Tramal

Leaflet accompanying the packaging: patient information

Tramal, 50 mg/1 ml, solution for injection

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 that 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tramal and what is it used for
• 2. Important information before using Tramal
• 3. How to use Tramal
• 4. Possible side effects
• 5. How to store Tramal
• 6. Contents of the packaging and other information

1. What is Tramal and what is it used for

Tramadol – the active substance of Tramal – is a pain-relieving substance belonging to the group of opioids affecting the central nervous system. It acts as a pain reliever by affecting specialized nerve cells in the spinal cord and brain. Tramal is used to treat 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 case of acute alcohol poisoning, sleeping pills, painkillers or psychotropic drugs (drugs affecting mood and emotions);
• in the case of concurrent treatment with MAO inhibitor drugs (some antidepressants) and for 14 days after their discontinuation (see "Tramal and other medicines");
• in patients with uncontrolled epilepsy;
• for the treatment of opioid dependence.

Warnings and precautions

You should discuss the initiation of Tramal treatment with your doctor:

• in case of dependence on other pain-relieving substances (opioids);
• in disorders of consciousness (if the patient feels fainting);
• in shock (cold sweats may be a symptom of it);
• 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 is depressed 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 so-called serotonin syndrome. If the patient experiences any symptoms of this severe syndrome, they should immediately consult a doctor (see section 4 "Possible side effects").

Tolerance, dependence, and addiction This medicine contains tramadol, which is an opioid drug. 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 side effects may increase with the dose and longer duration of treatment. Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of its administration. The risk of dependence on Tramal may be higher in people who: have a history of substance abuse (including drug or alcohol addiction); are smokers; have a history of mood problems (depression, anxiety, or personality disorders) or have 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. Need to take the medicine for a longer period 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 repeated, 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 treatment).

Respiratory disorders during sleepTramal 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 also taking drugs that depress the central nervous system (see Tramal and other medicines) or in case of using higher doses than recommended (see "Using a higher dose of Tramal" in section 3 and section 4), as in such cases, respiratory depression cannot be ruled out. Seizures have been observed in patients taking tramadol in 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 taking other drugs that lower the seizure threshold (see "Tramal and other medicines"). Tramal may cause physical and psychological dependence. Long-term use of Tramal may lead to decreased efficacy of the medicine, leading to the need for 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 consult a doctor, who will decide whether the patient needs hormone replacement. You should 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. In some people, there is a certain variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of serious side effects may be higher. You should stop taking the medicine and immediately consult a doctor if you experience any of the following side effects: slow breathing or shallow breathing, feeling confused, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Tramal and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.Tramal should not be used concurrently with MAO inhibitors (drugs used to treat depression) and for 14 days after their discontinuation. The pain-relieving effect of Tramal may be weakened, and the duration of action may be shortened if used concurrently with drugs containing: carbamazepine (an antiepileptic drug), pentazocine, nalbuphine, or buprenorphine (painkillers), ondansetron (an antiemetic). You should consult a doctor about using Tramal and its dosage. The risk of side effects increases: when Tramal is used concurrently with other painkillers like morphine and codeine (also as a cough medicine) and alcohol. Drowsiness or impending fainting may occur. In such cases, you should consult a doctor. when Tramal is used concurrently with sedatives or sleeping pills (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 conditions increases. For this reason, 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 by the doctor. You should inform your doctor about all sedatives you are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, you should contact a doctor. if the patient is 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 drugs that lower the seizure threshold (such as bupropion, mirtazapine, tetrahydrocannabinol). The risk of seizures may increase if Tramal is used concurrently with these medicines. You should consult a doctor about whether you can take Tramal while taking these medicines. if the patient is taking certain antidepressants, Tramal may interact with them and cause serotonin syndrome (see section 4 "Possible side effects"). if the patient is taking anticoagulant drugs, such as warfarin, concurrently with Tramal. Bleeding may occur due to the effect of these drugs on blood clotting.

