Tramadol/paracetamol Kern Pharma 75 mg/650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol/Paracetamol Kern Pharma 75 mg/650 mg tablets

tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Tramadol/Paracetamol Kern Pharma is a combination of two analgesics, 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 the 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 starting to 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 medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may alter mood and emotions) in cases 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 within the last 14 days before starting treatment with this medicine,
• if you have severe liver disease,
• if you have epilepsy that is not adequately controlled by your current treatment.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medicine:

• if you are taking other medicines containing paracetamol or tramadol,
• if you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate 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 experienced 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, such as morphine,
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine,
• if you are going to undergo anesthesia. Inform your doctor or dentist that you are using this medicine.

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

You have serious medical conditions such as severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), 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 regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

This medicine contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or breathing pauses 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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol/Paracetamol Kern Pharma may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much 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 a family member have 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 a 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 indicate 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 prescribed, for example, "to stay calm" or "to sleep".
• You have repeatedly tried and failed to stop or control the use of the medicine.
• 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, speak with your doctor to determine the best treatment approach for you, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, If you stop taking Tramadol/Paracetamol Kern Pharma).

There is a slight risk of experiencing a serotonin syndrome that may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Consult a doctor immediately if you experience any symptoms associated with 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 individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice 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 this medicine, inform your doctor. He or she 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. Safety and efficacy have not been established in children.

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing 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 Kern Pharma:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Other medicines and Tramadol/Paracetamol Kern Pharma

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

You must not take this medicine together 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 usually used to treat epilepsy or certain types of pain, such as intense facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of adverse effects increases if you also take:

• 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 limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

if you are taking other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines 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 this medicine with sedative medicines such as benzodiazepines or related medicines 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, your dose and duration of concomitant treatment should be limited.

Inform your doctor of 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 mentioned above. Inform your doctor if you experience any of these symptoms.

• if you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Kern Pharma simultaneously with these medicines. Your doctor will advise whether this medicine is suitable for you.
• if you are taking medicines for the treatment of depression. This medicine 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.
• inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (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),
• Cholestyramine (a medicine that reduces blood cholesterol),

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 may make you feel drowsy. Alcohol may increase drowsiness; therefore, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because Tramadol/Paracetamol Kern Pharma contains tramadol, the use of this medicine during pregnancy is not recommended. If you become pregnant while being treated with this medicine, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take this medicine more than once during breastfeeding, or if you take this medicine more than once, you must stop breastfeeding.

Fertility

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

Driving and using machinery:

Ask your doctor if you can drive or operate machinery while being treated with this medicine. It is important that before driving or operating machinery, you observe how this medicine affects you. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

This medicine contains sodium

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

3. How to take Tramadol/Paracetamol Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to 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 discontinue it (see also section 2).

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

You should take this medicine for the shortest time possible.

Posology

Use in adults and adolescents (12 years and older)

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents aged 12 years and older is 1 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 Kern Pharma per day.

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

Use in children

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

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

Treatment with this medicine is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration

This medicine is available as tablets for oral administration.

The tablets may be swallowed whole or split in half with a sufficient amount of liquid, preferably water. The tablet's score line is intended to facilitate splitting if you have difficulty swallowing the tablet whole or if you need to take a half dose. The tablet can be divided into equal doses. Do not chew the tablet.

If you feel that the effect of this medicine is too strong (for example, if you feel very drowsy or have difficulty breathing) or too weak (for example, if you do not get adequate pain relief), inform your doctor.

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

You must consult your doctor or pharmacist even if you feel well, because there is a risk of liver damage that may only become apparent later.

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

If you forget to take Tramadol/Paracetamol Kern Pharma:

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

If you stop taking Tramadol/Paracetamol Kern Pharma:

You should not stop taking this medicine abruptly unless instructed by your doctor. If you wish to stop taking this medicine, especially if you have been taking it for a long time, speak to your doctor first. Your doctor will advise you when and how to discontinue the treatment, which may involve gradually reducing the dose to minimize the risk 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 will experience them.

Very common: may affect more than 1 in 10 people;

• Nausea,
  dizziness, drowsiness.

Common: may affect 1 in 10 people;

• Vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling “high-spirited” all the time).

Uncommon: may affect 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, 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, urticaria),
• increased liver enzyme levels,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare: may affect 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:

• Decrease in blood sugar levels (hypoglycaemia),
• serotonin syndrome, which may present with changes in mental status (e.g., restlessness, 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 Kern Pharma”),
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

The following recognized adverse effects have been reported by people who have taken medicines containing either tramadol only or paracetamol only. However, if you experience any of these symptoms while taking this medicine, you must inform your doctor:

• Dizziness when 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 Tramadol/Paracetamol together with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin rashes indicating allergic reactions, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens to you, 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 for you to stop taking it.

Occasionally, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with this medicine, 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.

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

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects:

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

5. Storage of Tramadol/Paracetamol Kern Pharma

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

Store this medicine in a safe and secure place, inaccessible to others. It may cause serious harm or 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.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Kern Pharma:

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

Appearance of the product and contents of the pack:

Tramadol/Paracetamol Kern Pharma is presented as tablets for oral administration, in packs 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 most recent revision of this leaflet: February 2025

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