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

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

Do not take Tramadol/Paracetamol Andromaco

• if you are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you have taken any medicine for the treatment of insomnia, potent analgesics (opioids), or psychotropic medicines (medicines that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor before taking Tramadol/Paracetamol Andromaco, if

• you are taking other medicines that contain paracetamol or tramadol;
• you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be a sign of jaundice or problems with your bile ducts;
• you have kidney problems;
• you have severe breathing difficulties, for example, asthma or severe lung problems;
• you are epileptic 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 Andromaco");
• 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, for example, morphine;
• you are taking other medicines for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• you are going to be anesthetized. 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 can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Tramadol/Paracetamol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use 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 greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, 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 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 indicated 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 feel 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 using the medicine, and you feel better once you start taking it again ("withdrawal symptoms").

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

Sleep-related breathing disorders

Tramadol/Paracetamol Andromaco contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood).

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

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 alone. Talk to a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you 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 have had any of these problems in the past while taking Tramadol/Paracetamol, please inform your doctor. He will decide if you should continue taking this medicine.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

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

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These 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.

Other medicines and Tramadol/Paracetamol Andromaco

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

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

Tramadol/Paracetamol must not be takenwith monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Andromaco").

It is not recommended to use Tramadol/Paracetamol Andromaco 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.

Tell your doctor or pharmacist if you are taking:

Flucloxacillin (an 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 kidney or liver failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used, especially if the maximum daily dose of paracetamol is used for a longer period. Metabolic acidosis with high anion gap is a serious disease that requires urgent treatment.

The risk of side effects increases if you are taking:

• Triptans (for the treatment of migraine) or selective serotonin reuptake inhibitors, "SSRIs" (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, muscle contractions, or diarrhea, you should call your doctor.
• Other pain relievers such as morphine and codeine (also when used for the treatment of cough), baclofen (muscle relaxant), some medicines to lower blood pressure, medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.

The use of Tramadol/Paracetamol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medicine with sedative medicines, you should limit the dose and duration of concomitant treatment.

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

• Medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol at the same time as these medicines. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.
• Medicines for the treatment of depression. Tramadol/Paracetamol can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• 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.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting),
• Colestyramine (a medicine that reduces cholesterol in the blood).

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

Taking Tramadol/Paracetamol Andromaco with food and alcohol

This medicine can make you feel drowsy. Alcohol can make you feel drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Andromaco.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Breastfeeding

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

Based on human experience, tramadol is not expected to affect fertility in men and women. There are no data available on the combination of tramadol and paracetamol on fertility.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol/Paracetamol. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medicines.

Tramadol/Paracetamol Andromaco contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Tramadol/Paracetamol Andromaco

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from the use of 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.

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

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

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

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 Andromaco tablets per day.

Do not take this medicine more frequently than indicated by your doctor.

Elderly patients

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

Patients with liver or kidney 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 impairment, your doctor may prolong the dosing intervals.

Method of administration

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

If you think 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), tell your doctor.

If you take more Tramadol/Paracetamol Andromaco than you should

If you have taken more Tramadol/Paracetamol than you should, even if you feel well, talk to your doctor or pharmacist immediately, as 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, telephone 91 562 04 20.

If you forget to take Tramadol/Paracetamol Andromaco

If you forget to take a dose of the medicine, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses, simply continue taking the tablets as usual.

If you stop treatment with Tramadol/Paracetamol Andromaco

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 tell 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).

If you have any further questions on 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 all people suffer from them.

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

• nausea,
• dizziness, drowsiness.

Frequent: may affect 1 in 10 people;

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

Infrequent: may affect 1 in 100 people;

• increased pulse or increased blood pressure, cardiac rhythm and frequency disorders,
• 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 breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g. eruptions, urticarial hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flashes, chest pain.

Rare: may affect 1 in 1,000 people;

• seizures, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope),
• dependence on the medicine,
• delirium,
• blurred vision, pupil contraction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known:

• decrease in blood sugar levels (hypoglycemia),
• 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 "What you need to know before taking Tramadol/Paracetamol Andrómaco").

The following recognized adverse effects have been reported by people who have taken medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol, you should tell your doctor:

• Dizziness when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• The use of paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in acidity in the blood plasma.

• The use of this medicine with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin eruptions, being indicative of allergic reactions that can manifest through the sudden swelling of the face and neck, shortness of breath or 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, using a medicine like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or trembly. They may be hyperactive, have difficulty sleeping and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling sensation 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.

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

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

There have been reports of rare cases of respiratory depression with tramadol.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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. Conservation of Tramadol/Paracetamol Andrómaco

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

Keep this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at 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. Package Contents and Additional Information

Composition of Tramadol/Paracetamol Andrómaco

• The active ingredients 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: cellulose powder, pregelatinized corn starch, sodium starch glycolate (type A), corn starch, magnesium stearate.

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

Appearance of the Product and Package Contents

They are pale yellow tablets marked with the manufacturer's logo ? on one side and "T5" on the other. They are packaged in blisters and boxed in packs of 20, 60 and 100 tablets.

Only some package sizes may be marketed.

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 Last Revision of this Prospectus: December 2024

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/