Leaflet: information for the user

Tramadol / Paracetamol pensa 37.5 mg/325 mg Tablets EFG

Tramadol hydrochloride / Paracetamol

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to 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 additional information

Tramadol/Paracetamol Pensais a combination of two analgesics, tramadol and paracetamol, that act together to relieve pain.

Tramadol/Paracetamol Pensais indicated for symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamol Pensashould only be used by adults and children over 12 years old.

Do not takeTramadol/Paracetamol Pensa:

- If you are allergic to tramadol, paracetamol or any of the other components of this medication (listed in section 6).

- In case of acute alcohol intoxication, if you are taking sleeping medications, potent analgesics, or other psychotropic medications (medications that can alter mood and emotions).

- If you are taking monoamine oxidase inhibitors (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment withTramadol/Paracetamol Pensa.

- If you have severe liver disease.

- If you have uncontrolled epilepsy.

Warnings and precautions:

- If you are taking other medications 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 indicative of jaundice or bile duct problems;

- If you have kidney problems;

- If you have severe respiratory difficulties, for example asthma or severe lung problems;

- If you have epilepsy or have had seizures;

- If you have recently had a head injury, intense headaches associated with vomiting;

- If you have dependence on any other medication used to relieve pain, for example morphine;

- If you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;

- If you are to be anesthetized. Inform your doctor or dentist that you are usingTramadol/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 medications").

If you experience or have experienced any of these problems while taking Tramadol/Paracetamol Pensa, inform your doctor. He will decide if you should continue taking this medication.

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. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide if you should take a hormonal supplement.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe adverse effects. If you experience any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Respiratory disorders related to sleep:

Tramadol/Paracetamol Pensa may cause respiratory disorders related to sleep, such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. 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 monotherapy. Consult a doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible adverse effects").

Tolerance, dependence, and addiction:

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, known as tolerance). Repeated use ofTramadol/Paracetamol Pensacan also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer use.

Dependence or addiction can make you feel like you no longer control the amount of medication you need to take or the frequency with which you need to take it.

The risk of becoming dependent or addicted toTramadol/Paracetamol Pensamay vary from person to person. You may have a higher risk of becoming dependent or addicted toTramadol/Paracetamol Pensaif:

• You or someone in your family has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

If you experience any of the following signs while takingTramadol/Paracetamol Pensa,it may be a sign that you have become dependent or addicted:

• You need to take the medication for a longer period than recommended by your doctor.
• You need to take more than the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep".
• You have repeatedly and unsuccessfully tried to stop or control the use of the medication.
• You feel unwell when you stop taking the medication, and you feel better when you take it again ("withdrawal effect").

If you observe any of these signs, talk to your doctor to determine 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 for use in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Use ofTramadol/Paracetamol Pensawith other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Inform your doctor or pharmacist if you are taking:

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

- gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

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

Tramadol/Paracetamol Pensa is contraindicated in the following cases:

- Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as trigeminal neuralgia).

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

The risk of adverse effects increases:

• if you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Pensa simultaneously with these medications. Your doctor will tell you if Tramadol/Paracetamol Pensa is suitable for you.
• if you are taking medications for depression, Tramadol/Paracetamol Pensa may interact with these medications and may experience a serotonin syndrome (see section 4“Possible adverse effects”).

• if you are taking sedatives, sleeping medications, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or medications for allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• if you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. 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 (medications for nausea and vomiting),

- Cholestyramine (a medication that reduces cholesterol in the blood),

- Ketoconazole and erythromycin (medications used to treat infections).

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Pensa.

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

You should not take alcoholic beverages while taking this medication.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Tramadol may pass into breast milk. Therefore, do not take Tramadol/Paracetamol Pensa more than once during breastfeeding, or, if you take Tramadol/Paracetamol Pensa more than once, discontinue breastfeeding.

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

Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose should be adjusted according to the intensity of the pain and your individual sensitivity. In general, the smallest 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 old 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.

Before starting treatment and regularly during it, 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 tablets of Tramadol/Paracetamol Pensa per day.

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

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 medication is not recommended for children under 12 years old.

Use in elderly patients:

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

Patients with liver or kidney insufficiency/patients undergoing dialysis:

If you have a 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.

Administration form:

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

If you estimate that the action of Tramadol/Paracetamol Pensa is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., you do not have 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 will only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication 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 reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol Pensa:

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, 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 risk of unnecessary side effects (withdrawal symptoms).

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

Like all medicines, Tramadol/Paracetamol Pensa may cause side effects, although not everyone will experience them.

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

- nausea.

- dizziness, drowsiness.

Common:may affect between 1 and 10 in 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 "high" all the time–).

Uncommon:may affect between 1 and 10 in 1,000 patients;

- tachycardia, hypertension, cardiac rhythm and frequency disorders.

- difficulty or pain urinating.

- skin reactions (e.g. rashes, urticaria).

- tingling, numbness, or pins and needles sensation in the extremities, ear noises, involuntary muscle spasms.

- depression, nightmares, hallucinations (hearing, seeing, or perceiving something that is not real), memory loss.

- difficulty swallowing, blood in stool.

- chills, hot flashes, chest pain.

- difficulty breathing.

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

- convulsions, difficulties with coordinated movements.

- addiction.

- blurred vision.

The following side effects recognized have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Pensa, 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.

- In rare cases, skin eruptions, indicative of allergic reactions that may manifest through sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens, interrupt treatment and consult your doctor immediately. Do not take this medication again.

- Severe skin reactions have been reported very rarely.

• Unknown frequency: low blood sugar (hypoglycemia), hypophonia, and serotonin syndrome, which may 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 medication like tramadol, may create dependence, making it difficult to stop taking it.

In rare instances, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (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 may result in nasal or gum bleeding.

The use of Tramadol/Paracetamol Pensa with anticoagulants (e.g. femprocumona, warfarina) may increase the risk of bleeding. Inform your doctor immediately about any prolonged or unexpected bleeding.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Store this medication in a safe and protected place, where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

This medication does not require special storage conditions.

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

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTramadol/Paracetamol Pensa:

The active principles 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 carboxymethylcellulose (Type A) from potato and pregelatinized cornstarch.

Appearance of the product and contents of the packaging:

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization:
Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:
Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

This leaflet has been reviewed in May 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/