Tramal

Package Leaflet: Information for the Patient

Tramal, 100 mg/ml, Oral Drops, Solution in a Bottle with a Dropper

Tramadol Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What is Tramal and what is it 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 is Tramal and what is it used for

Tramadol, the active substance of Tramal, is a pain-relieving medicine belonging to the group of opioids that act on the central nervous system. It works by affecting specific receptors in the spinal cord and brain.

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, pain relievers, or psychotropic drugs (drugs that affect mood and emotions);
• in case of concurrent treatment with MAO inhibitors (certain antidepressants) and within 14 days of their discontinuation (see "Tramal and other medicines");
• in patients with uncontrolled epilepsy;
• for the treatment of opioid dependence.

Warnings and precautions

Before taking Tramal, consult your doctor:

• in case of dependence on other pain-relieving substances (opioids);
• in case of impaired consciousness (if the patient feels faint);
• in case of shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (may occur after head injury or brain diseases);
• in case of respiratory disorders;
• in patients with increased sensitivity to opioid drugs;
• in patients with epilepsy or increased risk of seizures, as this risk is further increased;
• in patients with liver or kidney disease;
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Tramal and other medicines"). After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. 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 addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can lead to decreased efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramal can also lead to dependence, abuse, and addiction, which can cause life-threatening overdose. The risk of these adverse effects may increase with the dose and duration of treatment.

Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of taking it.

The risk of dependence or addiction is different for different people. A 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 drugs, or illegal drugs ("addiction");
• the patient is a 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 following symptoms while taking Tramal, it may indicate dependence or addiction.
• Necessity to take the medicine for a longer period than recommended by the doctor.
• Necessity to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those for which it was prescribed, for example, "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, and after taking it again, they feel better ("withdrawal effects"). If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment option, including deciding when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramal).

Respiratory disorders during sleep

Tramal may cause respiratory disorders during sleep, 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 the patient or another person observes these symptoms, they should contact a doctor. The doctor may recommend reducing the dose.

Caution should be exercised in patients with impaired respiratory function, who are concurrently taking medicines that depress the central nervous system (see "Tramal and other medicines"), or in case of doses higher than recommended (see "Taking a higher dose than recommended" in section 3 and section 4), as it cannot be ruled out that respiratory depression may occur.

Seizures have been observed in patients taking tramadol in recommended doses. The risk of seizures may be higher if the dose of tramadol exceeds the recommended maximum daily dose (400 mg) or if the patient is taking other medicines that lower the seizure threshold (see "Tramal and other medicines").

Tramal may cause psychological and physical dependence. Long-term use of Tramal may lead to decreased efficacy of the medicine, resulting in the need to take increasingly higher doses (development of tolerance). In case of a tendency to abuse medicines or addiction, treatment should be short-term and under close medical supervision.

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 a doctor, who will decide whether hormone replacement is necessary.

Consult a doctor if you experience any of the above situations while taking Tramal, even if these warnings refer to situations that occurred in the past.

Tramadol is metabolized in the liver by an enzyme. Some people have a certain variation of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, while in others, it is more likely to experience severe side effects.

Stop taking the medicine and immediately consult a doctor if you experience any of the following side effects: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Tramal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Do not take Tramal with MAO inhibitors (medicines used to treat depression) or within 14 days of their discontinuation.

The pain-relieving effect of Tramal may be weakened, and the duration of action may be shortened if taken with medicines containing:

• carbamazepine (an antiepileptic medicine),
• pentazocine, nalbuphine, or buprenorphine (pain-relieving medicines),
• ondansetron (an antiemetic medicine). Consult a doctor about taking Tramal and its dosage.

The risk of side effects increases:

• when taking Tramal with other pain-relieving medicines, such as morphine and codeine (also as a cough medicine), and alcohol. Drowsiness or fainting may occur. In such cases, consult a doctor.
• when taking Tramal and sedatives or sleeping medicines (e.g., benzodiazepines) or gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain (nerve pain). The risk of drowsiness, breathing difficulties (respiratory depression), coma, and life-threatening effects increases. Therefore, concurrent use should only be considered when other treatment options are not possible. However, if a doctor prescribes Tramal with sedatives, the dose and treatment duration should be limited. Inform your doctor about all sedatives you are taking and strictly follow their dosage recommendations. It may be helpful to inform friends or relatives to be aware of these symptoms. If such symptoms occur, contact a doctor.
• if you are taking other medicines that may cause seizures, such as certain antidepressants or antipsychotics, including: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine 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 with these medicines. Consult a doctor about taking Tramal.

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

Tramal with food, drink, and alcohol

Do not drink alcohol while taking Tramal, as the effect of the medicine may be enhanced, leading to respiratory depression.

Food does not affect the efficacy of Tramal.

Children and adolescents

Use in children with respiratory disorders

Tramadol is not recommended for use in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.

The safety of tramadol during pregnancy has not been established. Therefore, Tramal should not be taken during pregnancy.

Long-term use of tramadol during pregnancy may lead to the development of a withdrawal syndrome in the newborn.

Breastfeeding

Tramadol is excreted into breast milk. Therefore, during breastfeeding, do not take Tramal 100 mg/ml, oral drops, solution, more than once, or if you have taken it more than once, stop breastfeeding.

Human experience with tramadol does not indicate that it affects fertility in men and women.

Driving and using machines

Tramal may cause drowsiness, dizziness, and blurred vision, which may affect reaction time. Therefore, do not drive vehicles or operate machines.

Tramal contains sucrose and macrogol hydroxy stearate

Before taking the medicine, consult a doctor if you have previously been diagnosed with intolerance to certain sugars, as Tramal oral drops contain sucrose. This may have a harmful effect on teeth if the medicine is taken for a long time (e.g., for 2 weeks or longer).

Tramal contains macrogol hydroxy stearate, a derivative of castor oil, which may cause stomach upset and diarrhea.

This medicinal product contains 150 mg of propylene glycol per ml.

This medicinal product contains less than 1 mmol of sodium (23 mg) per ml, which is considered "sodium-free".

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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect when taking Tramal, when and how long to take it, when to contact a doctor, and when to stop 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 with the dropper. For further information, read the instructions at the end of this leaflet.

Your doctor will adjust the dose according to the severity of the pain and your individual response to treatment. This will be the smallest dose that effectively relieves the pain. Do not take more than 160 drops per day (e.g., 8 doses of 20 drops) (equivalent to 400 mg of tramadol hydrochloride) unless your doctor recommends otherwise.

Unless your doctor recommends otherwise, the following dosing is usually used:

Adults and adolescents over 12 years:

20 to 40 drops (equivalent to 50-100 mg of tramadol hydrochloride).

The pain-relieving effect lasts for about 4 to 6 hours, depending on the severity of the pain.

Children:

For children over 1 year of age, the usual dose is 4 to 8 drops per 10 kg (1-2 mg of tramadol hydrochloride per kilogram of body weight).

For further information on dosage based on body weight, read the instructions at the end of this leaflet.

Use the smallest effective dose.

Do not take a total daily dose greater than 8 mg of tramadol hydrochloride per kilogram of body weight, up to a maximum of 400 mg of tramadol hydrochloride.

For children, it is recommended to use a bottle with a dropper rather than a dosing pump, as it allows for more accurate dosing based on body weight.

Elderly:

In patients over 75 years of age, the elimination of tramadol may be delayed. In these patients, the doctor may recommend prolonging the time interval between doses.

Patients with renal or hepatic impairment:

Do not take Tramal in case of severe hepatic or renal impairment.

In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.

Method of administration:

Take Tramal orally.

Take the drops with a small amount of liquid or sugar.

Tramal can be taken with or without food.

For further information on taking the drops from a bottle with a dropper, read the instructions at the end of this leaflet.

Duration of treatment:

Do not take Tramal for longer than necessary. If long-term treatment is necessary due to the type and severity of the disease, the doctor will regularly monitor the patient's condition (interrupting treatment for a period if necessary) to determine whether treatment with Tramal should be continued.

If you feel that the effect of Tramal is too strong or too weak, talk to your doctor or pharmacist.

Taking a higher dose than recommended

After taking higher doses than recommended, the following may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, fainting, impaired consciousness up to coma, seizures, and respiratory depression up to respiratory arrest.

In such cases, immediately consult a doctor!

Missing a dose

If you forget to take a dose at the right time, the pain symptoms will likely return.

Do not take a double dose to make up for a missed dose.

Return to the previous dosing schedule.

Stopping Tramal

If you suddenly stop taking Tramal or stop treatment too early, the pain symptoms will likely return.

If you want to stop treatment due to side effects, inform your doctor.

Do not suddenly stop taking this medicine without your doctor's advice. If you want to stop taking the medicine, discuss it with your doctor, especially if you have been taking it for a long time. The 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).

