TRAMADOL PARACETAMOL FARMA TARBIS 37.5 mg/325 mg TABLETS

2. What you need to know before you take Tramadol/Paracetamol Farma Tarbis

Do not takeTramadol/Paracetamol

• If you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• In case of acute alcohol intoxication, if you are taking sleeping pills, potent pain relievers, or other psychotropic medicines (medicines that can alter mood and emotions).
• 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 Farma Tarbis.
• 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 tramadol paracetamol.

• 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 indicative 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 have epilepsy or have had seizures;
• If you have recently had a head injury, 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-relieving medicines that contain buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol Farma Tarbis.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol Farma Tarbis").
• 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 experience serious side effects. If you notice any of the following side effects, you should 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.
• 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 a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Respiratory disorders related to sleep

Tramadol/Paracetamol Farma Tarbis may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes 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 Farma Tarbis:

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.

Use ofTramadol/Paracetamolwith other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use 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.

Do not take Tramadol/Paracetamol Farma Tarbis with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Farma Tarbis").

Contraindicated use ofTramadol/Paracetamolif you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as intense pain attacks in the face called trigeminal neuralgia)
• Buprenorphine, nalbuphine, or pentazocine (opioid pain relievers). Pain relief may be reduced.

The risk of side effects increases if you also use:

-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 limb or eye movements, or diarrhea, you should call your doctor.

• Sedatives, sleeping pills, other pain relievers such as morphine and codeine (also when used to treat cough), baclofen (a muscle relaxant), some medicines to lower blood pressure, antidepressants, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used as an aid to quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.
• 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.
  • Medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol at the same time as these medicines. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.
  • Medicines for the treatment of depression. Tramadol/Paracetamol Farma Tarbis may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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

• Metoclopramide, domperidone, and ondansetron (medicines for the treatment of nausea and vomiting),
• Colestyramine (a medicine that reduces cholesterol in the blood),
• Ketoconazole and erythromycin (medicines used against infections).

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

Taking Tramadol/Paracetamol with food, drinks, and alcohol:

Do not drink alcoholic beverages if you are taking this medicine.

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.

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

Tramadol can pass into breast milk. For this reason, you should not take Tramadol/Paracetamol Farma Tarbis more than once during breastfeeding, or, if you take Tramadol/Paracetamol Farma Tarbis more than once, you should interrupt breastfeeding.

Driving and using machines:

Ask your doctor if you can drive or use machines during treatment with this medicine. 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 in combination with other medicines.

3. How to take Tramadol/Paracetamol

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The dose should be adjusted according to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

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

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 Farma Tarbis tablets per day.

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

Your doctor may increase the interval between doses:

• If you are over 75 years old.
• If you have kidney problems.
• If you have liver problems.

Use in children and adolescents:

This medicine is not recommended for use in children under 12 years of age.

Elderly patients:

In elderly 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 failure/patients on dialysis

If you have severe liver or kidney disease, treatment with Tramadol/Paracetamol is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Method of administration:

The tablets can be taken whole or broken in half with the help of a glass of liquid, preferably water. The score line on the tablet is only for breaking the tablet if you find it difficult to swallow it whole, not for dividing it into equal doses.

If you think the effect of Tramadol/Paracetamol is too strong (i.e., you feel very drowsy or have difficulty breathing) or too weak (i.e., you do not have adequate pain relief), tell your doctor.

If you take more Tramadol/Paracetamol than you should:

You should consult your doctor or pharmacist, even if you feel well. There is a risk that liver damage may occur, which may only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol/Paracetamol:

If you forget to take the tablets, it is possible 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:

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).

Generally, no unwanted effects occur after stopping treatment with Tramadol/Paracetamol. However, in rare cases, patients who have been taking Tramadol/Paracetamol for some time and have stopped treatment abruptly may feel unwell (see section 4 "Possible side effects"). If you have been taking Tramadol/Paracetamol 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 medications, Tramadol/Paracetamol may have adverse effects, although not all people suffer from them.

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

• nausea.
• dizziness, drowsiness.

Frequent: may affect between 1 and 10 out of 100 patients;

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

Infrequent: may affect between 1 and 10 out of 1,000 patients;

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

Rare: may affect between 1 and 10 out of 10,000 patients;

• seizures, difficulties in carrying out coordinated movements.
• addiction
• blurred vision.

Frequency not known:

Decrease in blood sugar levels

Hiccup

Indeterminate frequency (cannot be estimated from available data):

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 Farma Tarbis").

The following recognized adverse effects 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 Tramadol/Paracetamol, you should tell your doctor:

• Feeling of dizziness when standing up after being 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 eruptions, 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, interrupt treatment and consult your doctor immediately. You should not take this medication again.

In rare cases, using a medication 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 suddenly stop treatment. 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, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol, please consult your doctor.

In exceptional cases, blood tests reveal abnormalities, such as low platelet count, which can result in nosebleeds or bleeding gums.

Taking Tramadol/Paracetamol with anticoagulants (e.g., femprocumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

Very rare cases of severe skin reactions have been reported.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

5. Storage of Tramadol/Paracetamol Farma Tarbis

Keep out of sight and reach of children.

This medication does not require special storage conditions.

Do not use Tramadol/Paracetamol Farma Tarbis after the expiration date shown on the packaging (after CAD). The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofTramadol/Paracetamol Farma Tarbis:

The active ingredients are tramadol hydrochloride and paracetamol.

One tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

The other components are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium carboxymethylcellulose (Type A) of potato and pregelatinized cornstarch.

Appearance of the product and package contents:

Tramadol/Paracetamol Farma Tarbis is presented in the form of oral tablets, in packages of 20 and 60 tablets.

Marketing authorization holder:Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Manufacturer:

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

Netherlands

Date of the last revision of this prospectus:February 2024

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