TRAMADOL 100 mg /Ml Drops

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Tramadol Synteza, 100 mg/ml, oral drops
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Tramadol Synteza and what is it used for
4. 1. When not to take Tramadol Synteza
   2. Warnings and precautions
   3. Children
   4. Tramadol Synteza and other medicines
   5. Tramadol Synteza with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
5. How to take Tramadol Synteza
   1. Using a higher dose of Tramadol Synteza than recommended
   2. Missing a dose of Tramadol Synteza
   3. Stopping treatment with Tramadol Synteza
6. Possible side effects:
   1. Very common (more than 1 in 10 patients):
   2. Common (more than 1 in 100 patients):
   3. Uncommon (more than 1 in 1000 patients):
   4. Rare (more than 1 in 10,000 patients):
   5. Very rare (less than 1 in 10,000 patients):
   6. Frequency not known:
   7. Other side effects
   8. Reporting side effects
7. How to store Tramadol Synteza
8. Contents of the packaging and other information
   1. What Tramadol Synteza contains
   2. What Tramadol Synteza looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Tramadol Synteza, 100 mg/ml, oral drops

Tramadol hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 any not listed in this leaflet, you should 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. How to store Tramadol Synteza
• 6. Contents of the packaging and other information

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

Tramadol Synteza contains the active substance tramadol hydrochloride, which has a pain-relieving effect.
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 or any of the other ingredients of this medicine (listed in section 6);
• in case of alcohol poisoning, drugs used to treat mental disorders, painkillers acting on the central nervous system, sleeping pills
• in patients who are also taking medicines containing so-called monoamine oxidase inhibitors (MAOIs) (used in severe depression) or within 2 weeks after their withdrawal,
• in patients who are being treated for addiction to substances from the opioid group,
• in patients with uncontrolled epilepsy. Tramadol Synteza is not a suitable agent for use in patients addicted to opioids.

Warnings and precautions

Before starting treatment with Tramadol Synteza, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Tramadol Synteza:

• in patients after head injury, in shock, in disorders of consciousness of unknown origin, in cases of respiratory disorders or disorders of respiratory center function, and in case of increased intracranial pressure
• in patients with increased sensitivity to opioid drugs
• in patients with a history of epilepsy and those prone to seizures of cerebral origin. Such patients should be treated with tramadol hydrochloride only when absolutely necessary.
• in patients taking other drugs that lower the seizure threshold (tramadol hydrochloride may increase the risk of seizures)
• in patients with a tendency to abuse drugs or addiction. Treatment should then be short-term and under close medical supervision.
• in patients with renal and hepatic impairment

Tramadol hydrochloride should not be used in replacement therapy in patients addicted to opioids, as although tramadol is an opioid receptor agonist, it does not alleviate withdrawal symptoms of morphine.
You should not drink alcohol during treatment with tramadol hydrochloride.
Sleep apnea
Tramadol Synteza may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and sleep-related 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 you or another person observes these symptoms, you should contact your doctor. The doctor may recommend reducing the dose.
If you experience any of the following symptoms while taking Tramadol Synteza, you should tell your doctor, pharmacist, or nurse:
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate that you have adrenal insufficiency (low cortisol levels). If such symptoms occur, you should contact your doctor, who will decide whether you need hormone replacement therapy.

Children

Due to the content of ethanol (alcohol), the medicine cannot be given to children.

Tramadol Synteza and other medicines

You should inform your doctor about all medicines you have taken recently, even those bought without a prescription.
The amount of alcohol in this medicine may change the effect of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.
Before starting treatment with Tramadol Synteza, you should inform your doctor or pharmacist about the use of any of the following medicines and substances:

• monoamine oxidase inhibitors,
• cimetidine (a hepatic metabolism inhibitor),
• carbamazepine (a hepatic metabolism inducer),
• buprenorphine, nalbuphine, pentazocine, etc.,
• coumarin derivatives (e.g., warfarin and acenocoumarol),
• ketokonazole and erythromycin,
• ondansetron,
• tricyclic antidepressants, antipsychotic drugs, and other drugs that lower the seizure threshold.

The risk of adverse reactions increases:

• if you are taking other medicinal products that may cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of seizure may increase if you take Tramadol Synteza with these medicines.

Your doctor should inform you whether Tramadol Synteza is suitable for you.
You should inform your doctor if you are taking certain antidepressants. Tramadol Synteza may interact with these medicines, which may cause the following symptoms in you: involuntary, rhythmic muscle contractions, including muscles that control eye movement, agitation, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C.

