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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Tramadol hydrochloride/Paracetamol

Read the entire leaflet carefully before you start taking this medicine, because 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 must not give it to other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

1. What Tramadol/Paracetamol Uxa is and what it is used for
2. What you need to know before taking Tramadol/Paracetamol Uxa
3. How to take Tramadol/Paracetamol Uxa
4. Possible adverse effects
5. How to store Tramadol/Paracetamol Uxa
6. Contents of the pack and other information

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

Tramadol/Paracetamol Uxa is a combination of two analgesics, tramadol and paracetamol, which work together to relieve pain.

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

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

Do not take Tramadol/Paracetamol Uxa

• 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 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 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 Uxa;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor before starting to take Tramadol/Paracetamol Uxa

• 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 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 serious lung problems;
• if you have epilepsy or have had seizures or fits;
• 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;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see section "Taking Tramadol/Paracetamol Uxa with other medicines").

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

• You have serious 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 imbalance in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

Tramadol/Paracetamol Uxa may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol/Paracetamol Uxa:

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.

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

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 Uxa may also lead to dependence, abuse, and addiction, which could 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 how much medicine you need to take or how often.

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 Uxa if:

• You or a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (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 Uxa, it could mean you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor;
• You need to take 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 your 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 notice any of these signs, talk to your doctor so they can advise you on the best treatment approach, 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 Uxa").

Taking Tramadol/Paracetamol Uxa with other medicines

Tell 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.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

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

Use of Tramadol/Paracetamol Uxa 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.

The risk of adverse effects increases:

• if you are taking triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhoea, contact your doctor;
• if you are taking sedatives, medicines for insomnia, other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (a 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;
• if you are taking medicines that may trigger or lower the seizure threshold, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Uxa at the same time as these medicines. Your doctor will advise whether Tramadol/Paracetamol Uxa is suitable for you;
• if you are taking medicines for depression. Tramadol/Paracetamol Uxa may interact with these medicines and may cause 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. Report any prolonged or unexpected bleeding to your doctor immediately;
• if you are taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Uxa may be reduced if you are also taking:

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting);
• colestyramine (a medicine that lowers blood cholesterol).

Your doctor will know which medicines are safe to use with Tramadol/Paracetamol Uxa.

Taking Tramadol/Paracetamol Uxa with food and alcohol

Tramadol/Paracetamol Uxa may make you feel drowsy. Alcohol can increase this effect. Therefore, it is recommended not to drink alcohol while taking Tramadol/Paracetamol Uxa.

Pregnancy, breastfeeding, and fertility

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

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

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

Breastfeeding

Tramadol can pass into breast milk. For this reason, you should not take Tramadol/Paracetamol Uxa more than once during breastfeeding. Otherwise, if you take Tramadol/Paracetamol Uxa more than once, you must stop breastfeeding.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with Tramadol/Paracetamol Uxa. 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. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

3. How to take Tramadol/Paracetamol Uxa

Follow exactly the instructions for use of this medicine provided 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 Uxa, when and for how long you should take it, when you should contact your doctor, and when you should discontinue it (see also section 2).

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

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 Uxa per day.

Do not take Tramadol/Paracetamol Uxa more frequently than prescribed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower. 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 Uxa is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

Tramadol/Paracetamol Uxa 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 Uxa 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 Uxa than you should

If you have taken more Tramadol/Paracetamol Uxa 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 Uxa

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

Generally, no adverse effects occur after stopping treatment with Tramadol/Paracetamol Uxa. However, in rare cases, patients who have taken Tramadol/Paracetamol Uxa for some time and stop treatment abruptly may feel unwell (see section 4 “Possible adverse effects”). If you have been taking Tramadol/Paracetamol Uxa for a prolonged period, you should consult your doctor before stopping treatment, as your body may have become accustomed to it.

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, diarrhoea), stomach ache, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “on a high” all the time).

Uncommon: may affect up to 1 in 100 people:

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• difficulty or pain when urinating,
• skin reactions (e.g. rashes, urticaria),
• tingling sensation, numbness or pins and needles in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or sensing something that is not real), memory loss,
• difficulty swallowing, blood in the stools,
• chills, hot flushes, chest pain,
• difficulty breathing.

Rare: may affect up to 1 in 1,000 people:

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

Frequency not known (cannot be estimated from available data):

• decrease in blood sugar levels,
• hiccups,
• serotonin syndrome, which may present with 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, diarrhoea) (see section 2 “What you need to know before taking”),
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

The following recognised adverse effects have been reported by people who have taken medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Uxa, you should tell your doctor:

• Dizziness when standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.

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

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult for you 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 sensations 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 Uxa, please consult your doctor.

In exceptional cases, blood tests may reveal certain abnormalities, for example low platelet count, which may result in nosebleeds or bleeding gums.

With unknown frequency, tramadol may cause hiccups.

The use of Tramadol/Paracetamol Uxa 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.

Very rarely, serious skin reactions have been reported.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 Uxa

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

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

Do not use this medicine after the expiry date stated on the container after EXP.

The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

• Composition of Tramadol/Paracetamol Uxa

• The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• Other components (excipients) are:

Tablet core: pregelatinized corn starch, powdered cellulose, sodium carboxymethyl starch (from potato), corn starch, and magnesium stearate.

Coating:

Opadry Yellow, containing: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, yellow iron oxide (E172), and polysorbate 80.

Appearance of the product and contents of the container

Tramadol/Paracetamol Uxa film-coated tablets are light yellow, biconvex, capsule-shaped tablets, engraved with "C8" on one side and smooth on the other.

Tramadol/Paracetamol Uxa film-coated tablets are packaged in blisters.

Available in packs of 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Uxa Farma, S.A.

Avda. J.V. Foix, 62

08034 Barcelona

Manufacturer:

Industria Química y Farmacéutica VIR

C/ Laguna 66-70. P.I. URTINSA II

28923 Alcorcón. Madrid

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/