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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

tramadol hydrochloride/paracetamol

Read the entire 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 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 may 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.

Contents of the leaflet

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

1. What Tramadol/Paracetamol Aurovitas 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 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 adolescents over 12 years of age.

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

Do not take Tramadol/Paracetamol Aurovitas

• 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 medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may affect mood and emotions) in cases of acute alcohol intoxication.
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease) or have taken them within the last 14 days before starting treatment with tramadol/paracetamol.
• 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 taking tramadol/paracetamol:

• if you are taking other medicines containing paracetamol or tramadol.
• if you have liver problems or liver disease, or if you notice your eyes or skin turning 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, such as asthma or serious lung conditions.
• if you have epilepsy or have experienced seizures or fits.
• if you have recently suffered a head injury, shock, 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 undergo anesthesia (inform your doctor or dentist that you are taking tramadol/paracetamol).
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Aurovitas”).
• there is a weak risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used alone. Contact your doctor immediately if you experience any symptoms related to this serious condition (see section 4 “Possible side effects”).

If you develop, or have previously experienced, any of these problems while taking tramadol/paracetamol, please inform your doctor. Your doctor will decide whether you should continue taking this medicine.

During treatment with tramadol/paracetamol, inform your doctor immediately if:

You have serious medical conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients with these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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 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 a family member 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, it could indicate 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.
• You feel unwell when you stop taking the medicine, and feel better when you take it again (“withdrawal effect”).

If you notice any of these signs, speak to your doctor to determine the best treatment approach for you, 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 Aurovitas”).

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 experience any of the following adverse effects, stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children with respiratory problems:

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Sleep-related breathing disorders

Tramadol/paracetamol may cause sleep-related breathing disorders, such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Inform your doctor or pharmacist if you experience any of the following symptoms while taking tramadol/paracetamol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

Other medicines and Tramadol/Paracetamol Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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.

Tramadol/paracetamol must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Aurovitas”).

The use of tramadol/paracetamol is not recommended 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-type painkillers). Pain relief may be reduced.

The risk of adverse effects increases if you are also taking:

• antidepressants, as tramadol/paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• sedatives, medicines for insomnia, other painkillers such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• antidepressants, anesthetics, neuroleptics (medicines that may affect your mental state), or bupropion (for smoking cessation). The risk of seizures increases. Your doctor will advise 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. Inform your doctor immediately if you experience prolonged or unexpected bleeding.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you also take any of the following medicines:

• metoclopramide, domperidone, or ondansetron (medicines for nausea and vomiting).
• colestyramine (a medicine that lowers blood cholesterol).
• ketoconazole or erythromycin (medicines for infections).

Your doctor will know which medicines are safe to use with tramadol/paracetamol.

Concurrent use of tramadol/paracetamol and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may result in death. For this reason, concurrent use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol/paracetamol together with sedative medicines, your doctor should limit the dose and duration of concurrent treatment.

Inform your doctor about all sedative medicines you are taking and follow the recommended dose carefully. It may be helpful to ask friends or family members to watch for the symptoms mentioned above. Contact your doctor if you experience such symptoms.

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

Tramadol/paracetamol may make you feel drowsy. Alcohol may increase drowsiness; therefore, it is recommended not to drink alcohol while taking tramadol/paracetamol.

Pregnancy, breastfeeding, and fertility

Because tramadol/paracetamol contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while taking 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 more than once during breastfeeding. Alternatively, if you take tramadol/paracetamol more than once, you must stop breastfeeding.

Based on human experience, tramadol does not appear to affect fertility in men and women. There are no available data on the combination of tramadol and paracetamol regarding 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.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with tramadol/paracetamol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after switching formulations, and/or when taking other medicines concurrently.

Tramadol/Paracetamol Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take Tramadol/Paracetamol Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to 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 for the shortest time possible. This medicine is not recommended for use in children under 12 years of age.

Unless otherwise prescribed by your doctor, 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 per day.

Do not take tramadol/paracetamol more frequently than directed by your doctor.

Your doctor may increase the time between doses if:

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

Method of administration

The tablets are for oral use.

Swallow the tablets whole with sufficient liquid. They must not be broken or chewed.

If you think that the effect of tramadol/paracetamol is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not get adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Aurovitas than you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, contact 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, contact 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 Aurovitas

If you forget to take your tablets, your pain may return.

Do not take a double dose to make up for missed doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Aurovitas

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking your 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 unnecessary adverse effects (withdrawal symptoms).

Generally, no unwanted effects occur after stopping treatment with tramadol/paracetamol.

However, in rare cases, patients who have taken tramadol 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 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• nausea
• dizziness, drowsiness

Common, may affect up to 1 in 10 people:

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

Uncommon, may affect up to 1 in 100 people:

• increased pulse or blood pressure, disturbances in heart rhythm and rate
• difficulty or pain when urinating
• skin reactions (e.g. rashes, hives)
• 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 real), memory loss
• difficulty swallowing, blood in the stools
• chills, hot flushes, chest pain
• difficulty breathing

Rare, may affect up to 1 in 1,000 people:

• seizures, difficulty performing coordinated movements
• addiction
• blurred vision
• transient loss of consciousness (syncope)
• pupil constriction (miosis)
• speech disorders
• excessive dilation of the pupil (mydriasis)

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

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which may present with changes in mental state (e.g. agitation, hallucinations, coma) and other symptoms 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 Aurovitas”)

The following recognised adverse effects have been reported by people who have taken medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should 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, changes in mood, 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 occurs, stop treatment immediately and consult your doctor without delay. 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 restless, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. A very small number of people may also experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping tramadol/paracetamol, 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 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.

In very rare cases, serious skin reactions have been reported.

Frequency not known (cannot be estimated from available data): a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Medicines: 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 Aurovitas

Keep this medicine 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 this medicine after the expiry date stated on the label, packaging, and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Aurovitas

• 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:

Tablet core: maize starch, powdered cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), pregelatinized maize starch and magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172) and polysorbate 80.

Appearance of the product and contents of the pack

Film-coated tablets, pale yellow, oblong, biconvex, marked with "I 03" on one side and plain on the other.

Tramadol/Paracetamol Aurovitas film-coated tablets are available in white, opaque PVC/PVdC-aluminium blister packs or in child-resistant white opaque PVC/PVdC-PVC blisters with an aluminium foil, as well as in containers made of white, opaque high-density polyethylene (HDPE) with a polypropylene closure.

Pack sizes:

Blister packs: 10, 20, 30, 60, 90 and 100 film-coated tablets.

HDPE containers: 30, 250 and 1,000 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Tramadol/Paracetamol AB 37.5 mg/325 mg filmomhulde tabletten

Spain: Tramadol/Paracetamol Aurovitas 37.5 mg/325 mg, film-coated tablets EFG

Italy: Tramadolo e Paracetamolo Aurobindo

Malta: Tramadol/ Paracetamol Aurobindo 37.5 mg/325 mg, film-coated tablets

Netherlands: Tramadol HCl/Paracetamol Aurobindo 37.5/325 mg, filmomhulde tabletten

Portugal: Tramadol + Paracetamol Aurobindo

Date of the most recent review of this leaflet: January 2025

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