Tramadol/paracetamol Mabo 37.5 mg/325 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

(Tramadol hydrochloride / Paracetamol)

Read the entire leaflet carefully before you start taking this medicine.

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

Leaflet Contents

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

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

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

Tramadol/Paracetamol MABO is indicated for the symptomatic treatment of moderate to severe pain, whenever your doctor considers that the 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 taking 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 medicines for insomnia, strong painkillers, or psychotropic drugs (medicines that may 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 within the last 14 days before starting treatment with Tramadol/Paracetamol MABO,

• if you have severe liver disease,

• if you have epilepsy that is not controlled by treatment.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you are taking other medicines containing paracetamol or tramadol,

• if you have liver problems or notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts,

• if you have kidney problems,

• if you have severe breathing difficulties, for example asthma or serious lung conditions,

• if you have epilepsy or have had seizures,

• if you have recently suffered a head injury, or have severe headaches associated with vomiting,

• if you are dependent on any other pain-relief medicines, for example morphine,

• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine,

• if you are going to be anaesthetised. 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 "Other medicines and Tramadol/Paracetamol MABO").

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

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

• You have serious conditions 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 are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

This medicine may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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

Talk 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormone supplements.

Tramadol is metabolised in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious 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 malaise or vomiting, constipation, or loss of appetite.

There is a low risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used alone. Contact a doctor immediately if you develop any 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 may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol/Paracetamol MABO may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much medicine you need to take or how often.

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 a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").

• You are a smoker.

• You have previously 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 indicate 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 prescribed, for example, "to stay calm" or "to sleep".

• You have repeatedly tried and failed to stop or control your use of the medicine.

• When you stop taking the medicine, you feel unwell, and feel better when you take it again ("withdrawal effect").

If you notice any of these signs, talk to your doctor for advice on the best treatment approach for you, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, "If you stop taking Tramadol/Paracetamol MABO").

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

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

Do not take Tramadol/Paracetamol MABO together 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 usually used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia).

• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

• Medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol MABO simultaneously with these medicines.

• Medicines for depression, as Tramadol/Paracetamol MABO may interact with these and cause serotonin syndrome (see section 4 "Possible side effects").

• Triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle contractions, or diarrhoea, contact your doctor.

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

• Antidepressants, anaesthetics, neuroleptics (medicines affecting mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will advise whether Tramadol/Paracetamol MABO is suitable for you.

• Warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. Inform your doctor immediately of any prolonged or unexpected bleeding.

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

• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),

• Colestyramine (a medicine that lowers blood cholesterol),

• 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 make you feel drowsy.

Alcohol may increase drowsiness, 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 breathing problems: The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Pregnancy and breastfeeding

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

Because Tramadol/Paracetamol MABO contains tramadol, the use of this medicine during pregnancy is not recommended. If you become pregnant while being treated 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 must stop breastfeeding.

Driving and using machines

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; this is essentially "sodium-free".

3. How to take Tramadol/Paracetamol MABO

Follow exactly the administration instructions for Tramadol/Paracetamol MABO given by your doctor. If in doubt, consult your doctor.

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

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

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

Use in children

The use of this medicine is not recommended in children under 12 years of age.

Use in adults

Unless your doctor prescribes otherwise, the usual 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), elimination of tramadol may be slower. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Use in patients with hepatic or renal impairment / patients on dialysis

Tramadol/Paracetamol MABO is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 8 tablets of Tramadol/Paracetamol MABO per day.

Do not take Tramadol/Paracetamol MABO more frequently than prescribed 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 available as tablets for oral administration.

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

If you feel 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 get 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, contact your doctor immediately, even if you feel well, because there is a risk of serious liver damage that may only become apparent later.

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

If you forget to take Tramadol/Paracetamol MABO

If you forget to take a dose of Tramadol/Paracetamol MABO, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol MABO

If stopping treatment with tramadol: Do not stop taking this medicine suddenly unless instructed by your doctor. If you wish to discontinue the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unwanted adverse effects (withdrawal symptoms).

Generally, no undesirable effects occur after stopping treatment with Tramadol/Paracetamol MABO. However, in rare cases, patients who have taken Tramadol/Paracetamol MABO for some time and stopped treatment abruptly may feel unwell (see section 4 “Possible side effects”).

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

If you have any further 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 everyone experiences 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 – a feeling of being "on a high" all the time)

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

• tachycardia, hypertension, disturbances in heart rhythm and rate
• difficulty or pain when urinating
• skin reactions (e.g., rashes, urticaria)
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or perceiving things that do not exist in reality), memory loss
• difficulty swallowing, blood in the stool
• chills, hot flushes, chest pain
• difficulty breathing

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: frequency cannot be estimated from the available data;

• decrease in blood sugar levels (hypoglycemia)
• Hiccups
• serotonin syndrome, which may present with 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Before taking Tramadol/Paracetamol MABO").
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

The following recognized adverse effects have been reported by individuals who have taken medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol MABO, you must inform your doctor:

• Dizziness upon standing up from a lying or sitting position, slow 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, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this occurs, stop treatment immediately and consult your doctor without delay. You must not take this medicine again.

In rare instances, individuals who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances.

Very few people may also experience 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 MABO, please consult your doctor.

Very rare cases of severe skin reactions have been reported.

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

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

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

Do not use Tramadol/Paracetamol MABO after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Tramadol/Paracetamol MABO

• The active substances 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 maize starch, 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 packaging

Tramadol/Paracetamol MABO is available as pale yellow, oblong, biconvex tablets packaged in PVC/Alu blisters.

Tramadol/Paracetamol MABO is available in packs 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 most recent review of this leaflet: February 2025

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