Tramadol/paracetamol teva 75 mg/ 650 mg comprimidos recubiertos con pelicula

Patient Information Leaflet

Tramadol/Paracetamol Teva75 mg/650 mg Film-Coated Tablets

Tramadol/Paracetamol Hydrochloride

Read this 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 or pharmacist.

- This medicine has been prescribed for you only. Do 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Tramadol/Paracetamol Teva

3. How to take Tramadol/Paracetamol Teva

4. Possible side effects

5. Storage of Tramadol/Paracetamol Teva

6. Contents of the pack and additional information

Tramadol/paracetamolis a combination of two analgesics: tramadol and paracetamol, which act together to relieve pain.

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

Tramadol/paracetamolshould only be used by adults and adolescents over 12 years old.

Do not takeTramadol/Paracetamol Teva:

-if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6).

• if you have taken any medicine for the treatment of insomnia, potent analgesics (opioids), or psychotropic medicines (medicines that can alter mood and emotions) in case of acute alcohol intoxication;

-if you are taking monoamine oxidase inhibitors (certain medicines used for the treatment of depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment withTramadol/Paracetamol Teva.

-if you have severe liver disease.

-if you have uncontrolled epilepsy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol/Paracetamol Teva if:

-if you are taking other medicines that contain tramadol or paracetamol;

-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 are epileptic or have had seizures or convulsions.

-if you have recently had a head injury, shock or severe headaches associated with vomiting.

-if you are taking other medicines for pain relief that contain buprenorphine, nalbuphine or pentazocine;

-if you are to be anaesthetized. Tell your doctor or dentist that you are usingTramadol/Paracetamol Teva.

- if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Teva”).

- If you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (metabolic acidosis with high anion gap) that must be treated urgently and which may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if you are taking the maximum daily doses of paracetamol for a longer period. Metabolic acidosis with high anion gap is a serious disease that must have urgent treatment.

During treatment with tramadol/paracetamol, inform your doctor immediately if you have severe diseases, 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 if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Consult your doctor or pharmacist before starting to takeTramadol/Paracetamol Teva.

If any of these problems occur while you are takingTramadol/Paracetamol Teva, please inform your doctor. They will decide if you should continue taking this medicine.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme and this may affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, you should stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite.

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 associated with this serious syndrome (see section 4 “Possible adverse effects”).

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (you become tolerant of it, which is known as tolerance). Repeated use of tramadol/paracetamol can also cause dependence, abuse and addiction, which can lead to a potentially fatal overdose. The risk of these adverse effects may increase with a higher dose and longer duration of 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 to tramadol/paracetamol varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or a family member has abused or been dependent on alcohol, prescription medicines 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 illnesses.

If you notice any of the following signs while taking tramadol/paracetamol, 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 of the recommended dose
• You use the medicine for reasons other than those prescribed, for example, “to keep calm” or “to sleep”
• You have tried repeatedly and unsuccessfully to stop or control the use of the medicine
• You feel unwell when you stop taking the medicine, and you feel better when you take it again (“withdrawal effect”)

If you observe any of these signs, talk to your doctor to get the best 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).

Respiratory problems related to sleep

Tramadol/Paracetamol Tevamay cause respiratory problems related to sleep, such as central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).Between the 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.

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

Inform your doctor if you experience any of the following symptoms while taking tramadol/paracetamol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. They may be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Children and adolescents

Do not recommend use in children under 12 years.

Use in children with respiratory problems:

Do not recommend the use of tramadol in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol/Paracetamol Teva

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, such as:

• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (metabolic acidosis) that must be treated urgently (see section 2)

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.

Youmust not takeTramadol/Paracetamol Tevawith monoamine oxidase inhibitors (MAOIs) (see section (“Do not takeTramadol/Paracetamol Teva”)

It is contraindicated to useTramadol/Paracetamol Tevaif you are being treated with:

-Carbamazepine (a medicine normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia). The harmful effects of paracetamol on the liver may be increased.

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

The concomitant use of Tramadol/Paracetamol Teva and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Tramadol/Paracetamol Teva with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking, and follow your doctor's dose recommendation carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

The risk of adverse effects increases:

- if you are taking medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Teva simultaneously with these medicines. Your doctor will tell you if Tramadol/Paracetamol Teva is suitable for you.

- if you are taking medicines for the treatment of depression, Tramadol/Paracetamol Teva may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”).

-Triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors, “SSRIs” (for the treatment of depression). If you experience confusion, agitation, fever, sweating, incoordinated limb or eye movements, uncontrolled muscle contractions or diarrhea, you should call your doctor.

-Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants or allergy medicines. You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of tramadol/paracetamol and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, 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 this medicine with sedatives, they should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking, and follow your doctor's dose recommendation carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Inform your doctor if you experience any of these symptoms.

-Antidepressants, anesthetics, neuroleptics (medicines that affect mood) or bupropion (medicine used as a smoking cessation aid). The risk of seizures may increase. Your doctor will tell you if Tramadol/Paracetamol Teva is suitable for you.

-Warfarin or phenprocoumon (medicine used to prevent blood clots). The effectiveness of these medicines may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness ofTramadol/Paracetamol Tevamay be altered if you are also using:

-Metoclopramide, domperidone or ondansetron (medicines for the treatment of nausea and vomiting),

-Colestiramine (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 Teva.

Administration ofTramadol/Paracetamol Tevawith food, drinks and alcohol

Tramadol/Paracetamol Tevamay cause drowsiness. Alcohol may make you feel more drowsy, so it is recommended not to take alcohol while takingTramadol/Paracetamol Teva.

Tramadol/Paracetamol Teva 75 mg/650 mg contains sodium

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

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

Before starting treatment and regularly during it, 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).

The dose should be adjusted to the intensity of the pain and your individual sensitivity.

You should take tramadol/paracetamol for the shortest time possible.

Use in children

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

Use in adults

Unless your doctor prescribes something different, the usual starting dose for adults and adolescents over 12 years old is one tablet.

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 4 tablets of tramadol/paracetamol per day.

Do not take tramadol/paracetamol more frequently than your doctor has indicated.

Older 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 disease/patients on dialysis

If you have a severe liver or kidney disease, treatment with tramadol/paracetamol is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Administration form

Tramadol/paracetamol is administered orally.

The tablets should be swallowed whole with sufficient liquid. They should not be broken or chewed.

If you estimate that the effect of tramadol/paracetamol is too strong (e.g. you feel very drowsy or have difficulty breathing) or too weak (e.g. you do not have adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Tevathan you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, consult your doctor immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to takeTramadol/Paracetamol Teva

If you forgot to take a dose of tramadol/paracetamol, the pain is likely to reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt the treatment withTramadol/Paracetamol Teva

Generally, no adverse effects occur after interrupting treatment with tramadol/paracetamol. However, in rare cases, patients who have been taking tramadol/paracetamol for a while and have interrupted treatment abruptly may feel unwell (see section 4. "Possible adverse effects"). Do 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 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, this medicine can cause side effects, although not everyone will experience them.

Very common(may affect more than 1 in 10 people)

- Nausea.

- Dizziness, drowsiness.

Common(may affect up to 1 in 10 people)

- 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 up to 1 in 100 people)

- Tachycardia, hypertension, cardiac rhythm and frequency disorders

- Presence of albumin in the urine, difficulty or pain when urinating

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

- Increased levels of liver enzymes.

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

- Depression, nightmares, hallucinations, (hearing, seeing or perceiving something that does not exist in reality), memory loss

- Difficulty swallowing, blood in the stool

- Chills, hot flashes, chest pain

- Difficulty breathing.

Rare(may affect up to 1 in 1,000 people)

- Convulsions, difficulties with coordinated movements, transient loss of consciousness (syncope).

- Dependence on the medication.

- Delirium

- Blurred vision, pupil constriction (miosis).

- Speech disorders

- Excessive pupil dilation (mydriasis)

Frequency not known(cannot be estimated from available data)

- Decreased blood sugar levels (hypoglycemia).

- Hipo.

- 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 Teva).

- A severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The following side 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 takingTramadol/Paracetamol Teva, you should 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.
• The use of paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in plasma acidity.
• The use ofTramadol/Paracetamol Tevawith anticoagulants (e.g. fenprocumon, warfarin) 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. In rare cases, skin rashes, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or low blood pressure and dizziness. If this happens to you,interrupt the treatment and consult your doctor immediately. Do not take this medication again.In rare cases, using a medication like tramadol, may make you dependent on it, making it difficult to stop taking it.

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 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 withTramadol/Paracetamol Teva, please consult your doctor.

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which may result in nasal or gum bleeding.

Rare cases of respiratory depression with tramadol have been reported

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 leaflet. You can also report them directly through the Spanish System for the 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 medicine

Keep this medication 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.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

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 Teva

-The active principles are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.

-The other components are:

Core of the tablet:

Pregelatinized maize starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethyl starch (Type A) (from potato), hydroxypropyl cellulose, magnesium stearate of vegetable origin, purified water.

Coating:OPADRY yellow 15B82958 (hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), polysorbate 80).

Appearance of the product and content of the container

Tramadol/Paracetamol Tevafilm-coated tablets are presented in the form of scored, oblong, biconvex, and yellow-colored tablets, packaged in PVC-white opaque/Al and PVC/PVDC-white opaque/Al blisters.

Tramadol/Paracetamol Tevais presented in packaging of 20, 60, and 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid Spain

Responsible for manufacturing

FARMALIDER, S.A

C/ Aragoneses, 2

28108 Alcobendas

Madrid Spain

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas

Madrid Spain

Last review date of this leaflet:February 2025

“Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/”