Tramadol/paracetamol tecnigen 37,5 mg/325 mg comprimidos efg

Leaflet: information for the user

Tramadol/paracetamol TecniGen37.5 mg/325 mg tablets EFG

Tramadol hydrochloride/ Paracetamol

1. What isTramadol/paracetamol TecniGenand what is it used for

2. What you need to know before starting to takeTramadol/paracetamol TecniGen.

3. How to takeTramadol/paracetamol TecniGen.

4. Possible side effects.

5. Storage ofTramadol/paracetamol TecniGen.

6. Contents of the pack and additional information.

Tramadol/paracetamol TecniGenis a combination of two analgesics, tramadol and paracetamol, that work together to relieve pain.

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

Tramadol/paracetamol TecniGenshould only be used by adults and children over 12 years old.

Do not takeTramadol/paracetamol TecniGen

- If you are allergic (hypersensitive) 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 (opioids), or other psychotropic medications (medications that can alter the level of consciousness).

- If you are taking monoamine oxidase inhibitors (MAOIs) (certain medications used for the treatment of 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, pharmacist, or nurse before starting to take Tramadol/paracetamol TecniGen.

- 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 problems with your bile ducts;

- 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 are dependent on any other medication used for pain relief, for example, morphine.

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

- If you are to be anesthetized. Inform 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 indicators of adrenal insufficiency (low cortisol levels). If you experience 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 medications and Tramadol/paracetamol TecniGen").

Respiratory problems related to sleep

Tramadol/paracetamol may cause respiratory problems related to sleep, 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, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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

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 your doctor immediately if you experience any of the symptoms linked to this severe syndrome (see section 4 "Possible side effects").

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 notice any of the following adverse effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, somnolence, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

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.

Other medications and Tramadol/Paracetamol TecniGen

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

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

Do not takeTramadol/paracetamol TecniGen with monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/paracetamol TecniGen").

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

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

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). 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, involuntary muscle contractions, or diarrhea, contact your doctor.

- 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.

- Antidepressants, anesthetics, neuroleptics (medications that affect mood), or bupropion (a medication used to help quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/paracetamol is suitable for you.

- If you are taking antidepressants, Tramadol/paracetamol may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible side effects").

- Warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, and there may be a risk of bleeding. Inform your doctor immediately of any prolonged or unexpected bleeding.

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

- Metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),

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

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

The concomitant use of Tramadol/paracetamol TecniGen and opioids (potent analgesics, medications for substitution therapy, and some medications for cough) increases the risk of somnolence, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, 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 should be limited by your doctor.

Inform your doctor about all the opioid medications you are taking and follow your doctor's recommendations on the dose. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), as there is a grave 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.

Your doctor will know which medications are safe to use with Tramadol/paracetamol TecniGen.

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

Tramadol/paracetamol may cause drowsiness. Do not take alcoholic beverages while taking this medication.

Pregnancy, breastfeeding, and fertility:

Pregnancy:

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

Because Tramadol/paracetamol TecniGen contains tramadol, it is not recommended to use this medication 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. Therefore, do not take Tramadol/paracetamol TecniGen more than once during breastfeeding, or if you take Tramadol/paracetamol TecniGen more than once, stop breastfeeding.

Small amounts of tramadol may pass into breast milk. Therefore, do not take Tramadol/paracetamol 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.

Tramadol/paracetamol TecniGen contains sodium

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

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

You should take Tramadol/paracetamol TecniGen for the shortest time possible.

This medication is not recommended for use in children under 12 years old.

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.

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

Do not take Tramadol/paracetamol TecniGen 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.

Administration form:

The tablets can be taken whole or divided in half with the help of a liquid, preferably water. The groove on the tablet is only for dividing the tablet if it is difficult to swallow whole. The tablet can be divided into two equal parts.

If you estimate that the action of Tramadol/paracetamol TecniGen 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 TecniGen than you should

You should consult 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Tramadol/paracetamol TecniGen

If you forgot 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 TecniGen

Generally, no adverse effects occur after interrupting treatment with Tramadol/paracetamol TecniGen. However, in rare cases, patients who have been taking Tramadol/paracetamol TecniGen for a while and have interrupted treatment abruptly may feel unwell (see section 4. "possible adverse effects"). If you have been taking Tramadol/paracetamol TecniGen for some time, you should consult your doctor before interrupting treatment as your body may have become accustomed to it.

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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse 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 TecniGen 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, heart rhythm or frequency disorders.

- difficulty or pain urinating.

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

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

- depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), 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.

- transient loss of consciousness (syncope)

Frequency not known::

- decrease in blood sugar level

• hypoglycemia

- Serotonin syndrome, which may manifest as 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 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").

The following adverse reactions recognized have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of those symptoms while taking Tramadol/paracetamol TecniGen, 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 as 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.

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 shaky. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ear noises (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 may result in nasal or gum bleeding.

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es

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

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not usethis medicationafter 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 medication if you observe visible signs of deterioration.

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

Composition ofTramadol/paracetamol TecniGen:

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

Appearance of the product and content of the packaging:

Tramadol/paracetamol TecniGenis 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 for easier swallowing, not to divide into equal doses.

Not all packages may be marketed.

Holder of the marketing authorization andResponsible for manufacturing:

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

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 with the following names:

Portugal:Tramadol + Paracetamol Farmoz

Spain:Tramadol/paracetamol TecniGen 37.5 mg/325 mg tablets EFG

This leaflet has been reviewed in April 2023

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