Leaflet: information for the user

Tramadol/Paracetamol Kern Pharma 75 mg/650 mg tablets

tramadol hydrochloride/paracetamol

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

This medication is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

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

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 medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medicines that can alter mood and emotions)in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (certain medications 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 uncontrolled epilepsy.

Warnings and precautions:

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

• if you are taking other medications 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 respiratory 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 since some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Kern Pharma”)
• if you have recently experienced head trauma, shock or severe headaches associated with vomiting,
• if you are dependent on any other medication used for pain relief, for example morphine,
• if you are taking other pain medications that contain buprenorphine, nalbuphine or pentazocine,
• if you are to be anaesthetized. Tell your doctor or dentist that you are usingthis medicine.

Inform your doctor immediately if you experience any of the following during treatment with Tramadol/Paracetamol Kern Pharma:

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 if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Respiratory disorders related to sleep

This medicine contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep; 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 dose of opioids if you experience central sleep apnea.

Tolerance, dependence and addiction

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

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

The risk of becoming dependent or addicted to Tramadol/Paracetamol Kern Pharma 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 medications or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (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 be a sign that you have become dependent or addicted:

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

If you notice any of these signs, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with 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 your doctor immediately if you experience any of the 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 and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects,stop taking this medication and consult your doctor immediately:slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite.

If you experience or have experienced any of these problems while taking this medication, inform your doctor. He will decide if you should continue taking this medication.

Children and adolescents

This medication is not recommended for use in children under 12 years of age. The safety and efficacy have not been established in children.

Use in children with respiratory problems

This medication is not recommended for use in children with respiratory problems, as the 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 indicative of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Other medicines and Tramadol/Paracetamol Kern Pharma

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Youmust not takethis medication with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Kern Pharma”).

This medication is not recommended for use if you are being treated with:

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

The risk of side effects increases if you are also 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, involuntary muscle contractions or diarrhea, you should call your doctor.

if you are taking other pain medications such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.The concomitant use of this medication and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and may 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 medication with sedatives, you should limit the dose and duration of concomitant treatment.

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

• if you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Kern Pharma simultaneously with these medications. Your doctor will tell you if this medication is suitable for you.
• if you are taking medications for depression treatment. This medication may interact with these medications and you may experience a serotonin syndrome (see section 4 “Possible side effects”)
• if you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should 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 must be treated urgently (see section 2).
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

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

• Metoclopramide, domperidone or ondansetron (medications for nausea and vomiting treatment),
• Colestiramine (a medication that reduces cholesterol in the blood),

Your doctor will know which medications are safe to use with this medication.

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

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

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the fact that Tramadol/Paracetamol Kern Pharma contains tramadol, it is not recommended to use this medication during pregnancy. If you become pregnant during treatment with this medication, consult your doctor before taking the next tablet.

Breastfeeding

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

Fertility

Based on human experience, it is not suggested that tramadol affects the fertility of men and women. There are no data available on the combination of tramadol and paracetamol in fertility.

Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation and/or when taking it concomitantly with other medications.

This medication contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

Before starting treatment and regularly 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 interrupt it (see also section 2).

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

You should take this medication for the shortest time possible.

Dosage

Use in adults and adolescents (12 years and older)

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents 12 years and older 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 tablets of Tramadol/Paracetamol Kern Pharma per day.

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

Use in children

This medication is not recommended for use in children under 12 years.

Older patients

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

Patients with liver or kidney disease/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 disease, your doctor may prolong the dosing intervals.

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Administration form:

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

The tablets can be taken whole or divided in half with a sufficient amount of liquid, preferably water. The groove in the tablet serves to divide the tablet if it is difficult to swallow 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 estimate that the action of this medication is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., you do not have adequate pain relief), inform 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 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, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Tramadol/Paracetamol Kern Pharma:

If you forgot to take the tablets, it is possible that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol Kern Pharma:

You should not stop taking this medication suddenly unless your doctor tells you to. 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 interrupt 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.

Like all medicines, this medicine can cause side 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, 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, cardiac rhythm and frequency disorders,
• Sensation of tingling, numbness, or pins and needles in the extremities, ear noises, 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, urticarial hives),
• Increased levels of liver enzymes,
• 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 performing coordinated movements, transient loss of consciousness (syncope),
• Dependence on the medication,
• Delirium,
• Blurred vision,
• Pupil constriction (miosis),
• Speech disorders,
• Excessive pupil dilation (mydriasis).

Frequency not known:

• Decreased blood sugar levels (hypoglycemia),
• Serotonin syndrome, which may 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting to take Tramadol/Paracetamol Kern Pharma")
• A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The following adverse effects recognized 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, please 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, changes in mood, 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. Please inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin eruptions, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens, discontinue treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol, may make you dependent, making it difficult to stop taking it.

In rare instances, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (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 abnormalities, such as a low platelet count, which may result in nasal or gum bleeding.

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

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

Keep this medication out of the 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 to 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 disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Kern Pharma:

• The active principles are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• The other components are: pregelatinized cornstarch, stearic acid, povidone, and sodium croscarmellose

Appearance of the product and contents of the packaging:

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

Holder of the marketing authorization and responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Date of the last review of this leaflet:February 2025

The detailed and updated information on this medication is available on the website

of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es