Tramadol/paracetamol Krka 75 mg/650 mg film-coated tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Tramadol/Paracetamol Krka 75 mg/650 mg film-coated tablets

tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Tramadol/Paracetamol Krka is a combination of two analgesics, tramadol and paracetamol, which work together to relieve your pain.

Tramadol/Paracetamol Krka is indicated for the symptomatic treatment of moderate to severe pain, whenever your doctor considers that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamol Krka should be taken by adults and adolescents over 12 years of age.

2. What you need to know before using Tramadol/Paracetamol Krka

Do not take Tramadol/Paracetamol Krka if

• you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• you are suffering from acute intoxication with alcohol, sleeping pills, analgesics, or other psychotropic medicines (medicines that affect mood and emotions).
• you are taking or have taken monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease) within the last 14 days before starting treatment with this medicine.
• you have severe liver disease.
• you have uncontrolled epilepsy with your current medication.

Warnings and precautions

Talk to your doctor before starting to take Tramadol/Paracetamol Krka if you:

• are taking other medicines containing paracetamol or tramadol;
• have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may be a sign of jaundice or problems with your bile ducts;
• have kidney problems;
• have severe breathing difficulties, for example, asthma or serious lung disease;
• have epilepsy or have had seizures or fits;
• have depression and are taking antidepressants, as some may interact with tramadol (see "Taking Tramadol/Paracetamol Krka with other medicines");
• have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• are dependent on any other pain-relief medicines, for example, morphine;
• are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• are going to be anaesthetized. Tell your doctor or dentist that you are taking tramadol/paracetamol.

During treatment with tramadol/paracetamol, inform your doctor immediately if:

You have serious medical conditions 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 regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Tolerance, dependence, and addiction

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

Dependence or addiction may make you feel that you no longer control how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction")
• You are a smoker
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses

If you notice any of the following signs while taking tramadol/paracetamol, it could indicate that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You use the medicine for reasons other than prescribed, for example, "to stay calm" or "to sleep"
• You have repeatedly tried and failed to stop or control 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, talk to your doctor so they can advise you on the best treatment approach, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, "If you stop taking tramadol/paracetamol").

Breathing problems related to sleep

Tramadol/Paracetamol Krka contains an active ingredient belonging to the opioid group. Opioids may cause breathing problems 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 central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

There is a slight risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol used alone. Contact a doctor immediately if you experience any symptoms associated with this serious syndrome (see section 4, "Possible side effects").

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

If you develop or have previously experienced any of these problems while taking tramadol/paracetamol, please inform your doctor. He/She will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with breathing problems

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

Other medicines and Tramadol/Paracetamol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Talk to your doctor if you experience any of the following symptoms while taking this medicine:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

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.

Do not take this medicine together with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Krka").

Use of Tramadol/Paracetamol Krka is not recommended if you are being treated with:

• carbamazepine (a medicine usually used to treat epilepsy or certain types of pain such as severe facial pain called trigeminal neuralgia),
• buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

The risk of adverse effects increases if you also use:

• triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhea, contact your doctor.
• other analgesics such as morphine and codeine (also cough medicines), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Concomitant use of Tramadol/Paracetamol Krka with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially 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, your dose and duration of concomitant treatment should be limited. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.
• medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take this medicine at the same time. Your doctor will advise you whether tramadol/paracetamol is suitable for you.
• certain antidepressants. Tramadol/Paracetamol may interact with these medicines, and you may experience serotonin syndrome (see section 4, "Possible side effects").
• warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Krka may be altered if you also use:

• metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• colestyramine (a medicine that reduces cholesterol in the blood).

Your doctor will advise you which medicines are safe to use together with tramadol/paracetamol.

Taking Tramadol/Paracetamol Krka with food and alcohol

Tramadol/paracetamol may make you feel drowsy. Alcohol may increase drowsiness; therefore, it is recommended not to drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because this medicine contains tramadol, it is not recommended during pregnancy or breastfeeding. If you become pregnant while taking tramadol/paracetamol, consult your doctor before taking the next tablet.

Breastfeeding

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

Fertility

Based on human experience, tramadol is considered not to affect male or female fertility. There are no data available on the influence of tramadol and paracetamol on fertility.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Tramadol/Paracetamol Krka may make you feel drowsy, which may affect your ability to drive or operate tools and machinery safely.

Tramadol/Paracetamol Krka contains sodium

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

3. How to take Tramadol/Paracetamol Krka

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

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from using tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor, and when you should stop taking it (see also section 2).

You should take tramadol/paracetamol for the shortest possible duration.

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

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

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents over 12 years of age is 1 tablet.

