TRAMADOL/PARACETAMOL TECNIGEN 37.5 mg/325 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol TecniGen37.5 mg/325 mg Tablets EFG

Tramadol, Hydrochloride/Paracetamol

Contents of the pack:

1. What Tramadol/Paracetamol TecniGen is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol TecniGen
3. How to take Tramadol/Paracetamol TecniGen
4. Possible side effects
5. Storage of Tramadol/Paracetamol TecniGen
6. Package contents and further information

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

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

Tramadol/Paracetamol TecniGen is used for the symptomatic treatment of moderate to severe pain, when your doctor considers that a 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 you take Tramadol/Paracetamol TecniGen

Do not takeTramadol/Paracetamol TecniGen

• If you are allergic (hypersensitive) 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 pills, strong pain relievers (opioids), or other psychotropic medicines (medicines that can alter your level of consciousness).
• 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 TecniGen.
• If you have severe liver disease.
• If you have uncontrolled epilepsy.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Tramadol/Paracetamol TecniGen.

• 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 be anesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol TecniGen.
• If you have 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 hormone supplements.

• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol TecniGen").

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 TecniGen 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 higher doses and longer use.

Dependence or addiction can make you feel like 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 TecniGen 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 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 TecniGen, 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, who will advise you on the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, "If you stop taking Tramadol/Paracetamol TecniGen").

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

If you have severe illnesses, such as severe kidney failure 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 severe 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.

Sleep-related breathing disorders

Tramadol/Paracetamol may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

If you have had any of these problems in the past while taking Tramadol/Paracetamol TecniGen, inform your doctor. He will decide if you should continue taking this medicine.

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 a doctor immediately if you experience any of the symptoms related to 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.

Children and adolescents

Use in children with respiratory problems

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

Other medicines and Tramadol/Paracetamol TecniGen

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

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

Do not takeTramadol/Paracetamol TecniGen withmonoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol TecniGen").

Contraindicated use ofTramadol/Paracetamol TecniGenif 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 also use:

• Triptans (for the treatment of migraines) 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.

• 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.

• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used as an aid to quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.

• 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 to treat epilepsy or pain due to nerve problems (neuropathic pain).

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

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

The concomitant use of Tramadol/Paracetamol TecniGen and opioids (strong pain relievers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Tramadol/Paracetamol TecniGen with opioids, the dose and duration of concomitant treatment must be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and carefully follow the dosage recommendations. It may be useful to inform friends or family members so that they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Tell your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the risk of a blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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

Taking Tramadol/Paracetamol TecniGen with food, drinks, and alcohol

Tramadol/Paracetamol may cause drowsiness. You should not drink alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility:

Pregnancy:

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

Breastfeeding:

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

Small amounts of tramadol may pass into breast milk. Therefore, do not take Tramadol/Paracetamol 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 administered concomitantly with other medicines.

Tramadol/Paracetamol TecniGen contains sodium

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

3. How to take Tramadol/Paracetamol TecniGen

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

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

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.

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 should be at least 6 hours.

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

Do not take this medicine 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.

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 this medicine 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 TecniGen than you should

You should consult your doctor or pharmacist immediately, 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 TecniGen

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 TecniGen

Generally, no unwanted effects appear after stopping treatment with this medicine. However, in rare cases, patients who have been taking Tramadol/Paracetamol for some time and have stopped treatment abruptly may feel unwell (see section 4 "Possible side effects"). If you have been taking this medicine for some time, you should consult your doctor before stopping treatment, as your body may have become accustomed to it.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop treatment, 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 TecniGen 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 or 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, muscle spasms, involuntary muscle contractions.
• 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.
• transient loss of consciousness (syncope)

Frequency not known:

• decrease in blood sugar levels
  • hypo

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

The following recognized adverse effects 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 TecniGen, you should tell your doctor:

• Feeling of 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 rashes, indicating 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, stop treatment and consult your doctor immediately. You should not take this medicine again.

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 TecniGen, please consult your doctor.

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

The use of Tramadol/paracetamol TecniGen along with anticoagulants (e.g., femprocumona, warfarina) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

In very rare cases, severe skin reactions have been reported.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tramadol/paracetamol TecniGen

Keep this medicine 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 this medicine after the expiration date that appears on the packaging and label (after CAD). The expiration date is the last day of the month indicated.

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

Medicines should not be thrown away through the sewers 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. Package Contents and Additional Information

Composition ofTramadol/paracetamol TecniGen:

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 (excipients) are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium glycolate starch (Type A) of potato and pregelatinized corn starch.

Appearance ofTramadol/paracetamol TecniGenand package contents:

It is presented in the form of oval-shaped tablets, white in color and scored, for oral administration. Each package contains 2, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 tablets. The score is to facilitate the division of the tablet to swallow it better, not to divide into equal doses.

Not all packages may be marketed.

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) ESPAÑA

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra - Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Tramadol + Paracetamol Farmoz

Spain: Tramadol/paracetamol TecniGen 37,5 mg/325 mg tablets EFG

Date of the last revision of this prospectus:May 2025

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