Tramal Retard 200

Leaflet accompanying the packaging: patient information

Tramal Retard 100, 100 mg, prolonged-release tablets

Tramal Retard 150, 150 mg, prolonged-release tablets

Tramal Retard 200, 200 mg, prolonged-release tablets

Tramadol hydrochloride

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 100, Tramal Retard 150, Tramal Retard 200 and what is it used for
• 2. Important information before taking Tramal Retard 100, Tramal Retard 150 or Tramal Retard 200
• 3. How to take Tramal Retard 100, Tramal Retard 150, Tramal Retard 200
• 4. Possible side effects
• 5. How to store Tramal Retard 100, Tramal Retard 150, Tramal Retard 200
• 6. Package contents and other information

1. What is Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 and what is it used for

what it is used for
Tramadol, the active substance of Tramal Retard 100, Tramal Retard 150, Tramal Retard 200, is
a pain-relieving substance belonging to the group of opioids affecting the central nervous system.
It exerts its pain-relieving effect by acting on specific receptors of nerve cells in the spinal cord and brain.
Tramal Retard is indicated for the treatment of moderate to severe pain.

2. Important information before taking Tramal Retard 100, Tramal Retard 150 or Tramal Retard 200

When not to take Tramal Retard:

• for the treatment of opioid dependence.

Warnings and precautions

Before starting treatment with Tramal Retard, the doctor should be consulted:

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 Retard 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 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 Retard may be higher in certain individuals.

• if the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illegal drugs ("addiction");
• if the patient is a smoker;
• if 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, 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 is taking 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 when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramal Retard).

Respiratory disorders during sleep
Tramal Retard 100, 150, and 200 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, concurrently taking medicines that depress the central nervous system (see Tramal and other medicines) or when taking higher doses than recommended (see "Taking a higher dose of Tramal Retard" in section 3 and section 4), as respiratory depression cannot be ruled out in these cases.
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 and other medicines").
Tramal Retard may cause physical and psychological dependence. Long-term use of Tramal Retard may lead to reduced efficacy and require increasingly higher doses (development of tolerance). In cases of drug abuse 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 taking Tramal Retard, even if these warnings refer to past situations.
Tramadol is metabolized in the liver by an enzyme. In some individuals, a variant of this enzyme occurs, which may have different effects. In some individuals, pain relief may be insufficient, while in others, severe side effects may be more likely.
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 Retard and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking, has recently taken, or plans to take.
Tramal Retard should not be taken concurrently with MAO inhibitors (medicines used to treat depression) or within 14 days of their discontinuation.
The pain-relieving effect of Tramal Retard may be reduced, and its duration of action shortened if taken concurrently with medicines containing:

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

The risk of side effects increases:

• when Tramal Retard 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 a doctor.
• when Tramal Retard is taken concurrently with sedatives or sleeping pills (e.g., benzodiazepines) or gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain. The risk of drowsiness, breathing difficulties (respiratory depression), coma, and life-threatening situations increases.

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

Tramal Retard with food, drink, and alcohol

Alcohol should not be consumed while taking Tramal Retard, as the effect of the medicine may be enhanced, leading to respiratory depression.
Food does not affect the efficacy of Tramal Retard.

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.
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 taking this medicine.
The safety of tramadol during pregnancy has not been established. Therefore, Tramal Retard should not be taken during pregnancy.
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, Tramal Retard 100, 150, and 200 mg should not be taken more than once, or if Tramal Retard 100, 150, or 200 mg has been taken more than once, breastfeeding should be discontinued.
Human experience with tramadol does not indicate that it affects fertility in men and women.

Driving and using machines

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

Tramal Retard contains lactose

In case of intolerance to certain sugars, the doctor should be consulted before taking the medicine. This medicine contains lactose.

