Poltram

Patient Information Leaflet

Poltram, 100 mg/ml, oral drops, solution
Tramadoli hydrochloridum
Read the following information carefully before using this 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 share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Poltram is and what it is 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 pack and other information

1. What Poltram is and what it is used for

Poltram is an analgesic medicine acting on the central nervous system (brain and spinal cord).
It is indicated for the treatment of moderate to severe pain.

2. Important information before using Poltram

When not to use 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 intoxication with alcohol, sedatives, painkillers, or psychotropic medicines (medicines affecting mood or feelings);
• 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 treatment with Poltram;
• if the patient suffers from epilepsy that is not adequately controlled by medication;
• if the patient is addicted to narcotics;
• during withdrawal syndrome.

Warnings and precautions
Before starting treatment with Poltram, discuss this with your doctor or pharmacist:

• if the patient is dependent on strong central nervous system (CNS) acting painkillers (opioids);
• if the patient has suffered 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 unexplained disturbances in consciousness;
• if the patient has respiratory disorders or dysfunction of the respiratory centre;
• if the patient has increased intracranial pressure;
• if the patient has increased sensitivity to opioids;
• if the patient has epilepsy or has previously experienced seizures of cerebral origin. The risk of seizures increases when exceeding the recommended daily dose (400 mg). Moreover, 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 approaches are ineffective.
• if the patient has a history of drug abuse or drug dependence, or if therapy is long-term. In such cases, treatment with this medicine should be closely supervised by a physician.
• if the patient has depression and is taking antidepressants, because some of these may interact with tramadol (see "Poltram with other medicines"). There is a small risk of developing so-called serotonin syndrome after taking tramadol alone or in combination with certain antidepressants. If any symptoms of this serious condition occur, the patient should seek immediate medical advice (see section 4 "Possible side effects").
• if the patient has liver and/or kidney impairment. In cases of long-term treatment with Poltram, monitoring of blood drug levels may be advisable.
• if the patient is taking sedatives, anxiolytics, neuroleptics, muscle relaxants, antidepressants, or other CNS depressants. Taking tramadol-containing medicines in high doses, either alone or in combination with other CNS depressants, including alcohol, may result in fatal overdose. Do not exceed the dose prescribed by the doctor.

Extreme caution is advised in patients with respiratory depression, as well as when using Poltram together with other medicines that depress the CNS or when significantly exceeding the recommended doses, since respiratory depression cannot be ruled out in such cases (see section 2 "Poltram with other medicines").

Sleep-related breathing disorders
Poltram may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, medical advice should be sought. The doctor may consider reducing the dose.

If any of the following symptoms occur during treatment with Poltram, inform your doctor or pharmacist:

• excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.

Tolerance, dependence, and abuse
This medicine contains tramadol, an opioid painkiller. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to the medicine, known as tolerance). Repeated use of Poltram may also lead to 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 treatment.
Dependence or addiction may cause the patient to lose control over the amount or frequency of medicine intake.
The risk of dependence or addiction varies among individuals. Higher risk may apply to patients in the following situations:

• the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• the patient is a smoker or uses nicotine-containing 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, this may indicate dependence or abuse:

• Need to take the medicine for longer 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, e.g., "to calm down" or "to sleep better".
• 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, the patient should consult a doctor to discuss the best treatment approach, including when and how to safely discontinue the medicine (see section 3, subsection "Discontinuing Poltram").

Tramadol should not be used in opioid substitution therapy in opioid-dependent patients, as it does not alleviate symptoms occurring after morphine withdrawal.
Tramadol is metabolized in the liver by an enzyme. Some patients have a genetic variation of this enzyme, which may lead to different effects. In some patients, pain relief may be inadequate, while in others, severe adverse effects are more likely. Discontinue the medicine and contact your doctor immediately if any of the following adverse effects (due to tramadol toxicity) occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents
Use after surgical procedures in children
Extreme caution is required when administering tramadol to children for postoperative pain relief; careful monitoring for signs of tramadol toxicity (see above) is essential, including respiratory depression.

Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as symptoms of tramadol toxicity (see above) may be more pronounced.

Poltram with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Poltram must not be used together with MAO inhibitors (medicines containing: isocarboxazid, iproniazid, tranylcypromine, pargyline, selegiline, moclobemide) – see section "When not to use Poltram".
Concomitant use of Poltram with the following medicines is not recommended:

• carbamazepine (commonly used in epilepsy or severe facial pain attacks known as trigeminal neuralgia);
• buprenorphine, nalbuphine, pentazocine (opioid painkillers). The analgesic effect may be reduced.
• gabapentin or pregabalin (used in epilepsy or nerve-related pain (neuropathic pain)).

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

• certain antidepressants – Poltram may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• sedatives, hypnotics, other painkillers such as morphine or codeine (which also has antitussive effects), baclofen (muscle relaxant), antihypertensives, antidepressants, or antihistamines. Drowsiness or dizziness may occur. If such symptoms occur, inform your doctor.
• other medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics, bupropion, mirtazapine, tetrahydrocannabinol. The risk of seizures may increase if Poltram is taken together with these medicines. The doctor should inform the patient whether Poltram is suitable for them.
• coumarin derivatives, e.g., warfarin (used as blood thinners). The effect of these medicines may be altered, leading to bleeding. Any prolonged or unexpected bleeding should be reported to the doctor immediately.
• other CNS depressants and alcohol.

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

• ondansetron (a medicine used to treat nausea and vomiting);
• ketoconazole or erythromycin (medicines used to treat infections).

Poltram and alcohol
Do not drink alcohol during treatment.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Poltram should not be used during pregnancy or breastfeeding.

Breastfeeding
Tramadol is excreted in 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 discontinued.

Driving and operating machinery
Poltram may prolong reaction time, even when used at recommended doses, especially when taken together with other psychotropic medicines.
Do not drive or operate machinery while taking this medicine.

Poltram contains sucrose, ethanol, and propylene glycol (E1520)
Poltram contains 200 mg of sucrose per 1 ml. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
The medicine contains 161.8 mg of alcohol (96% ethanol) per ml. The amount of alcohol in 1 ml of this medicine (equivalent to 40 drops or 8 applications from the dispenser) is less than that in 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
The medicine contains 124.5 mg of propylene glycol per 1 ml.

3. How to use Poltram

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a 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 for how long it should be taken, when to contact the
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.
The drops may be taken independently of meals, with a small amount of liquid or "on a sugar cube".

Adults and adolescents over 12 years of age
Orally: 50–100 mg tramadol (20–40 drops or 4–8 actuations from the dispenser), every 4–6 hours.
For acute pain, the initial dose is usually 100 mg; for chronic pain, 50 mg.
The maximum daily dose for adults and adolescents over 12 years of age should not exceed
400 mg tramadol, except in special clinical indications.

Children under 12 years of age
Use is not recommended.

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 interval between doses.

Patients with renal impairment, those on dialysis, and/or hepatic impairment
Poltram should not be taken in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend prolonging the intervals
between doses.

Duration of treatment
Poltram must not be used 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
treatment should continue (if necessary, treatment breaks should be introduced) (see section 2
"Warnings and precautions").
In patients with a tendency to drug abuse or dependence, tramadol treatment should be short-term
and under strict medical supervision (see section 2 "Warnings and precautions").

Taking more Poltram than recommended
If an overdose is taken, contact a doctor immediately. Symptoms of overdose include disturbances
of consciousness up to coma (a state of deep unconsciousness), seizures, drop in arterial blood
pressure, rapid heartbeat (tachycardia), pinpoint pupils, slowed breathing up to respiratory arrest,
and inhibition of intestinal peristalsis.

Missing a dose of Poltram
If a dose is missed, take the medicine as soon as possible. However, if it is almost time for the next
dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double
dose to make up for a missed dose.