Tramadol Synteza with food and drink

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

Pregnancy and breastfeeding

Pregnancy
The safety of using tramadol hydrochloride during pregnancy has not been established. Therefore, the medicine should not be used in pregnant women.
Breastfeeding
Tramadol hydrochloride is not recommended during breastfeeding. Stopping breastfeeding is not necessary in case of single-dose administration.

Driving and operating machinery

The amount of alcohol in this medicine may affect your ability to drive and operate machinery, as it may affect your judgment and reaction time.
Warnings regarding the excipient
This medicine contains 255 mg of alcohol (ethanol) per 0.5 ml of the medicine (which corresponds to 50 mg of tramadol hydrochloride, 20 drops). The amount of alcohol in the dose of this medicine is equivalent to 3 ml of wine or 7 ml of beer.
Harmful to people with alcoholism. If you are addicted to alcohol, you should consult your doctor or pharmacist before taking this medicine.
Due to the content of ethanol (alcohol), the medicine cannot be given to children; caution should be exercised in high-risk individuals, such as patients with liver disease or epilepsy. If you have epilepsy or liver problems, you should consult your doctor or pharmacist before taking the medicine.

3. How to take Tramadol Synteza

This medicine should be taken exactly as described in the patient leaflet or as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Oral administration.
Recommended dose:
Adults and children over 14 years: single dose 20 drops, which corresponds to 50 mg of tramadol hydrochloride (0.5 ml of the medicine) orally, on a sugar cube or in water, fruit juice. If the pain-relieving effect after 30 to 60 minutes from taking a single dose is insufficient, the dose can be repeated. Average daily dose: 20 drops, every 6 hours (4 times 20 drops, i.e., 200 mg). The recommended maximum daily dose is 400 mg (8 times 20 drops).
The dose should be adjusted according to the severity of the pain and the individual patient's response to treatment.
You should take the smallest dose that effectively relieves the pain.
In the treatment of chronic and cancer pain, your doctor may recommend a different dosing regimen.
Elderly patients
In patients over 75 years of age, the elimination of tramadol from the body may be delayed. In these patients, the doctor may recommend prolonging the time interval between doses.”
Patients with renal impairment, dialysis, or hepatic impairment
You should not take Tramadol Synteza in case of severe hepatic and/or renal impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the time intervals between doses.

Using a higher dose of Tramadol Synteza than recommended

In case of taking a dose higher than recommended, you should stop taking the medicine and immediately consult your doctor or pharmacist.
Prolonged use of the medicine in doses higher than prescribed by the doctor may lead to drowsiness, weakness, fainting.

Missing a dose of Tramadol Synteza

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

Stopping treatment with Tramadol Synteza

No symptoms related to stopping treatment with the medicine have been observed.
If you have any further doubts about taking this medicine, you should 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):

headache, drowsiness, constipation, dry mouth, vomiting, excessive sweating, feeling tired

Uncommon (more than 1 in 1000 patients):

disorders of the cardiovascular system (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, dysuric symptoms, 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 sense of reality, paranoia).

Frequency not known:

speech disorders, pupil dilation, hiccups

Other side effects

In case of taking doses significantly higher than recommended and concomitant use of other substances that depress the central nervous system, respiratory depression may occur.
Epileptic seizures occur mainly after taking large doses of tramadol and concomitant use of drugs that lower the seizure threshold.
After taking tramadol, various types of mental disorders may occur, varying in severity and symptoms; depending on the patient's personality and duration of treatment. These may be mood disorders (usually excitement, sometimes dysphoria), changes in activity (usually decreased, sometimes increased), and changes in the ability to feel and recognize (e.g., making decisions, perception disorders). The medicine may cause addiction.
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 any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Tramadol Synteza

Store in a temperature below 25°C.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use this medicine after the expiry date stated on the carton.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tramadol Synteza contains

• The active substance of the medicine is tramadol hydrochloride; 1 ml of the product contains 100 mg of tramadol hydrochloride (Tramadol hydrochloride). 20 drops correspond to 50 mg of tramadol hydrochloride (0.5 ml of the medicine)
• The other ingredient is ethanol (70%)

What Tramadol Synteza looks like and what the pack contains

Tramadol Synteza is an oral drop in an orange glass bottle (type III) with a dropper made of LDPE and a cap made of PP, in a cardboard box.
1 bottle contains 10 ml.

Marketing authorization holder and manufacturer

Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:
Poland
Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
Tel. 61 879-20-81

Date of last revision of the leaflet: