Tramadol Hexal

Package leaflet: Information for the patient

Tramadolo Hexal 50 mg hard capsules, 100 mg/ml oral drops, solution

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tramadolo Hexal is and what it is used for
2. What you need to know before taking Tramadolo Hexal
3. How to take Tramadolo Hexal
4. Possible side effects
5. How to store Tramadolo Hexal
6. Contents of the pack and other information

1. What Tramadolo Hexal is and what it is used for

Tramadolo Hexal contains the active substance tramadol, which belongs to a group of medicines called analgesics, used for the treatment of pain.
This medicine is indicated for the treatment of moderate to severe acute and chronic pain of various origins, as well as pain caused by medical procedures (diagnostic and surgical).

2. What you should know before taking Tramadolo Hexal

Do not take Tramadolo Hexal

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• If you have consumed excessive amounts of alcohol or of medicines such as hypnotics (medicines to help you sleep), analgesics and opioids (medicines for pain), or psychotropic medicines (medicines used to treat mental disorders);
• If you are being treated with medicines for depression called MAO inhibitors or if you have taken such medicines within the last 14 days;
• If you suffer from epilepsy (not adequately controlled by usual therapy).

Do not take Tramadolo Hexal for the treatment of drug dependence (detoxification).
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadolo Hexal.
Take this medicine with particular caution if:

• You are at risk of developing drug addiction or if you suffer from opioid dependence;
• You have brain injuries (head trauma) or are in shock;
• You have disturbances of consciousness (if you feel you are about to faint) and do not know the cause;
• You have severe respiratory problems (disorders of the respiratory center or respiratory function). Particular attention must be paid if you are taking high doses of the medicine or if you are administered medicines that reduce brain activity (CNS) during treatment;
• You suffer from high pressure in the brain (increased intracranial pressure);
• You are allergic to medicines called opioids;
• You have a tendency towards epilepsy or seizures, as the risk of an attack may increase;
• You suffer from liver or kidney disease;
• You suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see "Other medicines and Tramadolo Hexal"). There is a small risk that you may develop the so-called serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol used as monotherapy. Contact your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the opioid class.
Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient becomes accustomed to taking it, a phenomenon known as tolerance). Repeated use of Tramadolo Hexal may also lead to abuse and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control the amount of medicine you need or how often you need to take it.
The risk of developing physical or psychological dependence varies from person to person. The risk of developing physical or psychological dependence on Tramadolo Hexal may increase if:

• You or a family member have a history of alcohol, prescription medicine, or illegal drug abuse or dependence ("addiction");
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Tramadolo Hexal, you may have developed physical or psychological dependence:

• You need to take the medicine for a longer period than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, for example to "stay calm" or "help sleep";
• You have repeatedly tried, but failed, to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to evaluate the most appropriate treatment for you, including when it is appropriate to stop treatment and how to do so safely (see section 3, "If you stop taking Tramadolo Hexal").
Sleep-related breathing disorders
Tramadolo Hexal may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor, who may consider reducing the dose.
Contact your doctor, pharmacist, or nurse if you notice any of the following symptoms while using Tramadolo Hexal:
Extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether hormone replacement therapy is needed.
This medicine may cause seizures, especially in the following cases:

• If taken at doses higher than recommended;
• If you are taking certain medicines that make you more susceptible to seizures, such as centrally acting analgesics (painkillers), local anesthetics (see section “Other medicines and Tramadolo Hexal”);
• If you suffer from epilepsy or are at risk of seizures. In such cases, the medicine should only be taken when absolutely necessary. Seizures have been reported in patients taking tramadol at recommended doses. The risk may increase when tramadol doses exceed the recommended ones, beyond the daily dose limit of 400 mg.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious adverse effects.
If you experience any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of Tramadolo Hexal 50 mg hard capsules is not indicated in children under 12 years of age.
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children.
Other medicines and Tramadolo Hexal
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Do not take Tramadolo Hexal together with certain medicines used to treat depression called MAO inhibitors. In particular, before starting treatment with Tramadolo Hexal, your doctor must ensure that you have not taken these antidepressants within the last 14 days, as serious, potentially life-threatening interactions may occur.
Use particular caution if you are taking:

