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

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Uxa 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, as 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

1. What Tramadol/Paracetamol Uxa is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Uxa
3. How to take Tramadol/Paracetamol Uxa
4. Possible side effects
5. Storage of 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 pain relievers, 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 a 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 you take Tramadol/Paracetamol Uxa

Do not take Tramadol/Paracetamol Uxa

• 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 insomnia, strong pain relievers (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 Uxa;
• 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 Uxa

• 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 have recently had a head injury, shock, or severe headaches associated with vomiting;
• if you have dependence 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
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see <>)

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

-If you have severe illnesses, 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 are also taking flucloxacillin (an antibiotic). A severe 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 Uxa may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the 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 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.

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 present any of the symptoms related to this serious syndrome (see section 4 <>).

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 Uxa 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 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 Uxa 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 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 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 take 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 they 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 Uxa).

Taking Tramadol/Paracetamol Uxa with other medicines

Tell your doctor or pharmacist if you are taking, 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.

Tell your doctor or pharmacist if you are taking:

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

Tramadol/Paracetamol Uxa must not be takenwith monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Uxa”).

The use of Tramadol/Paracetamol Uxa is not recommended 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 pain reliever). Pain relief may be reduced.

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 sedatives, medicines for the treatment of insomnia, other pain relievers such as morphine and codeine (also when used for the treatment of cough), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• if you are taking medicines that can cause seizures, 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 tell you if Tramadol/Paracetamol Uxa is suitable for you.
• if you are taking medicines for the treatment of depression. Tramadol/Paracetamol Uxa may interact with these medicines, and you may experience a serotonin syndrome (see section 4 <>).
• if you are taking warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Uxa may be altered if you also take:

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

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 may make you feel drowsy, so 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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.

Breastfeeding

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

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol/Paracetamol Uxa. 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 taking it in combination with other medicines.

3. How to take Tramadol/Paracetamol Uxa

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

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

The use of this medicine is not recommended 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 Uxa tablets per day.

Do not take Tramadol/Paracetamol Uxa more frequently than your doctor has indicated.

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.

Patient with liver or kidney 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 impairment, your doctor may prolong the dosing intervals.

Method of administration

Tramadol/Paracetamol Uxa 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 Uxa 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 Uxa than you should

If you have taken more Tramadol/Paracetamol Uxa 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 Uxa

If you forget to take a dose of Tramadol/Paracetamol Uxa, it is likely that the pain will return. Do not take a double dose to make up for the forgotten doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Uxa

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

If you have any other 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 all people suffer from them.

Very frequent: may affect more than 1 in 10 people;

• nausea,
• dizziness, drowsiness.

Frequent: 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).

Infrequent: may affect 1 in 100 people;

• increased pulse or increased blood pressure, cardiac rhythm and frequency disorders,
• difficulty or pain when urinating,
• skin reactions (e.g., rashes, urticarial hives),
• tingling sensation, numbness or pinching sensation in the limbs, ear noises, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss,
• difficulty swallowing, blood in the stool,
• chills, hot flashes, chest pain,
• difficulty breathing.

Rare: may affect 1 in 1,000 people;

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

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

• decrease in blood sugar levels
• hypoglycemia
• 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").
• a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness 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 Uxa, you should tell your doctor:

• Dizziness when standing 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.

• In rare cases, skin rashes, indicating allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath, or a 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 ear noises (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, such as low platelet count, which can result in nosebleeds or bleeding gums.

With an unknown frequency, tramadol may cause hypoglycemia.

Taking Tramadol/Paracetamol Uxa 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 very rare cases, serious skin reactions have been reported.

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 Uxa

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.

Do not use this medicine after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated. This medicine does not require special storage conditions.

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. Packaging Content and Additional Information

• Composition of Tramadol/Paracetamol Uxa

• 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 (excipients) are:

Core of the tablet: pregelatinized corn starch, cellulose powder, sodium carboxymethyl cellulose (from potato), corn starch, and magnesium stearate.

Coating:

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

Appearance of the Product and Packaging Content

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

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

They are available in packages 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 Last Revision of this Prospectus: February 2025

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