Generally, after stopping Tramal, no serious side effects are observed. However, in rare cases, after sudden discontinuation of Tramal taken for a period, the patient may feel unwell. This may include restlessness, anxiety, nervousness, tremors, insomnia, and gastrointestinal disorders.

Very rarely, the following may occur: panic attacks, hallucinations, abnormal perception of stimuli (such as itching, tingling, numbness, and ringing in the ears), and other unusual central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions.

If you experience any of these symptoms after stopping the medicine, immediately consult a doctor.

If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramal can cause side effects, although not everybody gets them.

Immediately consult a doctor if you experience symptoms of an allergic reaction, such as a swollen face, tongue, and/or throat, and/or difficulty swallowing or hives accompanied by difficulty breathing, low blood pressure, weakness, or fainting due to a life-threatening anaphylactic shock.

These allergic reactions are rare (occurring in 1 to 10 per 10,000 patients).

The most common side effects reported in more than 1 in 10 people during treatment with Tramal were nausea and dizziness.

Very common (occurring in more than 1 in 10 people):

dizziness,

nausea.

Common (occurring in 1 to 10 per 100 people):

headache, drowsiness,

vomiting, constipation, dry mouth,

excessive sweating,

fatigue.

Uncommon (occurring in 1 to 10 per 1,000 people):

heart and blood vessel disorders (palpitations, rapid heartbeat, feeling of weakness due to decreased blood pressure when changing position from lying to standing, and fainting). These side effects may occur, especially when tramadol is administered intravenously, and in patients who have exercised.

Vomiting, stomach and intestinal upset (feeling of pressure in the stomach, bloating), diarrhea,

skin reactions (such as itching, rash, hives).

Rare (occurring in 1 to 10 per 10,000 people):

slow heartbeat,

high blood pressure,

changes in appetite,

slow breathing, "shortness of breath" (dyspnea).

It has been reported that tramadol may exacerbate asthma. However, a causal relationship between these facts has not been established. In case of doses significantly higher than recommended, and concurrent use of other medicines that depress the central nervous system (such as sedatives, sleeping medicines, other pain relievers, or alcohol), respiratory depression may occur.

Abnormal sensations (such as itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders;

Seizures occur mainly after taking high doses of tramadol and in case of concurrent use of other medicines that may cause seizures;

Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares. After taking Tramal, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). These may include mood changes (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), and decreased sensory and cognitive perception (changes in feelings and recognition, which may lead to incorrect assessment of the situation);

The medicine may cause dependence.

After stopping treatment, withdrawal symptoms may occur (see "Stopping Tramal");

Pupil constriction (miosis), blurred vision, excessive pupil dilation (mydriasis),

muscle weakness;

urination disorders or pain when urinating, decreased urine output (urinary retention);

allergic reactions (such as difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure);

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

increased liver enzyme activity.

low blood sugar, hiccups, serotonin syndrome, whose symptoms may include changes in mental status (such as agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and gastrointestinal symptoms (such as nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramal").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via their website or by phone. Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramal

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

Store the medicine in a closed and secure place, inaccessible to others. It may cause serious harm and be life-threatening to people for whom it has not been prescribed.

Do not take this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What is in Tramal, 100 mg/ml, oral drops, solution

• The active substance of Tramal is tramadol hydrochloride. 1 ml of the medicine contains 100 mg of tramadol hydrochloride (one drop contains 2.5 mg of tramadol hydrochloride).
• The other ingredients of the medicine are: sucrose 0.2 g/ml, potassium sorbate, glycerol 85%, propylene glycol, sodium cyclamate, sodium saccharin, macrogol hydroxy stearate, peppermint oil, partially demetholized, aniseed flavor, purified water.

What Tramal, 100 mg/ml, oral drops, solution looks like and contents of the pack

Tramal, 100 mg/ml, oral drops, solution is a clear, slightly viscous, colorless to pale yellow solution, packaged in orange glass bottles of 10 ml or 20 ml with a dropper made of low-density polyethylene (LDPE) and a child-resistant cap made of polypropylene (PP). Each bottle is placed in a carton.

Marketing authorization holder and manufacturer:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of last revision of the leaflet: 05/2024

Instructions for preparing Tramal in a bottle with a dropper for use

Packaging

For safety reasons, bottles with droppers of Tramal oral drops are produced by the manufacturer in tamper-evident packaging.

The cartons are glued. If the perforation and packaging are intact, the patient is assured that the packaging has not been opened.

The bottle with a dropper has a protective ring.

Only an intact protective ring guarantees that the packaging has not been opened.

If the packaging is damaged, contact a pharmacist.