• Medicines that act on the brain or central nervous system, such as hypnotics, neuroleptics, tranquillizers, and sleeping medicines (benzodiazepines and barbiturates);
• Carbamazepine, a medicine for seizures;
• Gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain);
• Buprenorphine, nalbuphine, pentazocine, pain medicines;
• Morphine derivatives such as certain medicines used to treat cough (antitussives) or drug dependence (substitution treatments);
• Medicines that may cause seizures (convulsive seizures), such as certain antidepressants, antipsychotics, or tetrahydrocannabinol, a medicine used for pain and other conditions;
• Medicines for depression such as selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), MAO inhibitors, tricyclic antidepressants, bupropion, mirtazapine. The risk of adverse effects increases if you take certain antidepressants; Tramadolo Hexal may interact with these medicines and you may develop serotonin syndrome (see section 4 "Possible side effects"). If you experience these symptoms, stop treatment and inform your doctor, who will determine appropriate therapy based on the type and severity of your symptoms;
• Coumarin anticoagulants (medicines that thin the blood), such as warfarin;
• Medicines that interfere with the elimination of tramadol from the body, such as ketoconazole, erythromycin;
• Ondansetron, a medicine to reduce vomiting;
• Medicines for psychiatric conditions such as antipsychotics.

Tramadolo Hexal and alcohol
Avoid drinking alcoholic beverages during treatment with this medicine, as alcohol may increase the sedative effects of the medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Tramadolo Hexal during pregnancy because it may harm the unborn child.
Your doctor will decide whether it is necessary to administer this medicine to you before or during childbirth.
There is limited information regarding the safety of tramadol in pregnant women. Therefore, if you are pregnant, you should not use Tramadolo Hexal. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tramadolo Hexal more than once during breastfeeding, or alternatively, if you take Tramadolo Hexal more than once, you must stop breastfeeding.
Driving and using machines
This medicine may cause drowsiness or dizziness and may therefore impair your ability to drive or operate machinery. This is especially likely if you have taken alcohol or medicines that act on the brain (psychoactive substances). If you experience impaired reaction ability, avoid driving and using machinery.
Tramadolo Hexal 50 mg hard capsules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.
Tramadolo Hexal 100 mg/ml oral drops, solution contains sucrose, propylene glycol, and ethanol
This medicine contains a sugar, sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. This medicine contains 161.8–155.328 mg of ethanol in 1 ml, thus containing 20.5–19.7 vol % ethanol (alcohol), e.g., up to 161.8–155.2 mg per 40 drops (100 mg), equivalent to 4.1–3.9 ml of beer and 1.76 ml of wine per dose. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 124.5 mg of propylene glycol in 1 ml.

3. How to take Tramadolo Hexal

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and at regular intervals during treatment, your doctor will discuss with you
what to expect from the use of Tramadolo Hexal, when and for how long you should take it, when to
contact your doctor, and when to stop taking it (see also section 2).
Depending on your condition and the intensity of pain, your doctor will determine the necessary dose
and advise you on the lowest effective dose. Except under special clinical conditions, do not exceed
400 mg of tramadol per day.
Do not take this medicine for longer than necessary. If long-term pain treatment is required, you must
undergo regular check-ups to determine whether further extension of treatment duration is appropriate.
The recommended dose for capsules is: 1–2 capsules (50–100 mg) every 4–6 hours.
Swallow the capsules whole with sufficient liquid, without dividing or chewing them.
You may take the capsules regardless of meals.
The recommended dose for oral drops is 20 drops (equivalent to 50 mg) to 40 drops (equivalent to 100 mg),
every 4–6 hours. You may dilute the drops in a small amount of beverage of your choice.

Use in children and adolescents
The use of capsules is not indicated in children under 12 years of age.
The dosage of drops for children over one year of age will be determined by the doctor based on body
weight, considering that the single dose is 1–2 mg of tramadol per kg of body weight. It is recommended
not to exceed the maximum daily dose of 8 mg per kg of body weight or 400 mg of tramadol hydrochloride.
The recommended doses are listed below:

• Body weight 10 kg (approximately 1 year): 4–8 drops;
• Body weight 15 kg (approximately 3 years): 6–12 drops;
• Body weight 20 kg (approximately 6 years): 8–16 drops;
• Body weight 30 kg (approximately 9 years): 12–24 drops;
• Body weight 40 kg (approximately 11 years): 18–36 drops.
  In adolescents over 12 years of age, Tramadolo Hexal may be administered using the normal recommended doses.

Use in the elderly
If you are under 75 years of age and do not have liver or kidney problems, you may take the normal
recommended dose. If you are over 75 years of age, your doctor will determine the appropriate dose based
on your condition.

Use in patients with kidney or liver problems
If you have any of these conditions, your doctor will determine the dose according to your health status.

If you take more Tramadolo Hexal than you should
If you take an excessive dose of this medicine, you may experience pupil constriction (miosis), vomiting,
severe circulatory problems (cardiocirculatory collapse), disturbances of consciousness up to coma,
seizures, and severe breathing difficulties (respiratory depression up to respiratory arrest).
Your doctor will determine the appropriate treatment depending on your symptoms.
In case of accidental ingestion or overdose of Tramadolo Hexal, contact your doctor immediately or go to
the nearest hospital.

If you forget to take Tramadolo Hexal
Take the medicine as soon as you remember. If it is almost time for the next dose, do not take the missed
dose, but take the next dose at the scheduled time. Do not take a double dose to make up for the missed one.

If you stop taking Tramadolo Hexal
If you stop or discontinue treatment too early, your pain is likely to return.
If you wish to stop treatment due to adverse effects, consult your doctor.
You must not stop taking this medicine abruptly, unless instructed by your doctor. If you wish to stop
taking the medicine, discuss it with your doctor first, especially if you have been taking it for a long time.
Your doctor will advise you when and how to stop treatment, which may involve gradually reducing the
dose to minimize the risk of avoidable side effects (withdrawal symptoms).
Generally, discontinuation of Tramadolo Hexal does not lead to withdrawal effects.
However, in rare cases, some individuals who have taken Tramadolo Hexal for a prolonged period may
feel unwell when stopping abruptly.
They may:

• • feel restless, anxious, nervous, or weak;
• • be hyperactive, have difficulty sleeping, or experience stomach or intestinal disturbances;
• • experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, or ringing in the ears (tinnitus);
• • experience other rare central nervous system (CNS) symptoms such as confusion, delusions, altered perception of self (depersonalization), altered perception of reality (derealization), and feelings of persecution (paranoia).

If you experience any of these symptoms after stopping treatment with Tramadolo Hexal, consult your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Consult a doctor immediately if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• hives
• difficulty breathing.

The following side effects may occur:
Very common (may affect more than 1 in 10 people):

• dizziness;
• nausea.

Common (may affect up to 1 in 10 people):

• headache (cephalalgia), drowsiness;
• constipation, dry mouth, vomiting;
• sweating;
• fatigue.

Uncommon (may affect up to 1 in 100 people):

• disturbances in vascular control: dizziness when standing up due to a rapid drop in blood pressure (postural hypotension), serious circulatory problems (cardiovascular collapse), irregular heart rhythm (palpitations, tachycardia). These side effects are more likely if you are physically stressed.
• nausea, irritation and gastrointestinal problems (sensation of pressure in the stomach, feeling of fullness), diarrhoea;
• skin reactions (e.g. itching, rash, hives).

Rare (may affect up to 1 in 1,000 people):

• reduced heart rate (bradycardia), increased blood pressure;
• changes in appetite;
• worsening of asthma, difficulty breathing (dyspnoea); you may experience respiratory depression if you take a dose much higher than recommended or if you take other substances that depress the central nervous system;
• speech disorders, altered sensation in arms, legs or other body parts (paraesthesiae), tremor, epileptic-type seizures, involuntary muscle contractions, abnormal coordination, transient loss of consciousness (syncope); the occurrence of seizures is more likely:
  • after taking high doses of Tramadolo Hexal;
  • after taking medicines that cause or make seizures more likely.
• hallucinations, confusion, sleep disturbances, delirium, anxiety, nightmares; during treatment with tramadol, psychological disturbances may occur, which may vary in severity and type depending on:
  • your personality;
  • the duration of your treatment with Tramadolo Hexal. Symptoms may include:
    • mood changes – usually excitement (euphoria), occasionally an unpleasant mood (dysphoria);
    • changes in activity (usually reduced activity, sometimes increased activity);
    • altered ability to think and perceive things clearly (cognitive and sensory functions), such as:
      • decision-making (decision behaviour);
      • lack of awareness or understanding (perception disorders).
• dependence;
• withdrawal symptoms such as restlessness, anxiety, nervousness, insomnia, excessive movement (hyperkinesia), tremors and gastrointestinal symptoms; other symptoms observed after discontinuation of tramadol include: panic attacks, severe anxiety, hallucinations, altered sensation in limbs or other body parts (paraesthesiae), ringing in the ears (tinnitus), and unusual central nervous system symptoms (such as confusion, hallucinations, depersonalization, perception disorders, paranoia);
• reduced or increased pupil size (miosis, mydriasis), blurred vision;
• muscle weakness;
• difficulty urinating (dysuria) and reduced urine output (urinary retention);
• allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema, anaphylaxis).

