Poltram 50

Leaflet attached to the packaging: patient information

Poltram 50, 50 mg/ml, solution for injection

Poltram 100, 50 mg/ml, solution for injection

Tramadol hydrochloride

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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Poltram and what is it used for

Poltram is a pain-relieving medicine that acts on the central nervous system (brain and spinal cord).
The indication for use of the medicine is moderate to severe pain.

2. Important information before using Poltram

When not to use Poltram:

• if the patient is 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 poisoning, sleeping pills, pain-relieving medicines, or psychotropic substances (mood- or feeling-affecting medicines);
• if the patient is taking MAO inhibitors (antidepressant medicines, selegiline used in Parkinson's disease) or has taken them within 14 days prior to treatment with Poltram;
• if the patient has epilepsy that is not properly controlled with medicines.
• if the patient is addicted to drugs;
• in withdrawal syndrome.

Warnings and precautions

Before starting treatment with Poltram, the patient should discuss it with their doctor or pharmacist:
if the patient is addicted to strong pain-relieving medicines acting on the central nervous system (opioids);
if the patient has had a head injury or is in shock (characterized by low blood pressure, pale skin, rapid breathing, cold sweats, weakness, and fainting) or if the patient has consciousness disorders of unknown origin;
if the patient has respiratory disorders or respiratory center function disorders;
if the patient has increased intracranial pressure;
if the patient has increased sensitivity to opioids;
if the patient has epilepsy or has had seizures of cerebral origin in the past. The risk of seizures increases when the recommended daily dose is exceeded (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-relieving treatments are ineffective.
if the patient has a history of drug abuse and drug dependence, and in cases where therapy is long-term. In such cases, treatment with the medicine should be carried out under close medical supervision (see section 2 "Warnings and precautions").
if the patient has depression and is taking antidepressant medicines, as some of them may interact with tramadol (see "Poltram and other medicines").
After taking tramadol in combination with certain antidepressant medicines or tramadol alone, there is a small risk of developing so-called serotonin syndrome. If the patient experiences any symptoms of this serious syndrome, they should immediately consult their doctor (see section 4 "Possible side effects").
if the patient has liver and/or kidney failure. In case of long-term treatment of such patients with Poltram, it is recommended to monitor the concentration of the medicine in the blood.
if the patient is taking sedative, anxiolytic, neuroleptic, muscle relaxant, antidepressant, 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, can cause fatal overdose. Do not take higher doses than recommended by the 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 and other medicines").
Respiratory disorders during sleep
Poltram may cause respiratory disorders during sleep, 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 their doctor. The doctor may consider reducing the dose.
If the patient experiences any of the following symptoms while taking Poltram, they 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 consult their 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 can 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 may be higher in certain individuals. A higher risk of dependence on Poltram may apply to individuals in the following situations:

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

prescription 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, it may indicate dependence or addiction.

• Need to take the medicine for a longer period than recommended by the doctor.
• Need to take a higher dose than recommended.
• The patient is taking the medicine for reasons other than those for which it was prescribed, such as "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 use of 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 their doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3, subsection "Stopping Poltram").

Tramadol should not be used for substitution therapy in patients addicted to opioids, as it does not eliminate the symptoms that occur after morphine withdrawal.
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 use of the medicine should be stopped and the doctor should be contacted immediately if the patient experiences any of the following side effects (due to tramadol toxicity): slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

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 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.
Poltram should not be used at the same time as MAO inhibitors (medicines whose active substances are: isocarboxazid, iproniazid, tranylcypromine, clorgyline, selegiline, moclobemide) - see section "When not to use Poltram".
It is not recommended to use Poltram at the same time as the following medicines:
carbamazepine (usually used to treat epilepsy or severe facial pain called trigeminal neuralgia);
buprenorphine, nalbuphine, pentazocine (pain-relieving medicines from the opioid group). This may reduce the pain-relieving effect.
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 may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
sedative, sleeping, or other pain-relieving medicines, such as morphine or codeine (which also has a cough-suppressing effect), baclofen (a muscle relaxant), blood pressure-lowering medicines, antidepressant, or allergy medicines. Drowsiness or a feeling of fainting may occur. If such symptoms occur, the patient should tell their doctor.
other medicines that may cause seizures (attacks), such as certain antidepressant or antipsychotic medicines, bupropion, mirtazapine, tetrahydrocannabinol. The risk of seizures may increase if the patient takes Poltram at the same time as these medicines. The doctor should inform the patient whether Poltram 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. Any prolonged or unexpected bleeding should be reported to the doctor immediately.
medicines acting depressively on the central nervous system and alcohol.
The efficacy of Poltram 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 and alcohol

Alcohol should not be consumed during treatment.