Fill level

Due to differences in the thickness of the glass walls and bottoms of the bottles, there may be a few millimeter differences in the fill levels between originally packaged individual bottles of Tramal.

Use

Bottles containing Tramal have a child-resistant cap.

To open the packaging, press the cap firmly and then unscrew it. After use, screw the cap back on tightly.

To dispense drops, turn the bottle upside down and gently tap the bottom with your finger until the first drop appears.

For dosing instructions, see section 3 "How to take Tramal in a bottle with a dropper".

Tramadol hydrochloride content in individual drops:

Dosing of Tramal in children from 1 year of age

Information on dosing based on body weight in children (see also section 3 "How to take Tramal in a bottle with a dropper").

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

This medication should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Tramal, when and how long to take it, when to contact the doctor, and when to stop the medication (see also section 2).
Tramal, 100 mg/ml, oral drops, solution, is available in a bottle with a dropper or a bottle with a dosing pump. The patient should note that one press of the dosing pump does not correspond to one drop obtained with the dropper. For further information, the patient should read the instructions at the end of this leaflet.
The doctor will adjust the dose according to the severity of the pain and the patient's individual response to treatment. This will be the smallest dose that effectively relieves the pain. The patient should not take more than 32 presses of the dosing pump per day (e.g., 8 doses of 4 presses) (equivalent to 400 mg of tramadol hydrochloride) unless the doctor recommends otherwise.
Unless the doctor recommends otherwise, the usual dosage is:
Adults and adolescents over 12 years old:
4 to 8 presses of the dosing pump (equivalent to 50-100 mg of tramadol hydrochloride).
Depending on the severity of the pain, the analgesic effect lasts for approximately 4 to 6 hours.
Children:
For children over 1 year old, the usual single dose is 1-2 mg of tramadol hydrochloride per kilogram of body weight.
The patient should use the smallest effective dose.
The total daily dose should not exceed 8 mg of tramadol hydrochloride per kilogram of body weight, up to a maximum of 400 mg of tramadol hydrochloride.
For children, it is recommended to use a bottle with a dropper rather than a dosing pump, as this allows for more accurate dosing according to body weight.
Elderly patients:
In patients over 75 years old, the elimination of tramadol may be delayed. The doctor may recommend extending the time interval between doses in these patients.
Patients with renal or hepatic impairment:
Tramal should not be taken in cases of severe hepatic or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend extending the time interval between doses.
Method of administration:
Tramal is taken orally.
The drops should be taken with a small amount of liquid or sugar.
For further information on using the drops with the dosing pump, the patient should read the instructions at the end of this leaflet.
Tramal can be taken with or without food.
Duration of use:
Tramal should not be used for longer than necessary. If long-term treatment is necessary due to the type and severity of the disease, the doctor will regularly monitor the patient's condition (interrupting treatment for a period if necessary) to determine whether and at what dose Tramal treatment should be continued.
If the patient feels that the effect of Tramal is too strong or too weak, they should consult their doctor or pharmacist.

Using a higher dose of Tramal than recommended

After using higher doses than recommended, the following may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, fainting, impaired consciousness up to coma, seizures, respiratory depression up to respiratory arrest.
In such cases, the patient should immediately consult their doctor!

Missing a dose of Tramal

If the patient forgets to take the medication at the right time, the pain symptoms will likely return.
The patient should not take a double dose to make up for the missed dose.
The patient should return to the previous dosing schedule.

Stopping Tramal treatment

If Tramal treatment is suddenly stopped or ended prematurely, the pain symptoms will likely return.
If the patient wants to stop treatment due to side effects, they should inform their doctor.
The patient should not suddenly stop taking Tramal without consulting their doctor. If the patient wants to stop taking Tramal, they should discuss it with their doctor, especially if they have been taking it for a long time.
The doctor will advise on when and how to stop taking Tramal; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms).
Generally, after stopping Tramal, no serious side effects are observed.
However, in rare cases, after sudden withdrawal of Tramal that has been used for some time, the patient may feel unwell. They may experience restlessness, anxiety, nervousness, tremors, excessive movement, difficulty sleeping, and gastrointestinal or intestinal disorders.
Very rarely, panic attacks, hallucinations, abnormal perception of stimuli (such as itching, tingling, numbness, and ringing in the ears), and other unusual central nervous system disorders, such as confusion, delusions, changes in self-perception (depersonalization), changes in perception of reality (derealization), and persecutory delusions (paranoia), may occur.
If the patient experiences any of these symptoms after stopping Tramal, they should immediately consult their doctor.
If the patient has any further doubts about using Tramal, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Tramal can cause side effects, although not everybody gets them.

