TRAMADOL/PARACETAMOL ALTER 75 mg/650 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tramadol/Paracetamol Alter 75 mg/650 mg Film-Coated Tablets

tramadol hydrochloride/paracetamol

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 Additional Information

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

Tramadol/Paracetamol is a combination of two pain relievers, tramadol and paracetamol, that work together to relieve pain.

Tramadol/Paracetamol is indicated for the symptomatic treatment of moderate to severe pain, provided that your doctor considers the combination of tramadol and paracetamol 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 nottake Tramadol/ParacetamolAlter

• if you are allergic to tramadol, paracetamol, or any of the other components of this medication (listed in section 6);
• if you have taken any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions), in case of acute alcohol intoxication;
• if you are 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 this medication;
• if you have severe liver disease;
• if you have uncontrolled epilepsy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you are taking other medications that contain tramadol or paracetamol.
• 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, such as asthma or severe lung problems.
  • If you have epilepsy or have suffered seizures or convulsions.
  • If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Alter").
  • If you have recently suffered a head injury, shock, or severe headaches associated with vomiting.
  • If you are dependent on any other medication used for pain relief, such as morphine.
  • If you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine.
  • If you are going to be anesthetized. Tell your doctor or dentist that you are using this medication.
  • If you have severe diseases, 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 disease called metabolic acidosis (an anomaly 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. The 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 medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Tramadol/Paracetamol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tramadol/Paracetamol may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have undergone psychiatric treatment for other mental illnesses.

If you notice any of the following symptoms while using Tramadol/Paracetamol, it could be a sign of dependence or addiction:

• You need to use the medication for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, such as "to feel calm" or "to help you sleep".
• You have made repeated, unsuccessful attempts to stop using the medication or control its use.
• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

If you notice any of these signs, consult your doctor to determine the best treatment option for you, when it is appropriate to stop the medication, and how to do so safely (see section 3, if you interrupt treatment with Tramadol/Paracetamol).

Sleep-Related Breathing Disorders

This medication contains an active ingredient that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, such as central sleep apnea (shallow or paused breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

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 symptoms related to this serious syndrome (see section 4 "Possible side effects").

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, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

If you have had any of these problems in the past while taking this medication, inform your doctor. He will decide whether you should continue taking this medication.

Children and Adolescents

The use of this medication is not recommended in children under 12 years of age. Safety and efficacy have not been established in children.

Use in children with respiratory problems

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

Tell your doctor if you experience any of the following symptoms while taking this medication:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need to take hormonal supplements.

Other medications and Tramadol/Paracetamol Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those purchased without a prescription.

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

You must nottake this medication with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Alter")

The use of Tramadol/Paracetamol Alter is not recommended if you are being treated with:

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

The risk of side effects increases if you also take:

• 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 limb or eye movements, or diarrhea, you should call your doctor.
• Other analgesics such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), certain medications to lower blood pressure, or medications for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of this medication and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medication with sedative medications, you should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medications you are taking and strictly follow your doctor's recommended dosage. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of these symptoms.

• tell your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Alter may be altered if you also take:

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

Your doctor will know which medications are safe to use with this medication.

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

This medication can make you feel drowsy. Alcohol can make you feel even drowsier, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol.

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 medication.

Because this medication contains tramadol, it is not recommended to use this medication during pregnancy. If you become pregnant during treatment with this medication, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take this medication more than once during breastfeeding, or if you take this medication more than once, you should interrupt breastfeeding.

Fertility

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 in fertility.

Driving and Using Machines

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

Tramadol/Paracetamol Alter contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Tramadol/Paracetamol Alter

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The dose should be adjusted to the intensity of your pain and your individual sensitivity to pain. Normally, you should take the smallest dose possible that provides pain relief.

The tablet can be divided into two equal doses.

You should take this medication for the shortest possible time.

Dosage

Use in adults and adolescents (12 years and older)

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years is 1 tablet.

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 4 Tramadol/Paracetamol Alter tablets per day.

Do not take this medication more frequently than indicated by your doctor.

Use in children

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

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be slow. If this is your 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 this medication is not recommended. If you have moderate liver or kidney impairment, your doctor may prolong the dosing intervals.

Method of administration

This medication is presented in the form of tablets for oral administration.

The tablets can be taken whole or divided in half with a sufficient amount of liquid, preferably water. The score line on the tablet is used to divide the tablet in half if you find it difficult to swallow whole or if you need to take half a dose. The tablet can be divided into two equal doses. Do not chew the tablet.

If you think the effect of this medication is too strong (i.e., you feel very drowsy or have difficulty breathing) or too weak (i.e., you do not have adequate pain relief), tell your doctor.

If you take more Tramadol/Paracetamol Alter than you should

You should consult your doctor or pharmacist, even if you feel well, as there is a risk of liver damage that may only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Tramadol/Paracetamol Alter

If you forget to take the tablets, it is possible 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 interrupt treatment with Tramadol/Paracetamol Alter

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 side effects (withdrawal symptoms).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may 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 "high" 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., eruptions, 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 disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known

• Decrease in blood sugar levels (hypoglycemia),
• 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").

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

• Feeling dizzy when standing up after being 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 along with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin eruptions, being indicative of allergic reactions that can manifest through the sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you, stop the treatment and consult your doctor immediately. You should not take this medicine again.
• 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, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with this medicine, please consult your doctor.

Frequency not known: hiccups.

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, serious skin reactions have been reported with paracetamol.

There have been reports of rare cases of respiratory depression with tramadol.

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 Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol/Paracetamol Alter

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

It does not require special storage conditions.

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.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. 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 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• The other components are:

• Tablet core: Pregelatinized starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethylcellulose type A, hydroxypropylcellulose, magnesium stearate.
• Coating material: Hypromellose, macrogol, titanium dioxide (E171), yellow iron oxide (E172), polysorbate.

Appearance of the Product and Package Contents

Tramadol/Paracetamol Alter film-coated tablets are presented in the form of film-coated, scored, oblong, biconvex tablets of yellow color, with a length of 21.2 mm ± 0.3 mm, width of 10.2 mm ± 0.2 mm, and thickness of 6.7 mm ± 0.2 mm.

The tablet can be divided into equal doses.

This medicine is presented in PVC-white opaque/Al and PVC/PVDC-white opaque/Al blisters, in packages of 20 or 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Manufacturer

FARMALIDER, S.A

C/ Aragoneses 2

28108 Alcobendas Madrid

Spain

or

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas Madrid

Spain

Date of the Last Revision of this Prospectus: February 2025

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