medicine's effect is too strong (e.g. excessive drowsiness or breathing difficulties) or too weak (e.g. incomplete pain relief), contact your doctor.

Overdose of Poltram Combo Forte
If an excessive dose of tramadol is taken, symptoms may include constricted pupils, vomiting, low blood pressure, rapid heartbeat, fainting, disturbances of consciousness up to coma (a state of deep unconsciousness), seizures, breathing difficulties up to respiratory arrest.
Paracetamol overdose may cause severe liver and kidney damage. In such a case, contact a doctor immediately, even if you feel well. This is because there is a risk of serious liver damage, the symptoms of which may appear later.

Missed dose of Poltram Combo Forte
If a dose is missed, pain will likely return.
Do not take a double dose to make up for the missed dose; instead, resume taking the medicine as previously directed.

Stopping Poltram Combo Forte
Do not suddenly stop taking this medicine without medical advice. If you wish to discontinue treatment, discuss this with your doctor, especially if this medicine has been taken for a prolonged period.
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.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (occur in more than 1 out of 10 patients)

• nausea;
• dizziness, drowsiness.

Common (occur in less than 1 out of 10 patients)

• vomiting, gastrointestinal disturbances (constipation, bloating, diarrhoea), abdominal pain, dry mouth;
• itching, excessive sweating;
• headache, tremor;
• confusion, sleep disturbances, mood changes (anxiety, nervousness, euphoria – an unnaturally good feeling with a tendency to laugh).

Uncommon (occur in less than 1 out of 100 patients)

• increased heart rate or elevated blood pressure, rapid or irregular heartbeat;
• difficulty or pain when urinating, presence of protein in the urine;
• skin reactions (e.g. rash, urticaria);
• tingling, numbness or pricking sensations in the limbs, tinnitus, involuntary muscle spasms;
• depression, nightmares, hallucinations (seeing, hearing or feeling things that are not there), memory disturbances;
• difficulty swallowing, tarry stools which may indicate gastrointestinal bleeding;
• chills, hot flushes, chest pain;
• difficulty breathing;
• changes in blood test results used to assess liver function (increased aminotransferase activity).

Rare (occur in less than 1 out of 1,000 patients)

• seizures, difficulty with coordination, fainting;
• drug dependence;
• blurred vision;
• speech disorders;
• constricted pupils, dilated pupils.

Very rare (occur in less than 1 out of 10,000 patients)

• drug abuse.

Frequency not known (cannot be estimated from available data)

• decreased blood sugar concentration;
• hiccups.

The following adverse effects have been reported in patients taking only paracetamol or only tramadol. However, you should inform your doctor if any of these occur during treatment with Poltram Combo Forte.

Tramadol:

• Feeling faint when standing up from a lying or sitting position, slow heartbeat, fainting, weakness.
• In rare cases, rash indicating an allergic reaction, with sudden swelling of the face and neck, difficulty breathing, or drop in blood pressure and fainting. If these occur, stop taking the medicine and consult your doctor immediately. Do not take the medicine again.
• Rare cases of altered warfarin effect, including prolonged prothrombin time.
• Rare cases: changes in appetite, skeletal muscle weakness, and respiratory depression.
• Variable in intensity and type, and dependent on duration of treatment: psychiatric disorders such as mood changes (usually euphoria, occasionally dysphoria), changes in activity (usually decreased, occasionally increased), and changes in cognitive abilities and sensory perception (e.g. decision-making, perceptual disturbances).
• Worsening of bronchial asthma, although a causal relationship has not been established.
• Frequency not known: serotonin syndrome, which may present with mental status changes (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 Important information before taking Poltram Combo Forte).

The use of medicines such as tramadol may lead to drug dependence, making it difficult to stop treatment. Patients who have taken tramadol for some time may feel unwell after abruptly stopping the medicine. Symptoms may include: agitation, anxiety, nervousness, and tremor. Patients may become overactive, experience sleep disturbances, or have stomach or intestinal complaints. Very rarely, panic attacks, hallucinations, or unusual sensations such as skin itching, tingling, and numbness, or tinnitus may occur. If such adverse effects occur after stopping the medicine, contact your doctor.

Paracetamol:

• Hypersensitivity reactions, including skin rash, may rarely occur.
• Very rare cases of severe skin reactions have been reported: blistering rash over the entire body or erosions in the mouth, eyes, genital organs and on the skin, or large rupturing blisters, peeling of large areas of skin, accompanied by weakness, fever and joint pain.
• Blood count disturbances have been described, including thrombocytopenia (reduced platelet count, with tendency to bleed) and agranulocytosis (reduced white blood cell count, leading to increased susceptibility to infections), although a causal relationship with paracetamol use has not been proven.
• The use of Poltram Combo Forte together with anticoagulant medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any unexpected or prolonged bleeding should be reported to the doctor immediately.
• A serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (frequency not known) (see section 2).

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Poltram Combo Forte

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should be stored in a secure place inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
No special storage conditions apply for this 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 stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Poltram Combo Forte contains

• The active substances are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• Other ingredients are: core of the tablet: pregelatinized starch, maize; microcrystalline cellulose; sodium carboxymethylstarch (type A); colloidal anhydrous silica; magnesium stearate.
  coating of the tablet: hypromellose (6 cP), 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, elongated, biconvex tablets with a division 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