Prospect: Information for the patient

Tramadol/Paracetamol Qualigen 75 mg/650 mg film-coated tablets

tramadol hydrochloride/paracetamol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Tramadol/Paracetamol Qualigen

4.Possible adverse effects

5.Storage of Tramadol/Paracetamol Qualigen

6. Contents of the pack and additional information

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

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

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

Do not take this medicine:

- if you are allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medicine (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 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;
• 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 medicine:

• 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 to relieve pain, (for example, morphine);
• if you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• if you are to be anaesthetized. 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 alone. 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 medicine and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell 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 medicine.

Tolerance, dependence, and addiction

This medicine 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 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 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 is not recommended for use 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 Qualigen:

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, have taken recently, or may need to take any other medication.

Important:This medicine 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 Qualigenshould not be takenwith monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol Qualigen").

Tramadol/Paracetamol is not recommended for use 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 to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (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 experienceconfusion, agitation, fever, sweating,uncoordinated movementsof the limbs or eyes, involuntary muscle contractions, ordiarrhea, 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 this medicine may be altered if you also take:

-metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting treatment).

-colestiramine (medication that reduces cholesterol in the blood).

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

Tramadol/Paracetamol Qualigen with food, and alcohol

This medicine may make you feel drowsy. Alcohol may make you feel drowsy, so it is recommended not to take alcohol while taking this medicine.

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 medicine.

Pregnancy

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

Breastfeeding

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

Fertility

Based on human experience, it is not suggested that tramadol affects the fertility of men and women. 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 this medicine. 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 especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Tramadol/Paracetamol Qualigen contains sodium

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

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

Your doctor will explain to you 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/paracetamolfor 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.

Use in children

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

Use in adults

Unless your doctor prescribes something different, the recommended starting dose for adults and adolescents over 12 years old is 1 tablet.

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 4 tablets of tramadol/paracetamol Qualigen 75 mg/650 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 insufficiency/patients on dialysis

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

Administration form
This medication is presented in the form of tablets for oral administration.

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

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

If you estimate that theeffect ofTramadol/Paracetamol Qualigen istoo strong (e.g., youfeel verysleepy or havedifficulty breathing)or tooweak (e.g., youdo not have adequatepain relief),inform 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 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 forgot to take Tramadol/Paracetamol Qualigen

If you forgot to take a dose of tramadol/paracetamol, it is likely that the pain will recur.

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 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 side 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 disorders, 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 disorders
• Feeling of tingling, numbness, or pinching sensations 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
• Presence of albumin in the urine, difficulty or pain urinating
• Chills, hot flashes, chest pain.

Rare (may affect 1 in 1,000 people)

• Seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope)
• Dependence on the medication
• Delirium
• Blurred vision, pupil constriction (miosis)
• Speech disorders
• Excessive pupil dilation (mydriasis).

Frequency not known (cannot be estimated from available data)

• Decreased blood sugar levels (hypoglycemia)
• Hypo
• 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 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 this medication, please inform 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 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 plasma acidity.

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

• In rare cases, skin rashes, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or low blood pressure and dizziness. If this happens, discontinue 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 disorders. 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 this medication, please consult your doctor.

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

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

Cases of rare respiratory depression with tramadol have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, please 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 medication.

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.

No special storage conditions are required.

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the containers and medications you no longer need. By doing so, you will help protect the environment.

-The active principles are hydrochloride of tramadol and paracetamol.

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

-The other components are:

Core of the tablet:

Maize pregelatinized starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, carboxymethyl starch sodium Type A, hydroxypropyl cellulose, magnesium stearate of vegetable origin.

Coating:

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

Appearance of the product and contents of the packaging

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 PVC-white opaque/Al and PVC/PVDC-white opaque/Al blisters.

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

Only some sizes of packaging 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

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid - Spain

Or

Toll Manufacturing Services, S.A.

C/Aragoneses, 2

28108 Alcobendas

Madrid - Spain

Revision date of this leaflet: February 2025

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