TRAMADOL/PARACETAMOL ARISTO 37.5 mg/325 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/ParacetamolAristo37.5 mg/325 mg Effervescent Tablets EFG

Tramadol/Paracetamol Hydrochloride

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 further 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 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 children over 12 years of age.

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

Do not take Tramadol/ParacetamolAristo

• 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 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 have epilepsy or have had seizures or fits previously;
• If you have recently had a head injury, shock, or severe headaches associated with vomiting (feeling dizzy);
• 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 using 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 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").

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 transformed 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 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 whether 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 whether you should take a hormonal supplement.
• If you have severe diseases, 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 of malaise (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 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 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 tried repeatedly and unsuccessfully 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 stop taking tramadol/paracetamol Aristo).

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/ParacetamolAristo

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 doctorif you are taking any other medicine that contains paracetamol or tramadolto avoid exceeding the maximum daily dose.

You must nottake tramadol/paracetamol with 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 painkillers). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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, uncontrolled muscle contractions, or diarrhea, you should call your doctor.

• If you are taking other painkillers, such as morphine and codeine (also when used to treat cough), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for the treatment of 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, breathing 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 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 dosage recommendation. 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),
• Colestyramine (a medicine that reduces cholesterol in the blood),

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

Taking Tramadol/ParacetamolAristowith food and alcohol

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

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 use this medicine during pregnancy or breastfeeding. If you become pregnant during treatment with tramadol/paracetamol, consult your doctor before taking the next tablet.

In case of necessity, 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 stop 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 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 concomitantly with other medicines.

Use in athletes

This medicine may produce a positive result in doping tests.

Tramadol/ParacetamolAristocontains sodium

This medicine contains 179.687 mg of sodium (the main component of table/cooking salt) per effervescent tablet. This is equivalent to 8.98% of the maximum recommended daily intake of sodium for an adult.

3. How to take Tramadol/Paracetamol Aristo

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

Before starting treatment and regularly during it, 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 for use 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 something different, the recommended starting dose for adults and adolescents over 12 years is 2 effervescent tablets.

If necessary, you can increase the dose, as your doctor recommends. The shortest interval between doses should be at least 6 hours.

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

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

Elderly patients

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

Patients with hepatic or renal insufficiency/patients on dialysis

If you have a severe liver or kidney disease, treatment with tramadol/paracetamol is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

Method of administration

The effervescent tablets are administered orally.

The effervescent tablets are taken dissolved in a glass of water.

If you think the action of tramadol/paracetamol is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., 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 severe liver damage that may become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center 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 forgot to take the tablets, it is possible that the pain will return. Do not take a double dose to make up for the missed doses; simply continue taking the tablets as usual.

If you stop taking tramadol/paracetamol

Do not stop taking this medication suddenly unless your doctor tells you to. 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 adverse effects (withdrawal symptoms).

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

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

• nausea.
• dizziness, drowsiness.

Common (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).

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

• increased heart rate or increased blood pressure, cardiac rhythm and frequency disorders,
• tingling, numbness, or prickling 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,
• breathing difficulties,
• swallowing difficulties, blood in the stool,
• skin reactions (e.g., rashes, urticaria),
• 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, difficulty coordinating movements, transient loss of consciousness (syncope),
• dependence on the medication,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• pupil dilation (mydriasis).

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

• decreased blood sugar levels,
• hypoglycemia,
• 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").

• a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

The following 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:

• 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 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 as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medication again.

In rare cases, using a medication 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 stop treatment abruptly. 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 abnormalities, such as low platelet count, which can result in nosebleeds or bleeding in the gums.

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

Respiratory depression has been reported in rare cases with tramadol.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tramadol/Paracetamol Aristo

Keep this medication out of the sight and reach of children.

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

Do not use Tramadol/Paracetamol Aristo effervescent tablets after the expiration date shown on the carton or on the bottom of the tablet container (after CAD). The expiration date is the last day of the month indicated.

Store below 30°C. Validity period after opening: 12 months, without exceeding the expiration date.

Store in the original container to protect it from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tramadol/Paracetamol Aristo effervescent tablets

• The active ingredients are tramadol hydrochloride and paracetamol.

One effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other ingredients are: povidone, maltodextrin, sodium saccharin dihydrate, orange flavor (contains citral and linalol), anhydrous citric acid, anhydrous sodium citrate, sodium hydrogen carbonate, copovidone, potassium acesulfame, macrogol.

Appearance of the product and package contents

Tramadol/Paracetamol Aristo effervescent tablets EFG are white or almost white effervescent tablets.

The effervescent tablets are packaged in tubes.

Packages with 20 and 60 effervescent 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 leaflet: December 2024

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