POLTRAM 200 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Poltram Retard 100, 100 mg, prolonged-release tablets
3. Poltram Retard 150, 150 mg, prolonged-release tablets
4. Poltram Retard 200, 200 mg, prolonged-release tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Poltram Retard and what is it used for
6. Important information before taking Poltram Retard
   1. When not to take Poltram Retard:
   2. Warnings and precautions
   3. Children and adolescents
   4. Poltram Retard and other medicines
   5. Poltram Retard with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
7. How to take Poltram Retard
   1. Children and adolescents
   2. Adults and adolescents over 14 years of age, with a body weight of more than 50 kg
   3. Elderly patients
   4. Patients with renal or hepatic impairment
   5. Duration of treatment
   6. Taking a higher dose of Poltram Retard than recommended
   7. Missing a dose of Poltram Retard
   8. Stopping Poltram Retard
8. Possible side effects
   1. If you experience any of the following serious side effects, inform your doctor immediately or go to the emergency department of your nearest hospital:
   2. Very common (occur in more than 1 in 10 patients)
   3. Common (occur in less than 1 in 10 patients)
   4. Uncommon (occur in less than 1 in 100 patients)
   5. Rare (occur in less than 1 in 1000 patients)
   6. Frequency not known (cannot be estimated from available data)
   7. Reporting side effects
9. How to store Poltram Retard
10. Contents of the packaging and other information
    1. What Poltram Retard contains
    2. What Poltram Retard looks like and contents of the packaging
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Poltram Retard 100, 100 mg, prolonged-release tablets

Poltram Retard 150, 150 mg, prolonged-release tablets

Poltram Retard 200, 200 mg, prolonged-release tablets

Tramadol hydrochloride

You should carefully read the contents of the leaflet before taking 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, 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Poltram Retard is a pain-relieving medicine, acting on the central nervous system (brain and spinal cord).
The indication for use of the medicine is moderate to severe pain.
The medicine is intended for use in adults and adolescents over 14 years of age.

2. Important information before taking Poltram Retard

When not to take Poltram Retard:

• if you are allergic to tramadol, other opioid pain-relieving medicines or any of the other ingredients of this medicine (listed in section 6);
• in case of acute alcohol intoxication, sleeping pills, pain-relieving medicines or psychotropic medicines (medicines affecting mood or emotions);
• if you are taking MAO inhibitors (antidepressant medicines, selegiline used in Parkinson's disease) or have taken them within 14 days prior to treatment with Poltram Retard;
• if you have epilepsy that is not adequately controlled by medicines;
• in children under 14 years of age, with a body weight of less than 50 kg;
• if you are addicted to drugs;
• in withdrawal syndrome.

Warnings and precautions

Before starting treatment with Poltram Retard, you should discuss it with your doctor or pharmacist:

• if you are addicted to strong pain-relieving medicines acting on the central nervous system (opioids);
• if you have had a head injury or are in shock (characterized by a drop in blood pressure, paleness, rapid breathing, cold sweats, weakness and

fainting) or if you have consciousness disorders of unknown origin;

• if you have respiratory disorders or respiratory center disorders;
• if you have increased intracranial pressure;
• if you have increased sensitivity to opioids;
• if you have epilepsy or have had seizures of cerebral origin in the past. The risk of seizures increases after exceeding the recommended daily dose (400 mg). Additionally, tramadol may increase the risk of seizures in patients taking other medicines that lower the seizure threshold. Such patients may be treated with tramadol only if other pain management is ineffective.
• if you have a tendency to abuse medicines and drug addiction, and in cases where therapy is long-term. In such cases, treatment with the medicine should be carried out under close medical supervision.
• if you have depression and are taking antidepressant medicines, as some of them may interact with tramadol (see "Poltram Retard and other medicines"). After taking tramadol in combination with certain antidepressant medicines or tramadol alone, there is a small risk of developing a so-called serotonin syndrome. If the patient experiences any symptoms of this severe syndrome, they should immediately consult a doctor (see section 4 "Possible side effects").
• if you have liver or kidney failure. In case of long-term treatment of such patients with Poltram Retard, it is recommended to monitor the concentration of the medicine in the blood.
• if you are taking sedatives, anxiolytics, neuroleptics, muscle relaxants, antidepressants and other medicines acting depressively on the central nervous system. Taking medicines containing tramadol in high doses, alone or in combination with other medicines acting depressively on the central nervous system, including alcohol, may cause fatal drug dependence. Do not take higher doses than recommended by your doctor.

Caution should be exercised in patients with respiratory depression, as well as when using other medicines acting depressively on the central nervous system or significantly exceeding the recommended doses, as respiratory depression cannot be ruled out in these cases (see section 2 "Poltram Retard and other medicines").
Sleep apnea
Poltram Retard 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 maintaining sleep or excessive daytime sleepiness. If the patient or another person notices these symptoms, they should contact a doctor. The doctor may consider reducing the dose.
If the patient experiences any of the following symptoms while taking Poltram Retard, they should inform 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 a doctor, who will decide whether the patient needs hormone replacement.

Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can lead to reduced efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Poltram Retard may also lead to dependence, abuse and addiction, which can cause life-threatening overdose. The risk of these side effects may increase with the dose and duration of treatment.
Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of its administration.
The risk of dependence on Poltram Retard may vary from person to person. A higher risk of dependence on Poltram Retard may apply to people in the following situations:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription or non-prescription medicines, or illegal drugs ("addiction");
• the patient is a smoker or uses nicotine products;
• the patient has ever had mood problems (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If the patient notices any of the following symptoms while taking Poltram Retard, it may indicate dependence or addiction.

• The need to take the medicine for a longer period than recommended by the doctor.
• The need to take a higher dose than recommended.
• The patient is taking the medicine for reasons other than those for which it was prescribed, for example "to calm down" or "to sleep better".
• 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 after taking it again, they feel better ("withdrawal effects"). If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment option for them, including when to stop taking the medicine and how to do it safely (see section 3, subsection "Stopping Poltram Retard").

Tramadol should not be used for substitution therapy in patients addicted to opioids, as it does not eliminate the symptoms that occur after withdrawal of morphine.
Tramadol is converted in the liver by an enzyme. In some patients, there is a certain variant of this enzyme, which can have different effects. In some patients, 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 consult a doctor if they experience any of the following side effects (due to tramadol toxicity): slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents

Do not use the medicine in children and adolescents under 14 years of age, with a body weight of less than 50 kg.
Use after surgical procedures in children
Extreme caution should be exercised when administering tramadol to children for pain relief after surgery; the patient should be closely monitored for signs of tramadol toxicity (see above), including respiratory depression.
Use in children with respiratory disorders
Tramadol is not recommended for use in children with respiratory disorders, as the symptoms of tramadol toxicity (see above) may be exacerbated in them.

Poltram Retard and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take.
Do not take Poltram Retard with MAO inhibitors (medicines whose active substances are: isocarboxazid, iproniazid, tranylcypromine, clorgyline, selegiline, moclobemide) - see section "When not to take Poltram Retard".
Do not recommend taking Poltram Retard with the following medicines:

• carbamazepine (usually used to treat epilepsy or severe facial pain called trigeminal neuralgia);
• buprenorphine, nalbuphine, pentazocine (opioid pain-relieving medicines). The pain-relieving effect may be reduced.
• gabapentin or pregabalin (used to treat epilepsy or nerve pain (neuropathic pain)).

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

• certain antidepressant medicines - Poltram Retard may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• sedatives, sleeping pills, other pain-relieving medicines, such as morphine or codeine (also acting as a cough suppressant), baclofen (muscle relaxant), blood pressure-lowering medicines, antidepressants or medicines used for allergies. Drowsiness or dizziness may occur. If such symptoms occur, inform your doctor.
• other medicines that may cause seizures (convulsions), such as certain antidepressant or antipsychotic medicines, bupropion, mirtazapine, tetrahydrocannabinol. The risk of seizures may increase if Poltram Retard is taken with these medicines. The doctor should inform the patient whether Poltram Retard is suitable for them.
• coumarin derivatives, e.g. warfarin (used to thin the blood). The effect of these medicines may be disrupted, and bleeding may occur. If any prolonged or unexpected bleeding occurs, it should be reported to the doctor immediately.
• medicines acting depressively on the central nervous system and alcohol. The effectiveness of Poltram Retard may be disrupted if the following medicines are taken at the same time:
• ondansetron (a medicine used to treat nausea and vomiting);
• ketokonazole or erythromycin (medicines used to combat infections).

Poltram Retard with alcohol

Do not drink alcohol during treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Poltram Retard during pregnancy and breastfeeding.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, during breastfeeding, do not take Poltram Retard more than once, or if you have taken Poltram Retard more than once, stop breastfeeding.

Driving and using machines

The medicine may prolong the reaction time, even when taken in the recommended doses, especially when taken with other psychotropic medicines.
Do not drive or operate machinery while taking the medicine.

3. How to take Poltram Retard

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Poltram Retard, when and for how long to take it, when to contact your 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 individual response of the patient to the treatment. Take the smallest dose that effectively relieves the pain.

Children and adolescents

Do not use the medicine in children and adolescents under 14 years of age, with a body weight of less than 50 kg.

Adults and adolescents over 14 years of age, with a body weight of more than 50 kg

The usual starting dose is 50 mg or 100 mg of tramadol twice a day, in the morning and evening. If a lower starting dose than 100 mg is necessary, another tramadol hydrochloride-containing medicinal product should be used. If the pain-relieving effect is insufficient, the dose can be gradually increased to 150 mg or 200 mg of tramadol twice a day. The principle of selecting the lowest effective pain-relieving dose should be followed. The dose is usually not higher than 400 mg per day, in divided doses. Swallow the tablets whole, do not chew or crush them. Take the medicine with a small amount of liquid; take it regardless of meals, preferably in the morning and evening.

