Poltram

Leaflet attached to the packaging: patient information

Poltram, 50 mg, capsules

Tramadol hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 taking Poltram
• 3. How to take 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 reliever that acts on the central nervous system (brain and spinal cord).
The indication for use is moderate to severe pain.

2. Important information before taking Poltram

When not to take Poltram:

if the patient is allergic to tramadol, other opioid painkillers, or any of the other ingredients of this medicine (listed in section 6);
in case of acute alcohol poisoning, sleeping pills, painkillers, or psychotropic drugs (drugs that affect mood or feelings);
if the patient is taking MAO inhibitors (antidepressants, 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 medication.
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 painkillers that act on the central nervous system (opioids);
if the patient has had a head injury or is in shock (characterized by a drop in blood pressure, paleness, rapid breathing, cold sweats, weakness, and fainting) or if the patient has consciousness disorders of unknown origin;
if the patient has respiratory disorders or disorders of respiratory function;
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 medications that lower the seizure threshold. Such patients may be treated with tramadol only if other pain management is ineffective.
if the patient has a tendency to abuse drugs 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 the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Poltram and other medicines").
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If the patient experiences any symptoms of this serious condition, they should immediately consult their doctor (see section 4 "Possible side effects").
if the patient has liver or kidney failure. In cases 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 sedatives, anxiolytics, neuroleptics, muscle relaxants, antidepressants, and other medicines that act depressively on the central nervous system.
Taking medicines containing tramadol in high doses, alone or in combination with other medicines that act depressively on the central nervous system, including alcohol, can cause fatal overdose. Do not take higher doses than prescribed by the doctor.
Caution should be exercised in patients with respiratory depression, as well as when taking other medicines that act depressively on the central nervous system or in significant excess of 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 contact 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 use.
The risk of dependence on Poltram is different for different people. A higher risk of dependence on Poltram 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 drugs, 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 prescribed by the doctor.
• Need to take a higher dose than prescribed.
• 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 medicine, the patient feels unwell, and after taking it again, they feel better ("withdrawal symptoms"). 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 withdrawal from 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 their doctor if they experience any of the following side effects (due to tramadol toxicity): slow breathing or shallow breathing, confusion, drowsiness, pupil constriction, nausea, or vomiting.

Children and adolescents

Use after surgical procedures in children
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.

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 taken at the same time as MAO inhibitors (medicines whose active ingredients are: isocarboxazid, iproniazid, tranylcypromine, clorgyline, selegiline, moclobemide) - see section "When not to take Poltram".
It is not recommended to take 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 (opioid painkillers). This may reduce the analgesic effect.
gabapentin or pregabalin (used to treat epilepsy or neuropathic pain).
The risk of side effects is higher if the following medicines are taken at the same time:
certain antidepressants - Poltram may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
sedatives, sleeping pills, other painkillers, such as morphine or codeine (which also has a cough suppressant effect), baclofen (a muscle relaxant), blood pressure lowering medicines, antidepressants, or medicines used for allergies. Drowsiness or a feeling of fainting may occur. If such symptoms occur, the patient should tell their doctor.
other medicines that may cause seizures (fits), such as certain antidepressants or antipsychotic medicines, bupropion, mirtazapine, tetrahydrocannabinol. The risk of seizures may increase if the patient takes Poltram with 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 that act 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 with 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 taking this medicine.
Poltram should not be taken 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 using machines

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

3. How to take Poltram

This medicine should always be taken as directed by the doctor or pharmacist. 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 taking Poltram, when and for 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 old
Acute pain: the initial dose is usually 100 mg. Subsequent doses of 50 mg or 100 mg should be taken no more frequently than every 4 hours. The duration of treatment should be as short as possible.
Chronic pain: the initial dose is 50 mg, and subsequent doses may be gradually increased if clinically justified.
The maximum daily dose for adults and adolescents over 12 years old should not exceed 400 mg of tramadol, except in special clinical cases.
Children under 12 years old
Not recommended.
Elderly patients
In patients over 75 years old, 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
Poltram should not be taken in cases of severe hepatic or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.
Duration of treatment
The medicine should not be taken 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 taking the medicine should be made) (see section 2 "Warnings and precautions").
In patients with a tendency to abuse drugs 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 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, drop in blood pressure, rapid heartbeat (tachycardia), pupil constriction, slow breathing up to respiratory arrest, and inhibition of intestinal peristalsis.

Missing a dose of Poltram

If a dose is missed, 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 their doctor's advice. 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 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 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) - rare
allergic reactions (rare; shortness of breath, feeling of pressure 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 - not very common)
cardiovascular collapse, whose symptom is, among other things, fainting (not very common);
slower than normal heartbeat (rare)
slow breathing, shortness of breath up to complete respiratory arrest (rare), exacerbation of asthma, although a causal relationship has not been established
urinary disorders, urinary retention (rare)
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:
Very common(occurring in more than 1 in 10 patients):
nausea
dizziness.
Common(occurring in less than 1 in 10 patients):
headache
drowsiness, fatigue
vomiting
constipation
dry mouth
excessive sweating.
Uncommon(occurring in less than 1 in 100 patients):
palpitations
rapid heartbeat
drop in blood pressure when changing position or standing up
belching
feeling of pressure in the stomach
feeling of fullness in the abdominal cavity
diarrhea.
Rare(occurring in less than 1 in 1,000 patients):
high blood pressure
disorders of appetite
feeling of burning or tingling in the limbs without any apparent reason (paresthesia)
tremors
muscle weakness, involuntary muscle contractions
coordination disorders
slow breathing, shortness of breath
seizures
anxiety
hallucinations
disorientation
sleep disorders and nightmares
blurred vision
urinary disorders, urinary retention.
After taking Poltram, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and the duration of treatment). 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 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 taking Poltram").

Side effects that may occur after sudden withdrawal of the medicine are the same as those that occur 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 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.
Reporting side effects will help to gather more information 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.
This medicine should be stored in a closed and secure place, to which other people do not have access. It can cause serious harm and be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation 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 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. Each capsule contains 50 mg of tramadol hydrochloride.
• The other ingredients are: calcium phosphate anhydrous, colloidal silica anhydrous, magnesium stearate; capsule shell: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

What Poltram looks like and what the packaging contains

Cream to light beige gelatin capsules filled with white to light yellow powder.
The packaging contains 20 capsules.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: