Tramal retard 100: detailed information

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
Tramadoli hydrochloridum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 is and what it is used for
Important information before taking Tramal Retard 100, Tramal Retard 150 or Tramal Retard 200
How to take Tramal Retard 100, Tramal Retard 150, Tramal Retard 200
Possible side effects
How to store Tramal Retard 100, Tramal Retard 150, Tramal Retard 200
Contents of the pack and other information

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

Tramadol – the active substance in Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 – is an analgesic belonging to the opioid group affecting the central nervous system.
It exerts analgesic action 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 using Tramal Retard 100, Tramal Retard 150 or

Tramal Retard 200
When not to use Tramal Retard:

if the patient is allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
in case of acute alcohol intoxication, sedatives, analgesics, or psychotropic medicines (medicines affecting mood and emotions);
if the patient is taking MAO inhibitors (a group of antidepressants) or within 14 days after discontinuation of these medicines (see "Tramal Retard and other medicines");
in patients with untreated epilepsy;
in the treatment of opioid dependence.

Warnings and precautions
Before starting treatment with Tramal Retard, discuss the following with your doctor:

if the patient has dependence on other painkillers (opioids);
in disorders of consciousness (if the patient feels faint);
in shock (cold sweats may be a symptom);
in increased intracranial pressure (which may occur after head injury or brain diseases);
in case of respiratory disorders;
in patients with increased sensitivity to opioid medicines;
in patients with epilepsy or increased risk of seizures, as this risk may be further increased;
in patients with liver or kidney disease;
if the patient suffers from depression and is taking antidepressants, because some of them may interact with tramadol (see "Tramal Retard and other medicines"). After taking tramadol alone or in combination with certain antidepressants, there is a small risk of developing so-called serotonin syndrome. If the patient experiences any symptoms of this serious condition, they should immediately consult a doctor (see section 4 "Possible side effects").

Tolerance, dependence and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may
reduce the effectiveness of the medicine (the patient's body becomes accustomed to the medicine, known as tolerance). Repeated use of Tramal Retard may also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer 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 may occur in the following situations:

the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines 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, 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 prescribed.
- The patient uses 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 the use of the medicine.
- After stopping the medicine, the patient feels unwell, and feels better after taking it again ("withdrawal effects"). If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment approach, including when and how to safely discontinue the medicine (see section 3, "Discontinuing Tramal Retard").

Tramal Retard may cause psychological and physical dependence. Long-term use of Tramal Retard 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 or a history of addiction, 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 these symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.
Sleep-related breathing disorders
Tramal Retard 100, 150 and 200 may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.
Caution is advised in patients with suppressed respiratory centre function, especially when taking other medicines that depress the central nervous system (see "Tramal Retard and other medicines") or when taking doses higher than recommended (see "Use of higher than recommended dose of Tramal Retard" in section 3 and section 4), as respiratory depression cannot be ruled out in such 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 when the patient is simultaneously taking other medicines that lower the seizure threshold (see section "Tramal Retard and other medicines").
Consult your doctor if any of the above situations occur during treatment with Tramal Retard, even if these warnings refer to conditions from the past.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation 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 the patient experiences any of the following adverse effects: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
Children and adolescents
Use in children with respiratory disorders
Tramadol is not recommended in children with respiratory disorders, as symptoms of tramadol toxicity may be more severe in this group.
Tramal Retard and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Tramal Retard must not be used together with MAO inhibitors (medicines used to treat depression) or within 14 days after discontinuation of such medicines (see section "When not to use Tramal Retard").
The analgesic effect of Tramal Retard may be reduced and its duration shortened when used concomitantly with medicines containing:

carbamazepine (an antiepileptic medicine),
pentazocine, nalbuphine or buprenorphine (analgesics),
ondansetron (an antiemetic medicine). Consult your doctor regarding the use and dosing of Tramal Retard.

