TRAMADOL/PARACETAMOL KERN PHARMA 75 mg/650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Kern Pharma 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 symptoms are the same as yours.
• If you experience 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 Tramadol/Paracetamol Kern Pharma is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Kern Pharma
3. How to take Tramadol/Paracetamol Kern Pharma
4. Possible side effects.
5. Storage of Tramadol/Paracetamol Kern Pharma
6. Contents of the pack and further information

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

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

This medicine 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 should only be used by adults and adolescents over 12 years of age.

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

Do not take Tramadol/Paracetamol Kern Pharma:

• if you are allergic to tramadol, 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, strong 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 for the treatment of depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with this medicine,
• 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 or pharmacist before taking this medicine:

• 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 indicative 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 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 Kern Pharma")
• 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 painkillers that contain buprenorphine, nalbuphine, or pentazocine,
• if you are going to be anesthetized. Tell your doctor or dentist that you are using this medicine.

During treatment with Tramadol/Paracetamol Kern Pharma, inform 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.

Sleep-related breathing disorders

This medicine 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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (you get used to it, which is known as tolerance). Repeated use of Tramadol/Paracetamol Kern Pharma can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may increase with a higher dose and longer use.

Dependence or addiction can make you feel like you no longer control the amount of medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Tramadol/Paracetamol Kern Pharma if:

• You or someone in your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever 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 signs while taking Tramadol/Paracetamol Kern Pharma, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You use the medicine for reasons other than those prescribed, for example, "to calm down" or "to sleep"
• You have tried to stop or control the use of the medicine repeatedly and unsuccessfully
• When you stop taking the medicine, you feel unwell, and you feel better when you take it again ("withdrawal effect")

If you notice any of these signs, talk to your doctor so that they can indicate the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking Tramadol/Paracetamol Kern Pharma).

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 a doctor immediately if you present 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, you must stop taking this medicine and consult a doctor immediately:slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, lack of appetite.

If you have had any of these problems in the past while taking this medicine, inform your doctor. They will decide whether you should continue taking this medicine.

Children and adolescents

The use of this medicine is not recommended in children under 12 years of age. The safety and efficacy in children have not been established.

Use in children with respiratory problems

The use of tramadol is not recommended 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 Kern Pharma:

Extreme fatigue, lack 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.

Other medicines and Tramadol/Paracetamol Kern Pharma

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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.

You must nottake this medicine with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Kern Pharma").

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

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

The risk of side effects increases if you also take:

• 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 limb or eye movements, 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 (a 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 concomitant use of this medicine 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 recommendations strictly. It may be useful 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 or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Kern Pharma 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. This medicine can 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 inform your doctor immediately of any prolonged or unexpected bleeding.
• tell your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Kern Pharma 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 this medicine.

Taking Tramadol/Paracetamol Kern Pharma with food, drinks, and alcohol:

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

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 Kern Pharma contains tramadol, it is not recommended to use this medicine during pregnancy. If you become pregnant during treatment with this medicine, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take this medicine 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 in fertility.

Driving and using machines:

Ask your doctor if you can drive or use machines during treatment with this medicine. 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 administered concomitantly with other medicines.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

3. How to take Tramadol/Paracetamol Kern Pharma

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and on a regular basis during it, your doctor will explain what you can expect from the use of Tramadol/Paracetamol Kern Pharma, when and for how long you should take it, when you should contact your doctor, and when you should stop it (see also section 2).

The dose must be adjusted to the intensity of your pain and your individual pain sensitivity. Normally, you should take the smallest possible dose that produces pain relief.

You should take this medication for the shortest possible time.

Dosage

Use in adults and adolescents (12 years and older)

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents from 12 years is 1 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 Kern Pharma tablets per day.

Do not take this medication more frequently than your doctor has indicated.

Use in children

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

Elderly patients

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

Patients with hepatic or renal insufficiency/patients on dialysis

If you have a severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

Form of administration:

This medication is presented in the form of tablets for oral administration.

The tablets can be taken whole or broken in half with a sufficient amount of liquid, preferably water. The score line on the tablet serves to break the tablet if you find it difficult to swallow it whole or if you need to take half a dose. The tablet can be divided into equal doses. Do not chew the tablet.

If you think the action of this medication is too strong (i.e., you feel very drowsy or have difficulty breathing) or too weak (i.e., you do not have adequate pain relief), tell your doctor.

If you take more Tramadol/Paracetamol Kern Pharma than you should:

You should consult your doctor or pharmacist, even if you feel well, as there is a risk that liver damage may occur that will only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Tramadol/Paracetamol Kern Pharma:

If you forget to take the tablets, it is possible that the pain will reappear. 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 Kern Pharma:

Do not stop taking this medication suddenly unless your doctor indicates it. If you want to stop taking your medication, 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 adverse effects (withdrawal symptoms).

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people 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).

Uncommon: may affect 1 in 100 people;

• increased heart rate or increased blood pressure, heart rhythm and frequency disorders,
• tingling sensation, numbness, or pinching sensation in the limbs, ringing in the ears, spasms, involuntary muscle contractions,
• 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, urticaria),
• 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, difficulty coordinating movements, transient loss of consciousness (syncope),
• dependence on the medication,
• delirium,
• blurred vision,
• pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known:

• decreased 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 Kern Pharma")
• A serious disease that can cause the blood to become more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

The following adverse effects 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 this medication, 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 Tramadol/Paracetamol 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 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. Do not take this medication again.

In rare cases, using a medication 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 trembling. 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 this medication, 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 in the gums.

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

Rare cases of respiratory depression have been reported with tramadol.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tramadol/Paracetamol Kern Pharma

Keep this medication out of sight and reach of children.

Store this medication in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for 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.

This medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Tramadol/Paracetamol Kern Pharma:

• 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: pregelatinized starch (from corn), stearic acid, povidone, and sodium croscarmellose

Appearance of the product and package contents:

Tramadol/Paracetamol Kern Pharma is presented in the form of tablets for oral administration, in packages of 20 or 60 tablets.

Marketing authorization holder and manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this prospectus:February 2025

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