Tramal Retard 150

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tramal Retard 150 (Tramal SR)

150 mg, prolonged-release tablets

Tramadol hydrochloride
Tramal Retard 150 and Tramal SR are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Tramal Retard 150 is and what it is used for
• 2. Important information before taking Tramal Retard 150
• 3. How to take Tramal Retard 150
• 4. Possible side effects
• 5. How to store Tramal Retard 150
• 6. Contents of the packaging and other information

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

Tramadol, the active substance of Tramal Retard 150, 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 Retard 150 is indicated for the treatment of moderate to severe pain.

2. Important information before taking Tramal Retard 150

When not to take Tramal Retard 150:

• 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 Retard 150 and other medicines");
• in patients with uncontrolled epilepsy;
• for the treatment of opioid dependence.

Warnings and precautions

Before starting treatment with Tramal Retard 150, you should consult a 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;

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, who are also taking drugs that suppress the activity of the central nervous system (see "Tramal Retard 150 and other medicines") or in case of taking doses higher than recommended (see "Taking a higher dose of Tramal Retard 150 than recommended" in section 3 and section 4), as in such cases, the possibility of 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 Retard 150 and other medicines").
Tramal Retard 150 may cause psychological and physical dependence. Long-term use of Tramal Retard 150 may lead to a decrease in the effectiveness of the action, leading to the need to take increasingly higher doses (development of tolerance). In the case of a tendency to abuse drugs 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 Retard 150, even if these warnings refer to situations that have occurred in the past.
Tramadol is converted 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, it is more likely to experience severe side effects.
You should stop taking the medicine and immediately consult a doctor if you experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Tramal Retard 150 and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Tramal Retard 150 should not be taken concurrently with MAO inhibitors (drugs used to treat depression) and for 14 days after their discontinuation.
The pain-relieving effect of Tramal Retard 150 may be weakened, and the duration of action may be shortened if taken concurrently with drugs containing:

• carbamazepine (an antiepileptic drug),
• pentazocine, nalbuphine, or buprenorphine (painkillers),
• ondansetron (an antiemetic drug). You should consult a doctor about taking Tramal Retard 150 and its dosage.

The risk of side effects increases:

• when taking Tramal Retard 150 concurrently with other painkillers such as morphine and codeine (also as a cough medicine) and alcohol. Drowsiness or fainting may occur. In such cases, you should consult a doctor.
• concurrent use of Tramal Retard 150 and sedative or sleeping drugs (e.g., benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible. However, if a doctor prescribes Tramal Retard 150 with sedative drugs, the dose and treatment duration should be limited by the doctor. You should inform your doctor about all sedative drugs 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.
• in case of concurrent use of anticoagulant drugs such as warfarin with Tramal Retard 150. Bleeding may occur due to the effect of these drugs on the blood coagulation system.

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

Tramal Retard 150 with food, drink, and alcohol

You should not drink alcohol while taking Tramal Retard 150, as the effect of the medicine may be enhanced, leading to respiratory depression.
Food does not affect the effect of Tramal Retard 150.

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 taking this medicine.

The safety of tramadol use during pregnancy has not been established. Therefore, Tramal Retard 150 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, you should not take Tramal Retard 150 more than once, or if you have taken Tramal Retard 150 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 Retard 150 may cause drowsiness, dizziness, and blurred vision, which may affect reaction time. Therefore, you should not drive vehicles or operate any machines.

Tramal Retard 150 contains lactose monohydrate

In case of intolerance to some sugars, you should consult a doctor before taking the medicine. This medicine contains lactose.

