Tramadol synteza

Patient Information Leaflet

Tramadol Synteza, 50 mg, hard capsules
Tramadoli hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If in doubt, 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet Contents:

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

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

Tramadol Synteza contains the active substance tramadoli hydrochloridum, which has analgesic properties.
The medicine is used for the treatment of moderate to severe pain.

2. Information before using Tramadol Synteza

When Tramadol Synteza must not be used

• if the patient is allergic to tramadol hydrochloride, other opioid analgesics, or any of the other ingredients of this medicine (listed in section 6),
• in cases of intoxication with alcohol, medicines used to treat mental disorders, centrally acting analgesics, or sleeping medicines,
• in patients simultaneously taking medicines containing monoamine oxidase inhibitors (MAOIs) (used in depression) or within 2 weeks after discontinuation of such treatment,
• in patients undergoing treatment for opioid dependence,
• in patients with epilepsy that is not controlled by treatment. Tramadol Synteza is not an appropriate medicine for patients dependent on opioids.

Warnings and precautions
Before starting treatment with Tramadol Synteza, discuss this with your doctor or pharmacist.
Exercise special caution when using Tramadol Synteza:

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

Tramadol hydrochloride should not be used in replacement therapy for patients dependent on opioids, since 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
There is a small risk of the so-called serotonin syndrome when tramadol is taken in combination with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, they should immediately consult a doctor (see section 4 "Possible side effects").

Tolerance, dependence, and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may result in reduced effectiveness of the medicine (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 may result in life-threatening overdose.
The risk of these adverse effects may increase with dose and longer duration of use.
Dependence may cause the patient to lose control over the dose or frequency of medicine intake.
The risk of dependence varies among individuals. The risk of dependence on Tramadol Synteza may be higher if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, 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 any of the following symptoms occur during treatment with Tramadol Synteza, this may indicate dependence:

• the patient needs to take the medicine longer 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, e.g., "to calm down" or "to help sleep",
• 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 the medicine again ("withdrawal effects").

If any of these symptoms occur, talk to your doctor to discuss the best treatment approach, including when and how to discontinue the medicine safely (see section 3 "Discontinuing Tramadol Synteza").

Sleep-related breathing disorders
Tramadol Synteza 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 observes these symptoms, contact the doctor. The doctor may recommend reducing the dose.

If any of the following symptoms occur during treatment with Tramadol Synteza, inform your doctor, pharmacist, or nurse:
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.

Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some individuals, pain relief may be insufficient, while in others, severe adverse effects may be more likely.
Discontinue the medicine and contact your doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents
Use in children and adolescents under 14 years of age is not recommended.

Use in children with breathing disorders
Tramadol should not be used in children with breathing disorders, as tramadol toxicity symptoms may be intensified in them.

Tramadol Synteza and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those without a prescription.
Before starting Tramadol Synteza, inform your doctor or pharmacist if you are taking any of the following medicines or substances:

• monoamine oxidase inhibitors (MAOIs),
• cimetidine (an inhibitor of hepatic metabolism),
• carbamazepine (a hepatic metabolism inducer),
• buprenorphine, nalbuphine, pentazocine, etc.,
• coumarin derivatives (e.g., warfarin and acenocoumarol),
• ketoconazole and erythromycin,
• ondansetron,
• tricyclic antidepressants, antipsychotics, and other medicines that lower the seizure threshold,
• gabapentin or pregabalin used in the treatment of epilepsy or nerve-related pain (neuropathic pain).

The risk of adverse effects increases:

• if the patient takes other medicinal products that may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if Tramadol Synteza is taken simultaneously with these medicines. The doctor should inform the patient whether Tramadol Synteza is suitable for them.
• if the patient takes 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 meals.
Do not drink alcohol during treatment.

Pregnancy and breastfeeding
Pregnancy:
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The safety of tramadol hydrochloride during pregnancy has not been established. Therefore, this medicine should not be used in pregnant women.

Breastfeeding:
Tramadol is excreted in breast milk. Therefore, during breastfeeding, Tramadol Synteza should not be taken more than once, or if Tramadol Synteza has been taken more than once, breastfeeding should be discontinued.

Driving and operating machinery
Do not drive or operate machinery during treatment with this medicine.

This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

This medicine contains quinoline yellow (E 104)
This medicine may cause allergic reactions.

3. How to use Tramadol Synteza

This medicine should be used exactly as described in the patient leaflet or as directed by a doctor.
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 Tramadol Synteza, when and for how long it should be taken, when to contact the doctor, and when it should be discontinued (see also section 2).

Recommended dose:
Adults and adolescents over 14 years of age: 1 capsule of 50 mg taken with a small amount of liquid.
If pain has not subsided after 60 minutes, the 50 mg dose may be repeated.
Average daily dose: 1 capsule every 6 hours (4 times 50 mg, i.e. 200 mg). The recommended maximum daily dose is 400 mg (8 times 1 capsule).
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.
For chronic or cancer-related pain, the doctor may recommend a different dosing regimen.

Children and adolescents
Tramadol Synteza should not be used in children and adolescents under 14 years of age.

Elderly patients
In elderly patients (over 75 years of age), tramadol elimination may be delayed. In such cases, the doctor may recommend extending the interval between doses.

Patients with severe hepatic or renal impairment (insufficiency) and (or) dialysis patients
Tramadol Synteza should not be used in patients with severe hepatic and (or) renal insufficiency.
If the patient has mild or moderate hepatic and (or) renal insufficiency, the doctor may recommend extending the intervals between doses.

Administration method
Oral administration.

Overdose of Tramadol Synteza
If more capsules of Tramadol Synteza than recommended have been taken, seek immediate medical advice or go to the nearest hospital emergency department.
Symptoms of overdose may include: constricted pupils, vomiting, circulatory collapse, disturbances of consciousness up to coma, seizures, respiratory depression up to respiratory arrest.
In such cases, seek immediate medical help!

Missed dose of Tramadol Synteza
Continue treatment according to the dose prescribed by the doctor.
Do not take a double dose to make up for a missed dose.

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

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

4. Possible adverse effects

Like all medicines, Tramadol Synteza may cause adverse effects, although not everyone experiences them.

The most common adverse effects during treatment with Tramadol Synteza are dizziness and nausea, which may occur in more than 1 in 10 patients.

Very common (affects more than 1 in 10 patients):
dizziness, nausea.

Common (affects more than 1 in 100 patients):
headache, drowsiness, constipation, dry mouth, vomiting, excessive sweating, feeling of fatigue.

Uncommon (affects more than 1 in 1000 patients):
cardiovascular disorders (palpitations, tachycardia, orthostatic hypotension, cardiovascular collapse), vomiting reflex, gastric and intestinal irritation (feeling of pressure in the stomach, bloating), diarrhoea, skin reactions (itching, rash, urticaria).

Rare (affects more than 1 in 10,000 patients):
bradycardia, increased blood pressure, appetite changes, paresthesia, tremor, respiratory depression, epileptic-type seizures, involuntary muscle contractions, coordination disorders, fainting, hallucinations, disorientation, sleep disturbances, restlessness and nightmares, blurred vision, skeletal muscle weakness, urinary disorders (difficulty in urination, dysuric symptoms and urinary retention), allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioedema) and anaphylaxis; withdrawal reactions similar to those observed after discontinuation of opioids, such as: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.

Very rare (affects less than 1 in 10,000 patients):
withdrawal symptoms: panic attacks, severe anxiety, hallucinations, paresthesia, tinnitus and unusual central nervous system disorders (disorientation, delusions, depersonalization, loss of sense of reality, paranoia).

Frequency not known:
speech disorders, pupil dilation, hiccups, serotonin syndrome, which may manifest with changes in mental status (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, increased heart rate, 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 Tramadol Synteza").

Other adverse effects
When doses significantly higher than recommended are used, especially in combination with other substances that depress the central nervous system, respiratory depression may occur.

Epileptic-type seizures occur mainly after administration of high doses of tramadol and concomitant use of drugs that lower the seizure threshold.

Psychiatric disorders of varying severity and symptoms may occur after tramadol administration; the type and intensity depend on the patient's personality and duration of treatment. These may include mood disturbances (usually euphoria, sometimes dysphoria), changes in activity (usually decreased, sometimes increased), and disturbances in perception and cognitive functions (e.g. decision-making, perceptual disturbances). The drug may cause dependence.

Increased liver enzyme activity has been observed in a few isolated cases after administration of tramadol.

Exacerbation of bronchial asthma during tramadol treatment has been reported, although a causal relationship has not been established.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 may 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 Tramadol Synteza

Keep the medicine in a safe place out of the reach of others. It may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Keep the medicine out of the sight and reach of children.

Store below 25°C.

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.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tramadol Synteza contains

• The active substance is tramadol hydrochloride. One capsule contains 50 mg of tramadol hydrochloride.
• Other ingredients are: sodium carboxymethyl starch (type A), microcrystalline cellulose, colloidal anhydrous 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 a hard capsule, packed in blisters made of Aluminium/PVC foil and cardboard box.
1 pack contains 20 capsules (2 blisters with 10 capsules each).

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

For more detailed information about this medicinal product, please contact the marketing authorisation holder:
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań Poland
Tel. 61 879-20-81