Tramal Retard 150

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! 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 medicine.

You should carefully read the contents of the leaflet before using 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.
• In case of 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 as yours.
• 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 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:

• for the treatment of opioid dependence.

Warnings and precautions

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

Respiratory disorders during sleep
Tramal Retard 150 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 Retard 150 and other medicines") or in case of taking higher doses than recommended (see "Taking a higher dose of Tramal Retard 150 than recommended" 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 Retard 150 and other medicines").
Tramal Retard 150 may cause physical and psychological dependence. Long-term use of Tramal Retard 150 may lead to a decrease in the effectiveness 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 therapy.
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 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, the risk of serious side effects may be higher.
You should stop taking the medicine and immediately consult a doctor if you 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 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 (medicines 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 medicines containing:

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

The risk of side effects increases:

• when Tramal Retard 150 is taken concurrently with other painkillers like 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 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 Retard 150 with sedative medicines, the dose and treatment duration should be limited by the doctor. You should inform your doctor about all sedative medicines 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 consult a doctor.
• in case of concurrent use of anticoagulant medicines, such as warfarin, with Tramal Retard 150. Bleeding may occur due to the effect of these medicines on blood clotting.

Ketoconazole (an antifungal medicine) 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, potentially 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 men and women.

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 monohydrate.

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 response of the patient to the 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.
Tramal Retard 100, Tramal Retard 150, and Tramal Retard 200 are available on the market.
Unless otherwise prescribed by your doctor, the following dosages are usually used:
Adults and adolescents over 12 years of age:
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, your doctor may prescribe a different, more tailored dosage of 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 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 recommend prolonging the time interval between doses.
Patients with renal or hepatic impairment, or those undergoing dialysis:
You should not take Tramal Retard 150 if you have 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 150 should be taken orally.
The tablet should always be taken whole, with a small amount of liquid, and should not be divided or crushed. It can be taken with or without food.
Duration of treatment:
You should not take Tramal Retard 150 for longer than necessary. If long-term treatment is necessary 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 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, low blood pressure, rapid heartbeat, fainting, impaired consciousness up to coma (a state of deep loss of consciousness), 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 dosing schedule.

Stopping treatment with Tramal Retard 150

If you suddenly stop taking Tramal Retard 150 or finish the treatment too early, the pain symptoms will likely return.
If you want to stop the 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 stopping Tramal Retard 150, no serious side effects are observed. However, in rare cases, after suddenly stopping 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 ringing in the ears), and other unusual central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions, may occur.
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 associated with 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 in more 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 fainting). 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).
There have been reports of worsening asthma during tramadol treatment, although a causal relationship between these facts has not been established. In case of taking significantly higher doses 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 cramps, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after taking high doses of tramadol and in case of concurrent use of other medicines that may cause seizures;
Hallucinations, confusion, sleep disorders, delirium, anxiety, and nightmares. After taking Tramal Retard 150, 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 cessation of treatment, withdrawal symptoms may occur (see "Stopping treatment with Tramal Retard 150");
Pupil constriction (miosis), blurred vision, excessive pupil dilation (mydriasis),
muscle weakness;
urination disorders 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 (occurring in less than 1 in 10,000 people):
increased liver enzyme activity.
Unknown (frequency cannot be determined from available data):
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 or pharmacist. 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 month.
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 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

The tablets are pale orange, round, and have "T2" embossed on one side and the manufacturer's logo on the other side.
The 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., 18th km Athens- Lamia National Road
146 71, Nea Erythrea, Greece

Manufacturer:

Grunenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:54733/27-06-2014
22044/15/06-03-2017

Parallel import authorization number: 415/22 Date of approval of the leaflet: 22.11.2022

[Information about the trademark]