Tramal Retard 100

Package Leaflet: Information for the Patient

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Tramal Retard 100, Tramal Retard 150, and Tramal Retard 200 are and what they are 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, and Tramal Retard 200
• 4. Possible side effects
• 5. How to store Tramal Retard 100, Tramal Retard 150, and Tramal Retard 200
• 6. Package contents and other information

1. What Tramal Retard 100, Tramal Retard 150, and Tramal Retard 200 are and what they are used for

what they are used for
Tramadol, the active substance in Tramal Retard 100, Tramal Retard 150, and Tramal Retard 200, is
a pain reliever belonging to the group of opioids that affect the central nervous system.
It produces a pain-relieving effect by acting on specific receptors 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:

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute intoxication with alcohol, hypnotics, analgesics, or psychotropic drugs (drugs that affect mood and emotions);
• in case of concomitant treatment with MAO inhibitors (certain antidepressants) and for 14 days after their discontinuation (see "Tramal Retard and other medicines");
• in patients with uncontrolled epilepsy;
• for the treatment of opioid dependence.

Warnings and precautions

Before starting treatment with Tramal Retard, consult your doctor:

• in case of dependence on other pain relievers (opioids);
• in case of impaired consciousness (if you feel faint);
• in case of shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (may occur after head injury or brain disease);
• 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 you are taking antidepressants, as some of them may interact with tramadol (see "Tramal Retard 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 you experience any symptoms of this serious condition, you should seek medical attention immediately (see section 4 "Possible side effects").

Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid drug. 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 may also lead to dependence, abuse, and addiction, which can cause life-threatening overdose. The risk of these side effects may increase with 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 may be higher in certain individuals. A higher risk of dependence on Tramal Retard 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, 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 symptoms"). 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).

Sleep apnea
Tramal Retard 100, 150, and 200 may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia related to sleep (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 someone else 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, concomitantly taking drugs that depress the central nervous system (see Tramal Retard 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 at 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 and other medicines").
Tramal Retard may cause physical and psychological dependence. Long-term use of Tramal Retard may lead to decreased efficacy of the medicine, resulting in the need for higher doses (development of tolerance). In cases 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 therapy.
Consult a doctor if you experience any of the above situations while taking Tramal Retard, even if these warnings refer to situations that occurred in the past.
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, and in others, serious side effects are more likely to occur.
Stop taking the medicine and consult a doctor immediately 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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Tramal Retard should not be taken concomitantly with MAO inhibitors (drugs used to treat depression) and for 14 days after their discontinuation.
The pain-relieving effect of Tramal Retard may be reduced, and the duration of action may be shortened if taken concomitantly with drugs containing:

• carbamazepine (an antiepileptic drug),
• pentazocine, nalbuphine, or buprenorphine (pain relievers),
• ondansetron (an antiemetic drug). Consult a doctor about taking Tramal Retard and its dosage.

The risk of side effects increases:

• when Tramal Retard is taken concomitantly with other pain relievers, such as morphine and codeine (also as a cough medicine), and alcohol. Drowsiness or fainting may occur. In such cases, consult a doctor.
• when Tramal Retard is taken concomitantly with sedatives or hypnotics (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 conditions 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

Do not drink alcohol 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The safety of tramadol during pregnancy has not been established. Therefore, Tramal Retard should not be used 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, do not take Tramal Retard 100, 150, or 200 mg more than once, or if you have taken Tramal Retard 100, 150, or 200 mg more than once, stop breastfeeding.
Experience with tramadol in humans 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, do not drive or operate any machines.

Tramal Retard contains lactose

In case of intolerance to certain sugars, consult your doctor before taking the medicine. This medicine contains lactose.

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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Tramal Retard, when and how long to take it, when to contact your doctor, and when to stop the medicine (see also section 2).
Your doctor will adjust the dose according to the severity of the pain and your individual response to treatment. This will be the lowest dose that effectively relieves the pain. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has told you to do so.
Unless your doctor has told you otherwise, the following dosages are usually used:
Adults and adolescents over 12 years:
Jelly. 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 should not be used in children under 12 years of age.
Elderly:
In patients over 75 years of age, the elimination of tramadol may be delayed. In these patients, your doctor may recommend prolonging the dosing interval.
Patients with renal or hepatic impairment:
Do not take Tramal Retard if you have severe hepatic or renal impairment.
In cases of mild or moderate impairment, your doctor may recommend prolonging the dosing interval.
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:
Do not take Tramal Retard for longer than necessary. If long-term treatment is necessary due to the type and severity of the disease, your doctor will regularly monitor your condition (interrupting treatment for a period if necessary) to determine whether and at what dose Tramal Retard should be continued.
If you feel that the effect of Tramal Retard is too strong or too weak, talk to your 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 unconsciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, consult a doctor immediately!

Missing a dose of Tramal Retard

If you forget to take the medicine at the right time, the pain may return.
Do not take a double dose to make up for the missed dose.
Return to the previous dosing schedule.

Stopping Tramal Retard

If you stop taking Tramal Retard suddenly or prematurely, the pain may return.
If you want to stop treatment due to side effects, inform your doctor.
Do not stop taking this medicine without your doctor's advice, especially if you have been taking it for a long time. If you want to stop taking the medicine, discuss it with your doctor, who will advise you on when and how to stop taking it; 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 have been reported. However, in rare cases, after sudden discontinuation of Tramal Retard taken for a certain period, the patient may feel unwell. Agitation, anxiety, nervousness, tremors, insomnia, and gastrointestinal disorders may occur.
Very rarely, panic attacks, hallucinations, disorientation, sleep disturbances, nightmares, and unusual sensations such as itching, tingling, numbness, and ringing in the ears may occur.
Other unusual central nervous system disorders, such as confusion, delusions, depersonalization (change in the perception of oneself), derealization (change in the perception of reality), and paranoid delusions, have occurred very rarely.
If you experience any of these symptoms after stopping the medicine, consult a doctor immediately.
If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention immediately if you experience symptoms of an allergic reaction, such as a swollen face, tongue, and/or throat, and/or difficulty swallowing or hives accompanied by difficulty breathing, low blood pressure, weakness, or 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 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 when changing body position from lying down to standing, and collapse). These side effects may occur especially during intravenous administration of tramadol and in patients who have exercised.
Vomiting, stomach and intestinal disorders (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, "shortness of breath" (dyspnea).
Worsening of asthma has been reported during treatment with tramadol, although a causal relationship between these events has not been established. In cases where higher doses than recommended are taken, and other drugs that depress the central nervous system are taken concomitantly (e.g., sedatives, sleeping pills, other pain relievers, 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 other drugs that can cause seizures are taken concomitantly;
Hallucinations, confusion, sleep disturbances, nightmares, and anxiety. After taking Tramal Retard, psychological disorders may occur. Their severity and type may vary (depending on the patient's personality and duration of treatment). 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.
After sudden discontinuation of treatment, withdrawal symptoms may occur (see "Stopping Tramal Retard");
Pinpoint pupils, blurred vision, dilated pupils (mydriasis),
muscle weakness;
difficulty or pain when urinating, decreased urine output (urinary retention);
allergic reactions (e.g., difficulty breathing, wheezing, swelling of the skin) 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 status (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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramal Retard").

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

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

Keep the medicine 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 life-threatening to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
No special precautions for storage are necessary.
Unknown (frequency cannot be estimated from available data):
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tramal Retard 100 contains

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 100 contains 100 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• Other ingredients 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.

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 (Tramadoli hydrochloridum).
• Other ingredients 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, iron oxide red (E 172), quinoline yellow lake (E 104).

What Tramal Retard 200 contains

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 200 contains 200 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• Other ingredients 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, 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 contents of the pack:

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.
Packaging contains 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 package leaflet: 05/2024