TRAMADOL/PARACETAMOL ARISTO 75 mg/650 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tramadol/Paracetamol Aristo 75 mg/650 mg Film-Coated Tablets

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

1. What Tramadol/Paracetamol Aristo 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 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 Aristo

Do not take Tramadol/Paracetamol Aristo

• 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, powerful pain relievers (opioids), or psychotropic drugs (drugs 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 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, for example 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 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. 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 medicines and Tramadol/Paracetamol Aristo"). There is a weak risk that you may experience a serotonin syndrome that may appear 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").

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 level 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 sleepiness during the day. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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 suffer from serious side effects. If you notice any of the following side effects, you should 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.

If you have had any of these problems in the past while taking tramadol/paracetamol, please inform your doctor. He will decide if you should continue taking this medicine.

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 if you should take a hormonal supplement.

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 a higher dose 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 a 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 treatment for you, including when it is appropriate to stop taking it and how to do it 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 medicines and Tramadol/Paracetamol Aristo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with Tramadol/Paracetamol.

Important: This medicine contains paracetamol and tramadol. Tell your doctor if you take other medicines that contain paracetamol or tramadol to avoid exceeding the maximum daily dose.

Tramadol/Paracetamol must 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 medicine 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.

Tell 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 that can occur particularly in case of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood that leads 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 medicines and you may experience a serotonin syndrome (see section 4: Possible side effects).
• if you are taking triptans (for the treatment of migraine) 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 (muscle relaxant), some medicines to lower blood pressure, medicines to treat allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of tramadol/paracetamol and sedative medicines such as benzodiazepines or related medicines 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 no other treatment options are possible. However, if your doctor prescribes this medicine with sedative medicines, you should limit the dose and duration of concomitant treatment. Inform your doctor of all sedative medicines you are taking and strictly follow your doctor's recommended dosage. It may be useful 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 medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol at the same time as these medicines. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• if you are taking warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines 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 pain due to nerve problems (neuropathic pain)

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

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

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

Taking Tramadol/Paracetamol Aristo with food 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.

Use in athletes

This medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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.

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 medicine 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 on 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 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.

This medicine 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 Aristo

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. 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.

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

The dose should be adjusted 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 1 tablet.

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 4 tramadol/paracetamol tablets 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.

Patient with liver or kidney failure/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 disease, your doctor may prolong the dosing intervals.

Method of administration

Tramadol/paracetamol is presented in the form of film-coated 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), tell 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 medicine and the amount taken.

If you forget to take Tramadol/Paracetamol

If you forget to take this medicine, 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 stop taking Tramadol/Paracetamol

You should 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).

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 of being "high" all the time).

Infrequent: may affect up to 1 in 100 people

• increased pulse or increased blood pressure, cardiac 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., eruptions, 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 contraction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known: cannot be estimated from available data

• decrease in blood sugar levels,
• hiccups,
• 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 medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol, you should tell your doctor:

• Feeling of dizziness when standing up after being 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 a blood and fluid anomaly (metabolic acidosis with high anion imbalance) 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 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 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 drains or into 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 Aristo75 mg/650 mg film-coated tablets

• The active ingredients are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 75 mg of tramadol hydrochloride and 650 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, with a break mark.

The tablets can be divided into equal doses.

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

Only certain 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/