Tramadol/paracetamol Farma Tarbis 37.5 mg/325 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol/Paracetamol Farma Tarbis 37.5 mg/325 mg Tablets EFG

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Tramadol/Paracetamol Farma Tarbis 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 by adults and children over 12 years of age.

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

Do not take Tramadol/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, strong painkillers, or other psychotropic medicines (medicines that may affect 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 within the last 14 days before starting 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

Talk to your doctor or pharmacist before starting to take tramadol paracetamol.

• 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 conditions;
• If you have epilepsy or have had seizures;
• If you have recently suffered 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 medicines containing buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anaesthetised. 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 section "Other medicines and Tramadol/Paracetamol Farma Tarbis").
• Tramadol is metabolized 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, 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 slight risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact your doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 "Possible side effects").

Sleep-related breathing disorders

Tramadol/Paracetamol Farma Tarbis may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

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 Farma Tarbis 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 how much 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 Farma Tarbis 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 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 Farma Tarbis, 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 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 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 Farma Tarbis").

Using Tramadol/Paracetamol with other medicines:

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

• Gabapentin or pregabalin for treating epilepsy or nerve pain (neuropathic pain).

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.

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

The use of Tramadol/Paracetamol is contraindicated if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain called 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 limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

• Sedatives, sleeping pills, other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will tell you whether Tramadol/Paracetamol is suitable for you.
• Warfarin or phenprocoumon (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.
  • Medicines that may trigger or facilitate 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 whether 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 serotonin syndrome (see section 4 "Possible side effects").

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if 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 treating nausea and vomiting),
• Colestipol (a medicine that lowers blood cholesterol),
• 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 drink alcoholic beverages while taking this medicine.

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.

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

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

Driving and using machines:

Ask your doctor if you can drive or operate machinery while being treated with this medicine. It is important 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 or double vision, or have difficulty concentrating. Be especially careful at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taking it together with other medicines.

3. How to take Tramadol/Paracetamol

Follow exactly the instructions for use of 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 you can expect from using Tramadol/Paracetamol Tarbis, when and for how long you should take it, when you should contact your doctor, and when you should stop taking it (see also section 2).

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

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

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 Farma Tarbis per day.

Do not take Tramadol/Paracetamol Farma Tarbis more frequently than your doctor has instructed.

Your doctor may recommend increasing the dosing interval:

• If you are over 75 years of age.
• 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), 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

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

Method of administration:

The tablets can be taken whole or split in half with a glass of liquid, preferably water. The tablet's score line is intended only to facilitate splitting if you have difficulty swallowing the tablet whole; it is not intended for dividing into equal doses.

If you feel that the effect of Tramadol/Paracetamol is too strong (for example, if you feel very drowsy or have difficulty breathing) or too weak (for example, if you do not get 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 Toxicology Information Service at telephone number 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, 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:

You should not stop taking this medicine suddenly unless your doctor tells you to. 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 stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing unwanted adverse effects (withdrawal symptoms).

Generally, no undesirable effects occur after discontinuation of Tramadol/Paracetamol treatment. However, in rare cases, patients who have taken Tramadol/Paracetamol for some time and stopped treatment abruptly may feel unwell (see section 4, "Possible side effects"). If you have been taking Tramadol/Paracetamol for a while, you should consult your doctor before stopping treatment, as your body may have become accustomed to it. If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Tramadol/Paracetamol may have adverse effects, although not everyone gets them.

Very common: may affect more than 1 in 10 people:

• nausea
• dizziness, drowsiness

Common: may affect between 1 and 10 in 100 people:

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth
• itching, increased sweating
• headache, agitation
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling "on a high" all the time)

Uncommon: may affect between 1 and 10 in 1,000 people:

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

Rare: may affect between 1 and 10 in 10,000 people:

• seizures, difficulty performing coordinated movements
• addiction
• blurred vision

Frequency not known:

Decrease in blood sugar levels

Hiccups

Frequency cannot be estimated from the available data:

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, diarrhoea) (see section 2, "What you need to know before taking Tramadol/Paracetamol Farma Tarbis").

The following 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, you must inform your doctor:

• Dizziness when standing up after lying down or sitting, slow 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, which may present as sudden swelling of the face and neck, breathlessness, or drop in blood pressure and dizziness.

If this happens, 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 to stop taking it.

Occasionally, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, 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, please consult your doctor.

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

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

Very rare cases of serious skin reactions have been reported.

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

5. Storage of Tramadol/Paracetamol Farma Tarbis

Keep 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.

This medicine does not require any special storage conditions.

Do not use Tramadol/Paracetamol Farma Tarbis after the expiry date stated on the packaging (after EXP). The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a 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 Farma Tarbis:

The active substances 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, colloidal anhydrous silica, sodium carboxymethylstarch (Type A) from potato, and pregelatinized corn starch.

Appearance of the product and contents of the pack:

Tramadol/Paracetamol Farma Tarbis is available as tablets for oral administration, in packs 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

The Netherlands

Date of the most recent revision of this leaflet: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/