Poltram retard 150

Package leaflet: Information for the patient

Poltram Retard 100, 100 mg, prolonged-release tablets
Poltram Retard 150, 150 mg, prolonged-release tablets
Poltram Retard 200, 200 mg, prolonged-release tablets
Tramadoli hydrochloridum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Poltram Retard and what is it used for
2. Important information before taking Poltram Retard
3. How to take Poltram Retard
4. Possible side effects
5. How to store Poltram Retard
6. Contents of the pack and other information

1. What is Poltram Retard and what is it used for

Poltram Retard 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.
The medicine is intended for use in adults and adolescents over 14 years of age.

2. Important information before using Poltram Retard

When not to use Poltram Retard:

• 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 MAO inhibitors (antidepressants, selegiline used in Parkinson's disease) or has taken them within the previous 14 days before treatment with Poltram Retard;
• if the patient suffers from epilepsy that is not adequately controlled by medication;
• in children under 14 years of age weighing less than 50 kg;
• if the patient is addicted to narcotics;
• during withdrawal syndrome.

Warnings and precautions
Before starting treatment with Poltram Retard, discuss 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 impaired function of the respiratory center;

• 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 (400 mg) is exceeded. Moreover, tramadol may increase the risk of seizures in patients concurrently taking other medicines that lower the seizure threshold. Such patients may only be treated with tramadol if other pain management strategies are ineffective.

• if the patient has a history of drug abuse or dependence, or if the therapy is long-term. In such cases, treatment 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 Retard 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 hepatic and/or renal impairment. In patients undergoing long-term treatment with Poltram Retard, monitoring of blood drug levels is recommended.

• if the patient is taking sedatives, anxiolytics, neuroleptics, muscle relaxants, antidepressants, or other CNS depressants. Taking tramadol-containing medicines at high doses, alone or in combination with other CNS depressants, including alcohol, may result in fatal overdose. Do not exceed the dose prescribed by the doctor.

Caution is advised in patients with respiratory depression, as well as when used concomitantly with other medicines that depress the CNS or when recommended doses are significantly exceeded, as respiratory depression cannot be ruled out in such cases (see section 2 "Poltram Retard and other medicines").
Sleep-related breathing disorders
Poltram Retard may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person notices these symptoms, contact a doctor. The doctor may consider reducing the dose.
If any of the following symptoms occur during treatment with Poltram Retard, 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 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 Retard 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 of dependence on Poltram Retard may apply to individuals in the following situations:

• the patient or a family member has ever abused or been dependent on alcohol, prescription drugs, 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 Retard, 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 prescribed.
• 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 multiple unsuccessful attempts to stop or control medicine use.
• After stopping the medicine, the patient feels unwell, and feels better after taking the medicine 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 Retard").

Tramadol must not be used in substitution treatment for 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 variation of this enzyme, which may lead to different effects. In some patients, pain relief may be insufficient, while in others, severe adverse effects are more likely. The medicine should be discontinued and medical advice sought 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
Do not use in children and adolescents under 14 years of age weighing less than 50 kg.
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), 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 Retard and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Poltram Retard must not be used concomitantly with MAO inhibitors (medicines containing: isocarboxazid, iproniazid, tranylcypromine, phenelzine, selegiline, moclóbemide) – see section "When not to use Poltram Retard".
Concomitant use of Poltram Retard with the following medicines is not recommended:

• carbamazepine (commonly used to treat epilepsy or severe facial pain known as trigeminal neuralgia);
• buprenorphine, nalbuphine, pentazocine (opioid painkillers). This may reduce analgesic effect.
• gabapentin or pregabalin (used to treat epilepsy or nerve-related pain (neuropathic pain)).

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

• certain antidepressants – Poltram Retard 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 antiallergic medicines. Drowsiness or faintness may occur. Inform your doctor if such symptoms occur.
• other medicines that may cause seizures, such as: certain antidepressants or antipsychotics, bupropion, mirtazapine, tetrahydrocannabinol. The risk of seizures may increase if Poltram Retard is taken with these medicines. The doctor should inform the patient whether Poltram Retard is suitable.
• 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.
• CNS depressants and alcohol. The effectiveness of Poltram may be affected when taken concomitantly with:
• ondansetron (used to treat nausea and vomiting);
• ketoconazole or erythromycin (used to treat infections).

