TRAMADOL/PARACETAMOL PENSA 37.5 mg/325 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Pensa 37.5 mg/325 mg Tablets EFG

Tramadol Hydrochloride/Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 Pensa is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Pensa
3. How to take Tramadol/Paracetamol Pensa
4. Possible side effects
5. Storage of Tramadol/Paracetamol Pensa
6. Contents of the pack and other information

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

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

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

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

Do not takeTramadol/Paracetamol Pensaif:

• You are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• You are suffering from acute alcohol intoxication, or you are taking sedatives, other pain relievers, or other psychoactive drugs (drugs that affect mood and emotions).
• You are taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease), or you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Pensa.
• You have severe liver disease.
• You have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions:

• If you are taking other medicines that contain paracetamol or tramadol;
• If 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;
• If you have kidney problems;
• If you have severe breathing difficulties, for example, asthma or severe lung problems;
• If you have epilepsy or have had seizures;
• If you have recently had a head injury, severe headaches associated with vomiting;
• If you are dependent on any other medicine used for pain relief, for example, morphine;
• If you are taking other pain relievers that contain buprenorphine, nalbuphine, or pentazocine;
• If you are going to have an anesthetic. Tell your doctor or dentist that you are using Tramadol/Paracetamol Pensa.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Using Tramadol/Paracetamol Pensa with other medicines").

If you have or have had any of these problems while taking Tramadol/Paracetamol Pensa, tell your doctor. He will decide whether you should continue taking this medicine.

Tell your doctor, pharmacist, or nurse if you experience any of the following symptoms while taking Tramadol/Paracetamol Pensa:

• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, tell your doctor, he will decide whether you need to take a hormonal supplement.

• If you have severe diseases, such as severe kidney disease or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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 unwell (nausea) and vomiting.

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.

Sleep-related breathing disorders:

Tramadol/Paracetamol Pensa may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may be pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep, or excessive sleepiness during the day. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

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. Consult your doctor immediately if you experience any of the symptoms associated with 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 Pensa can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening 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 Pensa 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 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 Pensa, 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 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 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").

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.

Using Tramadol/Paracetamol Pensa with other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those bought without a prescription.

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.

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that require urgent treatment (see section 2).
• gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain).

Do not take Tramadol/Paracetamol Pensa with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Pensa").

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

• carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as intense facial pain called trigeminal neuralgia).
• buprenorphine, nalbuphine, or pentazocine (opioid pain reliever). Pain relief may be reduced.

The risk of side effects increases:

• 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 Pensa at the same time as these medicines. Your doctor will tell you if Tramadol/Paracetamol Pensa is suitable for you.
• if you are taking medicines for the treatment of depression, Tramadol/Paracetamol Pensa may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

• if you are taking sedatives, sleeping pills, other pain relievers such as morphine and codeine (also when used to treat 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.
• if you are taking 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 must inform your doctor immediately of any prolonged or unexpected bleeding.

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

• metoclopramide, domperidone, and ondansetron (medicines for the treatment of nausea and vomiting),
• cholestyramine (a medicine that lowers 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 Pensa.

Taking Tramadol/Paracetamol Pensa with food, drinks, and alcohol:

Do not drink alcoholic beverages if you are taking this medicine.

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.

If you become pregnant during treatment with Tramadol/Paracetamol Pensa, consult your doctor before taking the next tablet.

Tramadol can pass into breast milk. For this reason, you should not take Tramadol/Paracetamol Pensa more than once during breastfeeding, or, if you take Tramadol/Paracetamol Pensa more than once, you should stop breastfeeding.

Small amounts of tramadol may pass into breast milk. Therefore, you should not take this medicine during breastfeeding.

Driving and using machines:

Ask your doctor if you can drive or use machines during treatment with this medicine. 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 taking it with other medicines.

3. How to take Tramadol/Paracetamol Pensa

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The dose should be adjusted to the intensity of the pain and your individual sensitivity. In general, the lowest possible dose should be used for pain relief and for the shortest possible time.

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

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

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from the use of Tramadol/Paracetamol Pensa, 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).

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

Do not take Tramadol/Paracetamol Pensa more frequently than indicated by your doctor.

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.

Use in children and adolescents:

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

Use in elderly patients:

In elderly patients (over 75 years old), 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 failure/patients on dialysis:

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

Method of administration:

The tablets can be taken whole or broken in half with the help of a glass of liquid, preferably water. The score line on the tablet is only for breaking the tablet if you find it difficult to swallow it whole.

If you think the effect of Tramadol/Paracetamol Pensa is too strong (i.e., you feel very drowsy or have difficulty breathing) or too weak (i.e., you do not have adequate pain relief), tell your doctor.

If you take more Tramadol/Paracetamol Pensa than you should:

You should consult your doctor or pharmacist, even if you feel well. There is a risk that liver damage may occur, which may only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol/Paracetamol Pensa:

If you forget to take the tablets, it is possible 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 Pensa:

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).

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

4. Possible Adverse Effects

Like all medicines, Tramadol/Paracetamol Pensa can have adverse effects, although not all people suffer from them.

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

• nausea.
• dizziness, drowsiness.

Frequent: may affect between 1 and 10 out of 100 patients;

• 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).

Infrequent: may affect between 1 and 10 out of 1,000 patients;

• 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 stools.
• chills, hot flashes, chest pain.
• difficulty breathing.

Rare: may affect between 1 and 10 out of 10,000 patients;

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

Frequency not known (cannot be estimated from available data):

• a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

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 Pensa, 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, which are indicative of 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.
• Very rare cases of severe skin reactions have been reported.
  • Frequency not known: decrease in blood sugar levels (hypoglycemia), hypotension, and 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 Pensa").

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 suddenly stop treatment. 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 Pensa, please consult your doctor.

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

Taking Tramadol/Paracetamol Pensa with anticoagulants (e.g., femprocumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

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 Pensa

Keep out of 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 to people who have not been prescribed it.

This medicine does not require special storage conditions.

Do not use Tramadol/Paracetamol Pensa after the expiration date stated on the packaging (after CAD). The expiration date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be thrown away through the sewage system or in the 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. Packaging Content and Additional Information

Composition of Tramadol/Paracetamol Pensa:

The active ingredients are tramadol hydrochloride and paracetamol.

One tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

The other components are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium carboxymethyl starch (Type A) of potato and pregelatinized corn starch.

Appearance of the Product and Packaging Content:

Tramadol/Paracetamol Pensa is presented in the form of oral tablets, in packages of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

This prospectus was revised in May 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/