TRAMADOL/PARACETAMOL QUALIGEN 75 mg/650 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tramadol/Paracetamol Qualigen 75 mg/650 mg Film-Coated Tablets

Tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before starting to take this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tramadol/Paracetamol Qualigen and what is it 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. Package Contents and Additional Information

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

This medication is a combination of two pain relievers: tramadol and paracetamol, which work together to relieve pain.

This medication is indicated for the symptomatic treatment of moderate to severe pain, provided that your doctor considers the combination of tramadol and paracetamol necessary.

This medication should only be used by adults and adolescents over 12 years of age.

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

Do not take this medication:

• 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 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 to treat depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with tramadol/paracetamol;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication:

• 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, such as 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, (e.g., morphine);
• if you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• if you are going 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:

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Sleep-Related Breathing Disorders

Tramadol/Paracetamol Qualigen contains an active ingredient that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders; for example, central sleep apnea (shallow or paused 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 may appear after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to suffer from serious side effects. If you notice any of the following side effects, you should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort or vomiting, constipation, lack of appetite.

If you have had any of these problems in the past while taking tramadol/paracetamol, please inform your doctor. He will decide if 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 get used to it, which is 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 side effects may increase with a higher dose and longer 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.

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

• You or someone in your family 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 illnesses.

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 than the recommended dose
• You use the medication for reasons other than those prescribed, for example, "to calm down" or "to sleep"
• You have repeatedly tried and failed 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 so safely (see section 3, If you stop taking Tramadol/Paracetamol Qualigen).

Children and Adolescents

Use in children with respiratory problems

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Tell your doctor if you experience any of the following symptoms while taking Tramadol/Paracetamol Qualigen:

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

Other Medications and Tramadol/Paracetamol Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Important:This medication contains paracetamol and tramadol. Tell 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 section "Do not take Tramadol/Paracetamol Qualigen").

It is not recommended to use tramadol/paracetamol if you are being treated with:

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

Tell your doctor or pharmacist if you are taking:

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

The risk of side effects increases:

• if you are taking 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, muscle contractions, or diarrhea, you should call your doctor.

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

The concomitant use of tramadol/paracetamol and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medication with sedative medications, you should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medications you are taking and follow your doctor's dosage recommendations strictly. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of these symptoms.

• if you are taking medications that 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 this medication is suitable for you.

• if you are taking medications for the treatment of depression. Tramadol/Paracetamol Qualigen can interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

• if you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of this medication may be altered if you also take:

• metoclopramide, domperidone, or ondansetron (medications for the treatment of nausea and vomiting).
• cholestyramine (a medication that lowers cholesterol in the blood).

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

Taking Tramadol/Paracetamol Qualigen with Food and Alcohol

This medication can make you feel drowsy. Alcohol can make you feel drowsy, so it is recommended not to drink alcohol while taking this medication.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Because this medication contains tramadol, it is not recommended to take this medication during pregnancy or breastfeeding. If you become pregnant during treatment with this medication, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take this medication more than once during breastfeeding, or if you take it more than once, you should interrupt breastfeeding.

Fertility

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

Driving and Using Machines

Ask your doctor if you can drive or use machines during treatment with this medication. It is important that before driving or using machines, you observe how this medication affects you. Do not drive or use 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 a dose increase, after a change in formulation, and/or when administered concomitantly with other medications.

Tramadol/Paracetamol Qualigen Contains Sodium

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

3. How to Take Tramadol/Paracetamol Qualigen

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from the use of Tramadol/Paracetamol Qualigen, when and for 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 for the shortest possible time.

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

Use in Children

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

Use in Adults

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age is 1 tablet.

If necessary, the dose can be increased, as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 4 Tramadol/Paracetamol Qualigen 75 mg/650 mg tablets per day.

Do not take Tramadol/Paracetamol Qualigen more frequently than indicated by your doctor.

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

Patients with Liver or Kidney Impairment/Patients on Dialysis

If you have severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

Method of AdministrationThis medication is presented in the form of tablets for oral administration.

Tramadol/Paracetamol Qualigen tablets can be divided into two equal halves.

The tablets should be swallowed with a sufficient amount of liquid and should not be broken or chewed.

If you think 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), tell your doctor.

If you take more Tramadol/Paracetamol Qualigen than you should

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

In case of overdose or accidental ingestion, consult the Toxicology 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, it is likely that the pain will return.

Do not take a double dose to make up for missed doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Qualigen

Do not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 disorders, mood changes (anxiety, nervousness, euphoria (feeling of being "high" all the time).

Uncommon (may affect 1 in 100 people)

• increased heart rate or increased blood pressure, cardiac rhythm and frequency disorders
• tingling sensation, numbness or pinching sensation in the limbs, ringing in the ears, 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. eruptions, urticarial hives)
• increased liver enzyme values
• presence of albumin in the urine, difficulty or pain when urinating
• chills, hot flashes, chest pain.

Rare (may affect 1 in 1,000 people)

• seizures, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope)
• dependence on the medicine
• delirium
• blurred vision, pupil constriction (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis).

Frequency Not Known (cannot be estimated from the available data)

• decrease in blood sugar levels (hypoglycemia)
• hiccups
• serotonin syndrome, which can manifest through 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 stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2. "What you need to know before you start taking Tramadol/Paracetamol Qualigen").
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

The following adverse effects have been reported by people who have taken medicines that contained only tramadol or only paracetamol. However, if you experience any of these symptoms while taking this medicine, you should tell your doctor:

• Feeling of dizziness when getting 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 existing 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 blood plasma acidity.

• The use of this medicine with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes, being indicative of allergic reactions that can manifest through the sudden appearance of swelling of the face and neck, shortness of breath or drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.

In rare cases, using a medicine like tramadol can create dependence, 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 trembly. They may be hyperactive, have difficulty sleeping and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with this medicine, please consult your doctor.

In exceptional cases, blood tests may reveal certain anomalies, such as low platelet count, which can result in nosebleeds or bleeding gums.

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

Respiratory depression has been reported in rare cases with tramadol.

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 is not listed in this prospectus.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol/Paracetamol Qualigen

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who have not been prescribed it.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging, bottle, and blister pack, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

• The active ingredients are tramadol hydrochloride and paracetamol.

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

• The other components are:

Tablet Core:

Pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethyl cellulose Type A, hydroxypropyl cellulose, vegetable magnesium stearate.

Coating:

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

Product Appearance and Package Contents

Tramadol/Paracetamol Qualigen 75 mg/650 mg film-coated tablets are presented in the form of film-coated tablets, scored, oblong, biconvex and yellow in color, packaged in white opaque PVC/Al and white opaque PVC/PVDC/Al blisters.

This medicine is presented in packages of 20 and 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid - Spain

Or

Toll Manufacturing Services, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid - Spain

Date of the Last Revision of this Prospectus: February 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/