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 renal or hepatic impairment

Do not take Poltram Retard in case of severe hepatic or renal impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.

Duration of treatment

Do not take the medicine for longer than absolutely necessary. In long-term pain treatment, the doctor should periodically check the patient's condition to assess whether and at what dose the treatment should be continued (if necessary, breaks in treatment should be made) (see section 2 "Warnings and precautions").
In patients with a tendency to abuse medicines and drug addiction, treatment with tramadol should be short-term and under close medical supervision (see section 2 "Warnings and precautions").

Taking a higher dose of Poltram Retard than recommended

In case of accidental, single ingestion of a double dose of the medicine, medical intervention is usually not necessary. Continue taking the medicine in the dose determined by the doctor and at the usual time intervals.
In case of ingestion of a higher dose of the medicine, contact a doctor as soon as possible.
Symptoms of overdose are: disturbances of consciousness up to coma (a state of deep unconsciousness), seizures, drop in blood pressure, rapid heartbeat (tachycardia), pinpoint pupils, slowed breathing up to cessation of breathing, and inhibition of intestinal peristalsis.

Missing a dose of Poltram Retard

If a dose is missed, take the medicine as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Poltram Retard

Do not stop taking the medicine abruptly without consulting a doctor. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if the medicine has been taken 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 likelihood of side effects (withdrawal symptoms).
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, inform your doctor immediately or go to the emergency department of your nearest hospital:

anaphylactic shock (a life-threatening sudden drop in blood pressure due to an allergic reaction, characterized by dizziness, disorientation, and fainting) - occurs rarely.
allergic reactions (occur rarely; shortness of breath, feeling of compression in the chest due to bronchospasm, wheezing, angioedema, whose symptoms are skin and mucous membrane swelling, e.g. throat or tongue, and difficulty breathing and (or) itching, rash, hives - occur not very often).
cardiovascular collapse, whose symptom is, among others, fainting (occurs not very often);
slower than normal heartbeat (occurs rarely).
slowed breathing, shortness of breath up to complete cessation (occur rarely), exacerbation of asthma, although a causal relationship has not been established.
urination disorders, urinary retention (occurs rarely).
addiction.
withdrawal symptoms: agitation, anxiety, fear, nervousness, insomnia, restlessness, tremors, and gastrointestinal disorders. See also section 3.
The following side effects may occur during treatment with the medicine:

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

Nausea, dizziness.

Common (occur in less than 1 in 10 patients)

Headache, drowsiness, fatigue, vomiting, constipation, dry mouth, excessive sweating.

Uncommon (occur in less than 1 in 100 patients)

Cardiovascular and circulatory disorders (palpitations, rapid heartbeat, decreased blood pressure when taking a sitting or standing position), belching, stomach discomfort, feeling of fullness in the abdominal cavity, diarrhea.

Rare (occur in less than 1 in 1000 patients)

Increased blood pressure, appetite disorders, burning or tingling sensation in the limbs without apparent cause (paresthesia), tremors, muscle weakness, involuntary muscle contractions, coordination disorders, slowed breathing, shortness of breath, seizures, hallucinations, anxiety, disorientation, sleep disorders and nightmares, blurred vision, urination disorders, urinary retention.
After taking Poltram Retard, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). These may include, for example, mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), excessive fatigue, and decreased sensory and cognitive perception (changes in sensations and recognition, which may lead to incorrect assessment of the situation).

Frequency not known (cannot be estimated from available data)

Flushing of the face, hot flashes, speech disorders, dilated pupils, swelling, hiccups, serotonin syndrome, whose symptoms may include changes in mental state (e.g. excitement, hallucinations, coma), as well as 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 Retard).
Side effects that may occur after sudden withdrawal of the medicine are the same as those after withdrawal of other opioids: agitation, anxiety, fear, nervousness, insomnia, restlessness, tremors, and gastrointestinal disorders.
Other side effects that have rarely occurred after withdrawal of tramadol include panic attacks, severe anxiety, hallucinations, paresthesia, ringing in the ears, and other symptoms from the central nervous system (e.g. disorientation, delusions, depersonalization, derealization, paranoia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
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 Retard

Store in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Store the medicine in a closed and secure place, inaccessible to others. It can cause serious harm and be fatal to people it has not been prescribed for.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. 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 Retard contains

• The active substance of the medicine is tramadol hydrochloride. Each prolonged-release tablet contains 100 mg or 150 mg or 200 mg of tramadol hydrochloride.
• The other ingredients are: calcium hydrogen phosphate dihydrate, hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate.

What Poltram Retard looks like and contents of the packaging

Poltram Retard 100: white, round, biconvex prolonged-release tablets.
Poltram Retard 150: white, oblong prolonged-release tablets.
Poltram Retard 200: white, oblong prolonged-release tablets.
Packaging contains 10, 30 or 50 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Medochemie Ltd., Facility A - Z, Mich. Erakleous
Ayios Athanassios Industrial Area
Limassol, Cyprus

Date of last revision of the leaflet: