TRAMADOL/PARACETAMOL QUALIGEN 37.5 / 325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Qualigen 37.5 mg/325 mg Film-Coated Tablets EFG

(Tramadol Hydrochloride/Paracetamol)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Tramadol/Paracetamol Qualigen is and what it is used for
2. What you need to know before you take 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 other information

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

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

Tramadol/paracetamol is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that a combination of tramadol and paracetamol is necessary.

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

2. Before taking Tramadol/Paracetamol Qualigen

Do not take Tramadol/Paracetamol Qualigen

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

• if you have taken any medicine for the treatment of insomnia, strong painkillers (opioids), or psychotropic drugs (medicines that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines 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 epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Consult your doctor before starting to take Tramadol/Paracetamol Qualigen

• if you are taking other medicines 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 a sign of jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe breathing 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 medicines 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 medicine used for pain relief, for example, morphine;

• if you are taking other medicines 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 if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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 unwell (nausea) and vomiting.

Sleep-related breathing disorders

Tramadol/Paracetamol Qualigen contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level 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 your 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 medicine and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss 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 medicine.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine 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 that you no longer control the amount of medicine you need to take or how often you need to take it.

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 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 medicines, 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 Qualigen, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to use more than the recommended dose
• You use the medicine 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 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 so that he can indicate the best 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 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:

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 medicines and Tramadol/Paracetamol Qualigen

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

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

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

It is not recommended to use Tramadol/Paracetamol Qualigen if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). 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 alteration of blood and fluids (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 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, muscle contractions, or diarrhea, you should call your doctor.

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

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

• metoclopramide, domperidone, or ondansetron (a medicine for the treatment of nausea and vomiting),
• cholestyramine (a medicine that reduces cholesterol in the blood),

Your doctor will know which medicines are safe to use with this medicine.

Taking 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Because Tramadol/Paracetamol Qualigen contains tramadol, it is not recommended to take this medicine 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. 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 interrupt breastfeeding.

Fertility

Based on human experience, tramadol does not appear to affect 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 Tramadol/Paracetamol Qualigen. It is important that before driving or using machines, you observe how this medicine 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.

Tramadol/Paracetamol Qualigen contains sodium

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

3. How to take Tramadol/Paracetamol Qualigen

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, 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 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 possible time.

It is not recommended to use this medicine in children under 12 years of age.

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.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age 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 Tramadol/Paracetamol Qualigen 37.5 mg/325 mg tablets per day.

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

Elderly patients

In elderly patients (over 75 years of age), 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 failure/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.

Method of administration

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 think 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), tell 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 serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 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 return. Do not take a double dose to make up for the missed doses, simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Qualigen

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 further questions on the use of this medicine, 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-spirited" 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., rashes, urticaria)
• 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)
• hypotension
• 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 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 recognized adverse effects have been reported by people who have taken medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Qualigen, you should tell your doctor:

• Dizzy feeling when getting up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.

• Taking 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.

• Taking Tramadol/Paracetamol Qualigen 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 sudden 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 sensation, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Qualigen.

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 does not appear 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 out of the reach and sight 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.

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.

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

Composition of Tramadol/Paracetamol Qualigen

• The active ingredients 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 corn starch, sodium carboxymethyl starch (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 Package Contents

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 packages of 20 and 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona- Spain

Manufacturer:

Pharmaceutical Works POLPHARMA S.A.

19 Pelplinska Street; 83-200 Starogard Gdanski

Poland

Date of the Last Revision of this Prospectus:February2025

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/