Very rare (may affect less than 1 in 10,000 people):

• increased liver enzyme levels

Not known (frequency cannot be estimated from the available data):

• reduced blood sugar levels (hypoglycaemia)
• hiccups
• serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma), and 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 "What you need to know before taking Tramadolo Hexal").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadolo Hexal

Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place, where other people cannot access it. 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 carton after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tramadolo Hexal 50 mg hard capsules contains

• The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.
• The other components are: calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch, magnesium stearate. Capsule shell constituents: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), indigo carmine (E 132).

What Tramadolo Hexal 100 mg/ml oral drops, solution contains

• The active substance is tramadol hydrochloride. 1 ml of solution contains 100 mg of tramadol hydrochloride.
• The other components are: potassium sorbate, ethanol 96%, propylene glycol, sucrose, polysorbate 80, peppermint flavor, purified water.

Description of the appearance of Tramadolo Hexal and contents of the pack

Tramadolo Hexal 50 mg hard capsules: cardboard pack containing 20 capsules of 50 mg.
Tramadolo Hexal oral drops, solution: bottle containing 10 ml of solution.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
Hard capsules:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany).
Oral drops, solution:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany).

Patient Information Leaflet: Information for the patient

Tramadolo Hexal 100 mg/2 ml solution for injection

Generic medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What Tramadolo Hexal is and what it is used for

Tramadolo Hexal contains the active substance tramadol, which belongs to a group of medicines called analgesics, used to treat pain.
This medicine is indicated for the treatment of moderate to severe acute and chronic pain of various origins, as well as pain caused by medical procedures (diagnostic and surgical).

2. What you need to know before using Tramadolo Hexal

Do not use Tramadolo Hexal

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• If you have consumed excessive amounts of alcohol or of medicines such as hypnotics (medicines to aid sleep), analgesics (painkillers), opioids, or psychotropic drugs;
• If you are currently being treated with antidepressant medicines called MAO inhibitors, or if you have taken such medicines within the last 14 days;
• If you suffer from epilepsy (not adequately controlled by therapy).

Do not use Tramadolo Hexal for the treatment of drug dependence (detoxification).
Warnings and precautions
Talk to your doctor or pharmacist before using Tramadolo Hexal.
Use this medicine with particular caution if:

• You are at risk of developing drug addiction or if you suffer from opioid dependence;
• You have brain injuries (head trauma) or are in a state of shock;
• You experience disturbances in consciousness (if you feel like fainting) and do not know the cause;
• You have severe respiratory problems (respiratory center or respiratory function disorders). Particular attention must be paid if you are using high doses of this medicine or if you are administered other medicines that reduce brain activity (CNS depressants) during treatment;
• You suffer from high pressure in the brain (increased intracranial pressure);
• You are allergic to medicines known as opioids;
• You suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see "Other medicines and Tramadolo Hexal").

There is a small but existing risk that you may develop the so-called serotonin syndrome, which
may occur after taking tramadol together with certain antidepressants or tramadol used as
monotherapy. Contact your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").
Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the opioid class.
Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient becomes accustomed to its use, a phenomenon known as tolerance). Repeated use of Tramadolo
Hexal may also lead to abuse and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control the amount of medicine you need or how often you need to take it.
The risk of developing physical or psychological dependence varies from person to person. The risk of developing physical or psychological dependence on Tramadolo Hexal may increase if:

• You or a family member has a history of alcohol, prescription medicine, or illegal drug abuse or dependence ("addiction");
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs while taking Tramadolo Hexal, you may have developed physical or psychological dependence:
• You need to take the medicine for longer than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, e.g., to "stay calm" or "help sleep";
• You have repeatedly tried, but failed, to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal effects"). If you notice any of these signs, consult your doctor to evaluate the most appropriate treatment plan for you, including when it is appropriate to discontinue treatment and how to do so safely (see section 3, "If you stop taking Tramadolo Hexal").

Sleep-related breathing disorders
Tramadolo Hexal may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor, who may consider reducing the dose.
Contact your doctor, pharmacist, or nurse if you experience any of the following symptoms while using Tramadolo Hexal:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These symptoms may indicate adrenal insufficiency (low cortisol levels).
If you experience these symptoms, contact your doctor, who will decide whether you need hormonal replacement therapy.
This medicine may cause seizures, especially in the following cases:

• If taken at doses higher than recommended;
• If you are taking certain medicines that lower the seizure threshold (see section “Other medicines and Tramadolo Hexal”);
• If you suffer from epilepsy or are at risk of seizures. In such cases, the medicine should only be taken when absolutely necessary.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation in this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience severe adverse effects.
If you notice any of the following adverse effects, you must stop taking this medicine and contact your doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, feeling unwell or malaise, constipation, loss of appetite.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse.
Other medicines and Tramadolo Hexal
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Do not use Tramadolo Hexal together with certain antidepressant medicines known as MAO inhibitors. In particular, before starting treatment with Tramadolo Hexal, your doctor must ensure that you have not taken these antidepressants within the last 14 days, as serious, potentially life-threatening interactions may occur.
Use particular caution if you are taking:

• Medicines that act on the central nervous system, such as hypnotics, neuroleptics, tranquilizers, and sleeping medicines (benzodiazepines and barbiturates);
• Carbamazepine, a medicine for seizures;
• Gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain);
• Buprenorphine, nalbuphine, pentazocine, pain medicines;
• Morphine derivatives, such as certain medicines used for cough (antitussives) or for drug addiction treatment (substitution therapies);
• Medicines that may cause seizures (seizure attacks), such as certain antidepressants, antipsychotics, or tetrahydrocannabinol, a medicine used for pain and other conditions;
• Antidepressant medicines such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), MAO inhibitors, tricyclic antidepressants, bupropion, mirtazapine. The risk of adverse effects increases; if you take certain antidepressants, Tramadolo Hexal may interact with these medicines and you may develop serotonin syndrome (see section 4 "Possible side effects"). If you experience these symptoms, stop treatment and inform your doctor, who will determine appropriate therapy based on the type and severity of your symptoms;
• Coumarin anticoagulants (blood-thinning medicines), such as warfarin;
• Medicines that interfere with the elimination of tramadol from the body, such as ketoconazole, erythromycin;
• Ondansetron, a medicine to reduce vomiting;
• Medicines for psychiatric conditions, such as antipsychotics.

Tramadolo Hexal and alcohol
Avoid drinking alcoholic beverages during treatment with this medicine, as alcohol may increase the effects of the medicine on the central nervous system.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not take Tramadolo Hexal during pregnancy, as it may harm the unborn child. Your doctor will decide whether it is necessary to administer this medicine before or during childbirth.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tramadolo Hexal more than once during breastfeeding; alternatively, if you take Tramadolo Hexal more than once, you must stop breastfeeding.
Driving and using machines
This medicine may cause drowsiness or dizziness and may therefore impair your ability to drive or operate machinery. This is particularly likely if you have consumed alcohol or medicines that act on the brain (psychoactive substances). If you experience impaired reaction ability, avoid driving and using machinery.
Tramadolo Hexal contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per vial, i.e., it is practically sodium-free.

3. How to use Tramadolo Hexal

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Before starting treatment and at regular intervals during treatment, your doctor will discuss with you what you can expect from using Tramadolo Hexal, when and for how long you should take it, when you should contact your doctor, and when you should stop taking it (see also section 2).

Depending on your condition and the intensity of pain, your doctor will determine the necessary dose and advise you on the lowest effective dose. Except under specific clinical conditions, do not exceed 400 mg of tramadol per day.

Do not use this medicine for longer than necessary. If long-term pain treatment is required, you must undergo regular check-ups to determine whether the treatment should be prolonged.

The recommended dose is 50–100 mg of tramadol hydrochloride every 4–6 hours.

This medicine must be injected slowly or administered via infusion after appropriate dilution with infusion solutions.

Do not mix Tramadolo Hexal with injectable solutions containing:

• non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation, particularly diclofenac, piroxicam, indometacin, phenylbutazone;
• diazepam and flunitrazepam, medicines used to treat anxiety and seizures;
• nitroglycerin, a medicine used to treat heart problems.

Use in children and adolescents
The recommended single dose is 1–2 mg of tramadol per kg of body weight. It is recommended not to exceed the maximum dose of 8 mg per kg of body weight or 400 mg of tramadol hydrochloride per day.
In adolescents over 12 years of age, Tramadolo Hexal may be administered using the normal recommended doses.

Use in the elderly
If you are under 75 years of age and do not have liver or kidney problems, you may use the normal recommended dose. If you are over 75 years of age, your doctor will determine the necessary dose based on your condition.

Use in patients with kidney or liver problems
If you have any of these conditions, your doctor will determine the dose according to your health status.

If you use more Tramadolo Hexal than you should
If you take an excessive dose of this medicine, you may experience pupil constriction (miosis), vomiting, severe circulatory problems (cardiocirculatory collapse), disturbances of consciousness up to coma, seizures, and severe breathing problems (respiratory depression up to respiratory arrest).

Your doctor will decide on appropriate treatment depending on your symptoms.

In case of accidental ingestion of Tramadolo Hexal, contact your doctor immediately or go to the nearest hospital.

If you forget to use Tramadolo Hexal
Take the medicine as soon as you remember. If it is almost time for your next dose, do not take the missed dose but take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop using Tramadolo Hexal
Do not stop taking this medicine suddenly, unless instructed by your doctor. If you wish to discontinue the medicine, discuss this first with your doctor, especially if you have been taking it for a long time.

Your doctor will advise you when and how to stop treatment, which may involve gradually reducing the dose to minimize the risk of avoidable side effects (withdrawal symptoms).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:

Very common (may affect more than 1 in 10 people):

• dizziness;
• nausea.

Common (may affect up to 1 in 10 people):

• headache (cephalalgia), drowsiness;
• constipation, dry mouth, vomiting;
• sweating;
• fatigue.

Uncommon (may affect up to 1 in 100 people):

• disturbances in vascular control: dizziness when standing up due to a rapid drop in blood pressure (postural hypotension), severe circulatory problems (cardiovascular collapse), irregular heart rhythm (palpitations, tachycardia). These side effects are more likely if you are under physical stress.
• retching, irritation and gastrointestinal disturbances (sensation of pressure in the stomach, feeling of fullness), diarrhoea;
• skin reactions (e.g. itching, rash, urticaria).

Rare (may affect up to 1 in 1,000 people):

• reduced heart rate (bradycardia), increased blood pressure;
• changes in appetite;
• worsening of asthma, breathing difficulties (dyspnoea); respiratory depression may occur if you take a dose much higher than recommended or if you take other substances that depress the central nervous system;
• speech disorders, altered sensation in arms, legs or other body parts (paraesthesia), tremor, epileptic-type seizures, involuntary muscle contractions, abnormal coordination, transient loss of consciousness (syncope); the occurrence of seizures is more likely:
  • after taking high doses of Tramadolo Hexal;
  • after taking medicines that cause or increase the risk of seizures.
• hallucinations, confusion, sleep disturbances, delirium, anxiety, nightmares; during treatment with tramadol, psychological disturbances may occur, which may vary in intensity and type depending on:
  • your personality;
  • the duration of your treatment with Tramadolo Hexal. Symptoms include:
    • mood changes – usually excitement (euphoria), occasionally an unpleasant mood (dysphoria);
    • changes in activity (usually reduced activity, sometimes increased activity);
    • altered ability to think and perceive things clearly (cognitive and sensory functions), such as:
      • decision-making (decision behaviour);
      • lack of awareness or understanding (perceptual disturbances).
• dependence;
• withdrawal symptoms such as restlessness, anxiety, nervousness, insomnia, excessive movement (hyperkinesia), tremors, and gastrointestinal symptoms; other symptoms observed after discontinuation of tramadol include: panic attacks, severe anxiety, hallucinations, altered sensation in limbs or other body parts (paraesthesia), ringing in the ears (tinnitus), and unusual central nervous system symptoms (such as confusion, hallucinations, depersonalisation, perceptual disturbances, paranoia);
• reduction or increase in pupil size (miosis, mydriasis), blurred vision;
• muscle weakness;
• difficulty urinating (dysuria) and reduced urine output (urinary retention);
• allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioedema, anaphylaxis).

Not known (frequency cannot be estimated from the available data):

• changes in levels of certain liver substances (increased liver enzymes);
• reduced blood sugar levels (hypoglycaemia);
• hiccups;
• serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and 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 "What you need to know before taking Tramadolo Hexal").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadolo Hexal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tramadolo Hexal contains

• The active substance is: tramadol hydrochloride. One vial contains 100 mg of tramadol hydrochloride.
• The other components are: sodium acetate, water for injections.

Description of the appearance of Tramadolo Hexal and contents of the pack
Carton containing 5 vials of 2 ml.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Weimer Pharma GmbH, Im Steingerust 30 - 76437 Rastatt (Germany)