Patient Information Leaflet

Tramadol/Paracetamol Alter 37.5 mg /325 mg Film-Coated Tablets

Tramadol Hydrochloride /Paracetamol

Read this leaflet carefully before you start to take 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. Do 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.

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

Tramadol/paracetamol is indicated for the symptomatic treatment of 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 Alter

• 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 any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medicines that can alter mood and emotions);
• in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medications used for the treatment of 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

Respiratory disorders related to sleep

Tramadol/paracetamol Alter 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 before starting to take Tramadol/Paracetamol Alter:

• 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 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 are epileptic or have had seizures or convulsions;
• if you have recently experienced head trauma, shock or severe headaches associated with vomiting;
• if you have dependence 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 anaesthetized. Inform your doctor or dentist that you are using tramadol/paracetamol;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Taking Tramadol/Paracetamol Alter with other medicines").
• if you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an abnormality in the blood and fluids) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, somnolence, feeling unwell (nausea) and vomiting.

If any of these problems occur while taking tramadol/paracetamol, please inform your doctor. He will decide if you should continue taking this medicine.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking this medicine:

• 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 have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

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 serious syndrome (see section 4 "Possible side effects").

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of 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 to Tramadol/Paracetamol 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 medications or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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 longer 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 tried repeatedly and unsuccessfully 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 stop taking Tramadol/Paracetamol").

Taking Tramadol/Paracetamol Alter with other medicines

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 serious risk of blood and fluid disorder (called metabolic acidosis) that must be treated urgently (see section 2).

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

Tramadol/paracetamol should not be taken with monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol Alter").

Tramadol/paracetamol should not be taken with:

• Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine or pentazocine (opioid analgesic). Pain relief may be reduced.

The risk of side effects increases:

• if you are taking triptans (for the treatment of migraines) 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.
• if you are taking 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, medications for allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• if you are taking medications that can cause or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these medications. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• if you are taking antidepressants, Tramadol/Paracetamol Alter may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible side effects").
• if you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should 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 effectiveness of tramadol/paracetamol may be altered if you also take:

• Metoclopramide, domperidone or ondansetron (medications for nausea and vomiting),
• Colestyramine (a medication that reduces cholesterol in the blood).

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

Taking Tramadol/Paracetamol Alter with food and drinks

Tramadol/paracetamol may make you feel drowsy. Alcohol may make you feel more drowsy, so 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 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.

Based on human experience, it is not suggested that tramadol affects male and female fertility. There are no data available on the combination of tramadol and paracetamol in fertility.

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

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 medications.

Follow exactly the administration instructions of this medication 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.

This medication is not recommended for use in children under 12 years old.

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

Unless your doctor prescribes otherwise, 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 Alter tablets per day.

Do not take tramadol/paracetamol more frequently than your doctor has indicated.

Older patients

In older 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 disease/patients on dialysis

If you have any severe liver or kidney disease, treatment with tramadol/paracetamol is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Use in children and adolescents

This medication is not recommended for use in children under 12 years old.

Administration form

Tramadol/paracetamol is presented in the form of tablets for oral administration.

The tablets should be swallowed whole with sufficient liquid. They should not be broken or chewed.

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

If you take more Tramadol/Paracetamol Alter than you should

If you have taken more tramadol/paracetamol than 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.

If you forgot to take Tramadol/Paracetamol Alter

If you forgot to take a dose of tramadol/paracetamol, it is likely that the pain will recur. 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 Alter

Generally, no adverse effects occur after interrupting treatment with tramadol/paracetamol. However, in rare cases, patients who have been taking tramadol/paracetamol for a while and have interrupted 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 interrupting 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 disorders, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Rare: may affect up to 1 in 100 people;

• increased heart rate, or increased blood pressure, heart rhythm and frequency disorders.
• tingling, numbness, or pins and needles sensation in the extremities, ear noises, involuntary muscle spasms.
• depression, nightmares, hallucinations, (hearing, seeing, or perceiving something that does not exist in reality), memory loss.
• difficulty breathing.
• difficulty swallowing, blood in the stool.
• skin reactions (e.g. rashes, urticarial hives).
• increased liver enzyme values.
• presence of albumin in the urine, difficulty or pain when urinating.
• chills, hot flashes, chest pain.

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

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope).
• dependence on the medication.
• delirium.
• blurred vision, pupil constriction (miosis).
• speech disorder,
• excessive pupil dilation (mydriasis).

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

decreased blood sugar levels (hypoglycemia).

The following recognized side effects 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, please 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.
• The use of tramadol/paracetamol with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Please inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin eruptions, indicating 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, interrupt treatment and consult your doctor immediately. Do not take this medication again.
• Frequency not known: Hiccups.
• 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 starting to take Tramadol/Paracetamol Alter').
• A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

In rare cases, using a medication like tramadol, may create dependence, 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 may reveal certain abnormalities, such as low platelet count, which may result in nasal or gum bleeding.

In very rare cases, skin reactions have been reported with paracetamol.

Cases of rare respiratory depression have been reported with tramadol.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.Meanwhile, reporting side effects can help provide more information about the safety of this medication.

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.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, 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 Alter

• 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:

Tablet core: pregelatinized cornstarch, cornstarch, sodium carboxymethylcellulose (Type A) from potato, microcrystalline cellulose, magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172).

Appearance of the product and content of the packaging

Tramadol/Paracetamol Alter film-coated tablets are presented in the form of pale yellow, oblong, biconvex tablets, packaged in blisters.

Tramadol/Paracetamol Alter is presented in packaging of 20 and 60 film-coated tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Responsible for manufacturing

Medis International a.s.,

výrobní závod Bolatice

Prumyslová 961/16

747 23 Bolatice

Republic of Czech

or

Martin Dow

Goualle Le Puy

Champ de Lachaud

19250 Meymac

France

Last review date of this leaflet: February 2025

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