3. How to take Tramal Retard 100, Tramal Retard 150, Tramal Retard 200

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramal Retard, 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. No more than 400 mg of tramadol hydrochloride should be taken per day, unless the doctor recommends otherwise.
Unless the doctor recommends otherwise, the following dosing regimen is usually used:
Adults and adolescents over 12 years old:
One Tramal Retard 100 tablet twice a day (equivalent to 200 mg of tramadol hydrochloride), preferably in the morning and evening.
or
One Tramal Retard 150 tablet twice a day (equivalent to 300 mg of tramadol hydrochloride), preferably in the morning and evening.
or
One Tramal Retard 200 tablet twice a day (equivalent to 400 mg of tramadol hydrochloride), preferably in the morning and evening.
If necessary, the doctor may recommend a different, more tailored dosing regimen for Tramal Retard.
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 should not be used in children under 12 years old.
Elderly patients:
In patients over 75 years old, the elimination of tramadol may be delayed. In these patients, the doctor may recommend prolonging the time interval between doses.
Patient with renal or hepatic impairment:
Tramal Retard should not be taken 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 Retard should be taken orally.
The tablet should always be taken whole, with a small amount of liquid, and not divided or chewed. It can be taken with or without food.
Duration of treatment:
Tramal Retard should not be taken for longer than absolutely 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 treatment for a period if necessary) to determine whether and at what dose Tramal Retard treatment should be continued.
If the patient feels that the effect of Tramal Retard is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Tramal Retard 100, Tramal Retard 150, Tramal Retard 200:

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 doctor should be consulted immediately!

Missing a dose of Tramal Retard

If a dose is missed, the pain symptoms will likely return.
A double dose should not be taken to make up for a missed dose.
The patient should return to the previous dosing schedule.

Stopping Tramal Retard

If Tramal Retard is stopped abruptly or prematurely, the pain symptoms will likely return.
If the patient wants to stop treatment due to side effects, they should inform their doctor.
Tramal Retard should not be stopped abruptly 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 Retard, no serious side effects are observed. However, in rare cases, after abrupt discontinuation of Tramal Retard taken for a period, the patient may feel unwell. They may experience agitation, anxiety, tremors, insomnia, and gastrointestinal disorders.
Very rarely, panic attacks, hallucinations, disorientation, sleep disturbances, and nightmares may occur. Other unusual central nervous system disorders, such as confusion, delusions, depersonalization, and derealization, have occurred very rarely.
If the patient experiences any of these symptoms after stopping the medicine, they should consult a doctor immediately.
In case of any further doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

The patient should consult a doctor immediately 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 a life-threatening anaphylactic shock. Allergic reactions are rare

The most common side effects reported in more than 1 in 10 people during treatment with Tramal Retard were nausea and dizziness.
Very common
(occurs in more than
1 in 10 people):
dizziness,
nausea.
Common
(occurs in 1 to 10 in
100 people):
headache, drowsiness,
vomiting, constipation, dry mouth,
excessive sweating,
fatigue.
Uncommon
(occurs in 1 to 10 in
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 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 in
10,000 people):
slow heartbeat,
increased blood pressure,
changes in appetite,
slow breathing, "short breath" (shortness of breath).
It has been reported that asthma worsens during tramadol treatment, 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 central nervous system depressants (e.g., sedatives, sleeping pills, other painkillers, 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 taking other medicines that can cause seizures;
Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares. After taking Tramal Retard, 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 sensations and recognition, which can lead to incorrect assessment of the situation);
The medicine may cause dependence.
In case of abrupt discontinuation of treatment, withdrawal symptoms may occur (see "Stopping Tramal Retard");
Pinpoint pupils, blurred vision, excessive pupil dilation (mydriasis),
muscle weakness;
urination difficulties or pain, decreased urine output (urinary retention);
allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure);
Very rare
(occurs 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., 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 (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramal Retard").

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tramal Retard 100, Tramal Retard 150, Tramal Retard 200

The medicine should be kept 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 life-threatening to individuals for whom it has not been prescribed.
The medicine should not be taken after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.
There are no special precautions for storage.
Unknown (frequency cannot be estimated from the 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. Package contents and other information

What does Tramal Retard 100 contain

• The active substance of Tramal Retard 100 is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 100 contains 100 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• The other ingredients of the medicine are: tablet core: hypromellose 100,000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose. coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide.

What does Tramal Retard 150 contain

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 150 contains 150 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• The other ingredients of the medicine are: tablet core: hypromellose 100,000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose. coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide, iron oxide red (E 172), quinoline yellow lake (E 104).

What does Tramal Retard 200 contain

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 200 contains 200 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• The other ingredients of the medicine are: tablet core: hypromellose 100,000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose. coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide, iron oxide red (E 172), iron oxide brown (E 172), quinoline yellow lake (E 104).

What Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 look like and what the package contains:

Tramal Retard 100: white, round, engraved "T1" on one side, manufacturer's logo  on the other side.
Tramal Retard 150: pale orange, round, engraved "T2" on one side, manufacturer's logo  on the other side.
Tramal Retard 200: light brown with an orange tint, round, engraved "T3" on one side, manufacturer's logo  on the other side.
Packages contain 10, 30, or 50 tablets in blisters of 10, in a cardboard box.
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