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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

(Tramadol hydrochloride/Paracetamol)

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Tramadol/Paracetamol Qualigen is 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. How to store 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 analgesics: 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 the combination of tramadol and paracetamol is necessary.

Tramadol/paracetamol should only be used in 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 medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may alter mood and emotions) in cases of acute alcohol intoxication;

• if you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease) or have taken them within the last 14 days before starting 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 containing paracetamol or tramadol;
• if you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe breathing difficulties, for example asthma or serious lung conditions;
• if you have epilepsy 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 pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anaesthetised. Inform your doctor or dentist that you are taking tramadol/paracetamol.

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

You have serious medical conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

Tramadol/Paracetamol Qualigen contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of experiencing central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

There is a low risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol used alone. Contact your doctor immediately if you experience any symptoms related to this serious condition (see section 4 “Possible side effects”).

Tramadol is metabolised in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

If you develop or have previously experienced any of these problems while taking tramadol/paracetamol, please inform your doctor. Your doctor will decide whether you should continue taking this medicine.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol/Paracetamol Qualigen may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control the amount of medicine you need to take or how often you take it.

Dependence or addiction may make you feel that you no longer control the amount of medicine you need to take or how often you 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 a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have previously 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 indicate 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 prescribed, for example, “to stay calm” 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 feel better when you take it again (“withdrawal effect”).

If you observe any of these signs, speak with your doctor so they can advise you on the best course of treatment, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, “If you stop taking Tramadol/Paracetamol Qualigen”).

Children and adolescents

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may 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. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Other medicines and Tramadol/Paracetamol Qualigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Tramadol/Paracetamol Qualigen must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Qualigen”).

The use of Tramadol/Paracetamol Qualigen is not recommended if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

• Gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

The risk of adverse effects increases:

• if you are taking triptans for migraine treatment or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhoea, contact your doctor immediately.

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

The concomitant use of Tramadol/Paracetamol Qualigen and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with other sedative medicines, they should limit the dose and duration of concomitant treatment.

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

• if you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Qualigen simultaneously with these medicines. Your doctor will advise whether Tramadol/Paracetamol Qualigen is suitable for you.

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

• if you are taking warfarin or fenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Tramadol/Paracetamol Qualigen may be affected if you also take:

• metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• colestyramine (a medicine that lowers blood cholesterol),

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 increase drowsiness; therefore, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because Tramadol/Paracetamol Qualigen contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while being treated with Tramadol/Paracetamol Qualigen, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, 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.

Fertility

Based on human experience, there is no indication that tramadol affects fertility in men and women. No data are available on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor whether you can drive or operate machinery during treatment with Tramadol/Paracetamol Qualigen. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken 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 instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to 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 discontinue it (see also section 2).

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

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

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides 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, the dose may be increased as advised by your doctor. The shortest interval between doses must 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 instructed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination may be slow. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/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 disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration

Tramadol/Paracetamol Qualigen is available as tablets for oral administration.

The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel 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 get 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, contact 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, contact 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, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Qualigen

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to discontinue treatment, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about 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 everyone will experience them.

Very common (may affect more than 1 in 10 people)

• nausea
• dizziness, drowsiness.

Common (may affect up to 1 in 10 people)

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth
• itching, increased sweating (hyperhidrosis)
• headache, restlessness
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “high-spirited” all the time).

Uncommon (may affect up to 1 in 100 people)

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate
• tingling sensation, numbness, or prickling sensations 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 stools
• skin reactions (e.g., rashes, urticaria)
• increased liver enzyme levels
• presence of albumin in urine, difficulty or pain when urinating
• chills, hot flushes, chest pain

Rare (may affect up to 1 in 1,000 people)

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope)
• drug dependence
• delirium
• blurred vision, pupil constriction (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis).

Frequency not known (cannot be estimated from available data)

• decrease in blood sugar levels (hypoglycemia)
• hiccups
• serotonin syndrome, which may present with changes in mental status (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 taking Tramadol/Paracetamol Qualigen).
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

The following adverse effects have been reported in individuals taking medicines containing either tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Qualigen, you must inform your doctor:

• Dizziness upon standing up from a lying or sitting position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, altered perception, worsening of asthma.

• The use of paracetamol alone or in combination with the antibiotic flucloxacillin may induce a blood and fluid disorder (metabolic acidosis with high anion gap) when there is increased acidity in the blood plasma.

• The use of Tramadol/Paracetamol Qualigen together with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes may occur, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens, stop treatment immediately and consult your doctor. You must not take this medicine again.

In rare cases, taking a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

Occasionally, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may become 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 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 abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

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

Rare cases of respiratory depression have been reported 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Qualigen

Keep out of the reach and sight of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm and be fatal to individuals for whom it has not been prescribed.

Do not use Tramadol/Paracetamol Qualigen 37.5 mg/325 mg tablets after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at a pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Qualigen

• The active substances 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 maize starch, 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 contents of the pack

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

Tramadol/Paracetamol Qualigen 37.5 mg/325 mg film-coated tablets are available in packs containing 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 most recent review of this leaflet: February 2025

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