The risk of adverse effects increases:

when Tramal Retard is used concomitantly with other analgesics such as morphine and codeine (including as a cough suppressant) and alcohol. Drowsiness or fainting may occur. In such cases, consult your doctor.
when Tramal Retard is used together with sedatives or hypnotics (e.g., benzodiazepines), gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain), as this increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and potentially life-threatening outcomes. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Tramal Retard together with sedatives, the dose and duration of combined treatment should be strictly limited by the doctor. Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the above-mentioned symptoms. Contact your doctor if such symptoms occur.
if the patient is taking other medicinal products 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 (e.g., bupropion, mirtazapine, tetrahydrocannabinol). The risk of seizures may increase if the patient takes Tramal Retard together with these medicines. Consult your doctor whether it is safe to take Tramal Retard while using the above-mentioned medicines.
if the patient is taking certain antidepressants, Tramal Retard may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
when using anticoagulant medicines such as coumarin derivatives (to reduce blood clotting), e.g., warfarin, together with Tramal Retard. Bleeding may occur due to the effects of these medicines on the blood clotting system.

Ketoconazole (an antifungal medicine) and erythromycin (a bacteriostatic antibiotic) may inhibit the metabolism of tramadol and its active metabolite.
Taking Tramal Retard with food, drink and alcohol
Do not drink alcohol while taking Tramal Retard, as the effect of the medicine may be intensified, potentially leading to respiratory depression.
Food does not affect the efficacy of Tramal Retard.
Pregnancy, breastfeeding and fertility:
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of using tramadol during pregnancy has not been established. Therefore, Tramal Retard should not be used during pregnancy.
Long-term 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 100, 150 and 200 mg should not be taken more than once, or if more than one dose has been taken, breastfeeding should be discontinued.
Experience with the use of tramadol in humans does not indicate that tramadol affects fertility in women or men.
Driving and operating machinery
Even at recommended doses, Tramal Retard may cause drowsiness, dizziness and blurred vision, which may affect reaction speed. Therefore, patients should not drive or operate machinery.
Tramal Retard contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

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

This medicine should always be used 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 using Tramal Retard, when and for how long the medicine should be taken, when to contact your doctor, and when the medicine should be discontinued (see also section 2).
Your doctor will adjust the dose according to the intensity of pain and your individual response to treatment. This will be the lowest dose effectively relieving pain. Do not take more than 400 mg of tramadol hydrochloride per day unless otherwise directed by your doctor.
Unless otherwise directed by your doctor, the usual dosage is as follows:

Adults and adolescents over 12 years of age
One tablet of Tramal Retard 100 twice daily (corresponding to 200 mg of tramadol hydrochloride per day), preferably in the morning and evening.
or
One tablet of Tramal Retard 150 twice daily (corresponding to 300 mg of tramadol hydrochloride per day), preferably in the morning and evening.
or
One tablet of Tramal Retard 200 twice daily (corresponding to 400 mg of tramadol hydrochloride per day), preferably in the morning and evening.

If necessary, your doctor may prescribe a different dosage regimen better suited to your needs.

Children
Tramal Retard 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, your doctor may recommend extending the time interval between doses.

Patients with renal impairment, on dialysis, or with hepatic impairment
Tramal Retard must not be taken in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, your doctor may recommend extending the dosing intervals.

Method of administration:
Tramal Retard tablets are for oral use only.
The tablet must always be taken whole, with a small amount of liquid. Do not divide or chew the tablet. The medicine may be taken independently of meals.

Duration of treatment:
Do not use Tramal Retard longer than absolutely necessary. If long-term treatment is required due to the type and severity of the condition, your doctor will regularly monitor your condition (possibly interrupting treatment for a period if necessary) to determine whether and at what dose Tramal Retard treatment should continue.

If you feel that the effect of Tramal Retard is too strong or too weak, consult your doctor or pharmacist.

Taking more Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 than prescribed:
After taking doses higher than recommended, the following may occur: pinpoint pupil constriction, vomiting, drop in arterial blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma (a state of deep unconsciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, seek medical advice immediately!

If you forget to take Tramal Retard:
If you miss a dose, your pain symptoms may return.
Do not take a double dose to make up for a missed dose.
Resume your regular dosing schedule.

Stopping Tramal Retard:
If treatment with Tramal Retard is stopped suddenly or prematurely, your pain symptoms are likely to return.
If you wish to discontinue treatment due to side effects, inform your doctor.
Do not stop taking this medicine suddenly without medical advice. If you wish to stop taking Tramal Retard, especially after long-term use, discuss this with your doctor.
Your doctor will advise you when and how to stop the medicine, possibly by gradually reducing the dose to minimize the risk of withdrawal symptoms.

