Poltram

Leaflet accompanying the packaging: patient information

Poltram, 100 mg/ml, oral drops, solution

Tramadol hydrochloride

Read the leaflet carefully before using 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 those not listed in this leaflet, they should inform 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 is moderate to severe pain.

2. Important information before using Poltram

When not to use Poltram:

• in case of acute alcohol poisoning, sleeping pills, painkillers, or psychotropic substances (mood- or feeling-affecting drugs);
• in withdrawal syndrome.

Warnings and precautions

Before starting treatment with Poltram, the patient should discuss the following with their doctor or pharmacist:

of the brain;

Care should be taken in patients with respiratory depression, as well as when using other drugs 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").
Sleep apnea
Poltram 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 their doctor. The doctor may consider reducing the dose.
If the patient experiences any of the following symptoms while using Poltram, 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 their doctor, who will decide whether the patient needs hormone replacement.

Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid drug. 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 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 recommended by the doctor.
• Need to take a higher dose than recommended.
• The patient uses 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 patient should stop taking the medicine and immediately consult their 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

Use after surgical procedures in children
Caution should be exercised when administering tramadol to children for pain relief after surgery; it is also necessary to carefully monitor for symptoms of tramadol toxicity (see above), including respiratory depression.
Use in children with respiratory disorders
Tramadol is not recommended for 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 (drugs whose active ingredients are: isocarboxazid, iproniazid, tranylcypromine, clorgyline, selegiline, moclobemide) - see "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 (opioid painkillers). The pain-relieving effect may be reduced.
• gabapentin or pregabalin (used to treat epilepsy or nerve 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 the development of serotonin syndrome (see section 4 "Possible side effects");

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

• sedatives, sleeping pills, other painkillers, such as morphine or codeine (which also has a cough-suppressing effect), baclofen (a muscle relaxant), blood pressure-lowering drugs, antidepressants, or allergy medications. Drowsiness or a feeling of fainting may occur. If such symptoms occur, the patient should inform their doctor.
• other medicines that may cause seizures (convulsions), such as certain antidepressants or antipsychotic drugs, bupropion, mirtazapine, tetrahydrocannabinol. The risk of seizures may increase if the patient takes Poltram at the same time as these medicines. The doctor will advise 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. If any prolonged or unexpected bleeding occurs, the patient should immediately inform their doctor.
• drugs acting depressively on the central nervous system and alcohol.

The efficacy of Poltram may be impaired 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

The patient should not drink alcohol 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, the patient should not take Poltram more than once, or if they have taken it more than once, they should stop breastfeeding.

Driving and using machines

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

Poltram contains sucrose, ethanol, and propylene glycol (E1520)

Poltram contains 200 mg of sucrose in 1 ml. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 161.8 mg of alcohol (96% ethanol) in each ml. The amount of alcohol in 1 ml of this medicine (which corresponds to 40 drops or 8 applications from the dropper) is equivalent to less than 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.
The medicine contains 124.5 mg of propylene glycol in 1 ml.

3. How to use Poltram

This medicine should always be used exactly as the doctor or pharmacist has advised. If the patient is unsure, 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 using Poltram, when and how long to take it, when to contact the doctor, and when to stop taking it (see also section 2).
The dose should be adjusted according to the severity of the pain and the individual response of the patient to treatment. The patient should take the smallest dose that effectively relieves the pain.
The drops can be taken regardless of mealswith a small amount of liquid or "on sugar".
Adults and adolescents over 12 years old
Orally: 50-100 mg of tramadol (20-40 drops or 4-8 applications from the dropper), every 4-6 hours.
In acute pain, the initial dose is usually 100 mg, and in chronic pain, it is 50 mg.
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 case of severe liver or kidney impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.
Treatment duration
Poltram should not be used 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 drugs 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 patient should take the medicine as soon as possible. If it is already time for the next dose, the patient should not take a double dose 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 they have been taking it for a long time.
The doctor will advise the patient 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 the patient experiences any of the following serious side effects, they 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 swelling, and difficulty breathing and (or) itching, rash, hives - not very common)
cardiovascular collapse, whose symptom is, among others, fainting (not very common);
slower than normal heartbeat (rare)
slowed breathing, shortness of breath up to complete respiratory arrest (rare), worsening 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):

• headaches
• drowsiness, fatigue
• vomiting
• constipation
• dry mouth
• excessive sweating.

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

• palpitations
• rapid heartbeat
• decreased blood pressure when sitting or standing
• belching
• feeling of fullness in the stomach
• diarrhea.

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

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

After using Poltram, psychological disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). 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 sensations and recognition, which can lead to incorrect assessment of the situation).
Frequency not known(cannot be estimated from 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 symptoms from the central nervous system (e.g., disorientation, delusions, depersonalization, derealization, paranoia).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 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, 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 carton and bottle. 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, it 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 they no longer use. 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 ml of the medicine (which corresponds to 40 drops or 8 applications from the dropper) contains 100 mg of tramadol hydrochloride.
• The other ingredients are: potassium sorbate, propylene glycol (E1520), sucrose, polysorbate 80, peppermint oil, purified water, 96% ethanol.

What Poltram looks like and what the packaging contains

Poltram drops are a clear, colorless to light yellow solution with a minty smell.
1 packaging contains: 10 ml or 96 ml solution.
The bottles are made of orange glass:

• 10 ml (with a screw cap and a dropper)
• 96 ml (with a dosing device) placed together with the leaflet in a cardboard box.

The screw cap is made of high-density polyethylene (HDPE), and the dropper with a safety ring is made of low-density polyethylene (LDPE).

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Polpharma S.A.
Medana branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: