Tramal retard 50: detailed information

Package leaflet: Information for the patient

Tramal Retard 50, 50 mg, prolonged-release tablets
Tramadoli hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Tramal Retard 50 is and what it is used for
Important information before taking Tramal Retard 50
How to take Tramal Retard 50
Possible side effects
How to store Tramal Retard 50
Contents of the pack and other information

1. What Tramal Retard 50 is and what it is used for
Tramadol – the active substance in Tramal Retard 50 – belongs to the group of opioid analgesics acting on the central nervous system (CNS). It exerts its analgesic effect by acting on specific receptors of nerve cells in the spinal cord and brain.
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

if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6),
in cases of acute alcohol intoxication, hypnotics, analgesics, or psychotropic drugs (medicines affecting mood and emotions),
during concomitant treatment with MAO inhibitors (certain antidepressants) or within 14 days after their discontinuation (see section "Tramal Retard 50 and other medicines"),
in patients with uncontrolled epilepsy,
as a substitute in narcotic withdrawal.

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

if you have disturbances of consciousness (if you feel faintness approaching);
in shock (cold sweats may be a symptom);
if you have increased intracranial pressure (which may occur after head injury or brain diseases);
if you have breathing difficulties;
in patients with epilepsy or increased risk of epileptic seizures, as this risk may be further increased;
if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see "Tramal Retard 50 and other medicines");
in patients with liver or kidney disease.

Tolerance, dependence and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to the medicine, known as tolerance). Repeated use of Tramal Retard 50 may also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with dose and prolonged duration of treatment.
Dependence or addiction may cause the patient to lose control over the amount or frequency of medicine intake.
The risk of dependence or addiction varies among individuals. Higher risk of dependence on Tramal Retard 50 may apply to individuals in the following situations:

if the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
if the patient is a tobacco 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 you notice any of the following symptoms while taking Tramal Retard 50, this may indicate dependence or addiction:
Need to take the medicine for longer than prescribed by the doctor.
Need to take a higher dose than recommended.
The patient takes the medicine for reasons other than those for which it was prescribed, e.g., "to calm down" or "to sleep better".
The patient has made multiple, unsuccessful attempts to stop or control medicine use.
After stopping the medicine, the patient feels unwell, and feels better after taking it again ("withdrawal effects"). If you notice any of these symptoms, you should consult your doctor to discuss the best treatment approach for you, including when and how to safely discontinue the medicine (see section 3, "Discontinuation of Tramal Retard 50").

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 medicines that lower the seizure threshold (see section "Tramal Retard 50 and other medicines").
Tramal Retard 50 may cause psychological and physical dependence. Long-term use of Tramal Retard 50 may lead to reduced effectiveness, resulting in the need to take increasingly higher doses (development of tolerance). In patients with a tendency to drug abuse, treatment should be short-term and under strict medical supervision.
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.
You should consult your doctor if any of the above situations occur during treatment with Tramal Retard 50, even if these warnings relate to past conditions.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a variant of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse reactions may be more likely. Discontinue the medicine and contact your doctor immediately if you experience any of the following adverse reactions: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Sleep-related breathing disorders
Tramal Retard 50 contains an active substance belonging to the opioid group.
Opioids may cause sleep-related breathing disorders, such as central sleep apnea (shallow breathing or breathing pauses during sleep) and nocturnal hypoxia (reduced oxygen levels in the blood during sleep).
The risk of central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if central sleep apnea occurs.
There is a small risk of developing serotonin syndrome when tramadol is taken concomitantly with certain antidepressants or tramadol alone. If you experience any symptoms of this serious condition, seek immediate medical advice (see section 4 "Possible side effects").

Tramal Retard 50 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tramal Retard 50 must not be taken concomitantly with MAO inhibitors (medicines used to treat depression) or within 14 days after their discontinuation.
The analgesic effect of Tramal Retard 50 may be reduced and its duration shortened if taken simultaneously with medicines containing:

carbamazepine (an antiepileptic medicine),
ondansetron (an antiemetic medicine). Your doctor will inform you whether you should take Tramal Retard 50 and at what dose.

The risk of adverse reactions increases if you take:

anxiolytics or hypnotics (such as benzodiazepines) or medicines that may impair respiratory function (such as other opioids, certain antitussives, certain medicines used in drug addiction treatment, medicines used to treat psychiatric disorders, antihistamines, or alcohol), because these medicines increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and potentially life-threatening effects. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Tramal Retard 50 together with sedatives, the dose and duration of combined treatment should be limited by the doctor. Inform your doctor about all sedative medicines you are taking and strictly follow dosing instructions. It may be helpful to inform friends or family members about the above symptoms. Contact your doctor if such symptoms occur.
medicines that may cause seizures, such as certain antidepressants or antipsychotics, including: selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline 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 if you take Tramal Retard 50 concomitantly with these medicines. Consult your doctor whether you can take Tramal Retard 50 while using the above medicines.
antidepressants, as Tramal Retard 50 may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
anticoagulants of the coumarin derivatives (blood-thinning medicines) such as warfarin, taken concomitantly with Tramal Retard 50. The effect of these medicines on blood clotting may be disturbed, leading to bleeding.
gabapentin or pregabalin used in the treatment of epilepsy or nerve-related pain (neuropathic pain).
medicines with anticholinergic effects, such as:
- medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics),
- medicines used to treat psychiatric disorders (antipsychotics or neuroleptics),
- muscle relaxants,
- medicines used to treat Parkinson's disease, because they may increase the risk of adverse effects such as constipation, urinary retention, dry mouth, or dry eyes. Ketoconazole (an antifungal medicine) and erythromycin (a bacteriostatic antibiotic) may inhibit tramadol metabolism and probably that of its active metabolite.

Tramal Retard 50 with food, drink, and alcohol
Do not drink alcohol while taking Tramal Retard 50, as its effects may be intensified. Food does not affect the efficacy of Tramal Retard 50.

Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more pronounced in them.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
The safety of tramadol use during pregnancy has not been established. Therefore, Tramal Retard 50 should not be used in pregnant women.
Prolonged use of tramadol during pregnancy may lead to withdrawal syndrome in the newborn.

Breastfeeding
Tramadol is excreted in breast milk. Therefore, during breastfeeding, Tramal Retard 50 should not be taken more than once, or if Tramal Retard 50 has been taken more than once, breastfeeding should be discontinued.

Experience with tramadol use in humans does not indicate that tramadol affects fertility in women and men.

Driving and operating machinery
Tramal Retard 50 may cause drowsiness, dizziness, and blurred vision, which may affect reaction speed. If you experience any of these symptoms, do not drive or operate machinery.

Tramal Retard 50 contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine. This medicine contains lactose.

3. How to use Tramal Retard 50

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to
expect from using Tramal Retard 50, when and for how long the medicine should be taken, when to
contact the doctor, and when the medicine should be discontinued (see also section 2).
The doctor will adjust the dose according to the intensity of pain and the individual patient's sensitivity to pain.
The lowest effective dose that adequately relieves pain will be used. Do not exceed 400 mg of tramadol hydrochloride
per day unless otherwise directed by a physician.
Unless otherwise prescribed by a doctor, the usual dosage is as follows:
Adults and adolescents over 12 years of age:
1 or 2 prolonged-release tablets of Tramal Retard 50 twice daily, 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 prescribe a different dosage regimen better suited to the individual.
If required, the dose may be increased to 150 mg or 200 mg twice daily (equivalent to
300 mg to 400 mg of tramadol hydrochloride per day).
Children:
Tramal Retard 50 must not be used in children under 12 years of age.
Elderly patients:
In patients over 75 years of age, tramadol elimination may be delayed. In these patients, the doctor may recommend
prolonging the interval between doses.
Patients with renal impairment, on dialysis, or with severe hepatic impairment:
Tramal Retard 50 must not be taken in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend extending the intervals between doses.
Method of administration:
Tramal Retard 50 prolonged-release tablets are for oral use.
The tablet must always be taken whole, with a small amount of liquid. Do not divide or chew the tablet.
Preferably take in the morning and evening. Tramal Retard 50 may be taken regardless of meals.
Duration of treatment:
Do not use Tramal Retard 50 longer than absolutely necessary.
If long-term treatment is required, the doctor will regularly monitor the patient's condition
(including temporarily interrupting treatment if necessary) to determine whether and at what dose
treatment with Tramal Retard 50 should continue.
If you feel the effect of Tramal Retard 50 is too strong or too weak, consult your
doctor or pharmacist.
Use of a higher than recommended dose of Tramal Retard 50
After taking very high doses, the following may occur: pinpoint pupils, vomiting,
drop in blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma (a state
of deep unconsciousness), seizures, breathing difficulties up to respiratory arrest, and death.
In such cases, seek immediate medical attention!
Missing a dose of Tramal Retard 50
If a dose is missed at the scheduled time, pain symptoms may return.
Do not take a double dose to make up for a missed dose. Resume the regular dosing schedule.
Stopping treatment with Tramal Retard 50
If treatment is stopped abruptly or discontinued prematurely, pain symptoms are likely to return.
If a patient wishes to discontinue treatment due to adverse effects, they should inform the doctor.
Do not suddenly stop taking this medicine without medical advice. If a patient wishes to stop taking
the medicine, this should be discussed with the doctor, especially if the medicine has been used long-term.
The doctor will advise when and how to discontinue the medicine; this may involve gradually reducing the dose
to minimize the risk of adverse withdrawal symptoms.
Generally, no serious post-treatment symptoms are observed after discontinuation of Tramal Retard 50.
However, in rare cases after abrupt discontinuation of Tramal Retard 50 prolonged-release tablets used for some time,
the patient may feel unwell. Symptoms may include agitation, anxiety, restlessness, tremors, hyperactivity,
difficulty falling asleep, and gastrointestinal or intestinal disturbances.
Very rarely, panic attacks, hallucinations, abnormal sensory perceptions such as itching,
tingling, numbness, and tinnitus may occur.
Other rare central nervous system disturbances, such as confusion, delusions, altered perception of self (depersonalization),
altered perception of reality (derealization), and persecutory delusions (paranoia), have been reported very rarely.
If any of the above symptoms occur after discontinuation of the medicine, consult a doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should consult a doctor immediately if symptoms of an allergic reaction occur,
such as: swollen face, tongue and (or) throat and (or) difficulty swallowing or hives
combined with difficulty breathing.
The most common adverse effects reported more frequently than in 1 out of 10 people during treatment
with Tramal Retard 50 are nausea and dizziness.
Very common: may occur in more than 1 out of 10 people