Generally, no serious post-treatment symptoms are observed after discontinuation of Tramal Retard. However, in rare cases, after abrupt discontinuation of Tramal Retard following prolonged use, patients may feel unwell. Symptoms may include restlessness, anxiety, nervousness, tremors, hyperactivity, difficulty falling asleep, and gastrointestinal or intestinal disturbances.

Very rarely, the following may occur: panic attacks, hallucinations, abnormal sensory perceptions such as itching, tingling, numbness, and tinnitus.
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 stopping the medicine, consult your doctor immediately.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should seek immediate medical advice if symptoms of an allergic reaction occur,
such as: swollen face, tongue and (or) throat and (or) difficulty swallowing or
urticaria associated with breathing difficulties, low blood pressure, weakness, fainting
due to life-threatening anaphylactic shock. Allergic reactions are rare

in 1 to 10 out of 10,000 patients.

The most commonly reported adverse reactions during treatment with Tramal Retard occurring more frequently than in 1 out of 10 people were nausea and dizziness.
Very common dizziness,
(occurs more frequently than nausea.
in more than 1 in 10 people):
Common headache, drowsiness,
(occurs in 1 to 10 in vomiting, constipation, dry mouth,
100 people): excessive sweating,
fatigue.
Uncommon cardiac and circulatory disorders (palpitations, rapid
(occurs in 1 to 10 in heartbeat, feeling of weakness due to reduced blood pressure
1,000 people): upon changing position from lying to standing, and collapse). Such
adverse reactions may occur especially during intravenous
administration of tramadol pharmaceutical forms, and in patients after
physical exertion.
Vomiting reflex, stomach and intestinal irritation (feeling of pressure
in the stomach, bloating), diarrhoea,
skin reactions (e.g. itching, rash, urticaria).
Rare slow heartbeat,
(occurs in 1 to 10 in increased blood pressure,
10,000 people): changes in appetite,
slow breathing, "shortness of breath" (dyspnoea).
Exacerbation of bronchial asthma has been reported during tramadol treatment,
although a causal relationship between these events has not been established.
When doses significantly higher than recommended are taken,
and when other medicines that depress the central nervous system are used
concomitantly (e.g. sedatives, sleep-inducing medicines, other analgesics, alcohol),
respiratory depression may occur.
Abnormal sensation of stimuli (e.g. itching, tingling, numbness), tremor,
seizures, muscle spasms, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after administration of high doses
of tramadol and when other medicines that may provoke seizures are used concomitantly;
Hallucinations, confusion, sleep disturbances, delirium, restlessness,
and nightmares. Psychiatric disorders may occur after administration of Tramal.
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 reduced sensory and cognitive perception
(changes in sensation and recognition which may lead to misjudgment of situations);
The medicine may cause dependence.
If treatment is suddenly discontinued, withdrawal symptoms may occur (see "Discontinuation of Tramal Retard");
Pupil constriction (miosis), blurred vision, excessive pupil dilation (mydriasis),
muscle weakness;
difficulty or pain when urinating, reduced urine volume
(urinary retention);
allergic reactions (e.g. breathing difficulties, wheezing, skin swelling) and shock (sudden circulatory failure);
Very rare increased liver enzyme activity.
(occurs less frequently than
in 1 in 10,000 people):
Unknown (frequency cannot be estimated from the available data): low blood sugar concentration, 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, diarrhoea)
(see section 2 Important information before taking Tramal Retard).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

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

Keep this medicine out of 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 packaging. The expiry date refers to the last day of the stated month.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tramal Retard 100 contains

The active substance is tramadol hydrochloride. Each 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 anhydrous silica, 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. Each 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 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 Tramal Retard 200 contains

The active substance is tramadol hydrochloride. Each prolonged-release tablet of Tramal Retard 200 contains 200 mg of tramadol hydrochloride (Tramadoli hydrochloridum) as the active substance.
Other ingredients 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 contents of the pack:
Tramal Retard 100: white, round tablets, embossed with "T1" on one side and the manufacturer's logo  on the other side.
Tramal Retard 150: pale orange, round tablets, embossed with "T2" on one side and the manufacturer's logo  on the other side.
Tramal Retard 200: slightly brownish with an orange tint, round tablets, embossed with "T3" on one side and the manufacturer's logo  on the other side.
Al/PVC/PVDC or Al/PP blisters in cardboard packaging. Each blister contains 10 tablets. Available pack sizes: 10, 30 and 50 tablets.
Not all pack sizes may be marketed.

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

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