3. How to take Tramal Retard 150

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult a doctor or pharmacist.
The doctor will adjust the dose according to the severity of the pain and the individual patient's response to treatment. This will be the smallest dose that effectively relieves the pain. You should not take more than 400 mg of tramadol hydrochloride per day, unless otherwise prescribed by your doctor.
Unless otherwise prescribed by your doctor, the usual dosage is:

Adults and adolescents over 12 years of age:
One Tramal Retard 150 tablet twice a day (equivalent to 300 mg of tramadol hydrochloride), preferably in the morning and evening.
If necessary, the doctor may prescribe a different, more tailored dosage of Tramal Retard 150.

In case of need, 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 150 should not be used in children under 12 years of age.
Elderly patients:
In patients over 75 years of age, the elimination of tramadol may be delayed. In these patients, the doctor may prescribe a longer interval between doses.
Patients with renal or hepatic impairment, dialysis patients:
Tramal Retard 150 should not be taken in case of severe hepatic or renal impairment.
In case of mild or moderate impairment, the doctor may prescribe a longer interval between doses.
Method of administration:
Tramal Retard 150 should be taken orally.
The tablet should always be taken whole, with a small amount of liquid, and should not be divided or chewed. It can be taken independently of meals.
Duration of treatment:
Tramal Retard 150 should not be taken for longer than necessary. In case of need 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 while if necessary) to determine whether and at what dose the treatment with Tramal Retard 150 should be continued.
If you feel that the effect of Tramal Retard 150 is too strong or too weak, you should consult a doctor or pharmacist.

Taking a higher dose of Tramal Retard 150 than recommended

After taking higher doses than recommended, the following may occur: pinpoint pupils, vomiting, decreased blood pressure, rapid heartbeat, collapse, impaired 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 Retard 150

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 dosage schedule.

Stopping treatment with Tramal Retard 150

In case of sudden discontinuation or premature termination of treatment with Tramal Retard 150, the pain symptoms will likely return.
If you want to stop treatment due to side effects, you should inform your doctor.
You should not suddenly stop taking this medicine without your doctor's advice. 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 you 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 discontinuation of Tramal Retard 150, no serious side effects are observed. However, in rare cases, after sudden discontinuation of Tramal Retard 150 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 tinnitus 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 you experience any of the above symptoms after stopping the medicine, you should immediately consult a doctor.
If you have any further doubts about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramal Retard 150 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, low blood pressure, weakness, fainting

due to a life-threatening anaphylactic shock. Allergic 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 treatment with Tramal Retard 150 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 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 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).
Worsening of asthma has been reported during treatment with tramadol, although a causal relationship between these facts has not been established. In the case of taking doses significantly higher than recommended, and concurrent use of other drugs that suppress 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 cramps, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after taking high doses of tramadol and in case of concurrent use of other drugs that may cause seizures;
Hallucinations, confusion, sleep disorders, delirium, anxiety, and nightmares. After taking Tramal Retard 150, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). They may include mood disorders (usually excitement, sometimes irritation), 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 treatment with Tramal Retard 150");
Pinpoint pupils, 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 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., 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 150").

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Tramal Retard 150

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Unknown
(frequency cannot be determined from available data):
There are no special precautions for storage.
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 Retard 150 contains

• The active substance of Tramal Retard 150 is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 150 contains 150 mg of tramadol hydrochloride (Tramadol hydrochloride).
• The other ingredients of the medicine are: Tablet core: hypromellose 100,000 mPas, colloidal silica anhydrous, magnesium stearate, microcrystalline cellulose. Coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), iron oxide red (E 172), quinoline yellow lake (E 104).

What Tramal Retard 150 looks like and contents of the pack:

Light orange, round, embossed with "T2" on one side, and the manufacturer's logo on the other side.
Packaging contains 10, 30, or 50 tablets in blisters of 10, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Greece, the country of export:

VIANEX S.A., Tatoiou Str., 18 km Athens-Lamia National Road, 146 71, Nea Erythrea, Greece

Manufacturer:

Grunenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 54733/27-06-2014
22044/15/06-03-2017

Parallel import authorization number: 167/22 Date of approval of the leaflet: 14.04.2022

[Information about the trademark]