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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Tramadol hydrochloride/Paracetamol

Read the entire leaflet carefully before you start taking this medicine, as 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 should 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.

Leaflet Contents

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

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

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

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

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

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

Do not take Tramadol/Paracetamol Combix

• 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 medicines for the treatment of insomnia, strong painkillers (opioids), 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 Combix.
• if you have severe liver disease.
• if you have epilepsy that is not controlled by treatment.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol/Paracetamol Combix:

• 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 had a head injury, or severe headaches associated with vomiting,
• if you are dependent on any other medicine used for pain relief, such as morphine,
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine,
• if you are due to have anaesthesia. Tell your doctor or dentist that you are taking Tramadol/Paracetamol Combix.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Taking Tramadol/Paracetamol Combix with other medicines”).

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you become used to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in a 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 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 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 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, 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 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 Combix”).

Sleep-related breathing disorders

Tramadol/Paracetamol Combix may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, 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 Combix:

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.

If you develop or have previously experienced any of these problems while taking Tramadol/Paracetamol Combix, please inform your doctor. They will decide whether you should continue taking this medicine.

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

Taking Tramadol/Paracetamol Combix 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.

Do not take Tramadol/Paracetamol Combix together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Combix”).

Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap), which must be treated urgently 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 when maximum daily doses of paracetamol are used.

Use of Tramadol/Paracetamol Combix 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 known as trigeminal neuralgia),
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of side effects increases if you also use:

• Triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhoea, you should contact your doctor.
• Sedatives, sleeping medicines, other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anaesthetics, 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 Combix is suitable for you.
• Warfarin or fenprocoumon (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 lower the seizure threshold, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Combix simultaneously with these medicines. Your doctor will tell you whether Tramadol/Paracetamol Combix is suitable for you.
• Medicines for the treatment of depression. Tramadol/Paracetamol Combix may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• Cholestyramine (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 Combix.

Taking Tramadol/Paracetamol Combix with food, drinks and alcohol

Tramadol/Paracetamol Combix may make you feel drowsy. Alcohol may increase this drowsiness, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Combix.

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

Breastfeeding

Tramadol may pass into breast milk. For this reason, you should not take Tramadol/Paracetamol Combix more than once during breastfeeding. Otherwise, if you take Tramadol/Paracetamol Combix 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 Combix. 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 taking other medicines at the same time.

3. How to take Tramadol/Paracetamol Combix

Follow exactly the dosing instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using tramadol/paracetamol, 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).

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

Use in children

The use of this medicine is not recommended in children under 12 years of age.

Use in adults

Unless otherwise prescribed by your doctor, the usual 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 Combix per day.

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

Your doctor may increase the dosing interval:

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

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

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

Method of administration

Tramadol/Paracetamol Combix 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 Combix 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 Combix than you should

If you have taken more Tramadol/Paracetamol Combix than prescribed, even if you feel well, contact your doctor immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tramadol/Paracetamol Combix

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

Generally, no adverse effects occur when stopping treatment with Tramadol/Paracetamol Combix. However, in rare cases, patients who have taken Tramadol/Paracetamol Combix for some time and stop treatment abruptly may feel unwell (see section 4 “Possible side effects”). If you have been taking Tramadol/Paracetamol Combix 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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Tramadol/Paracetamol Combix can cause adverse effects, although not everyone experiences them.

Very common: more than 1 in 10 people treated:

• nausea,
• dizziness, drowsiness.

Common: less than 1 in 10 but more than 1 in 100 people treated:

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating,
• headache, agitation,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being constantly “on a high”).

Uncommon: less than 1 in 100 but more than 1 in 1,000 people treated:

• 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 does not exist in reality), memory loss,
• difficulty swallowing, blood in the stools,
• chills, hot flushes, chest pain,
• difficulty breathing.

Rare: less than 1 in 1,000 but more than 1 in 10,000 people treated:

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

Frequency not known: frequency cannot be estimated from the available data:

• Decrease in blood sugar levels.
• Hiccups.
• 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 Combix").
• A serious illness that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

The following recognized adverse effects have been reported by individuals who have taken medicines containing either tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Combix, you must inform your doctor:

• Dizziness upon 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, altered perception, worsening of asthma.
• In rare cases, skin rashes indicating allergic reactions, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this occurs, stop treatment immediately and consult your doctor. 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 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 develop gastrointestinal and intestinal disturbances. Very few people may also experience 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 Combix, 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.

The use of Tramadol/Paracetamol Combix 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 rare cases of serious skin reactions have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 Combix

No special storage conditions are required.

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

Store this medicine in a safe and secure place, where other people 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 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 empty containers and unused medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Combix

• The active substances are tramadol hydrochloride and paracetamol.

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

• The other components are: pregelatinized corn starch, corn starch, sodium potato starch glycolate, microcrystalline cellulose (E460i), magnesium stearate (E470b), coating agent ?(hypromellose (E464), titanium dioxide (E171), macrogol (1521), talc (E553b)?.

Appearance of the product and contents of the pack

Tramadol/Paracetamol Combix film-coated tablets are presented as white, capsule-shaped, biconvex film-coated tablets, marked with the code "334" on one side and plain on the other.

Tramadol/Paracetamol Combix tablets are packed in PVC/PVDC-Aluminum blisters, in packs containing 20 or 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

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.gob.es/.