Leaflet: information for the user

Tramadol/Paracetamol Normon 37.5 mg/325 mg

film-coated tablets EFG

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, consult your doctor or pharmacist.

This medicine has been prescribed for you only, and you must 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.

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

Tramadol/Paracetamol Normon is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamol Normon should only be used by adults and adolescents over 12 years old.

• Do not take Tramadol/Paracetamol Normon

If you are allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medication (listed in section 6).

- If you have taken any medication for insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;

- If you are also taking MAO inhibitors (certain medications used for the treatment of depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Normon;

- If you have severe liver disease;

- If you have uncontrolled epilepsy with your current treatment.

Warnings and precautions

• Consult your doctor before starting to takeTramadol/Paracetamol Normon

- If you are taking other medications 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 indicative of jaundice or problems with your bile ducts.

- If you have kidney problems.

- If you have severe respiratory difficulties, for example, asthma or severe lung problems.

- If you are epileptic or have had seizures or convulsions.

- If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Normon").

- If you have recently experienced head trauma, shock, or severe headaches associated with vomiting.

- If you have dependence on any other medication used for pain relief, for example, morphine.

- If you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine.

- If you are to be anesthetized, inform your doctor or dentist that you are usingTramadol/Paracetamol Normon.

During treatment with Tramadol/Paracetamol Normon, immediately inform your doctor if:

You have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Respiratory disorders related to sleep

Tramadol/Paracetamol Normon 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 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 monotherapy. Immediately consult a doctor if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

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 becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Normon can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side 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 medication 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 Normon may be higher if:

- You or any family member have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").

- You are a smoker.

- You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

If you observe any of the following symptoms while using Tramadol Normon, 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, for example, "to feel calm" or "to help you sleep".

– You have made repeated and 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 for you, when it is appropriate to stop the medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol Normon).

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 be possible to achieve insufficient pain relief, while others may be more likely to experience severe 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 discomfort, or vomiting, constipation, loss of appetite.

• If you experience or have experienced any of these problems while taking Tramadol/Paracetamol Normon, please inform your doctor. He will decide if you should continue taking this medication.

Children and adolescents

Use in children with respiratory problems

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

Inform your doctor if you experience any of the following symptoms while taking Tramadol/Paracetamol Normon:

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 if you need to take hormone supplements.

• Other medications and Tramadol/Paracetamol Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Tramadol/Paracetamol Normon should not be taken with monoamine oxidase inhibitors (MAOIs) (see sectionNo takeTramadol/Paracetamol Normon).

Tramadol/Paracetamol Normon is not recommended for use if you are being treated with:

- Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

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

The risk of side 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 limb or eye movements, involuntary muscle contractions, or diarrhea, you should call your doctor.

- If you are taking other pain medications such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, or allergy medications. You may feel drowsy or dizzy. If this occurs, consult your doctor.

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

Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommended dose. 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 medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Normon simultaneously with these medications. Your doctor will tell you if Tramadol/Paracetamol Normon is suitable for you.

- If you are taking medications for depression treatment. Tramadol/Paracetamol Normon may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible side effects").

- Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

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- If you are taking warfarin or phenprocoumon (medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should immediately inform your doctor of any prolonged or unexpected bleeding.

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

- Metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting treatment).

- Cholestyramine (medication that reduces cholesterol in the blood).

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Normon.

• Tramadol/Paracetamol Normon with food and alcohol

Tramadol/Paracetamol Normon may cause drowsiness. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Normon.

• Pregnancy, lactation, and fertility

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

Due to the presence of tramadol in Tramadol/Paracetamol Normon, it is not recommended to take this medication during pregnancy or breastfeeding. If you become pregnant during treatment with Tramadol/Paracetamol Normon, consult your doctor before taking the next tablet.

Lactation

Tramadol is excreted in breast milk. Therefore, do not take Tramadol/Paracetamol Normon more than once during breastfeeding, or if you take Tramadol/Paracetamol Normon more than once, you should stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility. There are no available data 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 Tramadol/Paracetamol Normon. It is essential to observe how this medication affects you before driving or using machines. 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 increasing the dose, after changing the formulation, and/or when taking it with other medications.

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Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Tramadol/Paracetamol Normon, 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).

You should take Tramadol/Paracetamol Normon for the shortest time possible.

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

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

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years old 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 tablets of Tramadol/Paracetamol Normon per day.

Do not take Tramadol/Paracetamol Normon more frequently than your doctor has told you.

Older patients

In elderly patients (over 75 years old), 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 disease/patients on dialysis

If you have a severe liver or kidney disease, treatment with Tramadol/Paracetamol Normon is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Administration form

Tramadol/Paracetamol Normon is presented 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 estimate that the effect of Tramadol/Paracetamol Normon 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), inform your doctor.

If you estimate that the effect of Tramadol/Paracetamol Normon is too strong (for example: you feel very drowsy or have difficulty breathing) or too weak (for example: you do not have adequate pain relief), inform your doctor.

• If you take more Tramadol/Paracetamol Normon than you should

If you have taken more Tramadol/Paracetamol Normon than you should, although you feel well, consult your doctor or pharmacist immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

• If you forget to take Tramadol/Paracetamol Normon

If you forget to take a dose ofTramadol/Paracetamol Normonit is likely 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 Normon

Generally, no adverse effects occur after interrupting treatment with Tramadol/Paracetamol Normon. However, in rare cases, patients who have been taking tramadol hydrochloride for a while and have interrupted treatment abruptly may feel unwell (see sectionPossible adverse effects). If you have been taking Tramadol/Paracetamol Normon for some time, you should consult your doctor before interrupting treatment as your body may have become accustomed to it.

You should not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

If you have any other doubts about the use of this medicine, 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.

Common: may affect1 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 1 in 100 people;

− increased heart rate or increased blood pressure, heart 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 1 in 1,000 people;

− seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope)

− drug dependence

− delirium

− blurred vision, pupil constriction (miosis)

− speech disorders

− excessive pupil dilation (mydriasis)

Unknown frequency:

- 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 NORMON").

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 Tramadol/Paracetamol Normon, please tell your doctor:

• 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 paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in plasma acidity.

•The use of Tramadol/Paracetamol Normon with anticoagulants (e.g. fenprocoumon, 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 drop in blood pressure and dizziness. If this happens, interrupt treatment and consult your doctor immediately. Do not take this medicine again.

In rare cases, using a medication like tramadol can make you dependent on it, 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 prickling, tingling, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Normon, please consult your doctor.

- Unknown frequency: hiccups.

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

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

Rare cases of respiratory depression have been reported with tramadol.

Unknown frequency (cannot be estimated from available data): A serious disease that may make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store this medication in a safe and protected place, where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

No special storage conditions are required.

Do not use Tramadol/Paracetamol Normon after the expiration date that appears 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 in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Normon

The active principles are tramadol hydrochloride and paracetamol. Each tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

The other components are: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, colloidal silica, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide, talc, povidone, yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Tramadol/Paracetamol Normon is presented in the form of coated, elongated, biconvex tablets with a yellow color. Each package contains 20, 60, or 500 tablets

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:February 2025

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