TRAMADOL/PARACETAMOL STADA 37.5 mg / 325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol/Paracetamol Stada 37.5 mg/325 mg Film-Coated Tablets EFG

Tramadol Hydrochloride/Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Tramadol/Paracetamol Stada is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Stada
3. How to take Tramadol/Paracetamol Stada
4. Possible side effects
5. Storage of 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 pain relievers, 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.

Only adults and adolescents over 12 years of age should take tramadol/paracetamol.

2. What you need to know before you take 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 acute intoxication;
• with alcohol, with sedatives, pain relievers, 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 if you have taken them in the last 14 days before treatment with tramadol/paracetamol;
• if you have severe liver disease;
• if you have uncontrolled epilepsy.

Warnings and precautions

Consult your doctor before starting to take Tramadol/Paracetamol Stada:

• if you are taking other medicines that contain paracetamol or tramadol;

• if you have liver problems or liver disease or if you notice that your eyes and skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;
• if you have kidney problems;

• if you have severe breathing difficulties, for example, asthma or severe lung problems;
• if you have epilepsy or have had seizures or convulsions;
• if you have recently had any head injury or severe headaches associated with vomiting;
• if you are dependent on any medication, including those used for pain relief, for example, morphine;
• if you are taking other pain relievers that contain buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anesthetized. Inform your doctor or dentist that you are taking tramadol/paracetamol;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol Stada").

Consult 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. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take a hormonal supplement.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you present any of the symptoms linked to this serious syndrome (see section 4 "Possible side effects").

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

If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

Tramadol/paracetamol may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen level in the blood). The symptoms may include breathing pauses during sleep, nighttime awakenings due to lack of air, difficulties maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

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

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to suffer from serious side effects. If you notice any of the following side 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.

Use in children with respiratory problems

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

Tolerance, dependence, and addiction

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

Dependence or addiction can make you feel that you no longer control the amount of medicine you need to take or how often you need to take it.

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

• You or someone in your family 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 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 be a sign that you have become dependent or addicted:

• You need to take the medicine for a longer period than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than those prescribed, for example, "to calm down" or "to sleep".
• You have repeatedly tried and failed to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell, and you feel better when you take it again ("withdrawal effect").

If you observe any of these signs, talk to your doctor so that he can indicate the best treatment option for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you stop taking tramadol/paracetamol).

Other medicines and Tramadol/Paracetamol Stada

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

Important: This medicine contains paracetamol and tramadol. Tell your doctor if you are taking other medicines that contain 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 normally used to treat epilepsy and some types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid pain reliever). Pain relief may be reduced.

The risk of side 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 the limbs or eyes, muscle contractions, or diarrhea, you should call your doctor.
• if you are taking other pain relievers such as morphine and codeine (also as a cough medicine), baclofen (as a muscle relaxant), some medicines to lower blood pressure, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.

The effectiveness of tramadol/paracetamol may be altered if you are also taking

• Metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting).
• Colestyramine (a medicine to reduce cholesterol in the blood).

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

Taking Tramadol/Paracetamol Stada with alcohol

Tramadol/paracetamol may cause drowsiness. Alcohol may make you feel more drowsy, so it is best not to drink alcohol while taking tramadol/paracetamol.

Pregnancy, breastfeeding, and fertility

Since tramadol/paracetamol contains tramadol, you must not take this medicine during pregnancy or breastfeeding. If you become pregnant during treatment with tramadol/paracetamol, consult your doctor before taking more tablets.

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

According to human experience, it is suggested that tramadol does not affect female or male fertility. There is no data available on the influence of the combination of tramadol and paracetamol on fertility.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Tramadol/paracetamol may make you feel drowsy, and this can affect your ability to drive or use tools and machines safely.

Tramadol/Paracetamol Stada contains sodium

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

3. How to take Tramadol/Paracetamol Stada

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain what you can 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 it (see also section 2).

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

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

The dose must be adjusted to the intensity of the pain and your individual sensitivity. Normally, you should take the smallest dose that relieves the pain.

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

If necessary, you can increase the dose, 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 per day.

Do not take tramadol/paracetamol more frequently than your doctor has indicated.

Elderly patients:

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

Patient with severe liver or kidney disease (failure)/dialysis:

If you have severe liver or kidney disease, treatment with tramadol/paracetamol is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

Method of administration

Take the tablets orally.

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

If you think 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 have 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, consult your doctor or pharmacist immediately. There is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Stada

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any further questions on 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 all people suffer from 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, diarrhea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, agitation,
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling "high").

Uncommon: may affect up to 1 in 100 people

• increased heart rate or increased blood pressure, cardiac rhythm and frequency disorders,
• tingling sensation, numbness or pinching sensation in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or perceiving something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g., eruptions, urticarial habon),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flashes, chest pain.

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

• seizures, difficulties in making coordinated movements, transient loss of consciousness (syncope),
• addiction,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorder,
• pupil dilation (mydriasis).

Frequency not known: frequency cannot be estimated from available data

• decrease in blood sugar levels (hypoglycemia),
• Hypo.

The following are recognized adverse effects that have been reported by people using medicines that only contain tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should inform your doctor:

• feeling of 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.

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

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

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

In rare cases, taking a medicine of the tramadol type can make you dependent 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 agitated, anxious, nervous, or trembly. They may experience hyperactivity, have difficulty sleeping, and have stomach or intestinal disorders. 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 can manifest as changes in mental state (e.g., agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tramadol/Paracetamol 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, such as a low platelet count in the blood, which can lead to nosebleeds or bleeding gums.

In very rare cases, serious skin reactions have been reported.

There have been reports of rare cases of respiratory depression with tramadol.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol/Paracetamol Stada

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol/Paracetamol Stada

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

Coated tablet core:

Pregelatinized starch (from corn starch)

Corn starch

Sodium potato carboxymethylcellulose (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 Package Contents

Light yellow, oblong, biconvex film-coated tablet.

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

Only some package 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

This medicine has been authorized in the EEA member states with 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 last revision of this prospectus:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/