TRAMADOL/PARACETAMOL NORMON 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Normon 37.5 mg/325 mg

film-coated tablets EFG

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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tramadol/Paracetamol Normon and what is it used for
2. What you need to know before you take Tramadol/Paracetamol Normon
3. How to take Tramadol/Paracetamol Normon
4. Possible side effects
5. Storage of Tramadol/Paracetamol Normon
6. Contents of the pack and other information

1. What is Tramadol/Paracetamol Normon and what is it used for

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

Tramadol/Paracetamol Normon is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that a combination of tramadol and paracetamol is necessary.

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

2. What you need to know before you take Tramadol/Paracetamol Normon

• 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 medicine for the treatment of insomnia, potent painkillers (opioids), or psychotropic drugs (drugs that can 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 in the last 14 days before treatment with Tramadol/Paracetamol Normon.
• If you have severe liver disease.
• If you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

• Consult your doctor before starting to take Tramadol/Paracetamol Normon

• If you are taking other medicines 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 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 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 have a dependence on any other medicine used for pain relief, for example, morphine.
• If you are taking other painkillers that contain buprenorphine, nalbuphine, or pentazocine.
• If you are going to be anesthetized, tell your doctor or dentist that you are using Tramadol/Paracetamol Normon.

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

If you have severe illnesses, 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 are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Sleep-related breathing disorders

Tramadol/Paracetamol Normon contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example, central sleep apnea (shallow or paused breathing during sleep) and sleep-related hypoxemia (low oxygen level 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 alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

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 gets used to it, which is known as pharmacological tolerance). Repeated use of Tramadol Normon can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tramadol Normon may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription drugs, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Tramadol Normon, it could be a sign of dependence or addiction:

• You need to use the medicine for longer 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 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 treatment for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you stop treatment with Tramadol Normon).

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects.

If you notice any of the following side effects, you must stop taking this medicine and consult a doctor immediately:

• slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

• If you have had any of these problems in the past while taking Tramadol/Paracetamol Normon, please inform your doctor. He will decide if you should continue taking this medicine.

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.

Tell 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 indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

• Other medicines and Tramadol/Paracetamol Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

Tramadol/Paracetamol Normon should not be used if you are being treated with:

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

Tell your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious 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 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, muscle contractions, or diarrhea, you should call your doctor.
• If you are taking other painkillers such as morphine and codeine (also when used for the treatment of cough), baclofen (muscle relaxant), some medicines to lower blood pressure, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.

The use of Tramadol/Paracetamol Normon and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can 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 sedative medicines, you should limit the dose and duration of concomitant treatment.

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

• If you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Normon at the same time as these medicines. Your doctor will tell you if Tramadol/Paracetamol Normon is suitable for you.

• If you are taking medicines for the treatment of depression. Tramadol/Paracetamol Normon can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

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• If you are taking warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

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

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

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

• Taking Tramadol/Paracetamol Normon with food and alcohol

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

• Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Because Tramadol/Paracetamol Normon contains tramadol, it is not recommended to take this medicine 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. For this reason, you should 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 fertility in men and women. There are no data available 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 important that before driving or using machines, you observe how this medicine affects you. 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 a dose increase, after a change in formulation, and/or when administering it concomitantly with other medicines.

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3. How to take Tramadol/Paracetamol Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, 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 stop using it (see also section 2).

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

The use of this medicine is not recommended in children under 12 years of age.

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces 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, you can increase the dose, as your doctor recommends. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 Tramadol/Paracetamol Normon tablets per day.

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

Elderly patients

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

Patient with hepatic or renal insufficiency/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 disorders, your doctor may prolong the dosing intervals.

Method of administration

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 think 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), tell your doctor.

If you think 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), tell 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 serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 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 of Tramadol/Paracetamol Normon, it is likely that the pain will return. Do not take a double dose to make up for the forgotten doses, simply continue taking the tablets as usual.

• If you stop treatment with Tramadol/Paracetamol Normon

Generally, no unwanted effects appear after stopping treatment with Tramadol/Paracetamol Normon. However, in rare cases, patients who have been taking tramadol hydrochloride for a while and have stopped treatment abruptly may feel unwell (see section Possible side effects). If you have been taking Tramadol/Paracetamol Normon for some time, you should consult your doctor before stopping 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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, 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, heart rhythm and frequency disorders;

−tingling sensation, numbness, or sensation of pins and needles 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 stool;
• skin reactions (e.g., rash, urticaria);
• increased liver enzyme values;
• presence of albumin in the urine,
• difficulty or pain when urinating;

• chills, hot flashes, chest pain;

Rare: may affect up to 1 in 1,000 people;

• seizures, difficulty coordinating movements, transient loss of consciousness (syncope)
• dependence on the medicine
• delirium
• blurred vision, pupil constriction (miosis)
• Speech disorders

−Excessive dilation of the pupils (mydriasis)

Frequency not known:

• decrease in blood sugar levels (hypoglycemia).
• serotonin syndrome, which can 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start taking Tramadol/Paracetamol NORMON").

The following side effects have been reported by people who have taken medicines that contained only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Normon, you should tell your doctor:

• Dizziness when standing up after sitting or lying down, 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 a blood and fluid anomaly (metabolic acidosis with high anion gap) when there is an increase in blood plasma acidity.

• The use of Tramadol/Paracetamol Normon 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, being indicative of allergic reactions that can manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.

In rare cases, using a medicine like tramadol can create 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 trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (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 anomalies, such as low platelet count, which can result in nosebleeds or bleeding gums.

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

Rare cases of respiratory depression have been reported with tramadol.

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

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Normon

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

Store this medicine in a safe place, protected from other people who may accidentally take it. It can cause serious harm and be fatal for people it has not been prescribed for.

No special storage conditions are required.

Do not use Tramadol/Paracetamol Normon after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Tramadol/Paracetamol Normon

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

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

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet:June 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/74340/P_74340.html