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

Leaflet: information for the patient

Tramadol/Paracetamol Teva-ratiopharm75 mg/650 mg film-coated tablets

Tramadol/paracetamol hydrochloride

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 or pharmacist.

- 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isTramadol/Paracetamol Teva-ratiopharmand what it is used for

2. What you need to know before you start takingTramadol/Paracetamol Teva-ratiopharm

3. How to takeTramadol/Paracetamol Teva-ratiopharm

4. Possible side effects

5. Storage ofTramadol/Paracetamol Teva-ratiopharm

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-ratiopharm:

-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 medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;

-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 withTramadol/Paracetamol Teva-ratiopharm.

-if you have severe liver disease.

-if you have uncontrolled epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

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

-if you are taking other medications 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 suffered a head injury, shock or severe 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 anaesthetized. Tell your doctor or dentist that you are usingTramadol/Paracetamol Teva-ratiopharm.

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

- 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 insufficiency, 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..

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

If any of these problems occur while you are takingTramadol/Paracetamol Teva-ratiopharm, please inform your doctor. He 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 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, 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”).

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.

Tolerance, dependence and addiction

This medicine 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 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 medication you need to take or the frequency with which 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 have abused or been dependent on alcohol, prescription medications, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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 medication for longer than advised 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 tried repeatedly and unsuccessfully to stop or control the use of the medication
• When you stop taking the medication, 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 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).

Sleep-related respiratory disorders

Tramadol/Paracetamol Teva-ratiopharm may cause sleep-related respiratory disorders, 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 sleepiness. 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.

Children and adolescents

Do not recommend use in children under 12 years old.

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 medications and Tramadol/Paracetamol Teva-ratiopharm

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

• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

Important: This medicine 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.

Youmust not takeTramadol/Paracetamol Teva-ratiopharm with monoamine oxidase inhibitors (MAOIs) (see “Do not take Tramadol/Paracetamol Teva-ratiopharm”)

It is contraindicated to useTramadol/Paracetamol Teva-ratiopharm if you are being treated with:

-Carbamazepine (a medication 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-ratiopharm and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Tramadol/Paracetamol Teva-ratiopharm 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 these symptoms.

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 Teva-ratiopharm simultaneously with these medications. Your doctor will tell you if Tramadol/Paracetamol Teva-ratiopharm is suitable for you.

- if you are taking medications for depression, Tramadol/Paracetamol Teva-ratiopharm may interact with these medications 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 pain relievers such as morphine and codeine (also 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.

The concomitant use of tramadol/paracetamol and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medication with sedatives, you 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 (medications that affect mood) or bupropion (medication used as a smoking cessation aid). The risk of seizures may increase. Your doctor will tell you if Tramadol/Paracetamol Teva-ratiopharm is suitable for you.

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

The effectiveness ofTramadol/Paracetamol Teva-ratiopharm may be altered if you are also using:

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

-Colestiramine (medication that reduces cholesterol in the blood),

-Ketoconazole and erythromycin (medications used against infections).

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Teva-ratiopharm.

Administration ofTramadol/Paracetamol Teva-ratiopharm with food, drinks, and alcohol

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

Tramadol/Paracetamol Teva-ratiopharm 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 normal 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 Teva-ratiopharm than 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, contact the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Tramadol/Paracetamol Teva-ratiopharm

If you forgot to take a dose of tramadol/paracetamol, it is likely 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 Teva-ratiopharm

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").

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 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 urine, difficulty or pain when urinating

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

- increased levels of liver enzymes.

- sensation of tingling, numbness, or pins and needles 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, difficulty performing 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)

- decrease in 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-ratiopharm").

The following adverse 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 takingTramadol/Paracetamol Teva-ratiopharm, please inform your doctor:

• Dizziness when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or shallower 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. fenprocoumon, warfarin) may increase the risk of bleeding. Please inform your doctor immediately about any prolonged or unexpected bleeding.

• In very rare cases, severe skin reactions have been reported. In rare cases, skin eruptions, indicating 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, using a medication like tramadol can 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 withTramadol/Paracetamol Teva-ratiopharm, please consult your doctor.

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

Rare cases of respiratory depression with tramadol have been reported.

Reporting of adverse effects

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

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 the packaging and medications you no longer need at the SIGRE collection pointat 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 Teva-ratiopharm

-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:

Maize pregelatinised starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethyl starch (Type A) from potato, hydroxypropyl cellulose, magnesium stearate from 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 contents of the packaging

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

Tramadol/Paracetamol Teva-ratiopharm are presented in packs 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

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas

Madrid

Last review date of this leaflet:July 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77385/P_77385.html