Tramadol/paracetamol teva-ratiopharm 37,5 mg/325 mg comprimidos recubiertos con pelicula efg

Leaflet: information for the user

Tramadol/Paracetamol Teva-ratiopharm 37.5 mg /325 mg

film-coated tablets EFG

tramadol hydrochloride /paracetamol

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, consult 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-ratiopharm and what it is used for

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

3. How to take Tramadol/Paracetamol Teva-ratiopharm

4. Possible side effects

5. Storage of Tramadol/Paracetamol Teva-ratiopharm

6. Contents of the pack and additional information

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

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

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

Do not take Tramadol/Paracetamol ratiopharm

• if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6).
• in case of acute alcohol intoxication, if you have taken any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic drugs (drugs 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 ratiopharm.
• 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 if you:

• are taking other medications that contain tramadol or paracetamol;
• 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;
• have kidney problems;
• have severe respiratory difficulties, for example asthma or severe lung problems;
• are epileptic or have had seizures or convulsions;
• have recently experienced head trauma, shock or severe headaches associated with vomiting;
• are dependent on any other medication used for pain relief, for example morphine;
• are taking other medications for pain relief that contain buprenorphine, nalbuphine or pentazocine;
• are to be anaesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol ratiopharm.
• are depressed and taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol ratiopharm").
• are taking flucloxacillin (an 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 the maximum daily doses of paracetamol are taken.

Inform your doctor immediately if you have any serious diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid disorder) has been reported in patients in these situations when paracetamol is used regularly for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

If you experience or have experienced any of these problems while taking Tramadol/Paracetamol 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.

Talk to your doctor, pharmacist or nurse if you experience any of the following symptoms while taking Tramadol/Paracetamol ratiopharm:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. These 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.

There is a weak risk that you may experience a serotonin syndrome that can appear after taking tramadol in combination with certain antidepressants or tramadol in monotherapy. Consult your 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. 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 that 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 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 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 a longer period 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 stay calm" or "to sleep".
• You have tried repeatedly and unsuccessfully 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 to get advice on 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").

Respiratory problems related to sleep

Tramadol/Paracetamol ratiopharm 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).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.

Children and adolescents

Not recommended for use in children under 12 years.

Use in children with respiratory problems:

Not recommended for use of tramadol in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Use of Tramadol/Paracetamol ratiopharm with other medicines

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

Youshould not takeTramadol/Paracetamol ratiopharm with monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol ratiopharm").

It is contraindicated to use Tramadol/Paracetamol 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). The pain relief may be reduced.

The concomitant use of Tramadol/Paracetamol ratiopharm and sedatives such as benzodiazepines or related medications 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 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 any of these symptoms.

The risk of adverse effects increases if you are also using:

• Depression medications, Tramadol/Paracetamol ratiopharm may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible adverse effects").
• 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, you should call your doctor.
• Sedatives, sleeping pills, other pain relievers 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.
• The concomitant use of tramadol/paracetamol and sedatives such as benzodiazepines or related medications 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 this medicine 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.
• 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 simultaneously with these medications. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• Warfarin or phenprocoumon (a 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 of Tramadol/Paracetamol ratiopharm may be altered if you are also using:

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

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

Use of Tramadol/Paracetamol ratiopharm with food and drinks

Tramadol/Paracetamol ratiopharm may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol ratiopharm.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take Tramadol/Paracetamol Teva more than once during breastfeeding, or if you take Tramadol/Paracetamol Teva more than once, you should stop breastfeeding.

Fertility

Based on human experience, it is not suggested that tramadol affects male and female fertility. There are no data available on the combination of tramadol and paracetamol in fertility.

Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with tramadol/paracetamol. It is essential to observe how this medicine 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.

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

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 interrupt it (see also section 2).

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

The dose should be adjusted according to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible that produces pain relief should be used.

Unless your doctor prescribes something different, the usual 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 per day.

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

Older patients

In older 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. Do not break or chew them.

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, although 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 indicating the medication and the amount ingested.

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 the 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"). 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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

If you have been taking tramadol/paracetamol for some time, you should consult your doctor before interrupting treatment as your body may have become accustomed to it.

If you have any other doubts about the use of this product, 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, heart rhythm and frequency disorders,
• Presence of albumin in the urine, difficulty or pain when urinating,
• Skin reactions (e.g. rashes, urticaria),
• 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,
• Increased liver enzyme values,
• Difficulty breathing.

Rare: may affect 1 in 100 people

- Seizures, difficulty performing coordinated movements,

- Dependence on the medication,

- Delirium,

- Blurred vision, pupil constriction (miosis),

- Transient loss of consciousness (syncope),-

- Speech disorders,

- Excessive pupil dilation (mydriasis).

Frequency not known: cannot be estimated from available data.

- Decreased blood sugar levels (hypoglycemia),

- Hiccups,

- 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 ratiopharm).

- 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 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 taking Tramadol/Paracetamol ratiopharm, please tell 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 a blood and fluid anomaly (metabolic acidosis with high anion gap) when there is an increase in plasma acidity.
• 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. In very rare cases, severe skin reactions have been reported. If this happens, stop treatment and consult your doctor immediately. Do not take this medicine again.

In rare cases, using a medication like tramadol, may make you dependent on it, 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 digestive and intestinal problems. 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 with Tramadol/Paracetamol 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.

The use of Tramadol/Paracetamol ratiopharm with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Inform your doctor immediately about any prolonged or unexpected bleeding.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of your usual pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Tramadol/Paracetamol Teva-ratiopharm

- The active principles are tramadol hydrochloride and paracetamol.

One film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

- The other components are:

Core tablet: kollicoat IR (75% polyvinyl alcohol, 25% polyethylene glycol, 0.3% colloidal silica), pregelatinized cornstarch, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate.

Coating: opadry II beige 85F97409 (polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)).

Appearance of the product and content of the packaging

Tramadol/Paracetamol Teva-ratiopharm film-coated tablets are presented in orange-colored tablets packaged in blisters.

Tramadol/Paracetamol Teva-ratiopharm is presented in packs of 20 and 60 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

28108 Alcobendas, Madrid

Responsible for manufacturing:

Teva Operations Poland sp.z.o.o.

Ul. Mogilska 80, 31-546, Krakow

Poland

Ó

Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

Date of the last review of this leaflet:February 2025

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