Leaflet: information for the user

Tramadol/Paracetamol Normon 75 mg/650 mg tablets

Tramadol hydrochloride/paracetamol

Read this 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, 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.

1. What isTramadol/Paracetamol Normonand what it is used for

2. What you need to know before you start takingTramadol/Paracetamol Normon

3. How to takeTramadol/Paracetamol Normon

4. Possible side effects

5. Storage ofTramadol/Paracetamol Normon

6. Contents of the pack and additional information

This medication 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 intense pain, provided that 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 ingredients of this medicine (listed in section 6).
• if you have taken any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medicines that can alter mood and emotions) in case of acute alcohol intoxication.
• if you are also taking MAO inhibitors (certain medications used for 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 take Tramadol/ Paracetamol Normon

• if you are taking other medications that contain tramadol or paracetamol.
• if you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts.
• if you have kidney problems.
• if you have severe respiratory difficulties, 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 medicines and Tramadol/Paracetamol Normon").
• if you have recently had a head injury, shock, or severe headaches associated with vomiting.
• if you are dependent 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. Tell your doctor or dentist that you are taking Tramadol/Paracetamol Normon.

Inform your doctor immediately if you experience any of the following during treatment with Tramadol/Paracetamol Normon:

• 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 have malnutrition, chronic alcoholism, or if you are 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Tolerance, dependence, and addiction

• This medicine 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/Paracetamol Normon 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 medication to be used or the frequency of use.
• The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tramadol/Paracetamol 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/Paracetamol 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 course of treatment for you, when it is appropriate to discontinue the medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol/Paracetamol Normon).

Respiratory problems related to sleep

Tramadol/Paracetamol Normon contains an active ingredient that belongs to the opioid group. Opioids can cause respiratory problems related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and hypoxemia related to sleep (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 of experiencing 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 severe syndrome (see section 4 "Possible adverse 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 be possible to achieve insufficient 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 medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

If you experience any of these problems while taking Tramadol/Paracetamol Normon, please inform your doctor. He will decide whether 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. These 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.

Use of Tramadol/Paracetamol Normon with other medications

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

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

Tramadol/Paracetamol Normon should not be taken with tramadol/paracetamol together with monoamine oxidase inhibitors (MAOIs) (see section: "Do not take Tramadol/paracetamol Normon").

Do not use Tramadol/Paracetamol Normon 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 serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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 the limbs or eyes, involuntary muscle contractions, or diarrhea, you should call your doctor.
• if you are taking other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications used to lower blood pressure, medications for allergy treatment. 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 can 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 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 medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increasesif you take Tramadol/Paracetamol Normon simultaneously with these medications. Your doctor will tell you if this medication is suitable for you. If you are taking medications for depression, Tramadol/Paracetamol Normon may interact with these medications and you may experienceaserotonin syndrome (see section 4 "Possible adverse effects").

• 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 inform your doctor immediately of any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

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

• metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),
• colestiramine (medication that reduces cholesterol in the blood),

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

Use of Tramadol/Paracetamol Normon with food and alcohol

Tramadol/Paracetamol Normon may make you feel drowsy. Alcohol can make you feel drowsy, so it is recommended not to take alcohol while taking Tramadol/Paracetamol Normon.

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 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.

Breastfeeding

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, discontinue breastfeeding.

Fertility

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

Driving and operating machinery

Tramadol hydrochloride may cause drowsiness or dizziness, which may be increased by alcohol or other central nervous system depressants (CNS). If this occurs, the patient should not drive or operate machinery.

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

Before starting treatment and regularly during it, your doctor will explain what you can expect from using this medicine, 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 Normon for the shortest time possible.

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

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

Unless your doctor prescribes otherwise, the starting dose for adults and adolescents over 12 years old is one 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 Normon tablets per day.

Do not take this medicine more frequently than your doctor has told you.

Older patients

In elderly patients (over 75 years old), 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

Patients with severe liver or kidney disease should not use this medicine. If you have moderate liver or kidney disease, your doctor may recommend prolonging the dosing intervals.

Administration form

The tablets should be taken orally, can be swallowed whole, or divided by the breaking line to facilitate swallowing, with sufficient liquid, and should not be crushed or chewed.

The tablet can be divided into equal doses of 37.5 mg/325 mg of tramadol/paracetamol.

If you estimate that the effect of this medicine 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 take more Tramadol/paracetamol Normon than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Tramadol/paracetamol Normon

If you forgot to take a dose of the medicine, it is likely that the pain will recur. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt the treatment with Tramadol/paracetamol Normon

You should not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop treatment, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the risk of unnecessary adverse effects (withdrawal symptoms).

If you have any other questions 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 affect 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),

Rare(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 limbs, 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,

Very rare(may affect 1 in 1,000 people)

• Seizures, difficulties with coordinated movements, transient loss of consciousness (syncope).
• Dependence on the medication,
• Delirium
• Blurred vision, pupil constriction (miosis),
• Speech disorders,
• Pupil dilation (mydriasis),

Frequency not known(cannot be estimated from available data)

• 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 standing 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 imbalance) 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, indicative of 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, stop treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol may lead to dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal problems. 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 Tramadol/Paracetamol Normon, please consult your doctor.

Frequency not known: 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.

Frequency not known (cannot be estimated from available data): a serious disease that may make the blood more acidic (metabolic acidosis) has been reported in patients with severe disease who use paracetamol (see section 2).

Tramadol has been reported to cause rare cases of respiratory depression.

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 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 medication.

This medication does not require special storage conditions.

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

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

Do not use this medication 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 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 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 75 mg of tramadol hydrochloride and 650 mg of paracetamol.

• The other components are: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, colloidal silica, magnesium stearate of vegetable origin, povidone.

Appearance of the product and content of the packaging

The tablets are white or almost white, elongated, biconvex, and scored on one side. They are available in aluminum/PVC blisters, in packs of 10, 20, 30, 60, and 90 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.ARonda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet:February 2025

Other sources of information

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/