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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol/Paracetamol Stada 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 must not be given to other people, even if they have the same symptoms as you, because it could 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 Stada is and what it is used for
2. What you need to know before taking Tramadol/Paracetamol Stada
3. How to take Tramadol/Paracetamol Stada
4. Possible side effects
5. How to store Tramadol/Paracetamol Stada
6. Contents of the pack and other information

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

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

Tramadol/paracetamol is indicated for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.

Tramadol/paracetamol should only be taken by adults and adolescents over 12 years of age.

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

DO NOT take Tramadol/Paracetamol Stada

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• in cases of acute intoxication;
• with alcohol, sedatives, painkillers, or other psychotropic medicines (medicines affecting mood and emotions);
• if you are currently taking, or have taken within the last 14 days, MAO inhibitors (IMAOs) (certain medicines used to treat depression or Parkinson’s disease);
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled by your current medication.

Warnings and precautions

Talk to your doctor before starting Tramadol/Paracetamol Stada:

• if you are taking other medicines containing paracetamol or tramadol;

• if you have liver problems or liver disease, or if you notice your eyes or skin turning yellow. This may be a sign of jaundice or problems with your bile ducts;

• if you have kidney problems;

• if you have serious breathing difficulties, such as asthma or severe lung disease;

• if you have epilepsy or have had seizures or fits;

• if you have recently suffered a head injury or have severe headaches associated with vomiting;

• if you are dependent on any medication, including those used for pain relief, such as morphine;

• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;

• if you are due to undergo anaesthesia. Inform your doctor or dentist that you are taking tramadol/paracetamol;

• if you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Stada”).

Talk to your doctor if you experience any of the following symptoms while taking tramadol/paracetamol: extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormone replacement therapy.

There is a low risk of developing serotonin syndrome after taking tramadol, either alone or in combination with certain antidepressants. Contact a doctor immediately if you experience symptoms related to this serious condition (see section 4 “Possible side effects”).

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 imbalance in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used regularly over a prolonged period or taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Sleep-related breathing disorders

Tramadol/paracetamol may cause sleep-related breathing disorders, such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

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

Tramadol is metabolized in the liver by an enzyme. Some people have a genetic variation of this enzyme, which may affect individuals differently. In some people, adequate 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, stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, or loss of appetite.

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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness (you become accustomed to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could 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 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 has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have previously had mood disorders (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 may 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, talk to your doctor for advice on the best treatment approach for you, including when and how to safely stop taking the medicine (see section 3, "If you stop taking tramadol/paracetamol").

Other medicines and Tramadol/Paracetamol Stada

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Important: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking other medicines containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Tramadol/paracetamol must not be taken with monoamine oxidase inhibitors (MAOIs) (see section “DO NOT take Tramadol/Paracetamol Stada”).

The use of tramadol/paracetamol is not recommended if you are being treated with:

• Carbamazepine (a medicine commonly used to treat epilepsy and certain types of pain, such as severe facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases:

• if you are taking triptans (for migraine) or selective serotonin reuptake inhibitors (SSRIs) (for depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhoea, contact your doctor.
• if you are taking other analgesics such as morphine and codeine (also used as a cough medicine), 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 and sedatives or sleeping pills (e.g., benzodiazepines) 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 doctor should limit the dose and duration of concomitant treatment.

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.

• if you are taking medicines that may cause seizures (fits), such as certain antidepressants and antipsychotics. The risk of having a seizure may increase if you take tramadol/paracetamol at the same time. Your doctor will advise whether tramadol/paracetamol is suitable for you.
• if you are taking certain antidepressants, tramadol/paracetamol may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking warfarin or phenprocoumon (for blood thinning). The effectiveness of these medicines may be altered, increasing the risk of bleeding. Report any prolonged or unexpected bleeding to your doctor immediately.
• if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis), which requires urgent treatment (see section 2).
• if you are taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you also take:

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting).
• Colestyramine (a medicine to lower blood cholesterol).

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

Taking Tramadol/Paracetamol Stada with alcohol

Tramadol/Paracetamol Stada may cause drowsiness. Alcohol may increase this effect, so it is best not to drink alcohol while taking tramadol/paracetamol.

