Tramadol/paracetamol Pensa 37.5 mg/325 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol / Paracetamol Pensa 37.5 mg/325 mg Tablets EFG

Tramadol hydrochloride / Paracetamol

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

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

Leaflet contents

1. What Tramadol / Paracetamol Pensa is and what it is used for
2. What you need to know before taking Tramadol / Paracetamol Pensa
3. How to take Tramadol / Paracetamol Pensa
4. Possible side effects
5. How to store 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 analgesics, 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 the 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 taking Tramadol/Paracetamol Pensa

Do not take Tramadol/Paracetamol Pensa:

• If you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• In case of acute alcohol intoxication, if you are taking sleeping medications, strong painkillers, or other psychotropic medicines (medicines that may alter mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (certain 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 Pensa.
• If you have severe liver disease.
• If you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions:

• If you are taking other medicines containing paracetamol or tramadol;
• If 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;
• If you have kidney problems;
• If you have severe breathing difficulties, such as 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 medicine, for example, morphine;
• If you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anesthetized. 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 “Use of Tramadol/Paracetamol Pensa with other medicines”).

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

Inform 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. These may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

• 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 body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, adequate 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.

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 blood oxygen levels). These symptoms may include: pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. 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 serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice 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 Pensa 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 the amount of medicine you need to take or how often you 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 a family member have 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 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 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 you feel better when you take it again ("withdrawal effect").

If you notice any of these signs, speak with your doctor so they can advise you on the best treatment approach, 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”).

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.

Taking Tramadol/Paracetamol Pensa with other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that requires urgent treatment (see section 2).
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

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

Tramadol/Paracetamol Pensa 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 are taking medicines that lower the seizure threshold or may provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Pensa simultaneously with these medicines. Your doctor will advise whether Tramadol/Paracetamol Pensa is suitable for you.
• If you are taking medicines for depression, Tramadol/Paracetamol Pensa may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• If you are taking sedatives, sleeping medicines, other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• If you are taking warfarin or phenprocoumon (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.

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

• Metoclopramide, domperidone, and ondansetron (medicines for treating nausea and vomiting),
• Colestipol (a medicine that reduces 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:

You must not drink alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility:

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

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

Tramadol may pass into breast milk. For this reason, you should not take Tramadol/Paracetamol Pensa more than once during breastfeeding. Alternatively, if you take Tramadol/Paracetamol Pensa more than once, you must 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 operate machinery while being treated with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taking it together with other medicines.

3. How to take Tramadol/Paracetamol Pensa

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

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

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

If necessary, your doctor may advise you to increase the dose. 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 using Tramadol/Paracetamol Pensa, when and for how long you should take it, when you should contact your doctor, and when you should discontinue treatment (see also section 2).

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

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

Your doctor may recommend increasing 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 use in children under 12 years of age.

Use in elderly patients:

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

Patients with hepatic or renal impairment/patients undergoing dialysis:

Tramadol/Paracetamol Pensa is not recommended for patients with severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration:

The tablets may be taken whole or split in half with a glass of liquid, preferably water. The tablet's score line is intended only for splitting the tablet if you have difficulty swallowing it whole.

If you feel that the effect of Tramadol/Paracetamol Pensa is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, you do not achieve adequate pain relief), inform 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 of liver damage that may only become apparent later.

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

If you forget to take Tramadol/Paracetamol Pensa:

If you forget to take your tablets, 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 Pensa:

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking this medicine, especially after prolonged use, speak to your doctor first. Your doctor will advise you when and how to discontinue treatment, which may involve gradually reducing the dose to minimize the risk of 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, Tramadol/Paracetamol Pensa can have adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 patients:

• Nausea.
• Dizziness, drowsiness.

Common: may affect between 1 and 10 in every 100 patients:

• Vomiting, digestive problems (constipation, flatulence, diarrhoea), 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: may affect between 1 and 10 in every 1,000 patients:

• 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 something that does not actually exist), memory loss.
• Difficulty swallowing, blood in stools.
• Chills, hot flushes, chest pain.
• Difficulty breathing.

Rare: may affect between 1 and 10 in every 10,000 patients:

• Seizures, difficulty performing coordinated movements.
• Addiction.
• Blurred vision.

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

• 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 people who have taken medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Pensa, you must inform your doctor:

• Feeling dizzy upon standing up after lying down or sitting, 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 and consult your doctor immediately. You must not take this medicine again.
• Very rare cases of serious skin reactions have been reported.
  • Frequency not known: decrease in blood sugar levels (hypoglycaemia), hiccups, and 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 Pensa”).

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

Occasionally, people 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 disorders. Very few people may also experience panic attacks, hallucinations, unusual sensations 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 Pensa, please consult your doctor.

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

The use of Tramadol/Paracetamol Pensa 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.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 Pensa

Keep 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.

This medicine does not require any special storage conditions.

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

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

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

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Pensa:

The active substances 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, colloidal anhydrous silica, sodium carboxymethylstarch (Type A) from potato, and pregelatinized corn starch.

Appearance of the medicine and pack sizes:

Tramadol/Paracetamol Pensa is presented as tablets for oral administration, in packs containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 tablets.

Only certain pack 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 leaflet has been reviewed in May 2025.

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