Leaflet: information for the user

Tramadol/Paracetamol Qualigen 37.5 mg/325 mg film-coated tablets EFG

(Tramadol hydrochloride/Paracetamol)

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

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

3. How to take Tramadol/Paracetamol Qualigen

4. Possible side effects

5. Storage of Tramadol/Paracetamol Qualigen

6. Contents of the pack and additional information

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

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

Do not take Tramadol/Paracetamol Qualigen

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medication (listed in section 6).

• if you have taken any medication for insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are also 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 Qualigen;
• if you have severe liver disease;
• if you have uncontrolled epilepsy with your current treatment.

Warnings and precautions

Consult your doctor before starting to take Tramadol/Paracetamol Qualigen

• if you are taking other medications that contain paracetamol or tramadol;
• if you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe respiratory difficulties, for example, asthma or severe lung problems;
• if you are epileptic or have had seizures or convulsions,
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Qualigen");
• 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 anesthetized. Tell your doctor or dentist that you are taking tramadol/paracetamol.

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 serious 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.

Respiratory disorders related to sleep

Tramadol/Paracetamol Qualigen contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

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.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, you should stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of illness or vomiting, constipation, loss of appetite.

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

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 cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these side 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 take it.

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 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 ever had any 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 Qualigen, it could be a sign that you have become dependent or addicted:

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

- You need to use 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 symptoms").

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.

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.

Other medications and Tramadol/Paracetamol Qualigen

Inform your doctor or pharmacist if you are taking or have taken any other medication.

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

Tramadol/Paracetamol Qualigen should not be takenwith monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol Qualigen").

Tramadol/Paracetamol Qualigen should not be used 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).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

• 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 imbalance (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

The risk of side effects increases:

• if you are taking triptans for migraine treatment or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, involuntary muscle contractions, or diarrhea, you should call your doctor.

• if you are taking other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, or medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

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

• Metoclopramide, domperidone, or ondansetron (medication for nausea and vomiting),
• Colestyramine (medication to reduce cholesterol in the blood),

Your doctor will know which medications are safe to use with this medication.

Tramadol/Paracetamol Qualigen with food and alcohol

Tramadol/Paracetamol Qualigen may make you feel drowsy.

Alcohol may make you feel 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 take this medication during pregnancy or breastfeeding. If you become pregnant during treatment with Tramadol/Paracetamol Qualigen, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, do not take Tramadol/Paracetamol Qualigen more than once during breastfeeding or, if you take Tramadol/Paracetamol Qualigen more than once, discontinue breastfeeding.

Fertility

Based on human experience, tramadol does not appear to affect male and female fertility. There are no data available on the combination of tramadol and paracetamol in fertility.

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with Tramadol/Paracetamol Qualigen. It is essential to observe how this medication affects you before driving or operating machines. Do not drive or operate machines 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, after changing the formulation, and/or when taking it concurrently.

Tramadol/Paracetamol Qualigen contains sodium

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

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

Before starting treatment and regularly during it, your doctor will explain what you can expect from the use of Tramadol/Paracetamol Qualigen, when and how long you should use 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.

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

The dose should be adjusted 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 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 37.5 mg/325 mg per day.

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

Administration form

Tramadol/Paracetamol Qualigen is presented in the form of tablets for oral administration.

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 Qualigen 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 Qualigen than you should

If you have taken more Tramadol/Paracetamol Qualigen than you should, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of severe liver damage that may only become apparent later.

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

If you forget to take Tramadol/Paracetamol Qualigen

If you forget to take a dose of Tramadol/Paracetamol Qualigen, 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 Qualigen

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 1 in 10 people)

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth
• itching, increased sweating (hyperhidrosis)
• headache, agitation
• confusion, sleep disturbances, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Rare (may affect 1 in 100 people)

• increased heart rate or increased blood pressure, heart rhythm and frequency disturbances
• 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 breathing
• difficulty swallowing, blood in the stool
• skin reactions (e.g., rashes, urticarial hives)
• increased liver enzyme values
• albumin in the urine, difficulty or pain urinating
• chills, hot flashes, chest pain

Rare (may affect 1 in 1,000 people)

• seizures, difficulty with coordinated movements, transient loss of consciousness (syncope)
• dependence on the medication
• delirium
• blurred vision, pupil constriction (miosis)
• speech disturbances
• excessive pupil dilation (mydriasis).

Frequency not known (cannot be estimated from available data)

• decreased blood sugar levels (hypoglycemia)
• hypotension
• 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 severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The following recognized 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 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 weaker breathing, changes in mood, 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 of Tramadol/Paracetamol Qualigen with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

• 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 to you, stop treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol can 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 gastrointestinal and intestinal disturbances.

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.

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

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

Cases of rare 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 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 side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

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

Do not use Tramadol/Paracetamol Qualigen 37.5 mg/325 mg tablets 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. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Qualigen

• The active principles are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components are: pregelatinized cornstarch, sodium carboxymethyl starch (from potato) (type A), microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E-470b), hypromellose (E-464), macrogol 400, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Tramadol/Paracetamol Qualigen 37.5 mg/325 mg film-coated tablets are presented in the form of pale yellow, oblong, and biconvex tablets packaged in PVC/Alu blisters.

Tramadol/Paracetamol Qualigen 37.5 mg/325 mg film-coated tablets are presented in packs of 20 and 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona, Spain

Responsible for manufacturing:

Pharmaceutical Works POLPHARMA S.A.

19 Pelplinska Street; 83-200 Starogard Gdanski

Poland

Last review date 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/