Tramadol/paracetamol Alter 37.5 mg/325 mg film-coated tablets EFG

Package leaflet: Information for the user

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 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 Alter 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 hydrochloride, 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 affect 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 tramadol/paracetamol;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled by your current treatment.

Warnings and precautions

Sleep-related breathing disorders

Tramadol/paracetamol Alter may cause sleep-related breathing disorders, such as sleep apnoea (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 breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Talk to your doctor or pharmacist before taking Tramadol/Paracetamol Alter:

• if you are taking other medicines containing paracetamol or tramadol;
• if you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe breathing difficulties, such as asthma or serious lung disease;
• if you have epilepsy or have had seizures or convulsions;
• if you have recently suffered 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 medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anaesthetised. Inform your doctor or dentist that you are taking tramadol/paracetamol.
• if you have depression and are taking antidepressants, as some may interact with tramadol (see “Taking Tramadol/Paracetamol Alter with other medicines”).
• 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 have 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 at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

If you develop or have previously experienced any of these problems while taking tramadol/paracetamol, please inform your doctor. Your doctor 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 hormonal supplements.

There is a slight risk of developing serotonin syndrome after taking tramadol, either alone or in combination with certain antidepressants. Contact a doctor immediately if you experience any symptoms associated with this serious condition (see section 4 “Possible side effects”).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (you become accustomed to it, known as 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 side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much medicine you need to take or how often.

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 have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have previously 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 signs while taking Tramadol/Paracetamol, it could indicate 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 prescribed, for example, "to stay calm" 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 feel better when you take it again ("withdrawal effect")

If you notice any of these signs, talk to your doctor so they can advise you on the best course of treatment, including when it is appropriate to stop taking the medicine and how to do so 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 recently taken, or might need to take any other medicines.

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbance (called metabolic acidosis) that requires urgent treatment (see section 2).

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.

Tramadol/paracetamol must not be taken together with 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 usually used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of adverse effects increases:

• If you are taking triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhoea, contact your doctor.
• If you are taking sedatives, medicines for insomnia, 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.
• 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 tramadol/paracetamol is suitable for you.
• If you are taking antidepressants, Tramadol/Paracetamol Alter may interact with these medicines and may cause 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.
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you also take:

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• Cholestyramine (a medicine that lowers blood cholesterol).

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

Taking Tramadol/Paracetamol Alter with food and drink

Tramadol/paracetamol 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

Because tramadol/paracetamol contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while taking 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 breastfeeding, or if you take tramadol/paracetamol more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects fertility in men or women. There are no data available on the combination of tramadol and paracetamol regarding 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.

Driving and using machines

Ask your doctor whether 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. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulations, and/or when taking this medicine together with other medicines.

3. How to take Tramadol/Paracetamol Alter

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

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

You should take tramadol/paracetamol for the shortest time possible.

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

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides 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, 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 8 tablets of Tramadol/Paracetamol Alter per day.

Do not take tramadol/paracetamol more frequently than prescribed by your doctor.

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

If you have severe liver or kidney disease, treatment with tramadol/paracetamol is not recommended. If you have moderate liver or kidney disorders, your doctor may extend 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 tablet form for oral administration.

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

If you feel 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 get adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Alter than you should

If you have taken more tramadol/paracetamol than prescribed, even if you feel well, contact 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 at telephone 91 562 04 20.

If you forget to take Tramadol/Paracetamol Alter

If you forget to take a dose of tramadol/paracetamol, 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

Generally, no adverse effects occur after stopping treatment with tramadol/paracetamol. However, in rare cases, patients who have taken tramadol/paracetamol for a prolonged period and 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 accustomed to it.

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 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, diarrhoea), stomach pain, dry mouth
• itching, increased sweating (hyperhidrosis)
• headache, restlessness
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling "high-spirited" all the time)

Uncommon: may affect up to 1 in 100 people:

• increased pulse, increased blood pressure, disturbances in heart rhythm and rate
• tingling sensation, numbness, or prickling sensations 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 stools
• skin reactions (e.g. rashes, urticaria)
• increased liver enzyme levels
• 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)
• drug dependence
• delirium
• blurred vision, pupil constriction (miosis)
• speech disorder
• excessive dilation of the pupils (mydriasis)

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

• decrease in blood sugar levels (hypoglycaemia)

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

• Dizziness when 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 should inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin rashes, indicative of 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 happens to you, stop treatment and consult your doctor immediately. You must not take this medicine again.
• Frequency not known: Hiccups
• Serotonin syndrome, which may present with 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 you start taking Tramadol/Paracetamol Alter’).
• A serious illness that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using 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 few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling sensations, 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 abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

Very rarely, 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 kind of adverse effect, talk to your doctor, pharmacist, or nurse, 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: https://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 the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure how to dispose of medicines and containers you no longer need, ask your pharmacist. 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 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components are:

Tablet core: pregelatinized corn starch, corn starch, sodium carboxymethyl starch (potato source, Type A), microcrystalline cellulose, magnesium stearate.

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

Appearance of the product and pack contents

Tramadol/Paracetamol Alter film-coated tablets are pale yellow, oblong, biconvex tablets supplied in blister packs.

Tramadol/Paracetamol Alter is available in packs containing 20 and 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Manufacturer

Martin Dow

Goualle Le Puy

Champ de Lachaud

19250 Meymac

France

Date of latest revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/