Leaflet: Information for the user

Tramadol/Paracetamol Kern Pharma 37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/ Paracetamol

Read this leaflet carefully before you start taking the medicine.

-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. Do not give it to others, even if they have the same symptoms, as it may harm them.

-If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

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

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

3.How to take Tramadol/Paracetamol Kern Pharma

4.Possible side effects

5Storage of Tramadol/Paracetamol Kern Pharma

6.Contents of the pack and additional informationinformation

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

Tramadol/Paracetamol Kern Pharma, 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 Kern Pharma should only be used by adults and children over 12 years old.

Do not take Tramadol/Paracetamol Kern Pharma

• if you are allergic (hypersensitive) to tramadol, paracetamol, or any of the other components of this medication, as indicated by skin rash, facial swelling, wheezing (or whooping), or difficulty breathing.
• in case of acute alcohol intoxication, if you have taken any medication for insomnia, potent analgesics (opioids), or psychotropic drugs (drugs that can alter the level of consciousness).
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Kern Pharma.
• if you have severe liver disease.
• if you have uncontrolled epilepsy.

Be especially careful with Tramadol/Paracetamol Kern Pharma

• 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, such as asthma or severe lung problems.
• if you are epileptic or have had seizures.
• if you have recently suffered a head injury, intense headaches associated with vomiting.
• if you have dependence on any other medication used to relieve pain, such as morphine.
• if you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine.
• if you are to be anesthetized. Inform your doctor or dentist that you are using Tramadol/Paracetamol.
• if you experience 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.

If you experience or have experienced any of these problems while taking Tramadol/Paracetamol Kern Pharma, please inform your doctor. They will decide if you should continue taking this medication.

Consult your doctor before starting to take Tramadol/Paracetamol Kern Pharma if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see 'Use of other medications').

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 monotherapy. 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 be possible to achieve insufficient 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 discomfort, or vomiting, constipation, loss of appetite.

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

Sleep-related respiratory disorders

Tramadol/Paracetamol Kern Pharma may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, 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 higher doses and longer 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 a family member has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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 than the recommended dose.
• You use the medication for reasons other than those prescribed, such as "to stay calm" or "to sleep."
• You have repeatedly and unsuccessfully tried 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 observe 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).

Use of other medications

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

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

Youmust not takeTramadol/Paracetamol Kern Pharma with monoamine oxidase inhibitors (MAOIs) (see section 2 "Do not take Tramadol/Paracetamol Kern Pharma").

It is contraindicated to use Tramadol/Paracetamol Kern Pharma if you are being treated with:

• Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

The risk of side effects increases if you are also using:

• Triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions, or diarrhea, you should call your doctor.
• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medications that affect mood) or bupropion (medication used as a smoking cessation aid). The risk of experiencing an attack may increase. Your doctor will tell you if Tramadol/Paracetamol Kern Pharma is suitable for you.
• Warfarin or phenprocoumon (medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. Inform your doctor immediately of any prolonged or unexpected bleeding.
• 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 Tramadol/Paracetamol Kern Pharma is suitable for you.
• If you are taking medications for depression treatment, Tramadol/Paracetamol Kern Pharma may interact with these medications and you may experience a serotonin syndrome (see section 4 'Possible side effects').
• 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 using:

• Metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting treatment).
• Colestiramine (medication that reduces cholesterol in the blood).
• Ketoconazole and erythromycin (medications used to treat infections).

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Kern Pharma.

The concomitant use of this medication and sedatives such as benzodiazepines or related medications increases the risk of somnolence, respiratory difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medication with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members to be aware of the mentioned signs and symptoms. Contact your doctor when you experience these symptoms.

Taking Tramadol/Paracetamol Kern Pharma with food and drinks

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

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Pregnancy and breastfeeding

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

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

Lactation

Tramadol is excreted in breast milk. Therefore, do not take Tramadol/Paracetamol Kern Pharma more than once during lactation, or, if you take Tramadol/Paracetamol Kern Pharma more than once, interrupt breastfeeding.

Driving and operating machinery

Tramadol/Paracetamol Kern Pharma may cause drowsiness, which may affect your ability to drive or operate tools or machines.

“The dose should be adjusted to the intensity of the pain and individual sensitivity. Normally, the smallest dose possible that produces pain relief should be used” […].

Follow exactly the administration instructions for Tramadol/Paracetamol Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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 stop it (see also section 2).

You should take Tramadol/Paracetamol Kern Pharma for the shortest time possible.

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

Unless your doctor prescribes something different, the usual starting dose for adults and adolescents over 12 years old is 2 tablets.

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 8 tablets of Tramadol/Paracetamol Kern Pharma per day.

Do not take Tramadol/Paracetamol Kern Pharma more frequently than your doctor has indicated.

Your doctor may increase the interval between doses.

• If you are over 75 years old.
• If you have kidney problems.
• If you have liver problems.

Older patients

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

Patients with liver or kidney insufficiency/patients on dialysis

If you have severe liver or kidney disease, treatment with Tramadol/Paracetamol Kern Pharma is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Administration form

Tramadol/Paracetamol Kern Pharma is presented in the form of tablets for oral administration.

The tablets should be swallowed whole with sufficient liquid. They should not be broken or chewed.

If you estimate that the effect of Tramadol/Paracetamol Kern Pharma 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 Kern Pharma than you should

If you have taken more Tramadol/Paracetamol Kern Pharma than you should, even if you feel well, consult your doctor immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Tramadol/Paracetamol Kern Pharma

If you forgot to take a dose of Tramadol/Paracetamol Kern Pharma, it is likely 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

Generally, no adverse effects occur after interrupting treatment with Tramadol/Paracetamol Kern Pharma. However, in rare cases, patients who have been taking Tramadol/Paracetamol Kern Pharma for a while and have stopped treatment abruptly may feel unwell (see section 4 “Possible adverse effects”).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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Like all medicines, Tramadol/Paracetamol Kern Pharma can cause side effects, although not everyone will experience them.

Very common: more than 1 in 10 people treated

• Nausea,
• Dizziness, drowsiness.

Common: less than 1 in 10, but more than 1 in 100 people treated

• Vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth,
• Itching, increased sweating,
• Headache, agitation,
• Confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Uncommon: less than 1 in 100, but more than 1 in 1,000 people treated

• Tachycardia, hypertension, heart rhythm and frequency disorders,
• Difficulty or pain urinating,
• Skin reactions (e.g. rashes, urticaria),
• Feeling of pins and needles, numbness, or feeling of prickling in the extremities, ear noises, involuntary muscle spasms,
• Depression, nightmares, hallucinations, (hearing, seeing or perceiving something that does not exist in reality), memory loss,
• Difficulty swallowing, blood in the stool,
• Chills, hot flashes, chest pain,
• Difficulty breathing.

Rare: less than 1 in 1,000, but more than 1 in 10,000 people treated

• Seizures, difficulties with coordinated movements,
• Dependence,
• Blurred vision.

Frequency not known: cannot be estimated from available data

- Hiccups

- 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 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 disease that can make the blood more acidic (metabolic acidosis) in severely ill patients using paracetamol (see section 2).

The following side 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 Tramadol/Paracetamol Kern Pharma, 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, mood changes, changes in activity, changes in perception, worsening of asthma.
• In rare cases, skin eruptions, 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, interrupt treatment and consult your doctor immediately. Do not take this medication again.
• Severe skin reactions have been rarely reported with the use of paracetamol.

In rare cases, using a medication like tramadol can 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 problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, feeling of pins and needles, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Kern Pharma, please consult your doctor.

There have been reports of cases of decreased blood sugar levels in patients treated with tramadol.

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which can cause nasal or gum bleeding.

The use of Tramadol/Paracetamol Kern Pharma with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Please inform your doctor immediately about any prolonged or unexpected bleeding.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Store this medication in a safe and protected place, where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

Do not use Tramadol/Paracetamol Kern Pharma after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, 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 37.5 mg/325 mg

• The active principles aretramadol hydrochlorideand paracetamol. A film-coated tablet contains 37.5 mg oftramadol hydrochlorideand 325 mg of paracetamol.
• The other components are: pregelatinized cornstarch without gluten, povidone, stearic acid, sodium croscarmellose, and opadry light yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide (E-171), polyethylene glycol, yellow iron oxide (E-172), polisorbate 80).

Appearance of the product and contents of the packaging

Tramadol/Paracetamol Kern Pharma is presented in the form of pale yellow tablets packaged in blisters.

Tramadol/Paracetamol Kern Pharma is presented in packaging of 20, 60, and 100 tablets.

Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date 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/