Poltram Retard and alcohol
Do not drink alcohol during treatment.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Poltram Retard must not be used during pregnancy and breastfeeding.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, during breastfeeding, Poltram Retard should not be taken more than once, or if Poltram Retard has been taken more than once, breastfeeding should be discontinued.
Driving and operating machinery
The medicine may prolong reaction time, even when used at recommended doses, especially when taken concomitantly with other psychotropic medicines.
Do not drive or operate machinery while taking this medicine.

3. How to use Poltram Retard

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to
expect from using Poltram Retard, when and for how long it should be taken, when to contact your
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.
Children and adolescents
Do not use this medicine in children and adolescents under 14 years of age, or with body weight less than 50 kg.
Adults and adolescents over 14 years of age, with body weight greater than 50 kg
The usual starting dose is 50 mg or 100 mg of tramadol twice daily, in the morning and evening.
If a starting dose lower than 100 mg is required, another medicinal product containing tramadol
hydrochloride should be used. If pain relief is inadequate, the dose may be gradually increased
to 150 mg or 200 mg of tramadol twice daily. The principle of using the lowest effective analgesic
dose should always be followed. Usually, a dose higher than 400 mg per day, given in divided doses,
is not necessary. Swallow tablets whole; do not chew or crush. Take with a small amount of liquid;
may be taken independently of meals, preferably in the morning and evening.
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
Do not take Poltram Retard 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 treatment
Do not use this medicine 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, drug-free intervals should be introduced) (see section 2
"Warnings and precautions").
In patients with a tendency to drug abuse or drug dependence, treatment with tramadol should
be short-term and under strict medical supervision (see section 2 "Warnings and precautions").
Taking more than the recommended dose of Poltram Retard
If a double dose is accidentally taken at one time, medical intervention is usually not required.
Continue taking the medicine at the dose prescribed by your doctor and at the usual intervals.
If you take more than the prescribed dose, contact your doctor as soon as possible.
Symptoms of overdose include: disturbances of consciousness up to coma (a state of deep
unconsciousness), seizures, drop in arterial blood pressure, rapid heartbeat (tachycardia), constricted
pupils, slowed breathing up to respiratory arrest, and inhibition of intestinal peristalsis.
Missed dose of Poltram Retard
If you miss a dose, take it 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 Retard
Do not suddenly stop using this medicine without your doctor's advice. If you wish to discontinue
treatment, discuss this with your doctor, especially if the medicine has been used long-term.
Your doctor will advise when and how to stop the medicine; this may involve gradually reducing
the dose to reduce the likelihood of withdrawal symptoms (withdrawal symptoms).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects 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) – occurs rarely.
allergic reactions (occur rarely; shortness of breath, feeling of tightness in the chest due to bronchospasm, wheezing, angioedema, characterized by swelling of the skin and mucous membranes, e.g. throat or tongue, and difficulty breathing and (or) itching, rash, urticaria – occur uncommonly).
cardiovascular collapse, of which fainting is one symptom (occurs uncommonly);
slower than normal heart rate (occurs rarely).
respiratory depression, 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: agitation, restlessness, anxiety, nervousness, insomnia, motor agitation, tremor, and gastrointestinal disturbances. See also section 3.

During use of the 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)
Cardiac and circulatory system disorders (palpitations, increased heart rate, decreased blood pressure upon sitting or standing), belching, pressure in the stomach, feeling of fullness in the abdominal cavity, diarrhoea.
Rare (affects less than 1 in 1000 patients)
Increased blood pressure, appetite disturbances, burning or prickling sensations in the limbs without clear 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 Retard. 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 that may lead to incorrect assessment of situations).

Frequency not known (cannot be estimated from available data)
Facial flushing, hot flushes, speech disorders, pupil dilation, oedema, hiccups, serotonin syndrome, which may present with 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 using Poltram Retard).

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

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Poltram Retard

Keep in the original packaging to protect from moisture.
This medicine should be stored in a place that is 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 packaging. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation 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 packaging and other information

What Poltram Retard contains

• The active substance is tramadol hydrochloride. Each prolonged-release tablet contains 100 mg, 150 mg or 200 mg of tramadol hydrochloride, respectively.
• Other ingredients are: calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate.

What Poltram Retard looks like and contents of the pack
Poltram Retard 100: white, round, biconvex prolonged-release tablets.
Poltram Retard 150: white, elongated prolonged-release tablets.
Poltram Retard 200: white, elongated prolonged-release tablets.
Packs contain 10, 30 or 50 tablets in blisters.
Not all pack sizes may be marketed.

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

Manufacturer
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
Medochemie Ltd., Facility A - Z, Mich. Erakleous
Ayios Athanassios Industrial Area
Limassol, Cyprus