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 or pharmacist before using this medicine.
Poltram should not be used during pregnancy and breastfeeding.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, during breastfeeding, Poltram should not be taken more than once, or if Poltram has been taken more than once, breastfeeding should be stopped.

Driving and operating machinery

Poltram may prolong reaction time, even when used in recommended doses, especially when used in combination with other psychotropic medicines.
The patient should not drive vehicles or operate machinery while taking Poltram.

Poltram contains sodium

Poltram contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which means the medicine is considered "sodium-free". The medicine contains 0.42 mg of sodium per 1 ml of solution.
The medicine may be diluted - see section "Information intended for healthcare professionals only". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, the patient information leaflet of the diluent should be consulted.

3. How to use Poltram

This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient 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, when and how long to take it, when to contact the doctor, and when to stop taking the medicine (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.
Adults and adolescents over 12 years of age
Depending on the severity of the pain, 1-2 ml of Poltram (corresponding to 50-100 mg of tramadol) is usually administered every 4-6 hours.
The maximum daily dose is 8 ml of Poltram (corresponding to 400 mg of tramadol). In exceptional cases, if clinically justified, the doctor may recommend higher daily doses.
Children over 1 year of age
Usually, the single dose is 1-2 mg of tramadol per kilogram of body weight. The patient should take the smallest effective dose of the medicine.
The total daily dose should not exceed 8 mg of tramadol per kilogram of body weight and should not exceed a total daily dose of 400 mg of tramadol.
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 and/or hepatic impairment
Poltram should not be taken in case of severe hepatic and/or renal impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.
Method of administration
Poltram should be administered by slow intravenous injection into a subcutaneous vein, e.g., the elbow fold, or into a muscle (usually the buttock), or subcutaneously.
It can also be administered by intravenous infusion after dilution.
Detailed information on the method of administration for healthcare professionals is provided at the end of this leaflet.
Duration of treatment
The medicine should not be used for longer than absolutely necessary. In long-term pain treatment, the doctor should periodically monitor the patient's condition to assess whether and at what dose the treatment should be continued (if necessary, breaks in administration should be made) (see section 2 "Warnings and precautions").
In patients with a tendency to abuse medicines and drug dependence, treatment with tramadol should be short-term and under close medical supervision (see section 2 "Warnings and precautions").

Using a higher dose of Poltram than recommended

In case of taking a higher dose of the medicine, the patient should contact their doctor as soon as possible.
Symptoms of overdose are: impaired consciousness up to coma (a state of deep unconsciousness), seizures, decreased blood pressure, rapid heartbeat (tachycardia), pinpoint pupils, slowed breathing up to respiratory arrest, and inhibition of intestinal peristalsis.

Missing a dose of Poltram

In case of missing a dose, the medicine should be taken as soon as possible. If it is already time for the next dose, the missed dose should not be taken. A double dose should not be taken to make up for the missed dose.

Stopping Poltram

The patient should not suddenly stop taking the medicine without consulting their 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 on 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 using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following serious side effects occur, the patient should immediately inform their doctor or go to the emergency department of the 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 (shortness of breath, feeling of pressure in the chest due to bronchospasm, wheezing, angioedema, whose symptoms are skin and mucous membrane swelling, and difficulty breathing (occur rarely) and (or) itching, rash, urticaria (occur not very often))
cardiovascular collapse, whose symptom is fainting (occurs not very often);
slowed heart rate (occurs rarely)
slowed breathing, shortness of breath up to complete respiratory arrest (occur rarely), worsening of asthma, although a causal relationship has not been established
urinary disorders, urinary retention (occurs rarely)
dependence
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 Poltram:

• nausea
• dizziness.

