Tramadol/paracetamol Normon 75 mg/650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol/Paracetamol Normon 75 mg/650 mg tablets

Tramadol hydrochloride/paracetamol

Read the entire 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, ask your doctor or pharmacist.

This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tramadol/Paracetamol Normon is and what it is used for
2. What you need to know before taking Tramadol/Paracetamol Normon
3. How to take Tramadol/Paracetamol Normon
4. Possible side effects
5. How to store 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 analgesics, 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 the 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 starting to take Tramadol/paracetamol Normon

Do not take Tramadol/paracetamol Normon:

• if you are allergic to tramadol hydrochloride, paracetamol, or to any of the other ingredients of this medicine (listed in section 6).
• if you have taken medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that can alter mood and emotions) in cases of acute alcohol intoxication.
• if you are currently taking MAO inhibitors (certain medicines used for depression or Parkinson's disease) or if you have taken them within the last 14 days before starting 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 Tramadol/Paracetamol Normon

• if you are taking other medicines containing tramadol or paracetamol.
• 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 serious lung conditions.
• if you have epilepsy or have had seizures or convulsions.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol Normon").
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting.
• if you are dependent on any other medicine used for pain relief, for example, morphine.
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine.
• if you are going to be anaesthetized. Tell your doctor or dentist that you are taking Tramadol/Paracetamol Normon.

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

• You have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol/Paracetamol Normon may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.
• Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take it.
• The risk of dependence or addiction varies from person to person. The risk of becoming dependent

or addicted to Tramadol/Paracetamol Normon may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction").

• You are a smoker.

• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

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

• You need to use the medicine for longer than prescribed by your doctor.

• You need to use a higher dose than recommended.

• You are using the medicine for reasons other than prescribed, for example, "to stay 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 taking the medicine, and feel better once you take it again ("withdrawal effects").

  • If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop treatment with Tramadol/Paracetamol Normon).

Sleep-related breathing disorders

Tramadol/Paracetamol Normon contains an active substance belonging to the group of opioids. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

There is a weak risk that you may develop a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Consult a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4, "Possible side effects").

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

If you experience any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

If you develop or have previously experienced any of these problems while taking Tramadol/Paracetamol Normon, please inform your doctor. He or she will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with respiratory problems:

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may 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 indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Taking Tramadol/Paracetamol Normon with other medicines

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

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

Tramadol/Paracetamol Normon must not be taken with monoamine oxidase inhibitors (MAOIs) (see section: “Do not take Tramadol/Paracetamol Normon”).

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

• Carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as severe facial pain attacks known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

The risk of adverse effects increases

• If you are taking triptans (for the treatment of migraine) or selective serotonin reuptake inhibitors (SSRIs), used to treat depression. If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle contractions, or diarrhea, you must contact your doctor immediately.
• If you are taking other analgesics such as morphine and codeine (also when used to treat 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 occurs, consult your doctor.

The concomitant use of Tramadol/Paracetamol Normon and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, they must limit the dose and duration of concomitant treatment.

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

If you are taking medicines that may trigger or lower the seizure threshold, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Normon simultaneously with these medicines. Your doctor will advise you whether 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 serotonin syndrome (see section 4, "Possible side effects").

• If you are taking warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting),
• Colestyramine (a medicine that lowers blood cholesterol),

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

Taking Tramadol/Paracetamol Normon with food and alcohol

Tramadol/Paracetamol Normon may make you feel drowsy. Alcohol can also cause drowsiness, therefore it is recommended not to consume 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Because Tramadol/Paracetamol Normon contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while being treated 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 must interrupt breastfeeding.

Fertility

Based on human experience, there is no indication that tramadol affects fertility in men and women. There are no data available regarding the effect of the combination of tramadol and paracetamol on fertility.

Driving and Operating Machinery

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

3. How to take Tramadol/paracetamol Normon

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

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 pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used.

Unless otherwise prescribed by your doctor, the starting dose for adults and adolescents over 12 years of age is one tablet.

If necessary, the dose may be increased as recommended by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 4 tablets of Tramadol/Paracetamol Normon per day.

Do not take this medicine more frequently than instructed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

This medicine must not be used in patients with severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may recommend prolonging the dosing intervals.

Administration method

The tablets should be taken orally and may be swallowed whole, or split in half along the break line to facilitate swallowing, with sufficient liquid. The tablets must not be crushed or chewed.

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

If you feel 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, contact your doctor or pharmacist immediately, even if you feel well, 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 at telephone number 91 562 04 20.

If you forget to take Tramadol/paracetamol Normon

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

If you interrupt treatment with Tramadol/paracetamol Normon

Do not stop taking this medicine suddenly unless your doctor tells you to. If you wish to discontinue treatment, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about 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 everyone experiences 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 – a feeling of being “high” all the time)

Uncommon (may affect up to 1 in 100 people)

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears (tinnitus), involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or sensing something that does not exist in reality), memory loss
• difficulty breathing
• difficulty swallowing, blood in the stool
• skin reactions (e.g., rashes, urticarial rash)
• increased levels of liver enzymes
• presence of albumin in urine, difficulty or pain when urinating
• chills, hot flushes, chest pain

Rare (may affect up to 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 dilation of the pupils (mydriasis)

Frequency not known (cannot be estimated from available data)

• Decrease in blood sugar levels (hypoglycemia)
• serotonin syndrome, which may present with 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 “What you need to know before taking Tramadol/Paracetamol Normon”).

The following adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Normon, you must inform your doctor:

• Dizziness upon standing up after lying down or sitting, slow 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 in combination with the antibiotic flucloxacillin may induce a blood and fluid disorder (metabolic acidosis with high anion gap) when there is increased acidity in the blood plasma.

• The use of Tramadol/Paracetamol Normon together with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You should immediately inform your doctor about any prolonged or unexpected bleeding.

• In rare cases, skin rashes may occur, 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, stop treatment and consult your doctor immediately. You must not take this medicine again.

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

Occasionally, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience digestive and intestinal disturbances. Very few people may also experience 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 abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

Very rarely, serious skin reactions have been reported with paracetamol.

With frequency not known (cannot be estimated from available data): a serious condition that may increase blood acidity (called metabolic acidosis) has been reported in patients with severe illness who are using paracetamol (see section 2).

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/paracetamol Normon

This medicine does not require any special storage conditions.

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

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tramadol/paracetamol Normon

The active substances 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 contents of the container

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

Only certain pack 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 most recent review of this leaflet: August 2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet 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