Tramadol Sinteza

Package Leaflet: Information for the Patient

Tramadol Synteza, 50 mg, Hard Capsules

Tramadol Hydrochloride

Read the package 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Tramadol Synteza and what is it used for

Tramadol Synteza contains the active substance tramadol hydrochloride, which acts as a pain reliever.
The medicine is used to treat moderate to severe pain.

2. Important information before taking Tramadol Synteza

When not to take Tramadol Synteza

• if you are allergic to tramadol hydrochloride, other opioid painkillers, or any of the other ingredients of this medicine (listed in section 6),
• in case of alcohol intoxication, taking medicines for mental disorders, central nervous system depressants, or sleeping pills,
• in patients taking monoamine oxidase inhibitors (MAOIs) (used in depression) or within 2 weeks of stopping them,
• in patients being treated for opioid dependence,
• in patients with uncontrolled epilepsy. Tramadol Synteza is not a suitable medication for patients addicted to opioids.

Warnings and precautions

Before starting treatment with Tramadol Synteza, discuss it with your doctor or pharmacist.

Be particularly cautious when taking Tramadol Synteza:

• in patients with head injuries, shock, consciousness disorders of unknown origin, respiratory disorders, or respiratory center disorders, as well as in cases of increased intracranial pressure,
• in patients with increased sensitivity to opioid medications,
• in patients with a history of epilepsy and those prone to seizures. Such patients should be treated with tramadol hydrochloride only when absolutely necessary,
• in patients taking other medications that lower the seizure threshold (tramadol hydrochloride may increase the risk of seizures),
• in patients with a tendency to abuse medications or addiction. Treatment should be short-term and under close medical supervision,
• in patients with renal and hepatic impairment,
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Tramadol Synteza and other medicines").

Tramadol hydrochloride should not be used as a replacement therapy in patients addicted to opioids, as although tramadol is an opioid receptor agonist, it does not alleviate morphine withdrawal symptoms.
Do not drink alcohol during treatment with tramadol hydrochloride.
Serotonin syndrome
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of serotonin syndrome. If the patient experiences any symptoms of this syndrome with a severe course, they should immediately consult a doctor (see section 4 "Possible side effects").
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid. Repeated use of opioids can lead to the medicine becoming less effective (the patient becomes accustomed to the medicine, known as tolerance). Repeated use of Tramadol Synteza may also lead to the development of dependence, abuse, and addiction, which can result in life-threatening overdose.
The risk of these side effects may increase with the dose and duration of treatment.
Dependence can make it difficult for the patient to control the dose they take or how often they take it.
The risk of dependence varies from person to person. The risk of dependence on Tramadol Synteza may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If the patient experiences any of the following symptoms while taking Tramadol Synteza, it may indicate dependence:

• the patient needs to take the medicine for a longer period than prescribed by the doctor
• the patient needs to take a higher dose than recommended
• the patient uses the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep"
• the patient has made multiple, unsuccessful attempts to stop or control the use of the medicine
• after stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal effects").

If the patient experiences any of these symptoms, they should discuss the best course of treatment with their doctor, including when to stop the medicine and how to do it safely (see section 3 "Stopping Tramadol Synteza").
Respiratory disorders during sleep
Tramadol Synteza may cause respiratory disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen levels 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 observes these symptoms, they should contact a doctor. The doctor may recommend reducing the dose.
If the patient experiences any of the following symptoms while taking Tramadol Synteza, they should tell their doctor, pharmacist, or nurse.
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.
Tramadol is metabolized in the liver by an enzyme. In some individuals, a variant of this enzyme occurs, which can have different effects. In some individuals, 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 contact their doctor if they experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, constricted pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

Tramadol Synteza is not recommended for children and adolescents under 14 years of age.
Use in children with respiratory disorders
Tramadol is not recommended for children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them

Tramadol Synteza and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take, including those without a prescription.
Before starting treatment with Tramadol Synteza, inform your doctor or pharmacist about the use of any of the following medicines and substances:

• monoamine oxidase inhibitors,
• cimetidine (a liver metabolism inhibitor),
• carbamazepine (a liver metabolism inducer),
• buprenorphine, nalbuphine, pentazocine, etc.,
• coumarin derivatives (e.g., warfarin and acenocoumarol),
• ketokonazole and erythromycin,
• ondansetron,
• tricyclic antidepressants, antipsychotics, and other medications that lower the seizure threshold
• gabapentin or pregabalin in the treatment of epilepsy or pain caused by nerve disorders (neuropathic pain).

The risk of side effects increases:

• if the patient is taking other medicinal products that may cause seizures (convulsions), such as certain antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Tramadol Synteza with these medicines. The doctor should inform the patient whether Tramadol Synteza is suitable for them.
• if the patient is taking certain antidepressants, Tramadol Synteza may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").

Tramadol Synteza with food and drink

It is recommended to take the medicine after a meal.
Do not drink alcohol during treatment.

Pregnancy and breastfeeding

Pregnancy:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The safety of tramadol hydrochloride during pregnancy has not been established. Therefore, the medicine should not be used in pregnant women.
Breastfeeding:
Tramadol is excreted into breast milk. Therefore, during breastfeeding, do not take Tramadol Synteza more than once, or if you have taken Tramadol Synteza more than once, stop breastfeeding..

Driving and using machines

Do not drive or operate machines while taking the medicine.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

The medicine contains quinoline yellow (E 104)

The medicine may cause allergic reactions.

