Patient Information Leaflet

Tramadol/Paracetamol Alter 75 mg/650 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 is a combination of two analgesics, tramadol and paracetamol, which act together to relieve pain.

Tramadol/Paracetamol is indicated for the symptomatic treatment of moderate to severe 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, paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you have taken any medicine for the treatment of insomnia, powerful analgesics (opioids), or psychotropic medicines (medicines that can alter mood and emotions), in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (certain medicines used for the treatment of depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with this medicine;
• if you have severe liver disease;
• if you have uncontrolled epilepsy.

Warnings and precautions

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

• If you are taking other medicines 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 breathing difficulties, for example asthma or severe lung problems.
  • 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 had a head injury, shock or severe headaches associated with vomiting.
  • If you are dependent on any other pain-relieving medicine, for example morphine.
  • If you are taking other pain-relieving medicines that contain buprenorphine, nalbuphine or pentazocine.
  • If you are to be anaesthetized. Tell your doctor or dentist that you are using this medicine.
  • 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 are malnourished, chronically alcoholic or also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) 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 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 can make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol/Paracetamol can also cause dependence, abuse and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you should use or the frequency with which you should 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 have abused alcohol or experienced dependence on it, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have had any problems with mood (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you observe 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 a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep”.
• You have made repeated and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, 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 course of treatment for you, when it is appropriate to stop taking the medicine and how to do it safely (see section 3, if you interrupt treatment with Tramadol/Paracetamol).

Respiratory disorders related to sleep

This medicine contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep; 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 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 in monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with 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, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medicine and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite.

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

Children and adolescents

This medicine is not recommended for use in children under 12 years of age. Safety and efficacy have not been established in children.

Use in children with respiratory problems

This medicine is not recommended for use in children with respiratory problems, as the 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. They may be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need to take hormone supplements.

Other medicines and Tramadol/Paracetamol Alter

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those purchased without a prescription.

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

Youmust not takethis medicinewith monoamine oxidase inhibitors (MAOIs) (see section (“Do not take Tramadol/ParacetamolAlter”)

This medicine is not recommended for use if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or some types of pain, such as intense pain attacks in the face called trigeminal neuralgia).
• Buprenorphine, nalbuphine or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you are also 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 other pain-relieving medicines such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medicines to lower blood pressure, or allergy medicines. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• The use of this medicine and sedatives 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 other treatment options are not possible. However, if your doctor prescribes this medicine with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's dose and duration recommendations strictly. 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 facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with these medicines. Your doctor will tell you if this medicine is suitable for you.
• if you are taking medicines for the treatment of depression. This medicine 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, with a risk of bleeding. Inform your doctor immediately if you experience any prolonged or unexpected bleeding.
• Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), as there is a serious risk of blood and fluid disorder (called metabolic acidosis) that must be treated urgently (see section 2).
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

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

• Metoclopramide, domperidone or ondansetron (medicines for the treatment of nausea and vomiting),
• Colestiramine (a medicine that reduces cholesterol in the blood),

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

Tramadol/Paracetamol Alter with food, drinks and alcohol

This medicinemay 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

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

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

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not takethis medicinemore than once during breastfeeding, or if you take this medicine more than once, you should stop breastfeeding.

Fertility

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

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with this medicine. It is essential to observe how this medicine affects you before driving or operating machines. Do not drive or operate machines 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 medicines.

Tramadol/Paracetamol Alter contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will also explain to you 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 discontinue use (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 lowest dose possible that produces pain relief.

The tablet can be split into equal doses.

You should take this medication for the shortest time possible.

Dosage

Use in adults and adolescents (12 years and older)

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents 12 years and older 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 your doctor has instructed.

Use in children

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

Older patients

In patients over 75 years, 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 a severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Administration form

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

The tablets can be taken whole or split in half with a sufficient amount of liquid, preferably water. The groove in the tablet serves to split the tablet if it is difficult to swallow 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 estimate that the action of this medication is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., you do not have 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, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Tramadol/Paracetamol Alter

If you forgot to take the tablets, it is possible that the pain will reappear. 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

You should not stop taking this medication suddenly unless your doctor instructs you to do so. 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 discontinue it, which can be done by gradually reducing the dose to reduce the risk of unnecessary side effects (withdrawal symptoms).

If you have any other questions 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.
• Vertigo, somnolence.

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).

Uncommon(may affect up to 1 in 100 people)

• Increased heart rate or increased blood pressure, cardiac 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 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 disorders,
• Excessive pupil dilation (mydriasis).

Frequency not known

• Decreased blood sugar levels (hypoglycemia),
• 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").

The following adverse effects recognized 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 this medication, please inform your doctor:

• Sensation of dizziness when getting 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.
• 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 a drop in blood pressure and dizziness. If this happens, discontinue treatment and consult your doctor immediately. Do not take this medication again.
• A severe 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 can 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 this medication, please consult your doctor.

Frequency not known: Hiccups.

In exceptional cases, blood tests may reveal certain abnormalities, such as a low platelet count, which may result in nasal or gum bleeding.

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

Cases of rare respiratory depression with tramadol have been reported.

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 System for the Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 location, inaccessible to others. This medication may cause severe harm or even be fatal to individuals not prescribed it.

No special storage conditions are required.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to properly dispose of packaging and unused medications. This will help protect the environment.

Composition of Tramadol/Paracetamol Alter

• The active principles 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, hydroxypropyl cellulose, magnesium stearate.
• Coating material : Hypromellose, macrogol, titanium dioxide (E171), yellow iron oxide (E172), polisorbate.

Appearance of the product and content of the packaging

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

The tablet can be divided into equal doses.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Responsible for manufacturing

FARMALIDER, S.A

C/ Aragoneses 2

28108 Alcobendas Madrid

Spain

or

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas Madrid

Spain

Last review date of this leaflet: February 2025

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