TRAMADOL/PARACETAMOL NORMON 75 mg/650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Normon 75 mg/650 mg Tablets

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 and other information

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

This medicine is a combination of two painkillers, tramadol and paracetamol, which work together to relieve pain.

Tramadol/Paracetamol is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that 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, powerful painkillers (opioids), or psychotropic drugs (drugs that can alter mood and emotions) in case of acute alcohol intoxication.
• if you are taking, or have taken in the last 14 days, monoamine oxidase inhibitors (MAOIs) (certain medicines used for depression or Parkinson's disease).
• if you have severe liver disease.
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor before you start taking Tramadol/Paracetamol Normon

• if you are taking other medicines that contain tramadol or paracetamol.
• if you have liver or kidney problems, 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 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 dependence on any other medicine used for pain relief, for example, morphine.
• if you are taking other medicines for pain relief that contain buprenorphine, nalbuphine, or pentazocine.
• if you are going to be anesthetized. Tell your doctor or dentist that you are taking Tramadol/Paracetamol Normon.

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

• 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 are also taking flucloxacillin (an antibiotic). A serious 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.

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/Paracetamol 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/Paracetamol Normon may be greater 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 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/Paracetamol 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, talk to your doctor to determine the best treatment option 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/Paracetamol Normon).

Respiratory disorders related to sleep

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 slight risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Talk to your doctor immediately if you experience any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

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, stop taking this medicine and talk to your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell, 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 whether 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 whether you need to take hormonal supplements.

Taking Tramadol/Paracetamol Normon with other medicines

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

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

Tramadol/Paracetamol Normon must not be takenwith monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Normon").

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

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as severe facial pain 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 migraines) 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 used for the treatment of cough), baclofen (a muscle relaxant), certain medicines used to lower blood pressure, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, talk to your doctor.

The concomitant 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 useful to inform your friends and family about the signs and symptoms mentioned 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 this medicine is suitable for you. If you are taking medicines for the treatment of depression, Tramadol/Paracetamol Normon 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, and there is a risk of bleeding. You should tell your doctor immediately if you experience any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

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

• metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting),
• cholestyramine (a medicine that lowers 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 may make you feel drowsy. Alcohol may make you feel 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, talk to 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.

Fertility

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 on fertility.

Driving and using machines

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

3. How to take Tramadol/Paracetamol Normon

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

Before starting treatment and regularly during treatment, 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 possible time.

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

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

Unless your doctor has prescribed otherwise, the initial dose for adults and adolescents over 12 years of age 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.

Elderly patients

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

Patients with liver or kidney impairment/patients on dialysis

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

Method of administration

The tablets should be taken orally, can be swallowed whole, or broken in half along the score 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 think 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), 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, talk to your doctor or pharmacist immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Tramadol/Paracetamol Normon

If you forget to take a dose of the medicine, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses, simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Normon

Do 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 tell 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very frequent (may affect more than 1 in 10 people)

• nausea.
• dizziness, drowsiness.

Frequent (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 of being "high" all the time),

Infrequent (may affect 1 in 100 people)

• increased pulse or increased blood pressure, cardiac rhythm and frequency disorders,
• tingling sensation, numbness or pinching sensation 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., rashes, urticarial hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flashes, chest pain,

Rare (may affect 1 in 1,000 people)

• seizures, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope).
• dependence on the medicine,
• delirium
• blurred vision, pupil contraction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis),

Frequency not known (cannot be estimated from the available data)

• Decrease in blood sugar levels (hypoglycemia)
• serotonin syndrome, which can manifest through changes in mental status (e.g., agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle 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 recognized adverse 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 lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, 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 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, indicating allergic reactions that can manifest through 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. 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 suddenly stop treatment. 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.

With frequency not known (cannot be estimated from the available data): a serious disease that can make the blood more acidic (called metabolic acidosis) has been reported in patients with severe illness using paracetamol (see section 2).

Rare cases of 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Normon

This medicine does not require special storage conditions.

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you 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 75 mg of tramadol hydrochloride and 650 mg of paracetamol.

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

Appearance of the Product and Package Contents

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

Only some package sizes may be marketed.

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 Prospectus:August 2024

Other Sources of Information

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 prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84429/P_84429.html