TRAMADOL AUROVITAS 50 mg/mL Injectable Solution and Perfusion Solution, Generic

Introduction

Package Leaflet: Information for the User

Tramadol Aurovitas 50 mg/ml Solution for Injection and Infusion EFG

Tramadol hydrochloride

Read this entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Tramadol Aurovitas is and what it is used for
2. What you need to know before taking Tramadol Aurovitas
3. How to take Tramadol Aurovitas
4. Possible side effects
5. Storage of Tramadol Aurovitas
6. Package Contents and Additional Information

1. What Tramadol Aurovitas is and what it is used for

Tramadol, the active ingredient of this medicine, is an analgesicof the opioid type that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

This medicine is used for the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol Aurovitas

Do not use Tramadol Aurovitas

• if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are also taking monoamine oxidase inhibitors (MAOIs), a certain type of medicine for the treatment of depression, or if you have taken them in the last 14 days before treatment with this medicine (see "Other medicines and Tramadol Aurovitas").
• if you are epileptic and your seizures are not adequately controlled with treatment.
• if you have drunk enough alcohol to feel dizzy or drunk.
• if you have taken more than the prescribed dose of sleeping pills or other analgesics that can slow down your breathing and reactions (see "Other medicines and Tramadol Aurovitas").

Do not use this medicine for the treatment of withdrawal syndrome caused by opioids (medicines similar to morphine).

Warnings and Precautions

Consult your doctor or nurse before starting to use this medicine:

• if you have a head injury, difficulty breathing, or severe kidney or liver problems.
• if you think you are addicted to other analgesics (opioids).
• if you think you are going to faint.
• if you are in a state of shock (a sign of this state may be cold sweat).
• if you are epileptic or suffer from convulsive crises, as the risk of seizures may increase.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol Aurovitas").
• there is a slight risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of tramadol can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to tramadol may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using tramadol, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and you feel better once you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3 "If you stop treatment with Tramadol Aurovitas").

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person in different ways. In some people, it may not be possible to achieve sufficient pain relief, while others are more likely to experience serious side effects. If you notice any of the following side effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Respiratory disorders related to sleep

Tramadol can cause sleep-related respiratory disorders, such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms can include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor or pharmacist if you experience any of the following symptoms while using tramadol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you should take a hormonal supplement.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

This medicine is not suitable for children under 12 years of age.

Other medicines and Tramadol Aurovitas

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines, as they can interact with this medicine:

• Medicines to thin the blood, such as warfarin.
• Medicines to treat epilepsy, such as carbamazepine.
• Ondansetron (to prevent nausea).
• Monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson's disease).
• Medicines that act on the nervous system, such as hypnotics, tranquilizers, sleeping pills, or analgesics, which can make you feel drowsy or dizzy.
• The risk of side effects increases if you are taking antidepressants; tramadol can interact with these medicines and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• Medicines that can cause seizures (attacks), such as some antidepressants.
• If you take medicines that can increase the accumulation of tramadol and, therefore, its side effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

The simultaneous use of tramadol and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can cause death. For this reason, simultaneous use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol with sedative medicines, they should limit the dose and duration of simultaneous treatment.

Tell your doctor about all sedative medicines you are taking and follow the recommended dose carefully. It may be useful to ask friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience these symptoms.

Pregnancy and breastfeeding

This medicine must not be administered during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not use tramadol more than once during breastfeeding, or if you use tramadol more than once, you should stop breastfeeding.

According to human experience, it is not suggested that tramadol affects the fertility of men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tramadol. It is essential that, before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it in combination with other medicines.

Using Tramadol Aurovitas with food, drinks, and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified.

Tramadol Aurovitas contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per 2 ml dose, so it is considered essentially "sodium-free".

3. How to use Tramadol Aurovitas

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using tramadol, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

Your doctor or nurse will administer the injection or infusion.

Your doctor will decide what the correct dose isfor you and how and whenthe injection or infusion will be administered.

Since a doctor or nurse will administer the injection or infusion, it is unlikelythat you will be given too much medicine. If you think you have been given too much, tell the person administering it.

If you stop or finish treatment with this medicine too early, it is likely that the pain will return. If you want to stoptreatment due to side effects, consult your doctor or nurse.

How and when to use Tramadol Aurovitas?

This medicine will be injected slowly, usually into a vein under the surface of the arm, or injected into a muscle (usually the buttocks) or under the skin. Alternatively, the tramadol injection solution can be diluted and administered into a vein by infusion.

At the end of this leaflet, additional information is included for doctors and healthcare professionals.

For how long should you use Tramadol Aurovitas?

This medicine should not be administered for longer than necessary. If you require prolonged treatment, your doctor will monitor you at short and regular intervals (with interruptions in treatment, if necessary) to determine whether you should continue treatment with tramadol and at what dose.

If you think the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you use more Tramadol Aurovitas than you should

In case of overdose, the following symptoms may occur: miosis (pupil constriction), vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), generalized epileptic seizures (severe), as well as breathing difficulties, which can lead to respiratory arrest. In these cases, consult a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Tramadol Aurovitas

If you forget to use the medicine, it is likely that the pain will return. Do not use a double dose to make up for forgotten doses; simply continue using the medicine as you have been doing until now.

If you stop treatment with Tramadol Aurovitas

You should not stop using this medicine suddenly unless your doctor tells you to. If you want to stop using your medicine, talk to your doctor first, especially if you have been using it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no side effects occur when stopping treatment with tramadol. However, in rare cases, people treated with tramadol for some time may not feel well when stopping treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be confused, hyperactive, have difficulty sleeping, or have stomach and intestinal problems. Very few people suffer from panic attacks, delirium, paranoia, hallucinations, or a feeling of loss of identity. They may experience unusual sensations, such as itching, tingling, numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment, consult your nurse or doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

• Allergic reactions to tramadol hydrochloride have been reported. If you have difficulty breathing, rash or itching of the skin, swelling of the face or tongue, or difficulty swallowing, stop using this medicine and consult your doctor immediately.
• You may suffer from seizures (attacks), headache, blurred vision, or dilation or constriction of the pupils.
• You may notice that you sweat more or are short of breath, develop a rash with itching or numbness.
• You may feel drowsy, sleepy, tired, with little energy, or dizzy, or you may have difficulty speaking.
• Muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), tingling sensation, and tremor or muscle weakness may occur.
• There may be an increase in liver enzymes.
• You may experience changes in heartbeats (faster or slower) or increased or decreased blood pressure.
• You may suffer from constipation, dry mouth, changes in appetite, or diarrhea.
• You may have psychological effects, including: changes in mood, activity, behavior, or perception, hallucinations, confusion, agitation, sleep disturbances, delirium, anxiety, and nightmares.
• You may have nausea or vomiting, retching, feeling of bloating or fullness.
• Dependence on tramadol may occur. Inform your doctor if you notice it.
• Shortness of breath, slow breathing, or worsening of asthma may occur.
• You may have difficulty urinating.
• You may experience a decrease in blood sugar levels, speech disorders, or dilation or constriction of the pupils.
• Hypo - Frequency not known (cannot be estimated from the available data).
  • Serotonin syndrome, which can manifest as changes in mental status (e.g., agitation, hallucinations, coma) and other effects, 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, diarrhea) (see section 2 "What you need to know before taking Tramadol Aurovitas").

Seizures have been reported in patients taking tramadol at the recommended doses. The risk may increase when the dose of tramadol exceeds the recommended daily dose (400 mg). Tramadol can cause physical and psychological addiction. When taken for a long time, its effect may decrease, so higher doses must be used (development of tolerance).

If you think that this injection or infusion is causing you adverse effects, or you are concerned about it, consult your doctor, nurse, or pharmacist.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol Aurovitas

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date shown on the box and label after CAD. The expiration date is the last day of the month indicated.

The nurse or doctor will check that the medicine is not expired before administering it by injection or infusion.

No special storage conditions are required.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol Aurovitas

• The active ingredient is tramadol hydrochloride.

Each 1 ml ampoule contains 50 mg of tramadol hydrochloride.

Each 2 ml ampoule contains 100 mg of tramadol hydrochloride.

• The other components are sodium acetate trihydrate and water for injectable preparations.

Appearance of Tramadol Aurovitas and Package Contents

Transparent and colorless solution.

