Leaflet: information for the user

Tramadol/Paracetamol MABO 37.5 mg/ 325 mg film-coated tablets EFG

(Tramadol hydrochloride / Paracetamol)

Read this leaflet carefully before you start taking the medicine.

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

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

2.What you need to know before you start taking Tramadol/ParacetamolMABO

3. How to take Tramadol/ParacetamolMABO

4. Possible side effects

5. Storage of Tramadol/ParacetamolMABO

6. Contents of the pack and additional information

Tramadol/ParacetamolMABO, is a combination of two analgesics: tramadol and paracetamol, which act together to relieve pain.

Tramadol/ParacetamolMABO, is indicated for the symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/ParacetamolMABOshould only be used by adults and children over 12 years old.

Do not take Tramadol/Paracetamol MABO

• if you are allergic (hypersensitive) to tramadol, paracetamol or any of the other components of this medicine (listed in section 6).

• in case of acute alcohol intoxication, or if you have taken any medication for the treatment of insomnia, potent analgesics, or psychotropic drugs (medicines that can alter the level of consciousness),
• if you are taking monoamine oxidase inhibitors (MAOIs) (medicines used for the treatment of depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol MABO
• if you have severe liver disease,
• if you have uncontrolled epilepsy.

Warnings and precautionsConsult your doctor or pharmacist before starting to take this medicine:

• if you are taking other medicines that contain paracetamol or tramadol,
• if you have liver problems or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts,
• if you have kidney problems,
• if you have severe respiratory difficulties, for example asthma or severe lung problems,
• if you are epileptic or have had seizures,
• if you have recently had a head injury, intense headaches associated with vomiting,
• if you have dependence on any other medication 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 to be anaesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol MABO.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Use of other medicines").
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and which may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Inform your doctor immediately if you have any of the following conditions during treatment with Paracetamol Mabo:

• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you are malnourished, have chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid imbalance) has been reported in patients in these situations when paracetamol is used regularly for a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Respiratory disorders related to sleep

This medicine may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

If any of these problems occur while taking Tramadol/Paracetamol MABO, please inform your doctor. Your doctor will decide whether you should continue taking this medicine.

Speak to your doctor, pharmacist, or nurse if you experience any of the following symptoms while taking this medicine:

• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme and this may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, 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.

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 in monotherapy. Consult a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible adverse effects").

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medicine less effective (you become tolerant of it, known as tolerance). Repeated use of Tramadol/Paracetamol MABO may also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer use.

Dependence or addiction may make you feel that you no longer control the amount of medicine you need to take or the frequency with which you need to take it.

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

• You or a family member have abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking Tramadol/Paracetamol MABO, 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 stay calm" or "to sleep"
• You have repeatedly and unsuccessfully tried 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, speak to your doctor to determine 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 MABO).

Other medicines and Tramadol/Paracetamol MABOTaking tramadol/paracetamol with other medicines. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

You should not takeTramadol/ParacetamolMABOwith monoamine oxidase inhibitors (MAOIs) (see "Do not takeTramadol/ParacetamolMABO").

It is contraindicated to useTramadol/ParacetamolMABOif you are being treated with:

• Carbamazepine (medicine normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

The risk of adverse effects increases if you are also using:

• If you are taking medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics, the risk of seizures increases if you take Tramadol/Paracetamol MABO simultaneously with these medicines.

• If you are taking antidepressants, Tramadol/Paracetamol MABO may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible adverse effects").

• 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, involuntary muscle contractions, or diarrhea, you should contact your doctor.

• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants, or allergy medications. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• Antidepressants, anesthetics, neuroleptics (medicines that affect mood) or bupropion (medicine used as a smoking cessation aid). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol MABO 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. Inform your doctor immediately of any prolonged or unexpected bleeding.

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Tramadol/Paracetamol MABO may be altered if you are also using:

• Metoclopramide, domperidone, or ondansetron (medicine for nausea and vomiting),
• Colestiramine (medicine that reduces cholesterol in the blood),
• Ketoconazole and erythromycin (medicines used to treat infections).

Your doctor will know which medicines are safe to use with Tramadol/Paracetamol MABO.

Taking Tramadol/Paracetamol MABO with food and drinks

Tramadol/Paracetamol MABO may cause drowsiness.

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

Tramadol/Paracetamol MABO can be taken with or without food.

