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

Introduction

Package Leaflet: Information for the User

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

(Tramadol hydrochloride / Paracetamol)

Read all of this leaflet carefully before you start taking this medicine.

• 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Tramadol/Paracetamol MABO 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 MABO should only be used by adults and children over 12 years of age.

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

Do not take Tramadol/Paracetamol MABO

• if you are allergic (hypersensitive) to tramadol, paracetamol, or any of the other ingredients 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 to treat 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 use 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 a sign of jaundice or problems with your bile ducts,
• if you have kidney problems,
• if you have severe breathing difficulties, for example, asthma or severe lung problems,
• if you are epileptic or have had seizures,
• if you have recently had a head injury, severe headaches associated with vomiting,
• if you have dependence 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 MABO.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Using other medicines").
• flucloxacillin (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 case 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.

During treatment with Paracetamol Mabo, inform your doctor immediately if:

• 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 suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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 discomfort (nausea) and vomiting.

Sleep-related breathing disorders

This medicine may cause sleep-related breathing disorders, such as 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 drowsiness during the day. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

If you have or have had any of these problems while taking Tramadol/Paracetamol MABO, please inform your doctor. He will decide if you should continue taking this medicine.

Talk to your doctor or 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. They may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

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.

There is a weak risk that you may experience a serotonin syndrome that may occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

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 MABO 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 MABO 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 MABO, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for a longer time 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 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 recently taken, or might 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 take Tramadol/Paracetamol MABO with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol MABO").

The use of Tramadol/Paracetamol MABO is contraindicated if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain 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 side effects increases if you also use:

• 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 MABO at the same time as these medicines.

• If you are taking medicines for the treatment of depression, Tramadol/Paracetamol MABO may interact with these medicines, and you may experience serotonin syndrome (see section 4 "Possible side effects").

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

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

• Antidepressants, anesthetics, neuroleptics (medicines that affect mood) or bupropion (a medicine used as an aid to quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol MABO is suitable for you.

• 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.

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

• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicine for the treatment of nausea and vomiting),
• Colestyramine (a medicine that lowers cholesterol in the blood),
• Ketoconazole and erythromycin (medicines used against 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 can make you feel drowsy.

Alcohol can make you feel even drowsier, 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 is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Pregnancy and breastfeeding

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 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, you should not take Tramadol/Paracetamol MABO more than once during breastfeeding, or if you take Tramadol/Paracetamol MABO more than once, you should interrupt breastfeeding.

Driving and using machines

Tramadol/Paracetamol MABO can cause drowsiness, and this can 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; this is essentially "sodium-free".

3. How to take Tramadol/Paracetamol MABO

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

Before starting treatment and regularly during treatment, 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 stop it (see also section 2).

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

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.

Use in children

This medicine is not recommended for use in children under 12 years of age.

Use in adults

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

Use in 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.

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

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

If necessary, the dose can be increased, 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.

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

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

Method of administration

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 think 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), tell 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 serious liver damage that may only become apparent later.

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

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

If you stop taking Tramadol/Paracetamol MABO

If you stop taking tramadol: Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no unwanted effects occur after stopping treatment with Tramadol/Paracetamol 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 side effects").

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

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

4. Possible Adverse Effects

Like all medicines, Tramadol/Paracetamol MABO can have adverse effects, although not all people suffer from 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 of being "high-spirited" all the time).

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

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

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

• seizures, difficulties in carrying out coordinated movements.
• addiction.
• blurred vision.

Frequency Not Known: the frequency cannot be estimated from the available data;

• decrease in blood sugar levels (hypoglycemia).
• 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 "Before taking Tramadol/Paracetamol MABO").
• 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 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 MABO, 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.

• In rare cases, skin rashes, indicating allergic reactions that can manifest through 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 medicine 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 trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders.

Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling sensation, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol MABO, please consult your doctor.

Very rare cases of severe skin reactions have been reported.

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

The use of Tramadol/Paracetamol MABO with 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 adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible 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. Storage of Tramadol/Paracetamol MABO

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 for people 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.

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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. Additional Information

Composition of Tramadol/Paracetamol MABO

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

• The other components are: pregelatinized corn starch, sodium carboxymethyl starch (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 Packaging Content

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

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

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Pharmaceutical Works POLPHARMA S.A.

19 Pelplinska Street; 83-200 Starogard Gdanski

Poland

Date of the Last Revision of this Prospectus:February 2025

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