Leaflet: information for the user

Tramadol/ParacetamolQualigen 37.5 mg/325 mg Effervescent Tablets EFG

Tramadol hydrochloride/ Paracetamol

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, inform your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Tramadol/Paracetamol Qualigen is a combination of two analgesics, tramadol hydrochloride and paracetamol, that act together to relieve pain.

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

Tramadol/Paracetamol Qualigen should only be used by adults and children over 12 years old.

Do not take Tramadol/Paracetamol Qualigen:

• If you are allergic 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, or other psychotropic medications (medications that can alter mood and emotions).
• If you are taking MAO inhibitors (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Qualigen.
• If you have severe liver disease.
• If you have uncontrolled epilepsy.

Warnings and precautions:

• 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 bile duct problems;
• 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, shock, or severe headaches associated with vomiting;
• If you are dependent on any other medication used to relieve pain, for example morphine;
• If you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;
• If you are to be anesthetized. Inform your doctor or dentist that you are using Tramadol/Paracetamol Qualigen.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Qualigen").

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

During treatment with Tramadol/Paracetamol Qualigen, inform your doctor immediately if:

You have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

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 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, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of discomfort 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 monotherapy. Consult a doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible adverse effects").

Tolerance, dependence, and addiction:

This medication 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 Qualigen can also lead to dependence, abuse, and addiction, which can result in 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 how often you need to take it.

The risk of becoming dependent or addicted to Tramadol/Paracetamol Qualigen varies from person to person. You may have a higher risk of becoming dependent or addicted to Tramadol/Paracetamol Qualigen if:

- You or a family member has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").

- You are a smoker.

- You have 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 symptoms while taking Tramadol/Paracetamol Qualigen, it could be a sign that you have become dependent or addicted:

- You need to take the medication for a longer period than recommended by your doctor.

- You need to take more of the recommended dose.

- You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep".

- You have repeatedly and unsuccessfully tried 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 Qualigen).

Children and adolescents:

Use in children with respiratory problems:

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Use of Tramadol/Paracetamol Qualigen with other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Inform your doctor or pharmacist if you are taking:

• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

You should not take Tramadol/Paracetamol Qualigen with MAO inhibitors (see "Do not take Tramadol/Paracetamol Qualigen").

Tramadol/Paracetamol Qualigen is contraindicated in the following situations:

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

The risk of adverse effects increases:

• If you are taking medications that facilitate or can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Qualigen simultaneously with these medications. Your doctor will tell you if Tramadol/Paracetamol Qualigen is suitable for you.
• If you are taking antidepressants, Tramadol/Paracetamol Qualigen may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible adverse effects").

The risk of adverse effects increases if you also use:

• Triptans (for the treatment of migraines) 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 medications, other analgesics such as morphine and codeine (also used to treat cough), 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 (medication used as a smoking cessation aid). The risk of seizures may increase. Your doctor will tell you if Tramadol/Paracetamol Qualigen 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. Inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Tramadol/Paracetamol Qualigen may be altered if you also use:

• Metoclopramide, domperidone, and ondansetron (medications for nausea and vomiting).
• Colestiramine (medication that reduces cholesterol in the blood).
• Ketoconazole and erythromycin (medications used to treat infections).

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Qualigen.

Tramadol/Paracetamol Qualigen with food, drinks, and alcohol:

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

Pregnancy, breastfeeding, and fertility:

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

Due to the presence of tramadol in Tramadol/Paracetamol Qualigen, it is not recommended to use this medication during pregnancy. If you become pregnant during treatment with Tramadol/Paracetamol Qualigen, consult your doctor before taking the next tablet.

Small amounts of tramadol may pass into breast milk. Therefore, you should not take this medication during breastfeeding.

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol/Paracetamol Qualigen more than once during breastfeeding, or if you take Tramadol/Paracetamol Qualigen more than once, you should stop breastfeeding.

Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with Tramadol/Paracetamol Qualigen. 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 especially careful at the start of treatment, after increasing the dose, and/or when taking it with other medications.

Tramadol/Paracetamol Qualigen contains Lactose and Sodium:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains 300.84 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 15% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 Qualigen, 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).

You should take Tramadol/Paracetamol Qualigen for the shortest time possible.

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

Unless your doctor prescribes something different, 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 Qualigen per day.

Do not take Tramadol/Paracetamol Qualigen 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.

Use in children and adolescents:

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

Older patients

In elderly patients (over 75 years old), tramadol elimination may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney insufficiency/patients on dialysis

If you have severe liver or kidney disease, treatment with Tramadol/Paracetamol Qualigen is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Administration form:

The effervescent tablets are administered orally.

The effervescent tablets are taken dissolved in a glass of water. Before ingesting the medication, the effervescence must cease.

If you estimate that the action of Tramadol/Paracetamol Qualigen 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 Qualigen than you should:

You should consult your doctor or pharmacist even if you feel well. There is a risk of liver damage that will 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 Qualigen:

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, simplycontinue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol Qualigen:

Generally, no adverse effects occur after interrupting treatment with Tramadol/Paracetamol Qualigen. However, in rare cases, patients who have been taking Tramadol/Paracetamol Qualigen for a while and have interrupted treatment abruptly may feel unwell (see section 4 "possible adverse effects"). If you have been taking Tramadol/Paracetamol Qualigen 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 medication,ask your doctor or pharmacist.

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).

Like all medicines, Tramadol/Paracetamol Qualigen 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, cardiac rhythm and frequency disorders
• Difficulty or pain urinating
• Skin reactions (e.g. rashes, urticaria)
• Tingling, numbness, 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;

• Seizures, difficulty performing coordinated movements
• Dependence
• Blurred vision
• Transient loss of consciousness (syncope).
• Severe skin reactions have been rarely reported.

Frequency not known::

• Decreased blood sugar levels.
• 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 starting to take Tramadol/Paracetamol Qualigen).
• A serious disease that can make the blood more acidic (metabolic acidosis) in severely ill patients using paracetamol (see section 2).

The following side effects 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 Qualigen, 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 shallower breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• 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 medicine again.

In rare cases, using a medicine like tramadol, may make you dependent, 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 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 Qualigen, please consult your doctor.

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

The use of Tramadol/Paracetamol Qualigen with anticoagulants (e.g. femprocumona, warfarina) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

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 Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Store this medication in a safe and protected place where others cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

Store below 86°F (30°C).

Shelf life once opened: 1 year, not exceeding the expiration date.

Once opened: maintain the container perfectly closed to protect it from moisture.

Store in the original container to protect it from moisture.

Do not use Tramadol/Paracetamol Qualigen effervescent tablets after the expiration date appearing on the container (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 trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Qualigen effervescent tablets:

• The active principles are tramadol hydrochloride and paracetamol. Each effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other components are: sodium hydrogen carbonate, anhydrous citric acid, povidone, lactose monohydrate, sodium saccharin anhydrous, polyethylene glycol 6000, and magnesium stearate.

Appearance of the product and contents of the packaging:

Tramadol/Paracetamol Qualigen effervescent tablets are presented in the form of white, round, flat, bisected effervescent tablets with a groove on one face.

The effervescent tablets are packaged in polypropylene tubes with a polyethylene plug with a silica gel desiccant and are presented in containers of 20 tablets (2 tubes of 10 tablets or 1 tube of 20 tablets).

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona, Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain.

Date of the last review of this leaflet:

February 2025

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