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

• vomiting
• constipation
• dry mouth
• excessive sweating
• headache
• drowsiness
• fatigue.

Common(occur in less than 1 in 10 patients):

• rapid heartbeat
• low blood pressure when standing up or sitting down
• belching
• feeling of fullness in the abdomen
• diarrhea.

Uncommon(occur in less than 1 in 100 patients):

• high blood pressure
• appetite disorders
• tingling or burning sensation in the limbs without a clear cause (paresthesia)
• tremors
• muscle weakness, involuntary muscle contractions
• coordination disorders
• slowed breathing, shortness of breath
• seizures
• anxiety
• hallucinations
• disorientation
• sleep disorders and nightmares
• blurred vision
• urinary disorders, urinary retention.

After using Poltram, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and duration of treatment). These may include mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), excessive fatigue, and decreased sensory and cognitive perception (changes in feelings and recognition, which can lead to incorrect assessment of the situation).
Frequency not known(cannot be estimated from the available data):

• flushing of the face, hot flashes
• speech disorders
• pupil dilation
• edema
• hiccups
• serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before using Poltram").

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 central nervous system symptoms (e.g., disorientation, delusions, depersonalization, derealization, paranoia).
Rapid intravenous administration may be associated with a higher frequency of side effects, so it should be avoided.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, more information can be collected on the safety of the medicine.

5. How to store Poltram

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
The medicine should be stored in a closed and secure place, inaccessible to other people. It can cause serious harm and be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Poltram contains

• The active substance of the medicine is tramadol hydrochloride. Poltram 50: each 1 ml ampoule contains 50 mg of tramadol hydrochloride. Poltram 100: each 2 ml ampoule contains 100 mg of tramadol hydrochloride.
• The other ingredients are: sodium acetate trihydrate, water for injections.

What Poltram looks like and contents of the pack

Poltram, solution for injection, is a clear solution, almost odorless.
Poltram 50: 1 pack contains 5 ampoules of colorless glass, 1 ml each.
Poltram 100: 1 pack contains 5 ampoules of colorless glass, 2 ml each.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Incompatibilities

Poltram, solution for injection, should not be used at the same time as solutions for injection of: diclofenac sodium, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam, piroxicam, nitroglycerin.
Estimation of injection volume

• 1) estimation of the total dose of tramadol hydrochloride (mg): body weight (kg) x dose (mg/kg body weight);
• 2) estimation of the volume (ml) of the diluted solution to be injected: the total dose (mg) should be divided by the appropriate concentration of the diluted solution (mg/ml; see the table below).

Table:Dilution of Poltram, solution for injection
Volume of the solution for injection containing 50 mg of tramadol hydrochloride in 1 ml + volume of diluent
Volume of the solution for injection containing 100 mg of tramadol hydrochloride in 2 ml + volume of diluent
Final concentration of the solution for injection after dilution (mg of tramadol hydrochloride/ml)
1 ml + 1 ml
2 ml + 2 ml
25.0 mg/ml
1 ml + 2 ml
2 ml + 4 ml
16.7 mg/ml
1 ml + 3 ml
2 ml + 6 ml
12.5 mg/ml
1 ml + 4 ml
2 ml + 8 ml
10.0 mg/ml
1 ml + 5 ml
2 ml + 10 ml
8.3 mg/ml
1 ml + 6 ml
2 ml + 12 ml
7.1 mg/ml
1 ml + 7 ml
2 ml + 14 ml
6.3 mg/ml
1 ml + 8 ml
2 ml + 16 ml
5.6 mg/ml
1 ml + 9 ml
2 ml + 18 ml
5.0 mg/ml
According to the calculations, the contents of the Poltram ampoule should be diluted with the appropriate diluent, mixed, and the calculated volume of the diluted solution administered. Unused residues of the solution should be discarded.
Mixing with metamizole
It has been shown that Poltram 50 and Poltram 100, 50 mg/ml, solution for injection can be mixed with Pyralgin, 0.5 g/ml, solution for injection.
The mixture of tramadol and metamizole is usually administered in a mass ratio of 1:10, after prior dilution.