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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol/Paracetamol Andrómaco 37.5/325 mg Film-Coated Tablets EFG

Tramadol hydrochloride/Paracetamol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

This medicine is a combination of two analgesics, tramadol and paracetamol, which work together to relieve pain.

Tramadol/Paracetamol is used for the symptomatic treatment of moderate to severe pain, whenever your doctor considers that the combination of tramadol and paracetamol is necessary.

This medicine should only be used by adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol/Paracetamol Andrómaco

Do not take Tramadol/Paracetamol Andrómaco

• 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 medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may affect mood and emotions) in cases of acute alcohol intoxication;
• if you are currently taking or have taken within the last 14 days monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease);
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor before taking Tramadol/Paracetamol Andrómaco if

• you are taking other medicines containing paracetamol or tramadol;
• you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• you have kidney problems;
• you have severe breathing difficulties, such as asthma or serious lung conditions;
• you have epilepsy or have had seizures or convulsions;
• you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Andrómaco”);
• you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• you are dependent on any other medicine used for pain relief, such as morphine;
• you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• you are going to be anaesthetised. Tell your doctor or dentist that you are taking this medicine.

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol/Paracetamol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tramadol/Paracetamol may be higher if:

• you or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”);
• you are a smoker;
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Tramadol/Paracetamol, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop treatment with Tramadol/Paracetamol).

During treatment with Tramadol/Paracetamol, inform your doctor immediately if:

you have serious illnesses 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 body 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 with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and being sick (vomiting).

Sleep-related breathing disorders

Tramadol/Paracetamol Andrómaco contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnoea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

The risk of experiencing central sleep apnoea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnoea.

There is a weak risk that you may experience serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you develop any symptoms related to this serious syndrome (see section 4 “Possible side effects”).

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

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.

Inform your doctor if you experience any of the following symptoms while taking Tramadol/Paracetamol Andrómaco:

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 hormonal supplements.

Other medicines and Tramadol/Paracetamol Andrómaco

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Tramadol/Paracetamol must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Andrómaco”).

The use of Tramadol/Paracetamol Andrómaco is not recommended 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 analgesics). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2). Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

The risk of adverse effects increases if you are taking:

• triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrolled muscle contractions, or diarrhoea, you should contact your doctor.
• other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

Concomitant use of Tramadol/Paracetamol and sedative medicines such as benzodiazepines or other sedatives or medicines that affect respiratory activity (e.g. opioids) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may 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, your doctor will limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with these medicines. Your doctor will advise whether Tramadol/Paracetamol is suitable for you.
• medicines for the treatment of depression. Tramadol/Paracetamol may interact with these medicines, and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• warfarin or fenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics).
• medicines for treating psychiatric disorders (antipsychotics or neuroleptics).
• muscle relaxants.
• medicines for treating Parkinson’s disease.

The effectiveness of this medicine may be altered if you also take:

• metoclopramide, domperidone, or ondansetron (medicines for treating 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 Andrómaco.

Taking Tramadol/Paracetamol Andrómaco with food and alcohol

This medicine may make you feel drowsy. Alcohol may also make you feel drowsy; therefore, it is recommended not to drink alcohol while taking Tramadol/Paracetamol Andrómaco.

Pregnancy, breastfeeding and fertility

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

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take this medicine more than once during breastfeeding, or if you take Tramadol/Paracetamol more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects fertility in men and women. There are no available data on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with Tramadol/Paracetamol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulation, and/or when taken together with other medicines.

Tramadol/Paracetamol Andrómaco contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

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

3. How to take Tramadol/Paracetamol Andrómaco

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

You should take this medicine for the shortest possible time.

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

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.

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

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 Andrómaco per day.

Do not take this medicine more frequently than your doctor has instructed.

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

The tablets are for oral use. They must be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel that the effect of this medicine 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 Andrómaco than you should

If you have taken more Tramadol/Paracetamol than you should, even if you feel well, consult your doctor or pharmacist immediately.

After taking very high doses, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest and death may occur. In such a case, call a doctor immediately!

An overdose of paracetamol may cause nausea and vomiting. There is a risk of serious liver damage, which may only become apparent later. Severe cases may lead to liver failure, brain disorders, coma, or death.

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

If you forget to take Tramadol/Paracetamol Andrómaco

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

If you stop taking Tramadol/Paracetamol Andrómaco

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking your 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further 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 everybody will experience them.

Very common: may affect more than 1 in 10 people;

• nausea,
• dizziness, drowsiness.

Common: may affect 1 in 10 people;

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

Uncommon: may affect 1 in 100 people;

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling sensation, numbness or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or sensing something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stools,
• skin reactions (e.g. rashes, urticarial rash),
• increased liver enzyme values,
• presence of albumin in urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare: may affect 1 in 1,000 people;

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope),
• drug dependence,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known:

• decrease in blood sugar levels (hypoglycaemia).

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

• Dizziness upon standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.

• The use of this medicine together with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes indicating allergic reactions may occur, which can manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens, stop treatment and consult your doctor immediately. You must not take this medicine again.

In rare cases, taking a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

In rare cases, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous or shaky. They may become hyperactive, have difficulty sleeping, and experience digestive 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, please consult your doctor.

Frequency not known: hiccups.

Serotonin syndrome, which may present 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 rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2, “What you need to know before taking Tramadol/Paracetamol Andrómaco”).

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

Very rarely, serious skin reactions have been reported with paracetamol.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) has been reported in patients with severe illness using paracetamol (see section 2), with unknown frequency.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Andrómaco

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

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Andrómaco

• The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet (tablet) contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are:

Tablet core: powdered cellulose, pregelatinized corn starch, sodium potato starch glycolate (type A), corn starch, magnesium stearate.

Film coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), propylene glycol (E1520), talc.

Appearance of the product and contents of the pack

These are pale yellow tablets marked with the manufacturer's logo ? on one side and "T5" on the other. They are packaged in blisters and supplied in cardboard boxes containing 20, 60, or 100 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Andrómaco Pharma, S.L.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse 6 – D-52078 Aachen, Germany

Date of the most recent review of this leaflet: December 2025

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