Tramal

Leaflet attached to the packaging: patient information

Tramal, 100 mg, suppositories

Tramadol hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• 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 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 affect the central nervous system.
It has a pain-relieving effect by acting on specific receptors in the spinal cord and brain cells.
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 case of acute alcohol poisoning, 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 a doctor:

• in case of dependence on other pain-relieving substances (opioids);
• in case of consciousness disorders (if the patient feels fainting);
• 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").

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 central nervous system (see Tramal and other medicines) or when 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 excluded.
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 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 a decrease in its effectiveness, 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 therapy.
The patient should consult a doctor if they experience any of the above situations while using 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 variation 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. The patient should stop using 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 its duration of action shortened when used concurrently with medicines containing:

• carbamazepine (an antiepileptic medicine),
• pentazocine, nalbuphine, or buprenorphine (pain-relieving medicines),
• ondansetron (an antiemetic medicine). The patient should consult a doctor about using Tramal and its dosage.

The risk of side effects increases:

• when Tramal is used concurrently 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, the patient should consult a doctor.
• concurrent use of Tramal and sedative or sleeping medicines (e.g., benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concurrent use should only be considered when other treatment options are not possible. However, if a doctor prescribes Tramal with sedative medicines, the dose and treatment duration should be limited by the doctor. The patient should inform their doctor about all sedative medicines 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 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-norepinephrine 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 concurrently with these medicines. The patient should consult a 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").
• when Tramal is used concurrently with anticoagulant medicines, such as warfarin. Bleeding may occur due to the effect of these medicines on blood clotting. Ketoconazole (an antifungal medicine) and erythromycin (an antibacterial antibiotic) may inhibit tramadol metabolism and its active metabolite.

Tramal with food, drink, and alcohol

The patient should not drink alcohol while using 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 is not recommended for children with respiratory disorders, as the symptoms of tramadol toxicity may be more severe 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 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, the patient should not take Tramal more than once, or if Tramal has been taken more than once, breastfeeding should be discontinued.
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. Therefore, the patient should not drive vehicles or operate any machines.

3. How to use Tramal

This medicine should always be used as directed by a doctor. In case of doubts, the patient should consult a doctor or pharmacist.
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 use more than 4 suppositories per day (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:

One 100 mg suppository (equivalent to 100 mg of tramadol hydrochloride) every 4 to 6 hours.

Children:

Tramal is not recommended for children under 12 years due to the high amount of tramadol in a single dose. The recommended form for this age group is oral drops, solution.

Elderly:

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

Patients with renal or hepatic impairment

The patient should 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:

The suppository should be inserted into the rectum, preferably after bowel movements. To facilitate this, the suppository can be warmed in the hand immediately before application.

Duration of treatment:

Tramal should not be used for longer than necessary. In case of necessity for long-term treatment due to the type and severity of the disease, the doctor will regularly monitor the patient's condition (interrupting the administration of the medicine for a certain period if necessary) to determine whether and at what dose the treatment with Tramal should be continued.

If the patient feels that the effect of Tramal is too strong or too weak, they should consult a doctor or pharmacist.

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, 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.
The patient should not take a double dose to make up for the missed dose.
The patient should return to the dosing schedule as established.

Stopping Tramal treatment

In case of sudden interruption or premature termination of Tramal treatment, 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 using this medicine without their doctor's recommendation. If the patient wants to stop using the medicine, they should discuss it with their doctor, especially if they have been taking it for a long time. The doctor will advise when and how to stop using 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 used for some time, 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, such as itching, tingling, numbness, and tinnitus.
Other atypical central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions, have occurred very rarely.
If the patient experiences any of the above symptoms after stopping the medicine, they should immediately consult a doctor.
In case of any further doubts about using the medicine, the patient should consult a 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 a 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.

Anaphylactic reactions are rare - occurring in 1 to 10 out of 10,000 patients.
The most common side effects reported more frequently 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):
headache, drowsiness,
vomiting, constipation, dry mouth,
excessive sweating,
fatigue.
Uncommon
(occurring in 1 to 10 out of 1,000 people):
heart and blood vessel 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-containing pharmaceutical forms and in patients after physical exertion.
Vomiting reflex, 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, "short breath" (shortness of breath).
It has been reported that asthma worsened during tramadol treatment, although a causal relationship between these facts has not been established. If the patient takes doses significantly higher than recommended and concurrently uses other medicines that depress the central nervous system (e.g., sedatives, sleeping pills, other pain-relieving medicines, alcohol), respiratory depression may occur.
Abnormal sensation (e.g., itching, tingling, numbness), tremors, seizures, muscle cramps, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after taking high doses of tramadol or when using other medicines that may cause seizures;
Hallucinations, confusion, sleep disorders, 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, for example, 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 treatment discontinuation, 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 volume (urinary retention);
allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure);
Very rare
(occurring less frequently 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 using 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

The medicine should be stored out of sight and reach of children.
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 precautions for storage.
Unknown (frequency cannot be determined from available data):
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.
• The other ingredients of the medicine are: hard fat.

What Tramal looks like and contents of the pack

The suppositories are white-yellowish wax and are packaged individually in aluminum foil and 5 in a cardboard box.

Marketing authorization holder and manufacturer:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Date of last revision of the leaflet: