Poltram

Patient Information Leaflet

Poltram, 50 mg, capsules
Tramadoli hydrochloridum
Please read the entire leaflet 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 pass it on to others. This medicine may harm others, even if their symptoms are identical.
• 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 or has taken monoamine oxidase inhibitors (MAOIs) (antidepressants, selegiline used in Parkinson’s disease) 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 drug-dependent;
in withdrawal syndrome.

Warnings and precautions
Before starting treatment with Poltram, discuss the following with your doctor or pharmacist:
if the patient is dependent on strong painkillers acting on the central nervous system (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 impaired function 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 brain-originated seizures. The risk of seizures increases when exceeding the recommended daily dose (400 mg). In addition, tramadol may increase the risk of seizures in patients taking other medicines that lower the seizure threshold. Such patients may only be treated with tramadol if other pain treatments are ineffective;
if the patient has a history of drug abuse or drug dependence, or if the treatment is long-term. In such cases, treatment should be closely supervised by a doctor;
if the patient has depression and is taking antidepressants, because some of them may interact with tramadol (see "Poltram and other medicines").
There is a small risk of developing serotonin syndrome when tramadol is taken together with certain antidepressants or tramadol alone. 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 medicines that depress the central nervous system.
Taking high doses of tramadol-containing medicines, either alone or in combination with other central nervous system depressants, including alcohol, may result in fatal overdose in drug-dependent individuals. Do not exceed the dose prescribed by the doctor.
Caution is advised in patients with respiratory depression, as well as when using Poltram with other medicines that depress the CNS or when recommended doses are significantly exceeded, as respiratory depression cannot be ruled out in these cases (see section 2 "Poltram and other medicines").

Sleep-related breathing disorders
Poltram may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact a doctor. 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 addiction
This medicine contains tramadol, an opioid medicine. 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 increases 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 individuals 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 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 addiction:

• Need to take the medicine for longer than prescribed 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 substitution treatment for opioid-dependent patients, as it does not relieve 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 insufficient, while in others, severe adverse reactions are more likely. Discontinue the medicine and contact your doctor immediately if any of the following adverse reactions (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. Close monitoring for signs of tramadol toxicity (see above), including respiratory depression, is essential.
Use in children with respiratory disorders
Tramadol is not recommended in children with respiratory disorders, as symptoms of tramadol toxicity (see above) may be intensified.

Poltram and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Poltram must not be used simultaneously 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 (usually used to treat epilepsy or severe facial pain attacks known as trigeminal neuralgia);
buprenorphine, nalbuphine, pentazocine (opioid painkillers). Pain-relieving effect may be reduced;
gabapentin or pregabalin (used to treat epilepsy or nerve-related pain (neuropathic pain)).
The risk of adverse effects is increased when Poltram is taken together with:
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 antitussive effects), baclofen (muscle relaxant), antihypertensives, antidepressants, or antiallergic medicines. Drowsiness or faintness may occur. Inform your doctor if such symptoms develop;
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 to thin the blood). The effect of these medicines may be altered, leading to bleeding. Any prolonged or unexpected bleeding should be reported to the doctor immediately;
central nervous system depressants and alcohol.
The effectiveness of Poltram may be reduced if taken together 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, breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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.

