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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Tramadol hydrochloride / Paracetamol

Read the entire leaflet carefully before you start taking this medicine.

• 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 and must not be given to other people, even if they have the same symptoms, as it may be harmful to them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. 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.

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

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

Do not take Tramadol/Paracetamol Kern Pharma

• if you are allergic (hypersensitive: skin rash, facial swelling, wheezing or difficulty breathing) to tramadol, paracetamol, or any of the other ingredients of this medicine,
• in cases of acute alcohol intoxication, if you have taken any medicines for insomnia, strong painkillers (opioids), or psychotropic drugs (drugs that may alter consciousness),
• 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 treatment with Tramadol/Paracetamol Kern Pharma,
• if you have severe liver disease,
• if you have epilepsy that is not controlled by treatment.

Take special care with Tramadol/Paracetamol Kern Pharma

• 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 problems,
• if you have epilepsy or have had seizures,
• if you have recently suffered head trauma, severe headaches associated with vomiting,
• if you are dependent on any other medicine used for pain relief, for example morphine,
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine,
• if you are going to be anaesthetised. 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

If you develop or have previously experienced any of these problems while taking Tramadol/Paracetamol Kern Pharma, please inform your doctor. Your doctor will decide whether you should continue taking this medicine.

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

There is a weak risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Consult a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).

Tramadol is metabolised 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.

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

You have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or 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 at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Sleep-related breathing disorders

Tramadol/Paracetamol Kern Pharma may cause sleep-related breathing disorders, such as sleep apnoea (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 breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine 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 may 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 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 a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or 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 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 feel better when you take it again ("withdrawal effect")

If you notice any of these signs, speak with your doctor so they can advise you on the best treatment approach, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking Tramadol/Paracetamol Kern Pharma).

Use of other medicines

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 Tramadol/Paracetamol Kern Pharma together 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 usually used to treat epilepsy or certain types of pain, such as severe facial pain attacks known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

• 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 diarrhoea, you should contact your doctor.
• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anaesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will advise whether Tramadol/Paracetamol Kern Pharma is suitable for you.
• Warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, posing a risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• Medicines that may trigger or lower the seizure threshold, 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 Tramadol/Paracetamol Kern Pharma is suitable for you.
• Medicines for the treatment of depression, as Tramadol/Paracetamol Kern Pharma may interact with these medicines and you may experience 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), which must be treated urgently (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 use:

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

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

Concomitant use of this medicine with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking Tramadol/Paracetamol Kern Pharma with food and drinks

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.

Children and adolescents

Use in children with respiratory problems

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Pregnancy and breastfeeding

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 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. Alternatively, if you take Tramadol/Paracetamol Kern Pharma more than once, you must stop breastfeeding.

Driving and using machines

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

3. How to take Tramadol/Paracetamol Kern Pharma

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

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

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using 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).

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

This medicine is not recommended for children under 12 years of age.

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

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 8 tablets of Tramadol/Paracetamol Kern Pharma per day.

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

Your doctor may increase the interval between doses:

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

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

Treatment with Tramadol/Paracetamol Kern Pharma is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

Tramadol/Paracetamol Kern Pharma is available as tablets for oral administration.

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

If you feel 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 get 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, contact your doctor immediately, even if you feel well, because there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at 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, 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

Generally, no adverse effects occur after discontinuation of treatment with Tramadol/Paracetamol Kern Pharma. However, in rare cases, patients who have taken Tramadol/Paracetamol Kern Pharma for a prolonged period and stopped treatment abruptly may feel unwell (see section 4 “Possible side effects”). You should not suddenly stop taking this medicine unless instructed by your doctor. If you wish to stop taking the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to discontinue treatment, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

4. Possible adverse effects

Like all medicines, Tramadol/Paracetamol Kern Pharma can produce adverse effects, although not everyone experiences 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, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating,
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “on a high” all the time).

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

• tachycardia, hypertension, disturbances in heart rhythm and rate,
• difficulty or pain when urinating,
• skin reactions (e.g. rashes, urticaria),
• 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 swallowing, blood in the stools,
• chills, hot flushes, chest pain,
• difficulty breathing.

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

• seizures, difficulty performing coordinated movements,
• addiction,
• blurred vision.

Frequency not known: cannot be estimated from available data

• hiccups
• serotonin syndrome, which may present as changes in mental status (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, diarrhoea) (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 are using paracetamol (see section 2).

The following adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Kern Pharma, you should inform your doctor:

• Dizziness upon standing up from a lying or sitting position, slow 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 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 occurs, stop treatment immediately and consult your doctor without delay. You must not take this medicine again.
• Very rare cases of serious skin reactions have been reported with the use of paracetamol.

In rare cases, taking a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

Occasionally, people who have taken 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 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, for example, low platelet count, which may result in nosebleeds or bleeding gums.

The use of Tramadol/Paracetamol Kern Pharma together with anticoagulants (e.g. fenprocoumon, 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 adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 out of sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to people for whom it has not been prescribed.

Do not use Tramadol/Paracetamol Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Kern Pharma 37.5 mg/325 mg

• The active substances 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 maize starch (gluten-free), 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 contents of the pack

Tramadol/Paracetamol Kern Pharma is presented as pale yellow film-coated tablets packed in blisters.

Tramadol/Paracetamol Kern Pharma is available in packs containing 20, 60, and 100 tablets.

Not all pack 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 most recent review 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/