TRAMADOL/PARACETAMOL AUROVITAS 37.5 mg / 325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Aurovitas 37.5 mg/325 mg Film-Coated Tablets EFG

Tramadol hydrochloride/paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Tramadol/Paracetamol Aurovitas is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Aurovitas
3. How to take Tramadol/Paracetamol Aurovitas
4. Possible side effects
5. Storage of Tramadol/Paracetamol Aurovitas
6. Contents of the pack and other information

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

Tramadol/paracetamol is a combination of two pain relievers, tramadol and paracetamol, which work together to relieve pain.

Tramadol/paracetamol is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that a combination of tramadol and paracetamol is necessary.

Tramadol/paracetamol should only be used by adults and adolescents over 12 years of age.

2. What you need to know before you take Tramadol/Paracetamol Aurovitas

Do not take Tramadol/Paracetamol Aurovitas

• if you are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6).
• if you have taken any medicine for the treatment of insomnia, strong painkillers (opioids) or psychotropic drugs (medicines that can alter mood and emotions) in case of acute alcohol intoxication.
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with tramadol/paracetamol.
• if you have severe liver disease.
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tramadol/paracetamol:

• if you are taking other medicines that contain paracetamol or tramadol.
• if you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may be a sign of jaundice or problems with your bile ducts.
• if you have kidney problems.
• if you have severe breathing difficulties, for example, asthma or severe lung problems.
• if you are epileptic or have had seizures or convulsions.
• if you have recently had a head injury, shock or severe headaches associated with vomiting.
• if you are dependent on any other medicine used for pain relief, for example, morphine.
• if you are taking other medicines for pain relief that contain buprenorphine, nalbuphine or pentazocine.
• if you are going to be anesthetized (inform your doctor or dentist that you are taking tramadol/paracetamol).
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol 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 alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

If you experience any of these problems while taking tramadol/paracetamol, please inform your doctor. He will decide whether you should continue taking this medicine.

During treatment with tramadol/paracetamol, inform your doctor immediately if:

If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Tolerance, dependence and addiction

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

Dependence or addiction can make you feel that you no longer control the amount of medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or someone in your family has abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction").
• You are a smoker.
• You have ever 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 signs while taking tramadol/paracetamol, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than those prescribed, for example, "to calm down" or "to sleep".
• You have repeatedly tried and failed to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell, and you feel better when you take it again ("withdrawal effect")

If you observe any of these signs, talk to your doctor so that he can indicate the best course of treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you stop taking Tramadol/Paracetamol 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, sufficient pain relief may not be achieved, 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 feeling of discomfort or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children with respiratory problems:

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

Respiratory disorders related to sleep

Tramadol/paracetamol may cause respiratory disorders related to sleep, such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may 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 taking tramadol/paracetamol:

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, he will decide whether you should take a hormonal supplement.

Other medicines and Tramadol/Paracetamol Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2).

Important: This medicine contains paracetamol and tramadol. Tell your doctor if you are taking any other medicine that contains paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Tramadol/paracetamol must notbe taken with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Aurovitas").

It is not recommended to use tramadol/paracetamol if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as intense pain attacks in the face called trigeminal neuralgia).
• Buprenorphine, nalbuphine or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of side effects increases if you are also taking:

• if you are taking antidepressants, tramadol/paracetamol may interact with these medicines and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• sedatives, medicines for the treatment of insomnia, other painkillers such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• antidepressants, anesthetics, neuroleptics (medicines that can affect your mental state) or bupropion (to stop smoking). The risk of having a seizure increases. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• warfarin or phenprocoumon (medicine used to prevent blood clots). The effectiveness of these medicines may be altered, with a risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you are also using any of the following medicines:

• Metoclopramide, domperidone or ondansetron (medicines for the treatment of nausea and vomiting).
• Colestyramine (medicine that reduces cholesterol in the blood).
• Ketoconazole or erythromycin (medicines against infections).

Your doctor will know which medicines are safe to use with tramadol/paracetamol.

The simultaneous use of tramadol/paracetamol and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (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/paracetamol with sedative medicines, he must 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 when you experience these symptoms.

Taking Tramadol/Paracetamol Aurovitas with food, drinks and alcohol

Tramadol/paracetamol may make you feel drowsy. Alcohol may make you feel drowsy, so it is recommended not to drink alcohol while taking tramadol/paracetamol.

Pregnancy, breastfeeding and fertility

Because tramadol/paracetamol contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant during treatment with tramadol/paracetamol, consult your doctor before taking the next tablet.

Tramadol can pass into breast milk. For this reason, you should not take tramadol/paracetamol more than once during breastfeeding or, otherwise, if you take tramadol/paracetamol more than once, you should stop breastfeeding.

According to human experience, tramadol does not appear to affect fertility in men and women. There is no data available on the combination of tramadol and paracetamol in fertility.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tramadol/paracetamol. It is important 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 administered with other medicines.

