Package Leaflet: Information for the User

Tramadol/Paracetamol Farma Tarbis37.5 mg/325 mg Film-coated Tablets

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isTramadol/Paracetamol Farma Tarbisand what it is used for

2. What you need to know before you start takingTramadol/Paracetamol Farma Tarbis

3. How to takeTramadol/Paracetamol Farma Tarbis

4. Possible side effects

5. Storage ofTramadol/Paracetamol Farma Tarbis

6. Contents of the pack and additional information

Tramadol/Paracetamol is a combination of two analgesics, tramadol and paracetamol, that act together to relieve pain.

Tramadol/Paracetamol Farma Tarbis is indicated for the symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamolshould only be used by adults and children over 12 years old.

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, powerful analgesics, or other psychotropic medicines (medicines that can alter mood and emotions).

- If you are taking MAO inhibitors (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 uncontrolled epilepsy.

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 respiratory 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 have dependence on any other pain-relieving medicine, for example morphine;

- If you are taking other pain-relieving medicines that contain buprenorphine, nalbuphine or pentazocine;

- If you are to be anaesthetized. 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 metabolized in the liver by an enzyme. Some people have a variation of this enzyme and this may affect each person differently. In some people, it may be possible to obtain insufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell 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 monotherapy. Consult a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible adverse effects").

Respiratory disorders related to sleep

Tramadol/Paracetamol Farma Tarbis may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Consult 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 indicative of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Use ofTramadol/Paracetamolwith other medicines:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine

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

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

It is contraindicated to useTramadol/Paracetamolif you are being treated with:

- Carbamazepine (medicine normally used to treat epilepsy or some types of pain, such as trigeminal neuralgia)

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

- Triptans (for the treatment of migraine) 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, involuntary muscle contractions, or diarrhea, you should call your doctor.

- Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some blood pressure-lowering medicines, antidepressants, or allergy medicines. You may feel drowsy or dizzy. If this occurs, consult your doctor.

- Antidepressants, anesthetics, neuroleptics (medicines that affect mood) or bupropion (medicine used as a smoking cessation aid). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.

- Warfarin or phenprocoumon (medicine used to prevent blood clots). The effectiveness of these medicines may be altered, with a risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.

• Medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with 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 may experience a serotonin syndrome (see section 4 "Possible adverse effects").

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing 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),

- Cholestyramine (medicine that reduces cholesterol in the blood),

- Ketoconazole and erythromycin (medicines used to treat infections).

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

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

You must not take alcoholic beverages while taking this medicine.

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

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.

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

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 particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medicines.

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

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

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

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

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 medication is not recommended for children under 12 years old.

Older patients:

In elderly patients (over 75 years old), tramadol elimination 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 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.

Administration form:

The tablets can be taken whole or split in half with the help of a liquid, preferably water. The tablet groove is only for splitting the tablet if it is difficult to swallow whole, not for dividing into equal doses.

If you estimate that the action 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), inform 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 of liver damage that may only become apparent later.

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

If you forgot to take Tramadol/Paracetamol:

If you forgot to take the tablets, it is possible that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol:

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 adverse 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 a while and have stopped treatment abruptly may feel unwell (see section 4. "possible adverse 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Tramadol/Paracetamol can have side effects, although not everyone will experience them.

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

- nausea.

- dizziness, drowsiness.

Common:may affect between 1 and 10 in 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 "high" all the time-).

Uncommon:may affect between 1 and 10 in 1,000 patients;

- tachycardia, hypertension, heart rhythm and frequency disorders.

- difficulty or pain urinating.

- skin reactions (e.g. rashes, urticaria).

- sensation of tingling, numbness, or pins and needles in the extremities, ear noises, 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 in 10,000 patients;

- convulsions, difficulties with coordinated movements.

- addiction

- blurred vision.

Frequency not known:

Decreased blood sugar levels

Low blood pressure

Frequency indeterminate (cannot be estimated from available data):

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 taking Tramadol/Paracetamol Farma Tarbis").

The following side 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 Tramadol/Paracetamol, 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 eruptions, indicative of allergic reactions that may manifest as 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. Do not take this medicine again.

In rare cases, using a medicine like tramadol, may make you dependent, 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 Tramadol/Paracetamol, please consult your doctor.

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

The use of Tramadol/Paracetamol with anticoagulants (e.g. femprocumona, warfarin) may increase the risk of bleeding. Inform your doctor immediately about any prolonged or unexpected bleeding.

Severe skin reactions have been rarely reported.

If you experience side effects, consult your doctor or pharmacist or nurse,even if it is about side effects that do not appear in this prospectus.

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 that appears on the packaging (after CAD). The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofTramadol/Paracetamol Farma Tarbis:

The active principles 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) from potato and pregelatinized cornstarch.

Appearance of the product and contents of the packaging:

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

Holder of the marketing authorization:
Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Responsible for manufacturing:

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

Netherlands

Date of the last review of this leaflet:February 2024

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