• if the patient is taking certain antidepressants, Tramal may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• if the patient is taking anticoagulant drugs, such as warfarin, concurrently with Tramal. Bleeding may occur due to the effect of these drugs on blood clotting.

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

Tramal with food, drink, and alcohol

You should not drink alcohol while taking Tramal, as the effect of the medicine may be enhanced, leading to respiratory depression. Food does not affect the effect of Tramal.

Children and adolescents

Use in children with respiratory disorders

Tramadol should not be used in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a 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 the development of withdrawal syndrome in the newborn. Breastfeeding Tramadol is excreted into breast milk. Therefore, during breastfeeding, you should not take Tramal more than once, or if you have taken Tramal more than once, you should stop breastfeeding. Human experience with tramadol does not indicate that it affects fertility in women and men.

Driving and using machines

Tramal may cause drowsiness, dizziness, and blurred vision, which may affect reaction time. If these symptoms occur, you should not drive or operate any machines.

Tramal contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 2 ml, which means the medicine is considered "sodium-free".

3. How to use Tramal

This medicine should always be used as directed by your doctor. If you are unsure, you should consult a doctor or pharmacist. Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Tramal treatment, when and how long to take it, when to contact a doctor, and when to stop the medicine (see also section 2). Your doctor will adjust the dose according to the severity of the pain and the individual response to treatment. This will be the smallest dose that effectively relieves the pain. Usually, a patient is given up to 8 ml of Tramal (equivalent to 400 mg of tramadol hydrochloride) per day. Exceptionally, if clinically justified, your doctor may recommend higher daily doses. If your doctor does not recommend otherwise, the following dosing is usually used: Adults and adolescents over 12 years: Depending on the severity of the pain, usually 1-2 ml of Tramal solution for injection (equivalent to 50-100 mg of tramadol hydrochloride) is used every 4-6 hours. Children over 1 year: Usually, the single dose is 1-2 mg of tramadol hydrochloride per kilogram of body weight. The smallest effective dose should be used. The total daily dose should not exceed 8 mg of tramadol hydrochloride per kilogram of body weight, not exceeding the maximum dose of 400 mg of tramadol hydrochloride. Elderly patients: In patients over 75 years, 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: Tramal should not be used 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: Tramal is administered by slow intravenous injection into a subcutaneous vein, e.g., in the elbow or into a muscle (usually in the buttock) or subcutaneously. It can also be diluted and administered by intravenous infusion. Duration of treatment: 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 you feel that the effect of Tramal is too strong or too weak, you should consult a doctor or pharmacist. Detailed information for healthcare professionals is provided at the end of the leaflet.

Using a higher dose of Tramal

After using higher doses than recommended, the following may occur: pinpoint pupils, vomiting, decreased blood pressure, rapid heartbeat, collapse, disorders of consciousness up to coma, seizures, respiratory depression up to respiratory arrest. In such cases, you should immediately consult a doctor!

Missing a dose of Tramal

If you forget to take the medicine at the right time, the pain symptoms will likely return. You should not take a double dose to make up for the missed dose. You should return to the previous dosing schedule.

Stopping Tramal treatment

If Tramal treatment is stopped suddenly or prematurely, the pain symptoms will likely return. If you want to stop treatment due to side effects, you should inform your doctor. You should not stop taking this medicine abruptly without consulting a doctor. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you have been taking it for a long time. The doctor will advise 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). In general, after stopping Tramal, no serious side effects are observed. However, in rare cases, after sudden discontinuation of Tramal used for a period, the patient may feel unwell. They may experience agitation, anxiety, nervousness, tremors, excessive restlessness, difficulty sleeping, and gastrointestinal or intestinal disorders. Very rarely, the following may occur: panic attacks, hallucinations, abnormal perception of stimuli (e.g., itching, tingling, numbness, and tinnitus). Other unusual central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions, have occurred very rarely. If you experience any of these symptoms after stopping the medicine, you should immediately consult a doctor. If you have any further doubts about using the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