3. How to take Tramadol Synteza

Take this medicine exactly as described in the patient information leaflet or as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Tramadol Synteza, when and how long to take it, when to contact your doctor, and when to stop it (see also section 2).
Recommended dose:
Adults and adolescents over 14 years: 1 capsule of 50 mg taken with a small amount of liquid.
If the pain does not subside after 60 minutes, the dose of 50 mg can be repeated. Average daily dose:
1 capsule every 6 hours (4 times 50 mg, i.e., 200 mg), recommended maximum daily dose 400 mg (8 times 1 capsule).
The dose should be adjusted according to the severity of the pain and the individual patient's response to treatment.
Take the smallest effective dose that relieves the pain.
In the treatment of chronic and cancer pain, the doctor may recommend a different dosing regimen.
Children and adolescents
Do not take Tramadol Synteza in children and adolescents under 14 years of age.
Elderly patients
In elderly patients (over 75 years), tramadol elimination may be delayed.
In such cases, the doctor may recommend prolonging the interval between doses.
Patient with severe hepatic or renal impairment (failure) and (or) patients on dialysis
Do not take Tramadol Synteza in patients with severe hepatic or renal impairment. If the patient has mild or moderate hepatic or renal impairment, the doctor may recommend prolonging the intervals between doses of the medicine.
Method of administration
Oral.

Taking a higher dose of Tramadol Synteza than recommended

In case of taking more capsules of Tramadol Synteza than recommended, immediately contact your doctor or go to the emergency department of the nearest hospital.
Overdose symptoms may include: constricted pupils, vomiting, cardiovascular collapse, impaired consciousness up to coma, seizures, respiratory depression up to respiratory arrest.
In such cases, immediately consult a doctor!

Missing a dose of Tramadol Synteza

Continue treatment according to the dosing regimen prescribed by your doctor.
Do not take a double dose to make up for a missed dose.

Stopping Tramadol Synteza

Do not suddenly stop taking this medicine without consulting your doctor. If you want to stop taking the medicine, discuss it with your doctor, especially if you have been taking it for a long time.
Your doctor will advise you 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 you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramadol Synteza can cause side effects, although not everybody gets them.
The most common side effects of Tramadol Synteza are dizziness and nausea, which may occur in more than 1 in 10 patients.

Very common (more than 1 in 10 patients):

dizziness, nausea.

Common (more than 1 in 100 patients):

headaches, drowsiness, constipation, dry mouth, vomiting, excessive sweating, feeling tired.

Uncommon (more than 1 in 1,000 patients):

cardiovascular disorders (palpitations, tachycardia, orthostatic hypotension, cardiovascular collapse), vomiting reflex, stomach and intestinal irritation (feeling of pressure in the stomach, bloating), diarrhea, skin reactions (itching, rash, hives).

Rare (more than 1 in 10,000 patients):

bradycardia, increased blood pressure, changes in appetite, paresthesia, tremors, respiratory depression, epileptic seizures, involuntary muscle contractions, coordination disorders, fainting, hallucinations, disorientation, sleep disorders, anxiety and nightmares, blurred vision, muscle weakness, urinary disorders (difficulty urinating, dysuria, and urinary retention), allergic reactions (e.g., shortness of breath, bronchospasm, wheezing, angioedema) and anaphylaxis; withdrawal reactions, similar to those observed after opioid withdrawal, such as: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremors, and gastrointestinal symptoms.

Very rare (less than 1 in 10,000 patients):

withdrawal symptoms: panic attacks, increased anxiety, hallucinations, paresthesia, tinnitus, and atypical central nervous system disorders (disorientation, delusions, depersonalization, loss of reality, paranoia).

Frequency not known:

speech disorders, dilated pupils, hiccups, serotonin syndrome, whose symptoms may include changes in mental status (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, 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 Tramadol Synteza").

Other side effects

In case of taking significantly higher doses than recommended and concurrent use of other central nervous system depressants, respiratory depression may occur.
Seizures occur mainly after taking high doses of tramadol and concurrent use of medications that lower the seizure threshold.
After taking tramadol, various psychological disorders may occur, varying in severity and symptoms; depending on the patient's personality and treatment duration. These may include mood disorders (usually excitement, sometimes dysphoria), changes in activity (usually decreased, sometimes increased), and changes in perception and recognition (e.g., decision-making, perception disorders). The medicine may cause dependence.
In a few individual cases, an increase in liver enzyme activity has been observed after taking tramadol.
Exacerbation of asthma has been reported during treatment with tramadol, although a causal relationship between these facts has not been established.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
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 Tramadol Synteza

Keep the medicine in a safe place, out of the reach of others. It can cause serious harm and be fatal to individuals for whom it has not been prescribed.
Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiration date stated on the carton. The expiration date refers to the last day of the month.
Medicines should 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 pack and other information

What Tramadol Synteza contains

• The active substance of the medicine is tramadol hydrochloride. One capsule contains 50 mg of tramadol hydrochloride.
• Other ingredients are: sodium carboxymethylcellulose (type A), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, gelatin, quinoline yellow (E104), iron oxide red (E172), titanium dioxide (E171).

What Tramadol Synteza looks like and contents of the pack

Tramadol Synteza is hard capsules, packaged in aluminum/PVC blisters and a cardboard box.
1 pack contains 20 capsules (2 blisters of 10 each)

Marketing authorization holder and manufacturer

Przedsiębiorstwo Farmaceutyczno-Chemiczne "Synteza" Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
Przedsiębiorstwo Farmaceutyczno-Chemiczne "Synteza" Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań, Poland
Tel. 61 879-20-81

Date of last revision of the leaflet: May 2025