Transparent glass ampoule type I with 1 ml or 2 ml of injectable solution. The ampoules are packaged in a pre-printed cardboard box. The boxes contain 5, 50, and 100 ampoules.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for doctors or healthcare professionals:

Tramadol Aurovitas 50 mg/ml solution for injection and infusion EFG

Read this information carefully before using Tramadol Aurovitas 50 mg/ml solution for injection and infusion EFG (hereinafter referred to as Tramadol injectable). For more information, see the technical sheet.

Presentation

Tramadol injectable is presented as a transparent and colorless solution in a transparent glass ampoule type I. Each milliliter contains 50 mg of tramadol hydrochloride.

Dosage and Administration

When the solution and packaging allow, parenteral medicines should be visually inspected before administration to detect particles and discoloration. Only clear solutions should be used.

This medicine is administered intramuscularly, by slow intravenous injection, or diluted in a solution for infusion or through a patient-controlled analgesia device.

The dose should be adjusted to the intensity of the pain and the individual susceptibility of each patient. The effective lowest dose should be used for analgesia. The total daily dose of 400 mg of tramadol hydrochloride should not be exceeded, except in special clinical circumstances.

This medicine should not be administered for longer than strictly necessary. If prolonged analgesic treatment is necessary, careful periodic monitoring should be carried out, with pauses in treatment if necessary.

Adults and Adolescents over 12 years

The usual dose is 50 or 100 mg every 4-6 hours, intravenously or intramuscularly. Intravenous injections should be administered slowly, over 2-3 minutes. The dose should be adjusted according to the intensity of the pain and the response.

For postoperative pain, an initial dose of 100 mg is administered as a bolus. During the following 60 minutes after the initial bolus, additional doses of 50 mg can be administered every 10-20 minutes, up to a total dose of 250 mg (including the initial dose). Subsequently, 50 or 100 mg can be administered every 4-6 hours, up to a total daily dose of 400 mg.

Elderly Patients

In general, it is not necessary to adjust the dose in elderly patients (up to 75 years) without symptomatic renal or hepatic insufficiency. In older patients (over 75 years), there may be a prolongation of elimination. Therefore, if necessary, the dosing intervals should be extended according to the individual needs of the patient.

Renal/Dialysis Insufficiency and Hepatic Insufficiency

In patients with renal and/or hepatic insufficiency, the elimination of tramadol is slow. In these patients, the prolongation of the dosing intervals should be carefully considered, according to the needs of the patient.

Children under 12 years

It is not recommended.

Contraindications

This medicine should not be administered to patients who have previously shown hypersensitivity to the active ingredient or to any of the excipients of this medicine. Tramadol should not be administered to patients with acute intoxication caused by alcohol, hypnotics, central-acting analgesics, opioids, or psychotropic drugs. Like other opioid analgesics, tramadol should not be administered to patients taking monoamine oxidase inhibitors or in the two weeks following their discontinuation. Tramadol is contraindicated in patients with epilepsy that is not adequately controlled with treatment. Tramadol should not be used for the treatment of opioid withdrawal syndrome.

Pharmaceutical Data

Excipients

Sodium acetate trihydrate and water for injectable preparations.

Incompatibilities

Precipitation will occur if the tramadol hydrochloride injection is mixed in the same syringe with injections of diazepam, diclofenac sodium, indomethacin, midazolam, and piroxicam.

Validity Period

3 years.

Storage Precautions

Keep the ampoule in the outer packaging. No special storage conditions are required.

Nature of the Packaging

Transparent glass ampoule type I with 1 ml or 2 ml of injectable solution. The ampoules are packaged in a pre-printed cardboard box. The boxes contain 5, 50, and 100 ampoules.

Instructions for Use and Handling

The solution for infusion should be prepared immediately before use.

Tramadol hydrochloride solution for injection and infusion is physically compatible and chemically stable at controlled room temperature (i.e., 15-25°C) for 24 hours with a 4.2% sodium bicarbonate solution or a Ringer's solution or up to 5 days when mixed with the following diluents for infusion in the concentration range of 0.5 mg/ml to 4.0 mg/ml:

• Intravenous infusion of 0.9% sodium chloride
• Intravenous infusion of 5% glucose
• Intravenous infusion of 0.18% sodium chloride and 4% glucose
• Ringer's lactate solution
• Haemaccel

From a microbiological point of view, the solution should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.