Tramadol/paracetamol Tecnigen 37.5 mg/325 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol/paracetamol TecniGen 37.5 mg/325 mg tablets EFG

Tramadol hydrochloride / Paracetamol

Package leaflet contents:

1. What Tramadol/paracetamol TecniGen is and what it is used for
2. What you need to know before taking Tramadol/paracetamol TecniGen
3. How to take Tramadol/paracetamol TecniGen
4. Possible side effects
5. How to store Tramadol/paracetamol TecniGen
6. Contents of the pack and other information

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

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

Tramadol/paracetamol TecniGen is used for the symptomatic treatment of moderate to severe pain, whenever your doctor considers that the combination of tramadol and paracetamol is necessary.

This medicine should only be used in adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol/paracetamol TecniGen

Do not take Tramadol/paracetamol TecniGen

• If you are allergic (hypersensitive: skin rash, facial swelling, wheezing or difficulty breathing) to tramadol, paracetamol, or any of the other components of this medicine (listed in section 6).
• In case of acute alcohol intoxication, if you are taking sleeping medications, strong painkillers (opioids), or other psychotropic medicines (medicines that may alter the 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 within the last 14 days before starting treatment with Tramadol/paracetamol TecniGen.
• If you have severe liver disease.
• If you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

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

• 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, for example asthma or serious lung conditions;

• If you have epilepsy or have had seizures;

• If you have recently suffered a head injury, 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 TecniGen.

  • If you experience extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal 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 may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of [product name] 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 how much 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 [product name] 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 previously had mood disorders (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 indicate 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 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 TecniGen”).

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

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 at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

If you develop or have previously experienced any of these problems while taking Tramadol/paracetamol TecniGen, inform your doctor. They will decide whether you should continue taking this medicine.

There is a slight risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or with tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

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, sufficient 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, 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 symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol/Paracetamol TecniGen

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

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.

Do not take Tramadol/paracetamol TecniGen together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/paracetamol TecniGen”).

The use of Tramadol/paracetamol TecniGen is contraindicated if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as intense facial pain known as trigeminal neuralgia)
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

• 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, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

• Sedatives, sleeping medicines, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines for lowering blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will tell you whether Tramadol/paracetamol is suitable for you.

• If you are taking antidepressants, tramadol/paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).

• 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.

• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• Colestipol (a medicine that reduces cholesterol in the blood),
• Ketoconazole or erythromycin (medicines used to treat infections).

The concomitant use of Tramadol/paracetamol TecniGen and opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible.

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

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

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

Your doctor will know which medicines are safe to use together 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, the use of this medicine during pregnancy is not recommended. If you become pregnant while being treated with Tramadol/paracetamol TecniGen, consult your doctor before taking the next tablet.

Breastfeeding:

Tramadol is excreted in breast milk. Therefore, you should not take Tramadol/paracetamol TecniGen more than once during breastfeeding, or if you take Tramadol/paracetamol TecniGen more than once, you must stop 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 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. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Tramadol/paracetamol TecniGen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Tramadol/paracetamol TecniGen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to 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 taking it (see also section 2).

You should take this medicine for the shortest time possible.

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

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

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

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

Do not take this medicine more frequently than your doctor has instructed.

Your doctor may increase the interval between doses:

• If you are over 75 years of age.
• If you have kidney problems.
• If you have liver problems.

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 solely for splitting the tablet if you find it difficult to swallow it whole.

If you feel that the effect of this medicine is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, you do not get adequate pain relief), inform your doctor.

If you take more Tramadol/paracetamol TecniGen than you should

Contact your doctor or pharmacist immediately, 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 TecniGen

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/paracetamol TecniGen

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

You should not stop taking this medicine suddenly unless your doctor tells you to do so. If you wish to discontinue treatment, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing 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 TecniGen may have adverse effects, although not everyone experiences them.

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

• nausea
• dizziness, somnolence

Common: may affect between 1 and 10 in every 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 – 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 or 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 things that are not actually present), 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
• transient loss of consciousness (syncope)

Frequency not known:

• decrease in blood sugar levels

  • hiccups

• 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, diarrhea) (see section 2, "What you need to know before taking Tramadol/paracetamol TecniGen").

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

The following recognized adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/paracetamol TecniGen, you must inform your doctor:

• Dizziness 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, breathlessness, or drop in blood pressure and dizziness.

If you experience any of these, stop treatment immediately and consult your doctor without delay. You must not take this medicine again.

In rare cases, individuals 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 disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions 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 TecniGen, 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 TecniGen together with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

Very rarely, serious skin reactions have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/paracetamol TecniGen

Keep this medicine 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 this medicine after the expiry date stated on the packaging and label (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 empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Tramadol/paracetamol TecniGen:

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

Appearance of Tramadol/paracetamol TecniGen and contents of the container:

It is presented as white, oval, scored tablets for oral administration. Each pack contains 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. The score line is intended to facilitate tablet splitting for easier swallowing, not for dividing into equal doses.

Not all pack sizes 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) SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra - Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Portugal: Tramadol + Paracetamol Farmoz
Spain: Tramadol/paracetamol TecniGen 37.5 mg/325 mg tablets EFG

Date of the most recent review of this leaflet: May 2025

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