Tramadol/Paracetamol Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Tramadol/Paracetamol Aurovitas

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

You should take tramadol/paracetamol for the shortest possible time. It is not recommended to use this medicine in children under 12 years of age.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age is 2 tablets.

If necessary, you can increase the dose, as recommended by your doctor.

The shortest interval between doses must be at least 6 hours.

Do not take more than 8 tramadol/paracetamol tablets per day.

Do not take tramadol/paracetamol more frequently than indicated by your doctor.

Your doctor may increase the time between doses if:

• you are over 75 years old.
• you have kidney problems.
• you have liver problems.

Method of administration

The tablets are for oral use.

Swallow the tablets whole with enough liquid. Do not break or chew them.

If you think the effect of tramadol/paracetamol is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have adequate pain relief), tell your doctor.

If you take more Tramadol/Paracetamol Aurovitas than you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol/Paracetamol Aurovitas

If you forget to take the tablets, it is likely that the pain will return.

Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Aurovitas

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking 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 unwanted effects occur after stopping treatment with tramadol/paracetamol.

However, in rare cases, patients who have been taking tramadol for a while and have stopped treatment abruptly may feel unwell (see section 4 "Possible side effects"). If you have been taking tramadol/paracetamol for some time, you should consult your doctor before stopping treatment, as your body may have become accustomed to it.

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

4. Possible Adverse Effects

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

Very frequent, may affect more than 1 in 10 people:

• nausea.
• dizziness, drowsiness.

Frequent, may affect up to 1 in 10 people:

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth.
• itching, increased sweating (hyperhidrosis).
• headache, agitation.
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Infrequent, may affect up to 1 in 100 people:

• increased heart rate or blood pressure, cardiac rhythm and frequency disorders.
• difficulty or pain when urinating.
• skin reactions (e.g., eruptions, hives).
• tingling sensation, numbness or pinching sensation in the limbs, ringing in the ears, involuntary muscle spasms.
• depression, nightmares, hallucinations, (hearing, seeing or perceiving something that does not exist in reality), memory loss.
• difficulty swallowing, blood in the stool.
• chills, hot flashes, chest pain.
• difficulty breathing.

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

• seizures, difficulties in carrying out coordinated movements.
• addiction.
• blurred vision.
• transient loss of consciousness (syncope).
• pupil contraction (miosis).
• speech disorders.
• excessive pupil dilation (mydriasis).

Frequency not known (cannot be estimated from the available data):

• decrease in blood sugar levels.
• hypothermia.
• 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 stiffness, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tramadol/Paracetamol Aurovitas").

The following recognized adverse effects have been reported by people who have taken medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should inform your doctor:

• feeling dizzy when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.
• in rare cases, skin eruptions, indicating allergic reactions that can manifest as sudden swelling of the face and neck. Shortness of breath or drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.

In rare cases, using a medicine like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they suddenly stop treatment. They may feel agitated, anxious, nervous, or trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with tramadol/paracetamol, consult your doctor.

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which can result in nosebleeds or bleeding gums.

Taking tramadol/paracetamol with anticoagulants (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

In very rare cases, serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of Adverse Effects

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

5. Conservation of Tramadol/Paracetamol Aurovitas

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the labeling, packaging, and blister pack after CAD. The expiration date is the last day of the month indicated.

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. 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/Paracetamol Aurovitas

• The active ingredients are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other components are:

Core of the tablet:cornstarch, powdered cellulose, sodium carboxymethylcellulose (type A) (derived from potato starch), pregelatinized cornstarch, and magnesium stearate.

Film coating:hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and polysorbate 80.

Appearance of the Product and Package Contents

Light yellow, oblong, biconvex film-coated tablets, with the mark "I 03" on one face and smooth on the other.

Tramadol/Paracetamol Aurovitas film-coated tablets are available in white and opaque PVC/PVdC-aluminum blister packs or in child-resistant PVC white opaque/PVdC-PVC blister packs with an aluminum foil, and in high-density polyethylene (HDPE) white and opaque bottles with a polypropylene cap.

Package sizes:

Blister packs: 10, 20, 30, 60, 90, and 100 film-coated tablets.

HDPE bottles: 30, 250, and 1,000 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Belgium: Tramadol/Paracetamol AB 37,5 mg/325 mg filmomhulde tabletten

Spain: Tramadol/Paracetamol Aurovitas 37,5 mg/325 mg, comprimidos recubiertos con película EFG

Italy: Tramadolo e Paracetamolo Aurobindo

Malta: Tramadol/ Paracetamol Aurobindo 37.5mg/325mg, film-coated tablets

Netherlands: Tramadol HCl/Paracetamol Aurobindo 37,5/325 mg, filmomhulde tabletten

Portugal: Tramadol + Paracetamol Aurobindo

Date of the last revision of this prospectus:January 2025

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/).