Children and adolescents

Use in children with respiratory problems: Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Pregnancy and breastfeeding

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

Because Tramadol/Paracetamol MABO contains tramadol, it is not recommended to use this medicine during pregnancy. If you become pregnant during treatment with Tramadol/Paracetamol MABO, consult your doctor before taking the next tablet.

Tramadol is excreted in breast milk. For this reason, do not takeTramadol/ParacetamolMABO more than once during breastfeeding, or if you takeTramadol/ParacetamolMABO more than once, you should stop breastfeeding.

Driving and operating machinery

Tramadol/Paracetamol MABO may cause drowsiness, which may affect your ability to drive or operate machinery.

Tramadol/Paracetamol MABO contains sodium

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

Follow exactly the administration instructions for Tramadol/Paracetamol MABO as indicated by your doctor. In case of doubt, consult your doctor.MABO

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

You should take Tramadol/Paracetamol MABO for the shortest time possible.MABO

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

Use in children

This medication is not recommended for use in children under 12 years old.

Use in adults

Unless your doctor prescribes something different, the usual starting dose for adults and adolescents over 12 years old is 2 tablets.

Use in elderly patients

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

Use in patients with liver or kidney insufficiency/patients on dialysis

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

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 Tramadol/Paracetamol MABO tablets per day.MABO

Do not take Tramadol/Paracetamol MABO more frequently than your doctor has indicated. Your doctor may increase the interval between doses:

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

Administration form

Tramadol/Paracetamol MABO 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 estimate that the effect of Tramadol/Paracetamol MABO 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 MABO than you should

If you have taken more Tramadol/Paracetamol MABO than you should, even if you feel well, consult your doctor immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Tramadol/Paracetamol MABO

If you forget to take a dose of Tramadol/Paracetamol MABO, it is likely that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt the treatment with Tramadol/Paracetamol MABO

If you interrupt the treatment with tramadol: 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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, no adverse effects occur after interrupting treatment with Tramadol/Paracetamol MABO. However, in rare cases, patients who have been taking Tramadol/Paracetamol MABO for a while and have stopped treatment abruptly may feel unwell (see section 4 "Possible adverse effects").

If you have been taking Tramadol/Paracetamol MABO for some time, you should consult your doctor before interrupting treatment as your body may have become accustomed to it.

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

Like all medicines, Tramadol/ParacetamolMABOmay cause side effects, although not everyone will experience them.

Very common: more than 1 in 10 people treated;

• nausea.
• dizziness, drowsiness.

Common: less than 1 in 10, but more than 1 in 100 people treated;

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

Rare: less than 1 in 100, but more than 1 in 1,000 people treated;

• tachycardia, hypertension, heart rhythm and frequency disorders.
• difficulty or pain urinating.
• skin reactions (e.g. rashes, urticaria).
• tingling, numbness, or pins and needles sensation in the extremities, ear noises, 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.

Very rare: less than 1 in 1,000, but more than 1 in 10,000 people treated;

• seizures, difficulty performing coordinated movements.
• addiction.
• blurred vision.

Frequency not known: the frequency cannot be estimated from the available data;

• decreased blood sugar levels (hypoglycemia).
• hiccups.
• serotonin syndrome, which may manifest as 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "Before taking Tramadol/Paracetamol MABO").
• a serious disease that can make the blood more acidic (designated metabolic acidosis) in severely ill patients using paracetamol (see section 2).

The following recognized side 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/ParacetamolMABO, you should tell your doctor:

• Dizziness when standing 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.

• In rare cases, skin eruptions, indicating allergic reactions that may 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 taking the medication and consult your doctor immediately. Do not take this medication again.

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 shaky. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal problems.

Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/ParacetamolMABO, please consult your doctor.

Severe skin reactions have been reported very rarely.

In exceptional cases, blood tests may reveal certain abnormalities, such as a low platelet count, which may cause nasal or gum bleeding.

The use of Tramadol/ParacetamolMABOwith anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

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

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

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

Do not use Tramadol/Paracetamol MABO after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol MABO

• The active principles 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: pregelatinized cornstarch, sodium carboxymethyl starch (from potato), microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E-470b), hypromellose (E-464), macrogol 400, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the package

Tramadol/Paracetamol MABO, is presented in the form of pale yellow, oblong, and biconvex tablets packaged in PVC/Alu blisters.

Tramadol/Paracetamol MABO, is presented in packages of 20 and 60 tablets.

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

Pharmaceutical Works POLPHARMA S.A.

19 Pelplinska Street; 83-200 Starogard Gdanski

Poland

Last review date of this leaflet:February 2025

The detailed updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es