Tramal

Leaflet attached to the packaging: patient information

Tramal, 50 mg, hard capsules

Tramadol hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• 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 Tramal is and what it is used for
• 2. Important information before taking Tramal
• 3. How to take Tramal
• 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 of Tramal, is a pain-relieving substance belonging to the group of opioids that affect the central nervous system.
It has a pain-relieving 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 the patient is allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute intoxication with alcohol, sleeping pills, painkillers, or psychotropic drugs (mood and emotion-affecting drugs);
• in the case of concurrent treatment with MAO inhibitors (certain 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

Before starting treatment with Tramal, consult 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);
• 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 reduced efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramal may 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 varies from person to person. 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 or non-prescription 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.
• The need to take the medicine for a longer period than recommended by the doctor.
• The need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those for which it was prescribed, such as "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).

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 also taking medicines that depress the activity of the central nervous system (see Tramal and other medicines) or in case of taking higher doses than recommended (see "Taking 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 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 physical and psychological dependence. Long-term use of Tramal may lead to reduced 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 consult a doctor, who will decide whether the patient needs hormone replacement.

The patient should consult a doctor if they experience any of the above situations while taking Tramal, even if these warnings refer to situations that have 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, serious side effects are more likely to occur. The patient should stop taking the medicine and immediately consult a doctor if they experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Tramal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tramal should not be used concurrently with MAO inhibitors (medicines 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 shortened if the patient is taking medicines containing:

• carbamazepine (an antiepileptic drug),
• pentazocine, nalbuphine, or buprenorphine (painkillers),
• ondansetron (an antiemetic drug). The patient should consult their doctor about taking Tramal and its dosage.

The risk of side effects increases:

• when Tramal is taken concurrently with other painkillers, such as morphine and codeine (also as a cough medicine), and alcohol. Drowsiness or fainting may occur. In such cases, the patient should consult their doctor.
• when Tramal is taken concurrently with sedatives or sleeping pills (e.g., benzodiazepines) or gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain (nerve pain). This increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concurrent use should only be considered if other treatment options are not possible. However, if the doctor prescribes Tramal with sedatives, the dose and treatment duration should be limited by the doctor. The patient should inform their doctor about all sedatives they 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, the patient should contact their doctor.

• if the patient is taking other medicines that may cause seizures, such as certain antidepressants or antipsychotic drugs, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotic drugs, and other medicines that lower the seizure threshold (such as bupropion, mirtazapine, tetrahydrocannabinol). The risk of seizures may increase if the patient takes Tramal concurrently with these medicines. The patient should consult their doctor about whether they 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").
• in case of concurrent use of blood-thinning medicines, such as warfarin, with Tramal. Bleeding may occur due to the effect of these medicines on blood clotting. Ketoconazole (an antifungal drug) and erythromycin (an antibacterial drug) 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 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The safety of tramadol during pregnancy has not been established. Therefore, Tramal should not be used during pregnancy.
Long-term administration 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, Tramal should not be taken more than once, or if Tramal has been taken more than once, breastfeeding should be stopped.
Experience with tramadol in humans 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.
Therefore, the patient should not drive vehicles or operate any machines.
This medicinal product contains less than 1 mmol of sodium (23 mg) per capsule, which is considered "sodium-free".

3. How to take Tramal

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramal, when and for how long to take it, when to contact the doctor, and when to stop taking the medicine (see also section 2).
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.
Do not take more than 400 mg of tramadol hydrochloride per day, unless the doctor recommends otherwise.
Unless the doctor recommends otherwise, the following dosing is usually used:
Adults and adolescents over 12 years of age:
1-2 capsules (i.e., 50-100 mg of tramadol hydrochloride).
The pain-relieving effect lasts for about 4 to 8 hours, depending on the severity of the pain.
Children:
Tramal is not recommended for children under 12 years of age due to the high amount of tramadol in a single dose. The recommended form for this age group is oral drops, solution.
Elderly patients:
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, dialysis patients
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:
Tramal is taken orally.
The capsule should always be taken with a sufficient amount of liquid, and it should not be divided or chewed.
Tramal can be taken with or without food.
Duration of treatment:
Do not take Tramal for longer than necessary. In case of prolonged treatment due to the type and severity of the disease, the doctor will regularly monitor the patient's condition (interrupting treatment for a while 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.

Taking a higher dose of Tramal

After taking higher doses than recommended, the following may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, impaired consciousness up to coma (a state of deep loss of consciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, the patient should immediately consult a doctor!

Missing a dose of Tramal

If the patient forgets to take the medicine at the right time, the pain symptoms will likely return.
Do not take a double dose to make up for the missed dose.
Return to the dosing schedule as established.

Stopping Tramal

If the patient suddenly stops taking Tramal or stops taking it too early, the pain symptoms will likely return.
If the patient wants to stop treatment due to side effects, they should inform their doctor.
Do not suddenly stop taking Tramal without the doctor's recommendation. If the patient wants to stop taking the medicine, 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 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 some time, the patient may feel unwell. Agitation, anxiety, nervousness, tremors, excessive restlessness, difficulty sleeping, and gastrointestinal or intestinal disorders may occur.
Very rarely, panic attacks, hallucinations, abnormal perception of stimuli (such as itching, tingling, numbness), and ringing in the ears may occur.
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), have occurred very rarely.
If the patient experiences any of the above symptoms after stopping the medicine, they should immediately consult a doctor.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, 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:

swollen face, tongue, and/or throat, and/or difficulty swallowing or hives accompanied by difficulty breathing, low blood pressure, weakness, fainting due to life-threatening anaphylactic shock. Allergic reactions are rare - they occur in 1 to 10 out of 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
(occurs in more than 1 in 10 people):
dizziness,
nausea.
Common
(occurs in 1 to 10 out of 100 people):
headache, drowsiness,
vomiting, constipation, dry mouth,
excessive sweating,
fatigue.
Uncommon
(occurs 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 collapse).
Such 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
(occurs in 1 to 10 out of 10,000 people):
slow heartbeat,
increased blood pressure,
changes in appetite,
slow breathing, "short breath" (shortness of breath).
It has been reported that asthma worsened during treatment with tramadol, although a causal relationship between these facts has not been established. In case of taking doses significantly higher than recommended, and concurrent use of other medicines that depress the activity of the central nervous system (e.g., sedatives, sleeping pills, other painkillers, alcohol), respiratory depression may occur.
Abnormal perception of stimuli (e.g., itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after taking high doses of tramadol or in case of concurrent use of other medicines that may cause seizures;
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.
In case of sudden discontinuation of treatment, withdrawal symptoms may occur (see "Stopping Tramal");
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
(occurs 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., excitement, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and (or) 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 any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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.
By reporting side effects, more information can be collected 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 can cause serious harm and be fatal to people it has not been prescribed for.
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.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Tramal contains

• The active substance of Tramal is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other ingredients of the medicine are: microcrystalline cellulose, sodium carboxymethylcellulose, colloidal silica, magnesium stearate, yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate. Unknown (frequency cannot be estimated from the available data):

What Tramal looks like and contents of the pack

Yellow, shiny, elongated capsules packaged in blisters and available in packs of 20.

Marketing authorization holder and manufacturer:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Date of last revision of the leaflet: 05/2024