Tramal

Package leaflet: information for the patient

Tramal, 50 mg, hard capsules
Tramadoli hydrochloridum
Please read the entire leaflet carefully before using 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 doubts, 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 the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is Tramal and what is it used for
2. Important information before using Tramal
3. How to use Tramal
4. Possible side effects
5. How to store Tramal
6. Contents of the pack and other information

1. What is Tramal and what is it used for

Tramadol – the active substance in Tramal – is an analgesic belonging to the opioid group acting on the central nervous system.
It exerts its analgesic effect by acting on specific receptors of nerve cells in the spinal cord and brain.
Tramal is indicated for the treatment of moderate to severe pain.

2. Important information before using Tramal

When not to use Tramal

• 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, painkillers or psychotropic medicines (medicines affecting mood and emotions);
• if the patient is taking medicines from the group of MAO inhibitors (certain antidepressants) and within 14 days after stopping them (see "Tramal and other medicines");
• in patients with epilepsy that is not controlled by treatment;
• in the treatment of opioid dependence.

Warnings and precautions
Before starting to use Tramal, discuss this with your doctor:

• in case of dependence on other painkillers (opioids);
• in disorders of consciousness (if the patient feels faint);
• in shock (cold sweats may be a symptom);
• in case of 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 and other medicines"). There is a small risk of developing the so-called serotonin syndrome when tramadol is taken together with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, he or she should immediately consult a doctor (see section 4 "Possible side effects").

Tolerance, dependence and addiction
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 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 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 may concern people 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, it may indicate dependence or addiction:
• Need to take the medicine for longer than recommended by the doctor.
• Need to take a higher dose than recommended.
• 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 medicine use.
• After stopping the medicine, the patient feels unwell, and feels better after taking it again ("withdrawal symptoms"). If the patient notices any of these symptoms, he or she should consult a doctor to discuss the best treatment approach, including when and how to stop taking the medicine safely (see section 3, "Stopping treatment with Tramal").

Tramal may cause psychological and physical dependence. Long-term use of Tramal
may reduce effectiveness, leading to taking increasingly higher doses (development of tolerance).
In patients with a tendency to drug abuse or 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.
This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.
Sleep-related breathing disorders
Tramal may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing 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 and other medicines") or when taking doses higher than recommended (see "Taking higher than recommended dose of Tramal" 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 if the patient is simultaneously taking other medicines that lower the seizure threshold (see section "Tramal and other medicines").
Consult your doctor if any of the above situations occur during treatment with Tramal,
even if these warnings refer to conditions from the past.

Tramadol is metabolized in the liver by an enzyme. Some people have a genetic variation of this
enzyme, which may lead to different effects. In some individuals, pain relief may be insufficient, while in others, severe adverse effects are more likely. Stop taking the medicine and contact your doctor immediately if any of the following adverse effects occur: 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
The use of tramadol is not recommended in children with respiratory disorders, as tramadol toxicity symptoms may be more severe in them.

Tramal and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Tramal must not be used together with MAO inhibitors (medicines used to treat depression) or within 14 days after stopping them; see section "When not to use Tramal".
The pain-relieving effect of Tramal may be reduced and duration shortened when taken together with medicines containing:

• carbamazepine (an antiepileptic medicine),
• pentazocine, nalbuphine or buprenorphine (painkillers),
• ondansetron (an antiemetic medicine). Consult your doctor about using Tramal and its dosage.

The risk of adverse effects increases:

• when Tramal is taken together with other painkillers such as morphine and codeine (also as a cough suppressant) and alcohol. Drowsiness or faintness may occur. In such cases, consult your doctor.

• when Tramal is taken together with sedatives or sleeping pills (e.g. benzodiazepines) or 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 may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if
  the doctor prescribes Tramal together with sedatives, the doctor should limit the dose and duration of combined treatment. Inform the doctor about all sedatives being taken and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or family members so they are aware of the above symptoms. If such symptoms occur, contact the doctor.

• 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 and 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 the patient takes Tramal together with these medicines. Consult your doctor whether it is safe to take Tramal while on these medicines.

• if the patient is taking certain antidepressants, Tramal may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").

• when anticoagulant medicines containing coumarin derivatives (to reduce blood clotting), e.g. warfarin, are taken together with Tramal. Bleeding may occur due to the effect 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 with food, drink and alcohol
Do not drink alcohol while taking Tramal, as the effect of the medicine may be intensified, potentially leading to respiratory depression.
Food does not affect the action of Tramal.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of tramadol use during pregnancy has not been established. Therefore, Tramal should not be used during pregnancy.
Long-term use of tramadol during pregnancy may lead to withdrawal symptoms in the newborn.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, during breastfeeding, Tramal should not be taken more than once, or if Tramal 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
Even at recommended doses, Tramal may cause drowsiness, dizziness and blurred vision, which may affect reaction speed. Therefore, do not drive or operate machinery.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to use Tramal

This medicine should always be taken exactly as directed by your doctor. 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 taking Tramal, when and for how long it should be taken, when you should 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. The dose will be the lowest effective dose that adequately relieves pain.

Do not take more than 400 mg of tramadol hydrochloride per day, except in cases where your doctor advises otherwise.

Unless otherwise directed by your doctor, the usual dosage is as follows:

Adults and adolescents over 12 years of age
1–2 capsules (corresponding to 50 mg–100 mg of tramadol hydrochloride) every 4–6 hours.

Depending on the severity of pain, the analgesic effect lasts from approximately 4 to 8 hours.

Children
Tramal is not recommended for children under 12 years of age due to the high amount of tramadol in a single dose. The recommended formulation for this age group is oral drops, solution.

Elderly patients
In patients over 75 years of age, elimination of tramadol may be delayed. In these patients, your doctor may recommend extending the interval between doses.

Patients with renal impairment, on dialysis, or with hepatic impairment
Tramal should not be taken in cases of severe hepatic and/or renal impairment.

In cases of mild or moderate impairment, your doctor may recommend increasing the interval between doses.

Method of administration:
Tramal is taken orally.
The capsule should always be taken with sufficient fluid. Do not divide or chew the capsule.
Tramal may be taken independently of meals.

Duration of treatment:
Do not take Tramal 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 (including temporarily interrupting treatment, if necessary) to determine whether and at what dose Tramal treatment should continue.

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

Taking more than the recommended dose of Tramal
After taking doses higher than recommended, the following may occur: pinpoint pupils (as small as a pinhead), vomiting, drop in 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 immediate medical attention!

Missing a dose of Tramal
If you forget to take your dose at the scheduled time, pain symptoms may return.
Do not take a double dose to make up for a missed dose.
Resume your regular dosing schedule.

Stopping Tramal treatment
If Tramal is stopped suddenly or treatment is prematurely discontinued, pain symptoms are likely to return.

If you wish to discontinue treatment due to adverse effects, inform your doctor.

Do not stop taking this medicine abruptly without your doctor’s advice. If you wish to stop taking Tramal, especially after long-term use, discuss this with your doctor. Your doctor will advise when and how to discontinue the medicine, which may involve gradually reducing the dose to minimize the risk of withdrawal symptoms.

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

Very rarely, the following may occur: panic attacks, hallucinations, abnormal sensations 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 discontinuation of Tramal, consult your doctor immediately.

If you have any further doubts about the use of this medicine, consult 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 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 breathing difficulties, low blood pressure, weakness, fainting due to
life-threatening anaphylactic shock. Allergic reactions are rare - occurring in 1 to 10
out of 10,000 patients.
The most common adverse reactions reported more frequently than in 1 out of 10 people during
treatment with Tramal were nausea and dizziness.
Very common dizziness,
(occurring more frequently than nausea.
in more than 1 in 10 people):
Common headache, drowsiness,
(occurring in 1 to 10 in vomiting, constipation, dryness of the oral mucosa,
100 people): excessive sweating,
fatigue.
Uncommon cardiac and circulatory disorders (palpitations, rapid
(occurring in 1 to 10 heartbeat, feeling of weakness due to reduced arterial blood pressure
in 1,000 people): in patients changing body position from lying to standing, and collapse).
Such adverse reactions may occur especially during
intravenous administration of tramadol-containing pharmaceutical forms,
and in patients after physical exertion.
Vomiting reflex, gastric and intestinal irritation (feeling of pressure
in the stomach, bloating), diarrhea,
skin reactions (e.g. itching, rash, urticaria).
Rare slow heartbeat,
(occurring in 1 to 10 in increased arterial blood pressure,
10,000 people): changes in appetite,
slow breathing, "shortness of breath" (dyspnea).
Exacerbation of bronchial asthma has been reported during tramadol treatment,
although a causal relationship between these events has not been established. In case of ingestion of doses significantly higher than recommended,
and simultaneous use of other medicines that depress central nervous system function (e.g. sedatives,
sleep-inducing drugs, other analgesics, alcohol),
respiratory depression may occur.
Abnormal perception of stimuli (e.g. itching, tingling, numbness),
tremors, seizures, muscle spasms, uncoordinated movements,
fainting, speech disorders;
Seizures occur mainly after administration of high doses
of tramadol or when used concomitantly with other drugs that may
induce seizures;
Hallucinations, confusion, sleep disturbances, delirium, anxiety, 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, for example, mood disturbances (usually excitement, sometimes
irritability), changes in activity (usually decreased, sometimes
increased), and reduced sensory and cognitive perception (changes
in sensation and cognition which may lead to incorrect assessment
of situations);
The medicine may cause dependence.
Withdrawal symptoms may occur if treatment is stopped abruptly (see "Discontinuation of Tramal");
Pupil constriction (miosis), blurred vision, excessive pupil dilation (mydriasis),
muscle weakness;
difficulty or pain during urination, reduced urine volume
(urinary retention);
allergic reactions (e.g. breathing difficulties, wheezing,
skin swelling) and shock (sudden circulatory failure);
Very rare increase in liver enzyme activity.
(occurring less frequently than
in 1 in 10,000 people):
Unknown (frequency cannot be estimated from the available data): low blood sugar levels, hiccups, serotonin syndrome, the symptoms of which
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 rigidity, lack of coordination and (or) gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section
2 "Important information before using Tramal").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Tramal

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 even be fatal to persons to 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.
Do not store above 25°C.
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 contains

• The active substance is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• Other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate.

What Tramal looks like and contents of the pack
Yellow, shiny, elongated capsules packed in Al/PVC/PVDC or Al/PP blisters in a cardboard box.
Each blister contains 10 capsules. Available pack sizes: 20 capsules.
Marketing Authorisation Holder and Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20