Tramadol/paracetamol Krka 37.5 mg/325 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol/Paracetamol Krka 37.5 mg/325 mg film-coated tablets EFG

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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 adverse 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).
• If you are suffering from acute intoxication with alcohol, sleeping pills, analgesics, or other psychotropic medicines (medicines that affect mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease), or have taken them within the last 14 days before starting treatment with this medicine.
• If you have severe liver disease.
• If you have epilepsy that is not adequately controlled 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, such as asthma or serious lung conditions;
• 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 medicine, for example morphine;
• are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• are due to undergo anaesthesia. Inform 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, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition known as metabolic acidosis (an imbalance 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 make the medicine less effective (you may 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 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 previously 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, e.g., "to stay calm" or "to sleep"
• You have repeatedly tried and failed to stop or control your use of the medicine
• You feel unwell when you stop taking the medicine, and feel better when you take it again ("withdrawal effect")

If you notice any of these signs, speak 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").

Sleep-related breathing disorders

Tramadol/Paracetamol Krka contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnoea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep).

The risk of central sleep apnoea depends on the opioid dose. Your doctor may consider reducing your total opioid dose if you experience central sleep apnoea.

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

Tramadol is metabolised in the liver by an enzyme. Some people have a variation in 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. They 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.

Contact 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.

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.

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”).

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

• carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as severe facial pain known as 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 imbalance (called metabolic acidosis) requiring 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 limb or eye movements, uncontrollable muscle contractions, or diarrhoea, contact your doctor.
• other analgesics such as morphine and codeine (including cough medicines), baclofen (a 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. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, they will limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing 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 whether tramadol/paracetamol is suitable for you.
• certain antidepressants. Tramadol/paracetamol may interact with these medicines and may cause serotonin syndrome (see section 4, "Possible side effects").
• warfarin or fenprocoumon (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 used to treat epilepsy or nerve-related pain (neuropathic pain).

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

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine that lowers blood cholesterol).

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

Taking Tramadol/Paracetamol Krka with food and alcohol

Tramadol/paracetamol may make you feel drowsy. Alcohol may increase drowsiness, so 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 repeatedly, 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 you can expect from using tramadol/paracetamol, 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 for the shortest time possible.

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 2 tablets.

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 8 tablets a 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 renal and/or hepatic impairment must not take this medicine.

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

Route of administration

The tablets should be taken orally.

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

If you think that 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 have inadequate 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 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 missed doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Krka

You must not stop this medicine abruptly 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 prolonged period. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the possibility 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, urticarial rash),
• 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),
• dependence on the medicine,
• 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 recognized adverse effects have been reported by people who have taken medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking this medicine, you should inform your doctor:

• feeling dizzy when standing up from a lying or sitting position, 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 when taken together with the antibiotic flucloxacillin may induce a blood and fluid abnormality (metabolic acidosis with high anion gap) when there is an increase in plasma blood acidity.
• The use of tramadol/paracetamol with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.
• in rare cases, skin rashes, indicative of 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 happens to you, stop treatment and consult your doctor immediately. You must not take this medicine again.

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

In rare cases, people who have been taking tramadol hydrochloride 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 digestive and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling sensations 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 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 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 medicines containing paracetamol.

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, where others cannot access it. It may cause serious harm or be fatal to individuals 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. Return any unused medicines and their containers to 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 37.5 mg of tramadol hydrochloride equivalent to 32.94 mg of tramadol and 325 mg of paracetamol.

• The other components are:

• tablet core: pregelatinized maize starch, sodium carboxymethyl starch from potato (type A), microcrystalline cellulose (E460), and magnesium stearate (E470b).

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

Appearance of Tramadol/Paracetamol Krka and contents of the pack

Yellow-brown, oval, slightly biconvex film-coated tablets.

Packs containing 2 film-coated tablets (blister packs with 2 tablets) or 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 film-coated tablets (blister packs with 10 tablets) are available.

Only some 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 more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10, Pta. Baja, Oficina 1,

28108 Alcobendas, Madrid,

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State	Medicinal Product Name
Germany	Tramabian 37.5 mg/325 mg Film Tablets
Austria	Tramadol/Paracetamol Krka 37.5 mg/325 mg Film-Coated Tablets
Belgium	Tramadol/Paracetamol Krka 37.5 mg/325 mg filmomhulde tabletten
Hungary	Doreta 37.5 mg/325 mg filmtabletta
Bulgaria	Doreta 37.5 mg/325 mg film-coated tablets
Czech Republic	DORETA
Estonia	DORETA
Spain	Tramadol/Paracetamol Krka 37.5 mg/325 mg film-coated tablets
France	Tramadol/Paracetamol Krka 37.5 mg/325 mg film-coated tablet
Ireland	Tramadol/Paracetamol Krka 37.5 mg/325 mg film-coated tablets
Italy	Tramadolo e Paracetamolo Krka
Lithuania	Doreta 37.5 mg/325 mg plėvelė dengtos tabletės
Latvia	Doreta 37.5 mg/325 mg apvalkotas tabletes
Netherlands	Tramadol/Paracetamol Krka 37.5 mg/325 mg filmomhulde tabletten
Poland	Doreta
United Kingdom (Northern Ireland)	Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg film-coated tablets
Romania	DORETA 37.5 mg/325 mg, film-coated tablets
Slovenia	Doreta 37.5 mg/325 mg filmsko obložene tablete
Slovakia	Doreta 37.5 mg/325 mg filmom obalené tablety

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/).