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.
Adults and adolescents over 12 years of age
Acute pain: the usual initial dose is 100 mg. Subsequent doses of 50 mg or 100 mg should be
administered 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 there
is a clinical justification.
The maximum daily dose for adults and adolescents over 12 years of age should not exceed
400 mg of tramadol, except in special clinical circumstances.
Children under 12 years of age
Use is not recommended.
Elderly patients
In patients over 75 years of age, tramadol elimination from the body may be delayed. In these
patients, the doctor may recommend extending the interval between doses.
Patients with renal impairment, those undergoing dialysis, and/or with 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 extending the intervals
between doses.
Duration of use
Poltram must 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
treatment should continue (if necessary, treatment breaks should be introduced) (see section 2
"Warnings and precautions").
In patients with a history of 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, low blood pressure,
rapid heartbeat (tachycardia), pinpoint pupils, slowed breathing up to respiratory arrest, and
intestinal motility inhibition.
Missing a dose of Poltram
If a dose is missed, take the medicine as soon as possible. If it is almost time for the next dose, do
not take the missed dose. Do not take a double dose to make up for a missed dose.
Stopping Poltram treatment
Do not suddenly stop taking 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
taken for a prolonged period. The doctor will advise when and how to discontinue the medicine; this
may involve gradually reducing the dose to reduce the likelihood 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 medicine can cause adverse reactions, although not everyone will experience them.

If any of the following serious adverse reactions occur, contact 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, manifesting as dizziness, disorientation, and fainting) – rare
• Allergic reactions (rare; shortness of breath, feeling of tightness in the chest due to bronchospasm, wheezing, angioedema with symptoms such as swelling of the skin and mucous membranes, e.g. throat or tongue, and difficulty breathing and/or itching, rash, urticaria – not uncommon)
• Cardiovascular collapse, which may include fainting (not uncommon)
• Slower than normal heart rate (rare)
• Slowed breathing, shortness of breath up to complete respiratory arrest (rare), exacerbation of bronchial asthma, although a causal relationship has not been established
• Urinary disturbances, urinary retention (rare)
• Dependence
• Withdrawal symptoms: agitation, restlessness, anxiety, nervousness, insomnia, motor agitation, tremor, and gastrointestinal disturbances. See also section 3.

During treatment with this medicine, the following may occur:

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

• Nausea
• Dizziness

Common (affects less than 1 in 10 patients):

• Headache
• Drowsiness, fatigue
• Vomiting
• Constipation
• Dry mouth
• Excessive sweating

Uncommon (affects less than 1 in 100 patients):

• Palpitations
• Increased heart rate
• Low blood pressure when sitting or standing (orthostatic hypotension)
• Belching
• Epigastric discomfort
• Feeling of fullness in the abdomen
• Diarrhea

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

• High blood pressure
• Appetite disturbances
• Sensation of burning or prickling in the limbs without apparent cause (paresthesia)
• Tremor
• Muscle weakness, involuntary muscle contractions
• Coordination disturbances
• Slowed breathing, shortness of breath
• Seizures
• Restlessness
• Hallucinations
• Disorientation
• Sleep disturbances and nightmares
• Blurred vision
• Urinary disturbances, 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 level (usually decreased, sometimes increased), excessive fatigue, and reduced sensory and cognitive perception (changes in sensation and recognition that may lead to incorrect assessment of situations).

Frequency unknown (cannot be estimated from available data):

• Facial flushing, hot flushes
• Speech disorders
• Pupil dilation (mydriasis)
• Edema
• Hiccups
• Serotonin syndrome, which may present with changes in mental state (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, diarrhea) (see section 2 "Important information before using Poltram").

Adverse reactions that may occur after abrupt discontinuation of the medicine are identical to those seen with withdrawal from other opioids: agitation, restlessness, anxiety, nervousness, insomnia, motor agitation, tremor, and gastrointestinal disturbances.

Other adverse reactions that have occurred rarely after discontinuation of tramadol include: panic attacks, severe restlessness, hallucinations, paresthesia, tinnitus, and other symptoms affecting the central nervous system (e.g. disorientation, delusions, depersonalization, derealization, paranoia).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of 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 provide more information on the safety of this 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 blister after EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging after EXP indicates the expiry date, and after Lot/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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Poltram contains

• The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.
• The other ingredients are: anhydrous calcium hydrogen phosphate, anhydrous colloidal silicon dioxide, magnesium stearate; capsule shell ingredients: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

What Poltram looks like and contents of the pack
Cream to light beige coloured gelatin capsules filled with white to slightly yellowish powder.
The pack contains 20 capsules.

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