Leaflet: Information for the user

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

tramadol hydrochloride/paracetamol

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

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

3.How to take Tramadol/Paracetamol Aurovitas

4.Possible side effects

5.Storage of Tramadol/Paracetamol Aurovitas

6.Contents of the pack and additional information

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

Tramadol/paracetamol is indicated for symptomatic treatmentof moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/paracetamol should only be used by adults and adolescents over 12 years old.

Do not take Tramadol/Paracetamol Aurovitas

•if you are allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medication (listed in section 6).

•if you have taken any medication for insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication.

•if you are also taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with tramadol/paracetamol.

•if you have severe liver disease.

•if you have uncontrolled epilepsy with your current treatment.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take tramadol/paracetamol:

•if you are taking other medications 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 bile duct problems.

•if you have kidney problems.

•if you have severe respiratory difficulties, for example, asthma or severe lung problems.

•if you are epileptic or have had seizures or convulsions.

•if you have recently had a head injury, shock, or intense headaches associated with vomiting.

•if you are dependent on any other medication used for pain relief, for example, morphine.

•if you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine.

•if you are to be anesthetized (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 Medications and Tramadol/Paracetamol Aurovitas”).

•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 your doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 “Possible Adverse Effects”).

If you experience, or have experienced in the past, any of these problems while taking tramadol/paracetamol, please inform your doctor. He will decide if you should continue taking this medication.

Tolerance, Dependence, and Addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become accustomed to it, known as tolerance). Repeated use of tramadol/paracetamol can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer control the amount of medication 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 medications, or illegal drugs (“addiction”).

•You are a smoker.

•You have had problems with your mood (depression, anxiety, or 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 medication for a longer period than advised by your doctor.

•You need to take more of the recommended dose.

•You use the medication for reasons other than those prescribed, for example, “to stay calm” or “to sleep”.

•You have repeatedly and unsuccessfully tried to stop or control the use of the medication.

•When you stop taking the medication, you feel unwell, and you feel better when you take it again (“withdrawal symptoms”)

If you observe any of these signs, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If You Interrupt Treatment with Tramadol/Paracetamol Aurovitas).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may be possible to achieve 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 medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

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.

Respiratory Disorders Related to Sleep

Tramadol/paracetamol may cause respiratory disorders related to sleep, such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes 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 that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, and he will decide if you should take a hormonal supplement.

Other Medications and Tramadol/Paracetamol Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

•Flucloxacillin (antibiotic), due to a severe risk of blood and fluid disorder (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.

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

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

Tramadol/paracetamol is not recommended for use if you are being treated with:

•carbamazepine (a medication 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 are also taking:

•antidepressants, tramadol/paracetamol may interact with these medications and may experience a serotonin syndrome (see section 4 “Possible Adverse Effects”).

•sedatives, medications for insomnia, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or medications for allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

•antidepressants, anesthetics, neuroleptics (medications that can affect your mental state) or bupropion (for quitting smoking). The risk of seizures increases. Your doctor will tell you if tramadol/paracetamol is suitable for you.

•warfarin or phenprocoumon (medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. Inform your doctor immediately of any prolonged or unexpected bleeding.

•gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The efficacy of tramadol/paracetamol may be altered if you are also using any of the following medications:

•metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting).

•colestiramine (medication that reduces cholesterol in the blood).

•ketoconazole or erythromycin (medications against infections).

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

The simultaneous use of tramadol/paracetamol and sedatives, such as benzodiazepines or related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may cause death. Therefore, simultaneous use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol/paracetamol with sedatives, they should limit the dose and duration of simultaneous treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to ask friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Tramadol/Paracetamol Aurovitas with Food, Drinks, and Alcohol

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

Pregnancy, Breastfeeding, and Fertility

Due to tramadol/paracetamol containing tramadol, it is not recommended to take this medication during pregnancy or breastfeeding. 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, do not take tramadol/paracetamol more than once during breastfeeding or, if you take tramadol/paracetamol more than once, stop breastfeeding.

According to human experience, it does not appear that tramadol affects male and female fertility. There are no available data on the combination of tramadol and paracetamol in fertility.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

Ask your doctor if you can drive or use machines during treatment with tramadol/paracetamol. It is essential to observe how this medication affects you before driving or using machines. Do not drive or use machines 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 medications.

Tramadol/Paracetamol Aurovitas contains sodium

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

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

Before starting treatment and regularly during it, your doctor will explain what you can expect from the use of tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor, and when you should stop it (see also section 2).

You should take tramadol/paracetamol for the shortest time possible. It is not recommended to use this medication in children under 12 years old.

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 tablets of tramadol/paracetamolper day.

Do not take tramadol/paracetamol more frequently than indicated 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.

Administration Form

The tablets are for oral use.

Swallow the tablets whole with enough liquid. Do not break or chew them.

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

If you take more Tramadol/Paracetamol Aurovitas than you should

If you have taken moretramadol/paracetamolthan you should, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of severe liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tramadol/Paracetamol Aurovitas

If you forgot to take the tablets, it is likely 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 Aurovitas

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 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, this medicine can cause side 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, diarrhea), stomach pain, dry mouth.

-itching, increased sweating (hyperhidrosis).

-headache, agitation.

-confusion, sleep disturbances, mood changes (anxiety, nervousness, euphoria – feeling "high" all the time).

Rare, may affect up to 1 in 100 people:

-increased heart rate or blood pressure, cardiac rhythm and frequency disturbances.

-difficulty or pain urinating.

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

-tingling, numbness, or pins and needles sensation in the extremities, ear noises, involuntary muscle spasms.

-depression, nightmares, hallucinations, (hearing, seeing or perceiving something that is not real), memory loss.

-difficulty swallowing, blood in the stool.

-chills, hot flashes, chest pain.

-difficulty breathing.

Rare, may affect up to 1 in 1000 people:

-seizures, difficulty with coordinated movements.

-addiction.

-blurred vision.

-transient loss of consciousness (syncope).

-pupil constriction (miosis).

-speech disturbances.

-excessive pupil dilation (mydriasis).

Unknown frequency (cannot be estimated from available data):

-decreased blood sugar level.

-hypoglycemia.

-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 Aurovitas").

The following adverse 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, you should inform your doctor:

-dizziness when standing up after lying down or sitting, low 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 eruptions, indicative of allergic reactions that may manifest as sudden swelling of the face and neck. Shortness of breath or drop in blood pressure and dizziness. If this happens, stop treatment and consult your doctor immediately. Do not take this medicine again.

In rare cases, using a medicine like tramadol can 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 digestive and intestinal problems. 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, consult your doctor.

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store this medication in a safe and protected place, where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

This medicationdoes not require special storage conditions.

Do not use this medication after the expiration date that appears on the labeling, the packaging, and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Aurovitas

-The active principles 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:

Core of the tablet: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, yellow iron oxide (E172), and polisorbate 80.

Appearance of the product and contents of the package

Film-coated tablets of pale yellow color, oblong, biconvex, with the mark “I 03” on one face and smooth on the other.

Tramadol/Paracetamol Aurovitas film-coated tablets are available in white and opaque PVC/PVdC-aluminium foil blisters or in child-resistant PVC white opaque/PVdC-PVC blisters with an aluminium foil, and in high-density polyethylene (PEAD) white and opaque bottles with a polypropylene closure.

Package sizes:

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

PEAD bottles: 30, 250, and 1,000 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with 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 37.5mg/325mg, film-coated tablets

Netherlands:Tramadol HCl/Paracetamol Aurobindo 37,5/325 mg, filmomhulde tabletten

Portugal:Tramadol + Paracetamol Aurobindo

Last review date of this leaflet:July 2024

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