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

These 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): disorders of heart and blood vessel function (rapid heartbeat, decreased blood pressure, fainting), nausea, 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). Asthma exacerbation has been reported during tramadol treatment, although a causal relationship between these facts has not been established. If higher doses than recommended are taken, and other drugs that depress the central nervous system (e.g., sedatives, sleeping pills, other painkillers, alcohol) are used concurrently, respiratory depression may occur. Abnormal perception of stimuli (e.g., itching, tingling, numbness), tremors, seizures, muscle cramps, uncoordinated movements, fainting, speech disorders; Seizures occur mainly after taking high doses of tramadol and when other drugs that may cause seizures are used concurrently. Hallucinations, confusion, sleep disorders, delirium, anxiety, and nightmares. After taking Tramal, psychological 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 medicine may cause dependence. If treatment is stopped suddenly, withdrawal symptoms may occur (see "Stopping Tramal treatment"); Pinpoint pupils, 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. Unknown (frequency cannot be estimated from available data): 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 using Tramal").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tramal

The medicine should be stored out of sight and reach of children. This medicine should be stored in a closed and secure place, inaccessible to others. It can cause serious harm and be fatal to people for whom it has not been prescribed. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. There are no special storage precautions. 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 Tramal contains

• The active substance of Tramal is tramadol hydrochloride. Each 1 ml ampoule of solution for injection contains 50 mg of tramadol hydrochloride. Each 2 ml ampoule of solution for injection contains 100 mg of tramadol hydrochloride.
• The other ingredients are: sodium acetate trihydrate, water for injection.

What Tramal looks like and contents of the pack

Clear, colorless solution in glass ampoules of 1 or 2 ml, packaged in cardboard boxes of 5. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Date of last revision of the leaflet: 05/2024

Information intended for healthcare professionals only:

Instructions for using Tramal ampoules

Tramal is supplied in ampoules for breaking, which have a marked breaking line to facilitate opening: 1) The ampoule should be positioned with the breaking line at the top, 2) The neck of the ampoule should be broken with a downward movement.

• 1) The ampoule should be positioned with the breaking line at the top,
• 2) The neck of the ampoule should be broken with a downward movement.

Incompatibilities

Tramal, 50 mg/1 ml, solution for injection should not be used concurrently with solutions for injection of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam, glyceryl trinitrate.

Use of Tramal in children over 1 year of age (see section 3).

Dose estimation

• 1) Estimation of the total dose of tramadol hydrochloride (mg): body weight (kg) x dose (mg/kg body weight)
• 2) Estimation of the volume (ml) of the diluted solution to be administered: the total dose (mg) should be divided by the appropriate concentration of the diluted solution (mg/ml; see the table below).

Table:Dilution of Tramal, 50 mg/1 ml, solution for injection

According to the calculations, the contents of the Tramal ampoule should be diluted by adding the appropriate diluent, mixed, and the calculated volume of the diluted solution administered. Unused portions of the solution should be discarded.

Example

If the doctor recommends a dose of 1.5 mg of tramadol hydrochloride per kilogram of body weight for a child weighing 27 kg, the total required dose is 27 kg x 1.5 mg/kg = 40.5 mg of tramadol hydrochloride. The appropriate concentration of the diluted solution is 10.0 mg/ml, which corresponds to approximately 4 ml (40.5 mg/10 mg/ml = 4.05 ml) of the diluted solution. According to the above, to obtain a solution with a concentration of 10.0 mg/ml, 1 ml of Tramal, 50 mg/1 ml solution for injection (1 ampoule of 1 ml solution containing 50 mg) should be added to 4 ml of 0.9% NaCl or 5% glucose solution. 4 ml of the diluted solution containing 40 mg of tramadol hydrochloride should be administered.