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

Introduction

Package Leaflet: Information for the Patient

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

Tramadol hydrochloride/paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tramadol/Paracetamol Aristo and what is it used for
2. What you need to know before taking Tramadol/Paracetamol Aristo
3. How to take Tramadol/Paracetamol Aristo
4. Possible side effects
5. Storage of Tramadol/Paracetamol Aristo
6. Package contents and additional information

1. What is Tramadol/Paracetamol Aristo and what is it 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 treatment of moderate to severe pain when your doctor considers that the 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 taking Tramadol/Paracetamol Aristo

Do not take Tramadol/Paracetamol Aristo

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medication (listed in section 6);
• if you have taken any medication for the treatment of insomnia, potent pain relievers (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medications 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 uncontrolled epilepsy.

Warnings and precautions

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

• if you are taking other medications that contain paracetamol or tramadol.
• if you have liver problems or liver disease or if you notice that your eyes and skin turn yellow. This may be indicative of jaundice or problems with your bile ducts.
• if you have kidney problems.
• if you have severe breathing difficulties, such as asthma or severe lung problems.
• if you have epilepsy or have had seizures or attacks previously.
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting.
• if you are dependent on any other medication used for pain relief, such as morphine.
• if you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine.
• if you are going to be anesthetized. Tell 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 medications and Tramadol/Paracetamol Aristo"). There is a weak 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 symptoms related to this serious syndrome (see section 4 "Possible side effects").

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).

Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. 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 should stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

If you have or have had any of these problems while taking tramadol/paracetamol, please inform your doctor. He will decide whether you should continue taking this medication. Inform 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, and he will decide whether you should take a hormonal supplement.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body gets used to it, which is known as pharmacological 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 be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication 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/paracetamol may be greater if:

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

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

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

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medication, and how to do so safely (see section 3, if you interrupt treatment with tramadol/paracetamol).

Children and adolescents

Treatment is not recommended in children under 12 years of age.

Use in children with respiratory problems

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

Other medications and Tramadol/Paracetamol Aristo

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Your doctor will indicate which medications are safe to take with Tramadol/Paracetamol.

Important: This medication contains paracetamol and tramadol. Inform your doctorif you take other medications that contain paracetamol or tramadolto avoid exceeding the maximum daily dose.

Tramadol/Paracetamol should not be takenwith monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Aristo").

The use of tramadol/paracetamol is not recommended if you are being treated with:

• Carbamazepine (a medication used to treat epilepsy or certain types of pain, such as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid pain relievers). The pain-relieving effect may be reduced.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

The risk of side effects increases,

• if you are taking antidepressants, tramadol/paracetamol may interact with these medications, and you may experience a serotonin syndrome (see section 4: Possible side effects).
• if you are taking triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, muscle contractions, or diarrhea, you should call your doctor.
• if you are taking other pain relievers, such as morphine and codeine (also when used to treat cough), baclofen (a muscle relaxant), certain medications to lower blood pressure, or medications for the treatment of allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of Tramadol/paracetamol and sedative medications, such as benzodiazepines or related medications, increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medication with sedative medications, you should limit the dose and duration of concomitant treatment. Inform your doctor of all sedative medications you are taking and strictly follow your doctor's recommended dosage. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms.

• if you are taking medications that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these medications. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• if you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

• if you are taking gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain)

The effectiveness of tramadol/paracetamol may be altered if you are also taking:

• metoclopramide, domperidone, or ondansetron (medications for the treatment of nausea and vomiting),
• cholestyramine (a medication that lowers cholesterol in the blood).

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

Taking Tramadol/Paracetamol Aristo with food and alcohol

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

Use in athletes

This medication contains tramadol, which can produce a positive result in doping tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Because Tramadol/Paracetamol contains tramadol, it is not recommended to take this medication during pregnancy or breastfeeding. If you become pregnant during treatment with Tramadol/Paracetamol, consult your doctor before taking the next tablet.

If necessary, tramadol/paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol/Paracetamol more than once during breastfeeding, or if you take Tramadol/Paracetamol more than once, you should interrupt breastfeeding.

Based on human experience, it is not suggested that tramadol affects fertility in men and women. There are no data available on the combination of tramadol and paracetamol in fertility.

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 medication 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 concomitantly with other medications.

This medication contains sodium.

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

3. How to take Tramadol/Paracetamol Aristo

Follow the administration instructions for this medication 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 the use of tramadol/paracetamol, 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).

You should take tramadol/paracetamol for the shortest possible time.

The use of tramadol/paracetamol is not recommended in children under 12 years of age.

The dose should be adjusted according to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

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 should be at least 6 hours.

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

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

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with Tramadol/Paracetamol is not recommended. If you have moderate liver or kidney impairment, your doctor may prolong the dosing intervals.

Method of administration

Tramadol/paracetamol is presented in the form of tablets for oral administration.

The tablets should be swallowed whole with sufficient liquid. They should not be broken or chewed.

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

If you take more Tramadol/Paracetamol than you should

If you have taken more tablets than you should, contact your doctor or go to the nearest hospital emergency department immediately, even if you feel well, as there is a risk of serious liver damage that may become apparent later.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Tramadol/Paracetamol

If you forget to take this medication, you may experience pain again.

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

If you interrupt treatment with Tramadol/Paracetamol

You should not stop taking this medication suddenly unless your doctor indicates otherwise. If you want to stop taking your medication, 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).

If you have any other questions about the use of this medication, 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 of being "high" all the time).

Infrequent:may affect up to 1 in 100 people

• Increased pulse or increased blood pressure, heart rhythm and frequency disorders,
• 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 breathing,
• Difficulty swallowing, blood in the stool,
• Skin reactions (e.g., rashes, urticarial hives),
• Increased liver enzyme values,
• Presence of albumin in the urine, difficulty or pain when urinating,
• Chills, hot flashes, chest pain.

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

• Seizures, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope),
• Dependence on the medicine,
• Delirium,
• Blurred vision, pupil constriction (miosis),
• Speech disorders,
• Excessive dilation of the pupils (mydriasis).

Frequency not known: cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hiccup.
• Serotonin syndrome, which can manifest through changes in mental state
• (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").

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

• Feeling dizzy when getting up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.

• The use of paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in blood plasma acidity.

• The use of 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 rare cases, skin rashes, indicating allergic reactions that can manifest through 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, please consult your doctor.

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

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

Rare cases of respiratory depression have been reported with tramadol.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that is not listed 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 Aristo

Keep this medicine out of the 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.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging, bottle, 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 at the SIGRE point in 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/Paracetamol Aristo37.5 mg/325 mg film-coated tablets

• 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 excipients are: powdered cellulose, pregelatinized corn starch, sodium carboxymethyl starch (type A) (from potato), corn starch, magnesium stearate, hypromellose, titanium dioxide (E-171), talc, triethyl citrate.

Appearance of the Product and Package Contents

Film-coated tablets, white or almost white in color.

They are presented in PVC-aluminum blisters with 20 and 60 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Laboratorios Medicamentos Internacionales S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Date of the Last Revision of this Prospectus:May 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/