Tramadol/paracetamol Alter 75 mg/650 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol/Paracetamol Alter 75 mg/650 mg film-coated tablets

tramadol hydrochloride/paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Tramadol/Paracetamol Alter is and what it is 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. How to store Tramadol/Paracetamol Alter
6. Contents of the pack and other information

1. What Tramadol/Paracetamol Alter 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 Alter

Do not take Tramadol/Paracetamol Alter

• if you are allergic to tramadol, 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 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 within the last 14 days before starting treatment with this medicine;
• 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 this medicine.

• If you are taking other medicines containing 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 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 serious lung conditions.
  • If you have epilepsy or have had seizures or convulsions.
  • If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines 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 pain-relief medicines, for example, morphine.
  • If you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine.
  • If you are going to be anaesthetized. Tell your doctor or dentist that you are using this medicine.
  • If you have serious illnesses 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 in these situations 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 (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol/Paracetamol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may make you feel unable to control how much medicine you use or how often you use it.

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

• You or any member of your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist 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 medicine for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than prescribed, for example, “to feel calm” or “to help you sleep”.
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again (“withdrawal effects”).

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

Sleep-related breathing disorders

This medicine contains an active ingredient belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

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

There is a slight risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms related to this serious condition (see section 4 “Possible side effects”).

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

If you develop or have previously experienced any of these problems while taking this medicine, inform your doctor. He or she will decide whether you should continue taking this medicine.

Children and adolescents

The use of this medicine 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 symptoms of tramadol toxicity may worsen in these children.

Inform your doctor 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 hormonal supplements.

Other medicines and Tramadol/Paracetamol Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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.

You must not take this medicine together 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 medicine usually used to treat epilepsy or certain types of pain, such as intense facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of adverse effects increases if you also take:

• 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 limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.
• Other painkillers such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• The concomitant use of this medicine with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, your dose and duration of concomitant treatment should be limited.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• If you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with these medicines. Your doctor will advise whether this medicine is suitable for you.
• If you are taking medicines for depression. This medicine may interact with these medicines, and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• If you are taking warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting),
• Colestipol or cholestyramine (medicines that reduce cholesterol in the blood),

Your doctor will know which medicines are safe to use with this medicine.

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

This medicine 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

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.

Because this medicine contains tramadol, its use during pregnancy is not recommended. If you become pregnant while taking this medicine, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take this medicine more than once during breastfeeding, or if you take it more than once, you must stop breastfeeding.

Fertility

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

Driving and using machines

Ask your doctor if you can drive or operate machinery while being treated with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Tramadol/Paracetamol Alter contains sodium

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

3. How to take Tramadol/Paracetamol Alter

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using 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 according to the intensity of your pain and your individual sensitivity to pain. Normally, the lowest possible dose that provides pain relief should be taken.

The tablet can be divided into equal doses.

You should take this medicine for the shortest time possible.

Dosage

Use in adults and adolescents (12 years and older)

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents aged 12 years and older is 1 tablet.

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 4 tablets of Tramadol/Paracetamol Alter per day.

Do not take this medicine more frequently than prescribed by your doctor.

Use in children

This medicine is not recommended for use in children under 12 years of age.

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

Treatment with this medicine is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration

This medicine is available as tablets for oral administration.

The tablets may be taken whole or split in half with a sufficient amount of liquid, preferably water. The tablet's score line is intended to help divide the tablet if you have difficulty swallowing it whole or if you need to take half a dose. The tablet can be divided into equal doses. Do not chew the tablet.

If you feel that the effect of this medicine is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, you do not get adequate pain relief), inform 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 at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol/Paracetamol Alter

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Alter

You should not suddenly stop taking this medicine unless instructed by your doctor. If you wish to stop taking the 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).

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 can cause adverse effects, although not everyone experiences 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, feeling "on a high" all the time).

Uncommon (may affect up to 1 in 100 people)

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling sensation, numbness, or prickling sensation in the extremities, 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 stools,
• skin reactions (e.g. rashes, urticarial rash),
• increased levels of liver enzymes,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare (may affect up to 1 in 1,000 people)

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

Frequency not known

• Decrease in blood sugar levels (hypoglycaemia),
• Serotonin syndrome, which may present as changes in mental status (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, diarrhoea) (see section 2, "What you need to know before taking Tramadol/Paracetamol Alter").

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

• Dizziness upon 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.
• 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 rare cases, skin rashes indicating allergic reactions, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this occurs, stop treatment and consult your doctor immediately. You must not take this medicine again.
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

Occasionally, people who have been taking 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 digestive and intestinal disturbances. Very rarely, people may also experience panic attacks, hallucinations, unusual sensations 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 abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

Very rarely, serious 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 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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Alter

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container 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. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Alter

• The active substances 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 carboxymethyl starch type A, hydroxypropylcellulose, magnesium stearate.

• Coating material: hypromellose, macrogol, titanium dioxide (E171), yellow iron oxide (E172), polysorbate.

Appearance of the product and contents of the pack

Tramadol/Paracetamol Alter film-coated tablets are presented as yellow, oblong, biconvex, film-coated tablets with a score line, measuring 21.2 mm ± 0.3 mm in length, 10.2 mm ± 0.2 mm in width and 6.7 mm ± 0.2 mm in thickness.

The tablet can be divided into equal doses.

This medicine is available in PVC/opaque white/Al and PVC/PVDC/opaque white/Al blisters, in pack sizes 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 most recent revision of this leaflet: February 2025

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