TRAMADOL/PARACETAMOL KERN PHARMA 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Tramadol hydrochloride / Paracetamol

Read all of this leaflet carefully before you start taking this medicine.

• 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 get 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 Conservation of Tramadol/Paracetamol Kern Pharma

1. Contents of the pack and additional information

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

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

Tramadol/Paracetamol Kern Pharma 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 Kern Pharma should only be used by adults and children 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 (hypersensitive) to tramadol, paracetamol or any of the other ingredients of this medicine,
• in case of acute alcohol intoxication, if you have taken any medication for the treatment of 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 epilepsy that is not controlled with treatment.

Be 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, for example, asthma or severe lung problems,
• if you are epileptic or have had seizures,
• if you have recently suffered a head injury, 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 going to be anesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol.
• if you have extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

If you have or have had any of these problems while taking Tramadol/Paracetamol Kern Pharma, please inform your doctor. He will decide if you should continue taking this medicine.

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 medicines').

There is a weak risk that you may experience a serotonin syndrome that may appear after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your 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 in different ways. In some people, sufficient pain relief may not be achieved, while others are more likely to suffer serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult a 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:

If you have serious illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism or if you 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 together with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (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 level in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breath, difficulty maintaining sleep or excessive drowsiness during the day. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

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 fatal overdose. The risk of these side effects may increase with a higher dose and longer use.

Dependence or addiction can make you feel that 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 drugs 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 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 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 observe any of these signs, talk to your doctor so that he can indicate the best treatment option for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you stop taking Tramadol/Paracetamol Kern Pharma).

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 Tramadol/Paracetamol Kern Pharma with monoamine oxidase inhibitors (MAOIs) (see section 2 "Do not take Tramadol/Paracetamol Kern Pharma").

The use of Tramadol/Paracetamol Kern Pharma is contraindicated if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain 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 also use:

• 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, uncontrolled muscle contractions or diarrhea, you should call your doctor.
• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants or medications for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood) or bupropion (a medicine used as an aid to quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol Kern Pharma is suitable for you.
• Warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• if you are taking medications that can cause or facilitate 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 the treatment of depression, Tramadol/Paracetamol Kern Pharma may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• Flucloxacillin (an antibiotic), due to a serious risk of alteration of 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 use:

• Metoclopramide, domperidone or ondansetron (medicines for the treatment of nausea and vomiting).
• Colestyramine (a medicine that reduces cholesterol in the blood).
• Ketoconazole and erythromycin (medicines used against infections).

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

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 fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding the dose carefully. It may be useful to inform friends or family members so that they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Taking Tramadol/Paracetamol Kern Pharma with food and drinks

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.

Children and adolescents

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.

Pregnancy and breastfeeding

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 Tramadol/Paracetamol, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol/Paracetamol Kern Pharma more than once during breastfeeding or, otherwise, if you take Tramadol/Paracetamol Kern Pharma more than once, you should interrupt breastfeeding.

Driving and using machines

Tramadol/Paracetamol Kern Pharma may cause drowsiness and this can affect your ability to drive or use tools or machines.

3. How to take Tramadol/Paracetamol Kern Pharma

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

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

Before starting treatment and regularly during treatment, 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 possible time.

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

Unless your doctor prescribes otherwise, the normal starting dose for adults and adolescents over 12 years of age is 2 tablets.

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

Do not take more than 8 Tramadol/Paracetamol Kern Pharma tablets per day.

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

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.

Elderly patients

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

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

Method of administration

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

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

If you think 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), tell 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 serious liver damage that may only become apparent later.

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

If you forget to take Tramadol/Paracetamol Kern Pharma

If you forget to take a dose of Tramadol/Paracetamol Kern Pharma, it is likely that the pain will return. Do not take a double dose to make up for the forgotten doses, simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Kern Pharma

Generally, no unwanted effects appear after stopping treatment with Tramadol/Paracetamol Kern Pharma. However, in rare cases, it may happen that patients who have been taking Tramadol/Paracetamol Kern Pharma for a while and have stopped treatment abruptly feel unwell (see section 4 "Possible side effects"). You should not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 side effects (withdrawal symptoms).

4. Possible Adverse Effects

Like all medicines, Tramadol/Paracetamol Kern Pharma can cause adverse effects, although not all people suffer from them.

Very frequent: more than 1 in 10 people treated

• nausea,
• dizziness, drowsiness.

Frequent: 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 of being "high-spirited" all the time).

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

• tachycardia, hypertension, cardiac rhythm and frequency disorders,
• difficulty or pain when urinating,
• skin reactions (e.g., rashes, hives),
• tingling sensation, numbness, or pinching sensation in the limbs, ringing in the ears, 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 in carrying out coordinated movements,
• addiction,
• blurred vision.

Frequency not known: cannot be estimated from the available data

• hypothermia
• serotonin syndrome, which can manifest through 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 taking Tramadol/Paracetamol Kern Pharma").
• A severe disease that can make the blood 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 medications that contained only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Kern Pharma, you should tell your doctor:

• Feeling of dizziness when standing up after being 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 rashes, which are indicative of allergic reactions that can manifest through 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. You should not take this medication again.
• Very rare cases of severe skin reactions have been reported with the use of paracetamol.

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 suddenly stop treatment. They may feel agitated, anxious, nervous, or trembly. 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 sensation, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Kern Pharma, please consult your doctor.

Isolated cases of decreased blood sugar levels have been reported in patients treated with tramadol.

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which can result in nosebleeds or bleeding gums.

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

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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Tramadol/Paracetamol Kern Pharma

Keep 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 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.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, 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 37.5 mg/325 mg

• The active ingredients are tramadol hydrochloride and paracetamol. One film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other components are: pregelatinized cornstarch, povidone, stearic acid, sodium croscarmellose, and opadry light yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide (E-171), polyethylene glycol, yellow iron oxide (E-172), polysorbate 80).

Appearance of the Product and Package Contents

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

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

Not all package sizes may be marketed.

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/