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 4 tablets per day.

Do not take tramadol/paracetamol more frequently than prescribed by your doctor.

Elderly patients

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

Patients with severe hepatic or renal impairment/dialysis

Patients with severe hepatic or renal impairment must not take this medicine.

If you have mild or moderate impairment, your doctor may recommend prolonging the dosing interval.

Route of administration

The tablets should be taken orally.

They should be swallowed whole with sufficient liquid. The tablets may be divided into equal doses. However, they must not be broken or chewed.

If you think the effect of this medicine is too strong (e.g. if you feel very drowsy or have difficulty breathing) or too weak (e.g. if you do not get adequate pain relief), contact your doctor.

If you take more Tramadol/Paracetamol Krka than you should

In such cases, contact your doctor or pharmacist immediately, even if you feel well. There is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tramadol/Paracetamol Krka

If you forget to take a dose of this medicine, 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 Krka

Do not stop this medicine abruptly unless instructed by your doctor. If you wish to discontinue taking this medicine, speak to your doctor first, especially if you have been taking it for a prolonged period. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of developing unnecessary side effects (withdrawal symptoms).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people):

• nausea,
• dizziness, drowsiness.

Common (may affect up to 1 in 10 people):

• vomiting, digestive problems (constipation, flatulence, diarrhoea), abdominal pain, dry mouth, itching, increased sweating (hyperhidrosis),
• headache, tremors,
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling "high").

Uncommon (may affect up to 1 in 100 people):

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stools,
• skin reactions (e.g. rashes, urticaria),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare (may affect up to 1 in 1,000 people):

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope),
• drug dependence,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Very rare (may affect up to 1 in 10,000 people):

• drug addiction.

Not known (frequency not known):

• decrease in blood sugar levels (hypoglycaemia).

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

• feeling dizzy when standing up after lying down or sitting, slowed heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• the use of paracetamol alone or in combination with the antibiotic flucloxacillin may induce a blood and fluid disorder (metabolic acidosis with high anion gap) when there is an increase in blood plasma acidity.
• the use of tramadol/paracetamol with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.
• in rare cases, skin rashes indicating allergic reactions, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this occurs, stop treatment and consult your doctor immediately. You should not take this medicine again.

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

In rare cases, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very rarely, 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, please consult your doctor.

Frequency not known: hiccups.

Serotonin syndrome, which may present with 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 Krka").

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

Very rare cases of skin adverse reactions have been reported with paracetamol-containing medicines.

Rare cases of respiratory depression have been reported with tramadol.

Frequency not known (cannot be estimated from available data): 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).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Krka

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 Krka

• The active substances are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 75 mg of tramadol hydrochloride, equivalent to 65.88 mg of tramadol, and 650 mg of paracetamol.
• The other components are:

Tablet core: pregelatinized maize starch, sodium potato carboxymethylstarch (type A), microcrystalline cellulose (E460), and magnesium stearate (E470b).

Coating: hypromellose (E464), macrogol 400, polysorbate 80, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172). See section 2 “Tramadol/Paracetamol Krka contains sodium”.

Appearance of Tramadol/Paracetamol Krka and contents of the pack

The film-coated tablets are slightly orange, oval-shaped, biconvex, with a wide score line on both sides, dimensions: 20 mm x 8 mm.

The tablet can be divided into two equal parts.

Pack sizes of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 film-coated tablets (blister packs containing 10 tablets) are available.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d.,

Novo mesto, Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Manufacturer

KRKA, d.d.,

Novo mesto, Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Straße 5,

27472 Cuxhaven,

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura, 10,

28108 Alcobendas, Madrid,

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State	Medicinal product name
Germany	Tramabian 75 mg/650 mg Film-coated tablets
Austria	Tramadol/Paracetamol Krka 75 mg/650 mg Film-coated tablets
Hungary	Doreta 75 mg/650 mg film-coated tablet
Bulgaria	Doreta 75 mg/650 mg film-coated tablets
Czech Republic	DORETA
Estonia	DORETA
Spain	Tramadol/Paracetamol Krka 75 mg/650 mg film-coated tablets
France	Tramadol/Paracetamol Krka 75 mg/650 mg film-coated tablet
Lithuania	Doreta 75 mg/650 mg film-coated tablets
Latvia	Doreta 75 mg/650 mg film-coated tablets
Poland	Doreta 75 mg/650 mg, film-coated tablets
Romania	Doreta 75 mg/650 mg, film-coated tablets
Slovenia	Doreta 75 mg/650 mg film-coated tablets
Slovakia	Doreta 75 mg/650 mg film-coated tablets

Date of the last revision of this leaflet: May 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)