Pregnancy, breastfeeding, and fertility

Since tramadol/paracetamol contains tramadol, you should not take this medicine during pregnancy or breastfeeding. If you become pregnant while taking tramadol/paracetamol, consult your doctor before taking any further tablets.

Tramadol is excreted in breast milk. Therefore, you should not take tramadol/paracetamol more than once during breastfeeding, or alternatively, if you take tramadol/paracetamol more than once, you must stop breastfeeding.

Based on human experience, tramadol is not thought to affect male or female fertility. Data on the influence of the combination of tramadol and paracetamol on fertility are not available.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Tramadol/Paracetamol Stada may cause drowsiness, which may affect your ability to drive or operate tools and machinery safely.

Tramadol/Paracetamol Stada contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per tablet; hence, it is essentially “sodium-free”.

3. How to take Tramadol/Paracetamol Stada

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 the use of 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 time.

This medicine is not recommended for use 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 relieves pain should be taken.

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 of tramadol/paracetamol 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 slowed. If this applies to you, your doctor may extend the dosing intervals.

Patients with severe liver or kidney disease (insufficiency)/dialysis:

Treatment with tramadol/paracetamol is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney impairment, your doctor may extend the dosing intervals.

Method of administration

Take the tablets orally.

Swallow the tablets whole with a sufficient amount of liquid (e.g., a glass of water of 200 ml). The tablets must not be split or chewed.

If you feel that the effect of tramadol/paracetamol 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 Stada than you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, contact your doctor or pharmacist immediately. There is a risk of serious liver damage which 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 taken.

If you forget to take Tramadol/Paracetamol Stada

If you forget to take a dose of tramadol/paracetamol, 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 Stada

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to discontinue 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 stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse 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 experiences 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), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• 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 sensing something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g., rashes, urticarial rash),
• increased levels of liver enzymes,
• 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),
• addiction,
• delirium,
• blurred vision, constriction of the pupil (miosis),
• speech disorder,
• excessive dilation of the pupils (mydriasis).

Frequency not known: frequency cannot be estimated from available data

• decrease in blood sugar levels (hypoglycaemia),
• Hiccups.

The following are recognised adverse effects reported by people using medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking tramadol/paracetamol, you must inform your doctor:

• dizziness when 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 existing asthma.

• The use of tramadol/paracetamol together with "blood-thinning" medicines (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

• In some rare cases, a skin rash may develop, indicating an allergic reaction, with sudden swelling of the face and neck, difficulty breathing, or low blood pressure and fainting.

If this happens to you, stop treatment and consult a doctor immediately. You must not take the medicine again.

In rare cases, taking a medicine of the tramadol type may lead to dependence on the medicine, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may experience hyperactivity, difficulty sleeping, and stomach or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus).

Frequency not known: 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 Stada").

If you experience any of these symptoms after stopping tramadol/paracetamol, please consult your doctor.

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

Very rarely, serious skin reactions have been reported.

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 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Stada

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. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tramadol/Paracetamol Stada

• The active substances are: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other components are:

Tablet core:

Pregelatinized starch (from corn starch)
Corn starch
Sodium carboxymethyl starch from potato (type A)
Microcrystalline cellulose (Avicel PH 102)
Magnesium stearate

Film coating:

Yellow Opadry 03K82345 (hypromellose 6 cPs (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172))

Appearance of the product and contents of the container

Light yellow, oblong, biconvex film-coated tablet.

Boxes containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

MEIJI PHARMA SPAIN S.A.
Avda. de Madrid, 94,
28802 Alcalá de Henares, Madrid
Spain

or

Medis International a.s.
výrobni závod Bolatice,
Prumyslová 961/16,
74723 Bolatice
Czech Republic

or

STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany

or

Martin Dow Pharmaceuticals
Goualle le Puy,
Champs de Lachaud,
Meymac, 19250,
France

or

Laboratori Fundació Dau
Calle Lletra C de la Zona Franca 12-14,
Polígono Industrial de la Zona Franca de Barcelona,
08040 Barcelona
Spain

or

Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland

This medicinal product has been authorized in the EEA Member States under the following names:

CZ: Trodon Combo
ES: Tramadol/Paracetamol Stada 37.5 mg/325 mg film-coated tablets EFG
PL: Tramaparastad
PT: Tramadol + Paracetamol Ciclum

Date of the most recent revision 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/