The patient should immediately consult their doctor if they experience symptoms of an allergic reaction, such as a swollen face, tongue, and/or throat, and/or difficulty swallowing or hives, accompanied by difficulty breathing, low blood pressure, weakness, and fainting, which can be life-threatening due to anaphylactic shock. Allergic reactions are rare

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

The most common side effects reported in more than 1 in 10 people during Tramal treatment were nausea and dizziness.
Very common
(occurring in more than 1 in 10 people):
dizziness,
nausea.
Common
(occurring in 1 to 10 out of 100 people):
headaches, drowsiness,
vomiting, constipation, dry mouth,
excessive sweating,
fatigue.
Uncommon
(occurring in 1 to 10 out of 1,000 people):
heart and circulatory disorders (palpitations, rapid heartbeat, feeling of weakness due to decreased blood pressure in patients changing body position from lying to standing, and fainting). These side effects may occur especially during intravenous administration of tramadol and in patients after physical exertion.
Vomiting, stomach and intestinal irritation (feeling of pressure in the stomach, bloating), diarrhea,
skin reactions (e.g., itching, rash, hives).
Rare
(occurring in 1 to 10 out of 10,000 people):
slow heartbeat,
increased blood pressure,
changes in appetite,
slow breathing, "shortness of breath" (dyspnea).
There have been reports of worsening asthma during tramadol treatment, although a causal relationship has not been established.
In the event of taking significantly higher doses than recommended, and simultaneous use of other medications that inhibit the central nervous system (e.g., sedatives, sleep aids, other pain medications, alcohol), respiratory depression may occur.
Abnormal sensations (e.g., itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after taking high doses of tramadol and when used simultaneously with other medications that may cause seizures;
Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares. After taking Tramal, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). These may include mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), and decreased sensory and cognitive perception (changes in feelings and recognition, which may lead to incorrect assessment of the situation).
The medication may cause dependence.
Upon sudden cessation of treatment, withdrawal symptoms may occur (see "Stopping Tramal treatment");
Pupil constriction (miosis), blurred vision, excessive pupil dilation (mydriasis),
muscle weakness;
difficulty or pain when urinating, decreased urine output (urinary retention);
allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure);
Very rare
(occurring in less than 1 in 10,000 people):
increased liver enzyme activity.
low blood sugar, hiccups, serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramal").

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 medication.

5. How to store Tramal

The medication should be stored out of sight and reach of children.
The medication should be stored in a closed and secure location, inaccessible to others. It can cause serious harm and be fatal to individuals for whom it was not prescribed.
The patient should not use this medication after the expiration date stated on the carton and label.
There are no special storage precautions.
Unknown (frequency cannot be estimated from available data):
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What does Tramal, 100 mg/ml, oral drops, solution, contain

• The active substance of Tramal is tramadol hydrochloride. 1 ml of the medication contains 100 mg of tramadol hydrochloride (one press of the dosing pump releases an oral solution containing 12.5 mg of tramadol hydrochloride).
• The other ingredients are: sucrose 0.2 g/ml, potassium sorbate, glycerol 85%, propylene glycol, sodium cyclamate, sodium saccharin, macrogol hydroxystearate, peppermint oil partially demetholized, aniseed flavor, purified water.

What Tramal, 100 mg/ml, oral drops, solution, looks like and contents of the pack

Tramal, 100 mg/ml, oral drops, solution, is a clear, slightly viscous, colorless to pale yellow solution, packaged in orange glass bottles with a dosing pump, 96 ml. Each bottle is placed in a carton box.

Marketing authorization holder and manufacturer:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Date of last revision of the leaflet: 05/2024

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

Fill level

Due to differences in glass wall and bottom thickness, there may be a few millimeter differences in fill levels between originally packaged bottles of Tramal.

Use

Before using the dosing pump for the first time, it should be pressed until the oral solution appears (this is necessary for technical reasons to activate the mechanism that allows regular amounts of solution to be dispensed).

Place a container (spoon, cup, etc.) under the pump opening and press the pump.
One full press of the pump releases an oral solution that corresponds 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 a dosing pump").
Tramal, 100 mg/ml, oral drops, solution, is available in a bottle with a dropper or a bottle with a dosing pump. The patient should note that one press of the dosing pump does not correspond to one drop obtained with the dropper. For further information, the patient should read the instructions at the end of this leaflet.

The following table provides further information: