TRAMADOL/PARACETAMOL ALTER 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

Tramadol Hydrochloride/Paracetamol

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tramadol/Paracetamol Alter and what is it used for
2. What you need to know before taking Tramadol/Paracetamol Alter
3. How to take Tramadol/Paracetamol Alter
4. Possible side effects
5. Storage of Tramadol/Paracetamol Alter
6. Package Contents and Further Information

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

Tramadol/Paracetamol Alter is a combination of two pain relievers, 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 a 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 Alter

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 medicine for insomnia, potent analgesics (opioids), or psychotropic drugs (drugs that can alter mood and emotions);
• in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines 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 epilepsy that is not adequately controlled with your current treatment.

Warnings and Precautions

Sleep-Related Breathing Disorders

Tramadol/Paracetamol Alter may cause sleep-related breathing disorders, 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, 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 before starting to take Tramadol/Paracetamol Alter:

• if you are taking other medicines 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 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 severe lung problems;
• if you are epileptic or have had seizures or convulsions;
• if you have recently had a head injury, shock, or 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-relieving medicines that contain buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anesthetized. Tell 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 illnesses, 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 are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

If you experience any of these problems while taking tramadol/paracetamol, please inform your doctor. He will decide whether 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether 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 alone. Consult a 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 medicine. Repeated use of opioids can make the medicine less effective (you get used to it, which is known as tolerance). Repeated use of Tramadol/Paracetamol can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may increase with a higher dose and longer use.

Dependence or addiction can make you feel that you no longer control the amount of 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 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 those prescribed, for example, "to calm down" 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 you feel better when you take it again ("withdrawal effect")

If you observe any of these signs, talk to your doctor, who will advise you on the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking Tramadol/Paracetamol).

Taking Tramadol/Paracetamol Alter with other medicines

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

• Flucloxacillin (antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2).

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

Tramadol/paracetamol must not be takenwith monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Alter").

The use of tramadol/paracetamol is not recommended if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain 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 migraine) 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, medicines for the treatment of insomnia, other analgesics such as morphine and codeine (also when used for the treatment of cough), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• If you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol at the same time as these medicines. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• If you are taking antidepressant medicines, Tramadol/Paracetamol Alter may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• If you are taking warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• Gabapentin or pregabalin to treat 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 (medicines for the treatment of nausea and vomiting),
• Colestyramine (a medicine that lowers cholesterol in the blood).

Your doctor will know which medicines 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, Breast-feeding, and Fertility

Because tramadol/paracetamol contains tramadol, it is not recommended to take this medicine during pregnancy or breast-feeding. 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, you should not take tramadol/paracetamol more than once during breast-feeding, or, if you take tramadol/paracetamol more than once, you should stop breast-feeding.

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

Ask your doctor whether you can drive or use machines while taking this medicine. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when taking it in combination with other medicines.

3. How to take Tramadol/Paracetamol Alter

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, 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 possible time.

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

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

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age 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 prescribed by your doctor.

Elderly Patients

In elderly patients (over 75 years of age), the elimination of tramadol may be slow. If this is the case, your doctor may recommend prolonging the dosing intervals.

Patients with Liver or Kidney Impairment/Patients on Dialysis

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

Use in Children and Adolescents

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

Method of Administration

Tramadol/paracetamol is available 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 think 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), tell 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, talk to 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, telephone 91 562 04 20.

If you forget to take Tramadol/Paracetamol Alter

If you forget to take a dose of tramadol/paracetamol, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Alter

Generally, no unwanted effects occur after stopping treatment with tramadol/paracetamol. However, in rare cases, patients who have been taking tramadol/paracetamol for a long time and have stopped treatment abruptly may feel unwell (see section 4 "Possible side 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 used to it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very frequent: may affect more than 1 in 10 people;

• nausea.
• dizziness, drowsiness.

Frequent: 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 of being "high-spirited" all the time).

Infrequent: may affect up to 1 in 100 people;

• increased pulse, or increased blood pressure, cardiac rhythm and frequency disorders.
• tingling sensation, numbness, or pinching sensation in the limbs, ringing in the ears, 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, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope).
• dependence on the medicine.
• delirium.
• blurred vision, pupil constriction (miosis).
• speech disorder,
• excessive dilation of the pupils (mydriasis).

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

decrease in blood sugar levels (hypoglycemia).

The following recognized adverse effects have been reported by people who have taken medicines that contained only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should tell your doctor:

• Dizzy sensation 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.
• Taking tramadol/paracetamol with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin rashes, indicating allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath or drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.
• Frequency not known: Hiccups.
• Serotonin syndrome, which can manifest through 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 stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tramadol/Paracetamol Alter").
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

In rare cases, using a medicine like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or trembly. They may be hyperactive, have difficulty sleeping and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling sensation 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 may reveal certain anomalies, such as low platelet count, which can result in nosebleeds or bleeding in the gums.

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

Rare cases of respiratory depression have been reported with tramadol.

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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Alter

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

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who have not been prescribed it.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol/Paracetamol Alter

• The active ingredients are tramadol hydrochloride and paracetamol.

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

• The other ingredients are:

Core of the tablet: pregelatinized corn starch, corn starch, sodium carboxymethyl cellulose (Type A) of potato, microcrystalline cellulose, magnesium stearate.

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

Appearance of the Product and Package Contents

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 packages of 20 and 60 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Manufacturer

Medis International a.s.,

výrobní závod Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

or

Martin Dow

Goualle Le Puy

Champ de Lachaud

19250 Meymac

France

Date of the Last Revision of this Prospectus: February 2025

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