dizziness,
nausea.

Common: may occur in no more than 1 out of 10 people

headache, drowsiness,
fatigue,
constipation, dryness of the oral mucosa, vomiting,
excessive sweating (hyperhidrosis).

Uncommon: may occur in no more than 1 out of 100 people

effects on the heart and circulation (palpitations, rapid heartbeat, feeling of weakness and collapse). These adverse effects may occur particularly in patients in an upright position or during physical exertion,
vomiting reflex, stomach problems (feeling of pressure in the stomach, bloating), diarrhoea,
skin reactions (e.g. itching, rash).

Rare: may occur in no more than 1 out of 1000 people

allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) occurred in very rare cases,
slow heartbeat,
increase in blood pressure,
abnormal sensations (e.g. itching, tingling, numbness), seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (fainting), speech disorders,
seizures occurred mainly after administration of high doses of tramadol or when tramadol was taken simultaneously with other medicines that may provoke seizures,
changes in appetite,
hallucinations, confusion, sleep disturbances, delirium, restlessness and nightmares,
psychiatric disorders may occur after treatment with Tramal Retard 50. Their severity and nature may vary (depending on the patient's personality and duration of treatment). They may manifest as mood disturbances (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased) and reduced sensory perception and cognitive abilities (changes in perception and recognition which may lead to misjudgement),
drug dependence may occur,
blurred vision, constricted pupils (miosis), excessive dilation of the pupils (mydriasis),
slow breathing, shortness of breath,
worsening of bronchial asthma has been reported, however, it has not been established whether tramadol was the cause. In case of exceeding recommended doses or simultaneous use of other medicines that suppress brain function, breathing may become slowed,
muscle weakness,
difficulty or pain during urination, passing less urine than usual (dysuria).

Very rare: may occur in no more than 1 out of 10,000 people

increased activity of liver enzymes.

Not known: frequency cannot be estimated from available data

decrease in blood sugar levels,
hiccups. Serotonin syndrome, the symptoms of which may include changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and (or) gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "Important information before taking Tramal Retard 50").

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information 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 may cause serious harm or be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the outer carton and blister pack.
The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tramal Retard 50 contains

The active substance is tramadol hydrochloride. One Tramal Retard 50 prolonged-release tablet contains 50 mg of tramadol hydrochloride.
The other ingredients are: Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, colloidal anhydrous 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 the manufacturer's logo  marked on one side and T0 on the other.
Pack sizes contain 10, 30, or 50 prolonged-release tablets in blisters of 10 tablets per cardboard box.
Not all pack sizes may be marketed.
Pack sizes contain 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 100 x 1, 150 x 1 ((10 x 1) x 15) prolonged-release tablets in single-dose perforated blisters of 10 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturers

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

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Contramal retard 50 mg
Finland: Tramal retard 50 mg
Germany: Tramal retard 50 mg
Luxembourg: Contramal retard 50 mg
Spain: Adolonta retard 50 mg
Poland: Tramal Retard 50
Slovenia: Tramal 50 mg