Stopping Poltram
Do not abruptly stop using this medicine without medical advice. If the patient wishes to stop
taking the medicine, this should be discussed with the doctor, especially if the medicine has been
used long-term. The doctor will advise when and how to discontinue Poltram, which may involve
gradually reducing the dose to minimize the risk of adverse effects (withdrawal symptoms).

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

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everybody will experience them.
If any of the following serious adverse reactions occur, immediately contact your physician
or go to the emergency department of the nearest hospital:
anaphylactic shock (life-threatening sudden drop in blood pressure due to an allergic reaction,
manifesting as dizziness, disorientation and fainting) – occurs rarely
allergic reactions (occur rarely; shortness of breath, feeling of tightness in the chest due to
bronchospasm, wheezing, angioedema, manifested as swelling of the skin and mucous membranes,
e.g. throat or tongue, and difficulty breathing and (or) itching, rash, urticaria – occur not uncommonly)
cardiovascular collapse, which may include fainting (occurs not uncommonly)
slower than normal heart rate (occurs rarely)
slowed breathing, shortness of breath up to complete respiratory arrest (occur rarely),
exacerbation of bronchial asthma, although a causal relationship has not been established
urinary disorders, urinary retention (occur rarely)
dependence
withdrawal symptoms: restlessness, anxiety, nervousness, insomnia, motor agitation, tremor, and gastrointestinal disturbances. See also section 3.

During treatment with this medicine, the following adverse reactions may occur:

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):

• palpitations
• increased heart rate
• low blood pressure when sitting or standing up (orthostatic hypotension)
• belching
• feeling of pressure in the stomach
• feeling of fullness in the abdominal cavity
• diarrhoea

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

• high blood pressure
• appetite disturbances
• burning or tingling sensations in the limbs without apparent cause (paresthesia)
• tremor
• muscle weakness, involuntary muscle contractions
• coordination disorders
• slowed breathing, shortness of breath
• seizures
• hallucinations
• restlessness
• disorientation
• sleep disturbances and nightmares
• blurred vision
• urinary disorders, urinary retention

Psychiatric disorders may occur after administration of Poltram. Their severity and type may vary
(depending on the patient's personality and duration of treatment). These may include mood disturbances (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), excessive fatigue, and reduced sensory and cognitive perception (changes in sensation and recognition which may lead to incorrect assessment of situations).

Frequency unknown (cannot be estimated from the available data):

• facial flushing, hot flushes
• speech disturbances
• dilated pupils
• swelling
• hiccups
• serotonin syndrome, which may include mental status changes (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, tachycardia, 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").

Adverse reactions that may occur after abrupt discontinuation of the medicine are identical to those observed after discontinuation of other opioids: restlessness, anxiety, nervousness, insomnia, motor agitation, tremor, and gastrointestinal disturbances.
Other adverse reactions which have occurred rarely after discontinuation of tramadol include:
panic attacks, severe anxiety, hallucinations, paresthesia, tinnitus, and other central nervous system symptoms (e.g. disorientation, delusions, depersonalization, derealization, paranoia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Poltram

Do not store above 25°C.
Keep this medicine out of sight and reach of children.
This medicine should be stored in a closed and secure place inaccessible to others. It may cause serious harm or 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 bottle. The expiry date refers to the last day of the specified month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
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 package and other information

What Poltram contains

• The active substance is tramadol hydrochloride. Each ml of the solution (corresponding to 40 drops or 8 applications from the dispenser) contains 100 mg of tramadol hydrochloride.
• Other ingredients: potassium sorbate, propylene glycol (E1520), sucrose, polysorbate 80, peppermint oil, purified water, ethanol 96%.

What Poltram looks like and contents of the pack
Poltram drops are a clear, colourless to pale yellow solution with a minty odour.
1 package contains: 10 ml or 96 ml of solution.
The bottles are made of amber glass:

• 10 ml bottles (with a cap fitted with a tamper-evident ring and a dropper)
• 96 ml bottles (with a dispenser)

Both are placed together with the package leaflet in a cardboard box.

The cap is made of high-density polyethylene (HDPE). The dropper with tamper-evident ring is made of low-density polyethylene (LDPE).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz