Tramal

Package leaflet: Information for the patient

Tramal, 100 mg/ml, oral drops, solution, in a bottle with a metering pump
Tramadoli hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Tramal is and what it is used for
2. Important information before using Tramal
3. How to use Tramal in a bottle with a metering pump
4. Possible adverse effects
5. How to store Tramal
6. Contents of the package and other information

1. What Tramal is and what it is used for

Tramadol – the active substance in Tramal – is an analgesic belonging to the group of opioids acting on the central nervous system. It exerts its analgesic effect by acting on specific nerve cell receptors in the spinal cord and brain.
Tramal is indicated for the treatment of moderate to severe pain.

2. Important information before using Tramal

When not to use Tramal

• if the patient is allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in cases of acute alcohol intoxication, hypnotics, analgesics or psychotropic medicines (medicines affecting mood and emotions);
• if the patient is taking medicines from the group of MAO inhibitors (certain antidepressants) or within 14 days after discontinuation of such treatment (see "Tramal with other medicines");
• in patients with epilepsy that is not controlled by treatment;
• in the treatment of opioid dependence.

Warnings and precautions
Before starting treatment with Tramal, discuss the following with your doctor:

• if the patient has a history of dependence on other painkillers (opioids);
• in disorders of consciousness (if the patient feels fainting coming on);
• in shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (which may occur after head injury or brain diseases);
• in case of respiratory disorders;
• in patients with increased sensitivity to opioid medicines;
• in patients with epilepsy or an increased risk of seizures, as this risk may be further increased;
• in patients with liver or kidney disease;
• if the patient suffers from depression and is taking antidepressants, since some of these may interact with tramadol (see "Tramal with other medicines"). There is a small risk of developing so-called serotonin syndrome when tramadol is taken together with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, immediate medical advice should be sought (see section 4 "Possible side effects").

Tolerance, dependence and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may
reduce the effectiveness of the medicine (the patient's body becomes accustomed to the medicine, known as tolerance). Repeated use of Tramal may also lead to 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 treatment.
Dependence or addiction may cause the patient to lose control over the amount or frequency of medicine taken.
The risk of dependence or addiction varies among individuals. Higher risk of dependence on Tramal may apply to people in the following situations:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• the patient is a tobacco smoker;
• 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 symptoms listed below while taking Tramal, this may indicate dependence or addiction.
• Need to take the medicine for longer than recommended 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 multiple unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, the patient feels unwell, but feels better after taking it again ("withdrawal effects"). If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment approach, including when and how to stop taking the medicine safely (see section 3, "Stopping treatment with Tramal").

Tramal may cause psychological and physical dependence. Long-term use of Tramal may lead to reduced effectiveness, resulting in the need to take increasingly higher doses (development of tolerance). In patients with a tendency to drug abuse or history of addiction, treatment should be short-term and under strict medical supervision.
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.
Sleep-related breathing disorders
Tramal 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 another person observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.
Caution is advised in patients with suppressed respiratory centre function, especially when taking other medicines that depress the central nervous system (see "Tramal with other medicines") or when taking doses higher than recommended (see "Taking more Tramal than recommended" in section 3 and section 4), as respiratory depression cannot be ruled out in such cases.
Seizures have been observed in patients taking tramadol at recommended doses. The risk of seizures may be higher if the tramadol dose exceeds the recommended maximum daily dose (400 mg) or if the patient is simultaneously taking other medicines that lower the seizure threshold (see section "Tramal with other medicines").
Patients should consult their doctor if any of the above situations occur during treatment with Tramal, even if these warnings relate to past medical history.

Tramadol is metabolized in the liver by an enzyme. Some individuals have a variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, the risk of severe adverse effects may be higher.
Treatment should be discontinued and immediate medical advice sought if the patient experiences any of the following adverse effects: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.

Children and adolescents
Use in children with respiratory disorders
The use of tramadol is not recommended in children with respiratory disorders, as symptoms of tramadol toxicity may be more pronounced in this group.

Tramal with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Tramal must not be used together with MAO inhibitors (medicines used to treat depression) or within 14 days after stopping such treatment (see section "When not to use Tramal").
The analgesic effect of Tramal may be reduced and duration of action shortened when used concomitantly with medicines containing:

• carbamazepine (an antiepileptic medicine),
• pentazocine, nalbuphine or buprenorphine (analgesics),
• ondansetron (an antiemetic medicine). Consult your doctor regarding the use of Tramal and its dosage.

The risk of adverse effects increases:

• when Tramal is used together with other analgesics such as morphine and codeine (also as a cough suppressant) or alcohol. Drowsiness or fainting may occur. In such cases, consult your doctor.
• when Tramal is used together with sedatives or hypnotics (e.g. benzodiazepines) or gabapentin or pregabalin used in the treatment of epilepsy or nerve-related pain (neuropathic pain), as this increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and potentially life-threatening outcomes. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Tramal together with sedatives, the doctor should limit the dose and duration of combined treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or family members so they are aware of the symptoms mentioned above. If such symptoms occur, contact your doctor.

• if the patient is taking other medicinal products that may cause seizures, such as certain antidepressants or antipsychotics, including: selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other medicines that lower the seizure threshold (e.g. bupropion, mirtazapine, tetrahydrocannabinol). The risk of seizures may increase if the patient takes Tramal together with these medicines. Consult your doctor whether it is safe to take Tramal while on these medicines.
• if the patient is taking certain antidepressants, Tramal may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• when anticoagulant coumarin derivatives (to reduce blood clotting), e.g. warfarin, are used concomitantly with Tramal. Bleeding may occur due to the effects of these medicines on the blood clotting system.

Ketoconazole (an antifungal medicine) and erythromycin (a bacteriostatic antibiotic) may inhibit the metabolism of tramadol and its active metabolite.

Taking Tramal with food, drink and alcohol
Do not drink alcohol while taking Tramal, as the effect of the medicine may be intensified, potentially leading to respiratory depression.
Food does not affect the action of Tramal.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of tramadol use during pregnancy has not been established. Therefore, Tramal should not be used during pregnancy.
Long-term use of tramadol during pregnancy may lead to withdrawal symptoms in the newborn.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, during breastfeeding, Tramal 100 mg/ml oral drops, solution, should not be taken more than once, or if Tramal 100 mg/ml oral drops, solution, has been taken more than once, breastfeeding should be discontinued.
Human experience with tramadol does not indicate that tramadol affects fertility in women or men.

Driving and using machines
Even at recommended doses, Tramal may cause drowsiness, dizziness and blurred vision, which may affect reaction speed. Therefore, patients should not drive or operate machinery.

Tramal contains sucrose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine may harm teeth if used for a prolonged period (e.g. for 2 weeks or longer).

Tramal contains macrogol glycerol hydroxystearate
The medicine contains macrogol glycerol hydroxystearate, a derivative of castor oil, which may cause stomach irritation and diarrhoea.

Tramal contains propylene glycol (E 1520)
This medicine contains 75 mg of propylene glycol in 0.5 ml of solution.

Tramal contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e. the medicine is considered "sodium-free".

3. How to use Tramal oral solution in a bottle with a dosing pump

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using Tramal, when and for how long you should take it, when you should contact your doctor, and when the medicine should be discontinued (see also section 2).
Tramal 100 mg/ml oral drops, solution is available in a bottle with a dropper or in a bottle with a dosing pump. It is important to note that one press of the dosing pump does not correspond to one drop delivered using the dropper. For further information, please read the instructions provided at the end of this leaflet.
Your doctor will adjust the dose according to the intensity of pain and your individual response to treatment. The lowest effective dose that adequately relieves pain will be used. Do not use more than 32 pump presses per day (e.g. 8 doses of 4 pump presses each) (equivalent to 400 mg of tramadol hydrochloride), unless otherwise advised by your doctor.
Unless otherwise directed by your doctor, the usual dosage is as follows:
Adults and adolescents over 12 years of age
4 to 8 pump presses (equivalent to 50 mg to 100 mg of tramadol hydrochloride) every 4 to 6 hours.
Depending on the intensity of pain, the analgesic effect usually lasts from approximately 4 to 6 hours.
Children
For children over 1 year of age, the usual single dose is 1 mg to 2 mg of tramadol hydrochloride per kilogram of body weight.
The lowest effective dose should be used.
The total daily dose should not exceed 8 mg of tramadol hydrochloride per kilogram of body weight, and must not exceed the maximum daily dose of 400 mg of tramadol hydrochloride.
For children, the bottle with dropper is preferred over the dosing pump, as it allows more precise dose adjustment according to body weight.
Elderly patients
In patients over 75 years of age, tramadol elimination may be delayed. Your doctor may recommend extending the interval between doses for these patients.
Patients with renal impairment, on dialysis, or with hepatic impairment
Tramal should not be taken in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, your doctor may recommend extending the time intervals between doses.
Method of administration
Tramal is for oral use.
The drops should be taken with a small amount of liquid or sugar.
For further information on how to use the drops from the bottle with dosing pump, please read the instructions provided at the end of this leaflet.
Tramal may be taken independently of meals.
Duration of treatment
Do not use Tramal for longer than absolutely necessary. If long-term treatment is required due to the type and severity of the condition, your doctor will regularly monitor your condition (possibly interrupting treatment temporarily, if needed) to determine whether and at what dose Tramal treatment should continue.
If you feel that the effect of Tramal is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Tramal
After taking higher than recommended doses, the following may occur: pinpoint pupils, vomiting, drop in blood pressure, rapid heartbeat, circulatory collapse, disturbances of consciousness up to coma (a state of deep unconsciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, seek immediate medical attention!
Missed dose of Tramal
If you forget to take your dose at the scheduled time, your pain symptoms may return.
Do not take a double dose to make up for a missed dose.
Resume your regular dosing schedule.
Stopping Tramal treatment
If Tramal is stopped suddenly or discontinued prematurely, your pain symptoms are likely to return.
If you wish to stop treatment due to side effects, you should inform your doctor.
Do not stop taking this medicine abruptly without medical advice. If you wish to discontinue Tramal, discuss this with your doctor, especially if the medicine has been taken for a long time.
Your doctor will advise you when and how to stop the medicine; this may involve gradually reducing the dose to minimize the risk of withdrawal symptoms.
Generally, no serious post-treatment symptoms are observed after discontinuation of Tramal.
However, in rare cases, after abrupt discontinuation of Tramal following prolonged use, patients may feel unwell. Symptoms may include restlessness, anxiety, nervousness, tremors, excessive motor activity, difficulty falling asleep, and gastrointestinal or intestinal disturbances.
Very rarely, panic attacks, hallucinations, abnormal sensations such as itching, tingling, numbness, and tinnitus may occur.
Other rare central nervous system disturbances such as confusion, delusions, altered perception of self (depersonalization), altered perception of reality (derealization), and persecutory delusions (paranoia) have been reported very rarely.
If any of the above symptoms occur after stopping the medicine, consult your doctor immediately.
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 everybody will experience them.
You should consult a doctor immediately if symptoms of allergic reactions occur,
such as swollen face, tongue and (or) throat and (or) difficulty swallowing or
urticaria associated with breathing difficulties, hypotension, weakness, fainting,
due to life-threatening anaphylactic shock. Allergic reactions are rare

• occurring in 1 to 10 per 10,000 patients.

The most common adverse reactions reported more frequently than in 1 in 10 people during
treatment with Tramal were nausea and dizziness.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the package leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions
of the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather further information on the safety of the medicinal product.

5. How to store Tramal medicine

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 even death in individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the cardboard packaging and on the label of the bottle. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Package contents and other information
What Tramal 100 mg/ml oral drops, solution contains

• The active substance is tramadol hydrochloride. 1 ml of the medicine contains 100 mg of tramadol hydrochloride (one pump actuation delivers an oral solution containing 12.5 mg of tramadol hydrochloride).
• Other ingredients are: sucrose, potassium sorbitan, glycerol 85%, propylene glycol (E 1520), sodium cyclamate, sodium saccharin, macroglycerol hydroxystearate, partially dementhylated peppermint oil, aniseed flavour, purified water.

What Tramal 100 mg/ml oral drops, solution looks like and contents of the pack
A clear, slightly viscous, colourless to pale yellow solution in a 96 ml amber glass bottle with a dosing pump. Each bottle is contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information regarding this medicine, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Poland
Tel. +48 22 737 79 20

Instructions for preparing Tramal 100 mg/ml oral drops, solution in a bottle with dosing pump for use

Liquid level
Due to variations in glass wall and base thickness, there may be several millimetres difference in liquid level between individual Tramal bottles originally packed.

Use
Before first use, press the dosing pump until the oral solution appears (this is technically necessary to prime the pump mechanism to ensure consistent delivery of the solution).

Place a container (spoon, cup, etc.) under the pump nozzle and press the pump.

One full pump actuation delivers the oral solution equivalent to 5 drops and contains 12.5 mg of tramadol hydrochloride. (For dosing instructions, see section 3 "How to use Tramal in a bottle with dosing pump".)

Tramal 100 mg/ml oral drops, solution is available in a bottle with dropper or in a bottle with dosing pump. Please note that one pump actuation does not correspond to one drop delivered via dropper. For further information, see the table below:

Package leaflet: Information for the patient

Tramal, 100 mg/ml, oral drops, solution, in a bottle with a dropper
Tramadoli hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Tramal is and what it is used for
2. Important information before taking Tramal
3. How to take Tramal in a bottle with a dropper
4. Possible side effects
5. How to store Tramal
6. Contents of the pack and other information

1. What Tramal is and what it is used for

Tramadol – the active substance in Tramal – is an analgesic belonging to the group of
opioids affecting the central nervous system. It exerts its analgesic effect by acting on specific receptors of nerve cells in the spinal cord and brain.
Tramal is indicated for the treatment of moderate to severe pain.

2. Important information before taking Tramal

When not to take Tramal

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute intoxication with alcohol, sedatives, analgesics or psychotropic drugs (drugs affecting mood and emotions);
• if you are taking medicines from the group of MAO inhibitors (certain antidepressants) or within 14 days after discontinuation of such treatment (see "Tramal with other medicines");
• in patients with epilepsy not responding to treatment;
• in the treatment of opioid dependence.

Warnings and precautions
Before starting treatment with Tramal, discuss the following with your doctor:

• if you have dependence on other analgesics (opioids);
• in disorders of consciousness (if you feel faint);
• in shock (cold sweats may be a symptom);
• in increased intracranial pressure (which may occur after head injury or in brain diseases);
• in respiratory disorders;
• in patients with increased sensitivity to opioid drugs;
• in patients with epilepsy or an increased risk of seizures, as this risk may be further increased;
• in patients with liver or kidney disease;
• if you suffer from depression and are taking antidepressants, as some of these may interact with tramadol (see "Tramal with other medicines"). There is a small risk of developing so-called serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol alone. If you experience any symptoms of this serious condition, you should seek medical advice immediately (see section 4 "Possible side effects").

Tolerance, dependence and abuse
This medicine contains tramadol, which is 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 Tramal may also lead to
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 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 Tramal may affect individuals in the following situations:

• you or someone in your family has ever abused or been dependent on alcohol, prescription medicines or illegal drugs (addiction);
• you are a tobacco smoker;
• you have ever had mood problems (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following symptoms while taking Tramal, this may indicate dependence or addiction.
• Need to take the medicine for longer than recommended by your doctor.
• Need to take a higher dose than recommended.
• You take the medicine for reasons other than those for which it was prescribed, e.g. "to calm down" or "to sleep better".
• You have made repeated, unsuccessful attempts to stop or control taking the medicine.
• After stopping the medicine, you feel unwell, and feel better after taking it again ("withdrawal symptoms"). If you notice any of these symptoms, you should consult your doctor to discuss the best treatment for you, including when to stop taking the medicine and how to do so safely (see section 3, "Stopping treatment with Tramal").

Tramal may cause psychological and physical dependence. Long-term use of Tramal may
lead to reduced effectiveness, leading to the need to take increasingly higher doses (development of tolerance). In patients with a tendency to abuse medicines or
dependence, treatment should be short-term and under strict medical supervision.
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.
Sleep-related breathing disorders
Tramal may cause sleep-related breathing disorders, such as sleep apnoea (pauses in
breathing during sleep) and hypoxaemia (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 you or another person observe these
symptoms, contact your doctor. Your doctor may recommend reducing the dose.
Caution is advised in patients with suppressed respiratory centre function,
especially when taking medicines that depress the central nervous system (see "Tramal
with other medicines") or when taking doses higher than recommended (see "Taking
a higher than recommended dose of Tramal" in section 3 and section 4), as respiratory
depression cannot be ruled out in such cases.
Seizures have been observed in patients taking tramadol at recommended doses. The risk
of seizures may be higher if the tramadol dose exceeds the recommended maximum
daily dose (400 mg) or if you are taking other medicines that lower the seizure threshold (see section "Tramal with other medicines").
You should consult your doctor if any of the situations described above occur during treatment with Tramal, even if these warnings refer to past conditions.
Tramadol is metabolised in the liver by an enzyme. Some individuals have a variant of this enzyme, which may have different effects. In some people, pain relief may be
insufficient, while in others, severe adverse effects are more likely.
You should stop taking the medicine and contact your doctor immediately if you experience
any of the following adverse effects: slowed or shallow breathing, confusion, drowsiness,
pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as symptoms
of tramadol toxicity may be more severe in them.
Tramal with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tramal should not be used simultaneously with MAO inhibitors (medicines used to treat
depression) or within 14 days after discontinuation of such treatment; see section "When not to take Tramal".
The analgesic effect of Tramal may be reduced and duration of action shortened when used
concomitantly with medicines containing:

• carbamazepine (an antiepileptic),
• pentazocine, nalbuphine or buprenorphine (analgesics),
• ondansetron (an antiemetic). Consult your doctor regarding the use of Tramal and its dosing.

The risk of adverse effects increases:

• when used concomitantly with other analgesics such as morphine and codeine (also as a cough suppressant) or alcohol. Drowsiness or faintness may occur. In such cases, consult your doctor.
• concomitant use of Tramal with sedatives or hypnotics (e.g. benzodiazepines) or gabapentin or pregabalin in the treatment of epilepsy or nerve-related pain (neuropathic pain) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Tramal

together with sedatives, the dose and duration of combined treatment should be determined by the doctor.
Inform your doctor about all sedatives you are taking and strictly
follow the doctor's dosing instructions. It may be helpful to inform
friends or relatives so they are aware of the above-mentioned symptoms. If such symptoms occur, contact your doctor.

• if you are taking other medicinal products that may cause seizures, such as certain antidepressants or antipsychotics, including: selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other medicines that lower the seizure threshold (such as bupropion, mirtazapine, tetrahydrocannabinol). The risk of seizures may increase if you take Tramal simultaneously with these medicines. Consult your doctor whether you can take Tramal while on these medicines.
• if you are taking certain antidepressants, Tramal may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• when used concomitantly with anticoagulants such as coumarin derivatives (to reduce blood clotting), e.g. warfarin, with Tramal. Bleeding may occur due to the effects of these medicines on the coagulation system.

Ketoconazole (an antifungal) and erythromycin (a bactericidal antibiotic) may inhibit
tramadol metabolism and probably that of its active metabolite.
Taking Tramal with food, drink and alcohol
Do not drink alcohol while taking Tramal, as the effect of the medicine may be intensified,
potentially leading to respiratory depression.
Food does not affect the effect of Tramal.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have
a baby, you should consult your doctor or pharmacist before taking this medicine.
The safety of tramadol use during pregnancy has not been established. Therefore, Tramal should not be used during pregnancy.
Long-term use of tramadol during pregnancy may lead to withdrawal syndrome in the newborn.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, during breastfeeding, Tramal 100 mg/ml, oral drops, solution, should not be taken more than once, or if Tramal 100 mg/ml, oral drops, solution, has been taken more than once, breastfeeding should be discontinued.
Experience with the use of tramadol in humans does not indicate that tramadol affects fertility
in women and men.
Driving and operating machinery
Even at recommended doses, Tramal may cause drowsiness, dizziness and blurred vision,
which may affect reaction speed. Therefore, do not drive or operate any machinery.
Tramal contains sucrose
If you have previously been diagnosed with intolerance to certain sugars, you should
consult your doctor before taking this medicine.
The medicine may harm teeth if used for a long time (e.g. for 2 weeks or longer).
Tramal contains macrogol glycerol hydroxystearate
The medicine contains macrogol glycerol hydroxystearate, a derivative of castor oil, which may
cause gastric irritation and diarrhoea.
Tramal contains propylene glycol (E 1520)
This medicine contains 75 mg of propylene glycol in 0.5 ml of solution.
Tramal contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per ml, meaning the medicine is considered "sodium-free".

3. How to take Tramal in a bottle with a dropper

This medicine should always be taken as directed by your doctor. 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 taking Tramal, when and for how long to take it, when to
contact your doctor and when to discontinue the medicine (see also section 2).
Tramal, 100 mg/ml, oral drops, solution is available in a bottle with a dropper or
in a bottle with a dosing pump. Note that one press of the dosing pump does not correspond to one drop obtained using the dropper. For further information, please read the instructions at the end of this leaflet.
Your doctor will adjust the dose according to the intensity of pain and your individual response to treatment. This will be the lowest effective dose for pain relief. Do not take more than 160 drops per day (e.g. 8 doses of 20 drops) (equivalent to 400 mg of tramadol hydrochloride) except in cases where your doctor advises otherwise.
Unless otherwise advised by your doctor, the usual dosing is as follows:
Adults and adolescents over 12 years of age
20 to 40 drops (equivalent to 50 mg to 100 mg of tramadol hydrochloride) every 4-6 hours.
Depending on the intensity of pain, analgesic effect lasts from approximately 4 to 6 hours.
Children
In children over 1 year of age, the usual single dose is 4 to 8 drops per 10 kg (1 mg-2 mg of tramadol hydrochloride per kilogram of body weight).
For further information on dose adjustment according to body weight, please read the instructions at the end of this leaflet.
Use the lowest effective dose.
Do not exceed a total daily dose of 8 mg of tramadol hydrochloride per kilogram of body weight, not exceeding the maximum dose of 400 mg of tramadol hydrochloride.
In children, use of the bottle with a dropper is recommended over the dosing pump, as it allows for more precise dose adjustment according to body weight.
Elderly patients
In patients over 75 years of age, tramadol elimination may be delayed. In these patients,
your doctor may recommend extending the interval between doses.
Patients with renal impairment, on dialysis or with hepatic impairment
Do not take Tramal in case of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, your doctor may recommend extending the intervals
between doses.
Method of administration
Tramal is taken orally.
The drops should be taken with a small amount of liquid or sugar.
Tramal may be taken regardless of meals.
For further information on using drops from a bottle with a dropper, please read the instructions at the end of this leaflet.
Duration of treatment
Do not take Tramal longer than absolutely necessary. If long-term treatment is required due to the type and severity of the condition, your doctor will regularly monitor your condition (possibly interrupting treatment for a period if necessary)
to determine whether and at what dose treatment with Tramal should continue.
If you feel that the effect of Tramal is too strong or too weak, consult your doctor or pharmacist.
Taking a higher than recommended dose of Tramal
After taking doses higher than recommended, the following may occur: pinpoint pupils,
vomiting, drop in blood pressure, rapid heartbeat, collapse, disturbances of consciousness
up to coma (a state of deep unconsciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, seek medical advice immediately!
Missing a dose of Tramal
If you forget to take the medicine at the appropriate time, pain symptoms may return.
Do not take a double dose to make up for a missed dose.
Return to your usual dosing schedule.
Stopping treatment with Tramal
If you stop or discontinue Tramal abruptly or prematurely, pain symptoms are likely to return.
If you wish to discontinue treatment due to adverse effects, you should inform your doctor.
Do not suddenly stop taking this medicine without medical advice. If you wish to stop
taking the medicine, discuss this with your doctor, especially if the medicine has been taken long-term.
Your doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to
minimise the likelihood of adverse effects (withdrawal symptoms).
Generally, no serious post-treatment symptoms are observed after discontinuation of Tramal.
However, in rare cases, after abrupt discontinuation of Tramal taken for some time, you may feel unwell. Symptoms may include restlessness, anxiety, nervousness, tremors, hyperactivity, difficulty falling asleep and gastrointestinal or intestinal disturbances.
Very rarely: panic attacks, hallucinations, abnormal sensations such as itching, tingling, numbness and tinnitus may occur.
Other rare central nervous system disorders such as confusion, delusions, altered perception of self (depersonalisation), altered perception of reality (derealisation) and persecutory delusions (paranoia) have been reported very rarely.
If any of the above symptoms occur after stopping the medicine, consult your doctor immediately.
If you have any further doubts regarding the use of the medicine, please consult your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should consult your doctor immediately if you experience symptoms of an allergic
reaction such as: swollen face, tongue and/or throat and/or difficulty swallowing or
urticaria combined with breathing difficulties, low blood pressure, weakness, fainting
due to life-threatening anaphylactic shock. Allergic reactions are rare

• occurring in 1 to 10 out of 10,000 patients.

The most commonly reported adverse effects, occurring in more than 1 in 10 people during
treatment with Tramal, were nausea and dizziness.

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
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tramal

Keep the medicine out of the 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 even death in individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the cardboard box and on the label of the bottle. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must 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 Tramal 100 mg/ml oral drops, solution contains

• The active substance is tramadol hydrochloride. 1 ml of the medicinal product contains 100 mg of tramadol hydrochloride (one drop contains 2.5 mg of tramadol hydrochloride).
• Other components are: sucrose, potassium sorbitan, glycerol 85%, propylene glycol (E 1520), sodium cyclamate, sodium saccharinate, macroglycerol hydroxystearate, partially demethylated peppermint oil, anise flavour, purified water.

What Tramal 100 mg/ml oral drops, solution looks like and contents of the pack
A clear, slightly viscous, colourless to pale yellow solution in a 10 ml or 20 ml amber glass bottle with a dropper made of low-density polyethylene (LDPE) and a child-resistant closure made of polypropylene (PP). Each bottle is contained in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicinal product, contact the representative of the marketing authorisation holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Instructions for preparing Tramal in the dropper bottle for use
Packaging
For safety reasons, Tramal oral drop bottles with dropper are manufactured by the manufacturer in sealed packaging.
The cardboard boxes are glued. If the perforation and packaging are intact, the patient can be assured that the package has not been opened.
The dropper bottle has a tamper-evident ring.
Only an intact tamper-evident ring guarantees that the package has not been opened.
If the packaging is damaged, contact your pharmacist.
Fill level
Due to variations in glass wall and base thickness, there may be several millimetres' difference in liquid level between individual originally packaged Tramal bottles.
Use
Bottles containing Tramal have a child-resistant closure.
To open the container, press down firmly on the cap and then unscrew it. After use, close the bottle tightly again.
To dispense drops, turn the bottle upside down and gently tap the bottom with your finger until the first drop appears.
Dosage instructions – see section 3 "How to use Tramal in the dropper bottle".
Tramadol hydrochloride content in individual drops:

Dosage of Tramal in children from 1 year of age
Information on dosage dependence on body weight in children (see also section 3 "How to use Tramal oral drops").