Tramal Retard 50

Leaflet accompanying the packaging: patient information

Tramal Retard 50, 50 mg, prolonged-release tablets

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 is Tramal Retard 50 and what is it used for
• 2. Important information before taking Tramal Retard 50
• 3. How to take Tramal Retard 50
• 4. Possible side effects
• 5. How to store Tramal Retard 50
• 6. Contents of the packaging and other information

1.

What is Tramal Retard 50 and what is it used for

Tramadol, the active substance of Tramal Retard 50, belongs to the group of opioid analgesics acting on the central nervous system (CNS). It exerts its analgesic effect by influencing specific receptors in the spinal cord and brain cells.
Tramal Retard 50 is indicated for the treatment of moderate to severe pain.

2. Important information before taking Tramal Retard 50

When not to take Tramal Retard 50

• in case of acute alcohol intoxication, sleeping pills, painkillers, or psychotropic drugs (mood- and emotion-affecting drugs),
• in case of concomitant treatment with MAO inhibitors (certain antidepressants) and for 14 days after their discontinuation (see "Tramal Retard 50 and other medicines").
• in patients with uncontrolled epilepsy,
• as a treatment for opioid dependence.

Warnings and precautions

Before starting treatment with Tramal Retard 50, consult your doctor:

• 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 epilepsy or an increased risk of seizures, as this risk is further increased;
• in patients with liver or kidney disease;

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 Retard 50 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 duration of treatment.
Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of administration.
The risk of dependence on Tramal Retard 50 varies from person to person. A higher risk of dependence on Tramal Retard 50 may apply to individuals 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 Retard 50, 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 their doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramal Retard 50).
• 50).

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 Retard 50 and other medicines").
Tramal Retard 50 may cause physical and psychological dependence. Long-term use of Tramal Retard 50 can lead to decreased efficacy, resulting in the need for increasingly higher doses (development of tolerance). In the case of a patient's tendency to abuse medicines, treatment should be short-term and under close medical supervision.
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should consult their doctor, who will decide whether the patient needs hormone replacement therapy.
The patient should consult their doctor if they experience any of the above situations while taking Tramal Retard 50, even if these warnings refer to past situations.
Tramadol is metabolized in the liver by an enzyme. In some individuals, there is a certain variation of this enzyme, which can have different effects. In some individuals, pain relief may not be sufficient, while in others, the risk of serious side effects may be higher. The patient should stop taking the medicine and consult their doctor immediately 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.
Sleep-related breathing disorders
Tramal Retard 50 contains an active substance that belongs to the group of opioids.
Opioids can cause sleep-related breathing disorders, such as central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
The risk of central sleep apnea depends on the opioid dose. The doctor may consider reducing the total opioid dose if central sleep apnea occurs in the patient.
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 seek medical attention immediately (see section 4 "Possible side effects").

Tramal Retard 50 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 Retard 50 should not be taken with MAO inhibitors (medicines used to treat depression) and for 14 days after their discontinuation.
The analgesic effect of Tramal Retard 50 may be weakened, and the duration of action may be shortened if taken with medicines containing:

• carbamazepine (an antiepileptic medicine),
• ondansetron (an antiemetic medicine). The patient should consult their doctor about taking Tramal Retard 50 and its dosage.

The risk of side effects increases when taking:

• other painkillers like morphine and codeine (also as a cough medicine) and alcohol. The patient may feel drowsy or faint. In such cases, the patient should consult their doctor.
• The concomitant use of Tramal Retard 50 and sedatives or sleeping pills (e.g., benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if the doctor prescribes Tramal Retard 50 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 consult their doctor. If the patient is taking other medicines that can 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 (such as bupropion, mirtazapine, tetrahydrocannabinol), the risk of seizures may increase. The patient should consult their doctor if they can take Tramal Retard 50 while taking these medicines.
• certain antidepressants, Tramal Retard 50 may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• blood thinners like warfarin with Tramal Retard 50. Bleeding may occur due to the effect of these medicines on blood clotting.
• gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain (nerve pain).

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

Tramal Retard 50 with food, drink, and alcohol

The patient should not drink alcohol while taking Tramal Retard 50, as its effect may be enhanced. Food does not affect the efficacy of Tramal Retard 50.

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 Retard 50 should not be used in pregnant women.
Long-term administration 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, the patient should not take Tramal Retard 50 more than once, or if they have taken it more than once, they should stop breastfeeding.
Experience with tramadol in humans does not indicate that it affects fertility in men and women.

Driving and using machines

Tramal Retard 50 may cause drowsiness, dizziness, and blurred vision, which may affect reaction time. If these symptoms occur in the patient, they should not drive or operate any machines.

Tramal Retard 50 contains lactose

In case of intolerance to some sugars, the patient should consult their doctor before taking this medicine. This medicine contains lactose.

3. How to take Tramal Retard 50

The patient should always take this medicine exactly as their doctor has told them. If they are not sure, they should ask their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramal Retard 50, when and how to take it, when to consult the doctor, and when to stop the medicine (see also section 2).
The doctor will adjust the dose according to the severity of the pain and the patient's individual sensitivity to pain. This will be the lowest dose that effectively relieves the pain. The patient should not take more than 400 mg of tramadol hydrochloride per day, unless their doctor has told them to do so.
Unless the doctor has told them otherwise, the usual dose is:

Adults and adolescents over 12 years:

1 or 2 Tramal Retard 50 prolonged-release tablets twice a day, every 12 hours (equivalent to 100 mg to 200 mg of tramadol hydrochloride per day), preferably in the morning and evening.
If necessary, the doctor may recommend a different, more tailored dosage of Tramal Retard 50.
If necessary, the dose may be increased to 150 or 200 mg twice a day (equivalent to 300 mg to 400 mg of tramadol hydrochloride per day).
Children:

Tramal Retard 50 should not be used in children under 12 years.

Elderly:

In patients over 75 years, the elimination of tramadol may be delayed. In these patients, the doctor may recommend prolonging the dosing interval.

Patients with renal or hepatic impairment:

Tramal Retard 50 should not be taken in case of severe hepatic or renal impairment.
If the patient has mild or moderate impairment, the doctor may recommend prolonging the dosing interval.
Method of administration:

Tramal Retard 50 prolonged-release tablets should be taken orally.
The tablet should always be taken whole, with a small amount of liquid, without dividing or chewing, preferably in the morning and evening. Tramal Retard 50 can be taken with or without food.
Duration of treatment:

Tramal Retard 50 should not be taken for longer than necessary.
In case of prolonged treatment, the doctor will regularly monitor the patient's condition (interrupting treatment for a period if necessary) to determine whether and at what dose Tramal Retard 50 should be continued.
If the patient feels that the effect of Tramal Retard 50 is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Tramal Retard 50 than recommended

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

Missing a dose of Tramal Retard 50

If the patient forgets to take the medicine at the right time, their pain symptoms may return.
The patient should not take a double dose to make up for the missed dose. They should continue with their regular dosing schedule.

Stopping Tramal Retard 50

If the patient suddenly stops taking Tramal Retard 50 or stops taking it too early, their pain symptoms may return.
If the patient wants to stop treatment due to side effects, they should inform their doctor.
The patient should not stop taking this medicine abruptly without their doctor's advice. 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 Retard 50, no serious withdrawal symptoms are observed. However, in rare cases, after sudden discontinuation of Tramal Retard 50 prolonged-release tablets taken 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 symptoms may occur: panic attacks, hallucinations, abnormal perception of stimuli such as itching, tingling, numbness, and tinnitus.
Other unusual central nervous system disorders, such as confusion, delusions, depersonalization (change in self-perception), derealization (change in perception of reality), and paranoid delusions, have occurred very rarely.
If the patient experiences any of these symptoms after stopping the medicine, they should consult their doctor immediately.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramal Retard 50 can cause side effects, although not everybody gets them.

The patient should consult their doctor immediately if they experience any 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 patients during treatment with Tramal Retard 50 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 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 formulations 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 (occurs in 1 to 10 out of 10,000 people):
slow heartbeat,
increased blood pressure,
changes in appetite,
slow breathing, "short breath" (dyspnea).
Worsening of asthma has been reported during tramadol treatment, although a causal relationship between these facts has not been established.
In case of overdose or concomitant use of other medicines that depress the central nervous system (CNS), respiratory depression may occur; abnormal perception (e.g., itching, tingling, numbness), tremors, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (fainting), and speech disorders.
Seizures occur mainly after taking high doses of tramadol and in case of concomitant use of other medicines that can cause seizures, hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares. After taking Tramal Retard 50, 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 can lead to incorrect assessment of the situation).
The medicine can cause dependence.
After sudden discontinuation of treatment, withdrawal symptoms may occur (see "Stopping Tramal Retard 50").
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) occur in very rare cases.
Very rare (occurs in less than 1 in 10,000 people):
increased liver enzyme activity.
Unknown (frequency cannot be estimated from the available data):
decreased blood sugar levels, 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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramal Retard 50").

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 Drug Safety, Ministry of Health
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 Retard 50

Keep 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 individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Tramal Retard 50 contains

• The active substance of Tramal Retard 50 is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 50 contains 50 mg of tramadol hydrochloride.
• Other ingredients of the medicine are: Core:microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, anhydrous colloidal silica. Coating:hypromellose 6 mPa·s, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Tramal Retard 50 looks like and contents of the pack

Tramal Retard 50, 50 mg, prolonged-release tablets are round, biconvex, pale yellow with a logo on one side and T0 on the other side.
Packaging contains 10, 30, 50 prolonged-release tablets in blisters of 10, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturers

• 1. STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
• 2. Grünenthal GmbH Zieglerstrasse 6 52078 Aachen

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium
Contramal retard 50 mg
Finland
Germany
Tramal retard 50 mg
Tramal retard 50 mg
Luxembourg
Contramal retard 50 mg
Spain
Adolonta retard 50 mg
Poland
Tramal Retard 50
Slovenia
Tramal 50 mg

Date of last revision of the leaflet: 05/2024