Leaflet: information for the user

Tramadol/paracetamol Stada 75 mg/650 mg tablets

Tramadol, hydrochloride paracetamol

Read this leaflet carefully before you start taking the medicine, because

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, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others

even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, inform your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

1.What is Tramadol/Paracetamol Stada 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.Storage of Tramadol/Paracetamol Stada

6.Contents of the pack and additional information.

Tramadol/paracetamol is a combination of two analgesics, tramadol and paracetamol, that act together to relieve pain.

This medication is used for the symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/paracetamol should only be used by adults and children over 12 years old.

Do not takeTramadol/Paracetamol Stada:

-If you are allergic to any of the active ingredients or to any of the other components of this medicine (listed in section 6).

-In case of acute alcohol intoxication, if you are taking sleeping pills, potent analgesics (opioids), or other psychotropic medications (medicines that can alter mood and emotions).

-If you are taking monoamine oxidase inhibitors (MAOIs) (certain medications 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 or pharmacist before starting to take tramadol/paracetamol

-If you are taking other medications that contain paracetamol or tramadol;

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

• If you have kidney problems;

-If you have severe respiratory problems, for example asthma or severe lung disease;

-If you are epileptic or have had seizures or convulsions;

-If you have recently had a head injury, severe headaches associated with vomiting;

-If you are dependent on any other medication used to relieve pain, for example morphine;

-If you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;

-If you are to be anaesthetized. Tell your doctor or dentist that you are using tramadol/paracetamol.

-If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Stada").

Inform your doctor immediately if during treatment with Tramadol/Paracetamol Stada you experience:

-Severe diseases, 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 severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

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

Tolerance, dependence, and addiction

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

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

The risk of becoming dependent or addicted to tramadol/paracetamol 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 medications, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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

If you observe any of these signs, talk to your doctor to determine the best course of treatment 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").

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of illness or vomiting, constipation, loss of appetite.

Respiratory disorders related to sleep

Tramadol/paracetamol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Talk to your doctor, pharmacist, or nurse 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 be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

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 experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Children and adolescents

This medication is not recommended for children under 12 years old. Safety and efficacy have not been established in children.

Use in children with respiratory problems

This medication is not recommended for children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medications and Tramadol/Paracetamol Stada

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Do not taketramadol/paracetamol with monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol Stada").

Tramadol/Paracetamol Stada is contraindicated if you are being treated with:

-Carbamazepine (a medication normally used to treat epilepsy or certain types of pain, such 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 treatment) or selective serotonin reuptake inhibitors "SSRIs" (for depression treatment). If you experience confusion, agitation, fever, sweating, incoordinated limb or eye movements, uncontrolled muscle contractions, or diarrhea, you should contact your doctor.

-If you are taking sedatives, sleeping pills, other analgesics such as morphine and codeine (also used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or allergy medications. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• The concomitant use of tramadol/paracetamol with sedatives such as benzodiazepines or related medications increases the risk of sedation, respiratory depression, coma, or even death. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol/paracetamol with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dosage closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

• Medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics.The risk ofseizures increases if you take tramadol/paracetamol simultaneously with these treatments. Your doctor will tell you if tramadol/paracetamol is suitable for you.

• If you are taking antidepressants, tramadol may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").

• If you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, increasing the risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

• If you are taking flucloxacillin (an antibiotic), due to a severe risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

• If you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

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

-Metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),

-Colestiramine (a medication that reduces cholesterol in the blood),

Your doctor will know which medications are safe to use with tramadol/paracetamol.

Tramadol/Paracetamol Stada with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Because Tramadol/Paracetamol Stada contains tramadol, it is not recommended to use this medication during pregnancy or breastfeeding. If you become pregnant during treatment with tramadol/paracetamol, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol may pass into breast milk. Therefore, do not take tramadol/paracetamol more than once during breastfeeding, or, if you take tramadol/paracetamol more than once, you should stop breastfeeding.

Fertility

Based on human experience, it is not suggested that tramadol affects male and female fertility. There are no data available on the combination of tramadol and paracetamol in fertility.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

with other medications.

Tramadol/Paracetamol Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

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

Before starting treatment and regularly during it, 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 interrupt it (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the smallest possible dose that produces pain relief should be used.

You should take this medication for the shortest time possible.

This medication is not recommended for children under 12 years old.

Unless your doctor prescribes something different, the recommended starting dose for adults and adolescents over 12 years old is 1 tablet.

If necessary, you can increase the dose as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 4 tablets of tramadol/paracetamol per day.

Do not take this medication more frequently than your doctor has indicated.

Older patients

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

Patients with liver or kidney disease/patients on dialysis

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

Administration form

The tablets can be swallowed whole or broken in half with the help of a glass of liquid, preferably water. The groove in the tablet serves to break the tablet if it is difficult to swallow it whole or if you need to take half a dose.

If you estimate that the action of this medication is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., you do not have adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Stada than you should

You should consult your doctor or pharmacist even if you feel well. There is a risk of liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tramadol/Paracetamol Stada

If you forgot to take the tablets, it is possible that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt the treatment with Tramadol/Paracetamol Stada

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, 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 interrupt it, which can be done by gradually reducing the dose to reduce the risk of unnecessary adverse effects (withdrawal symptoms).

Like all medicines, tramadol/paracetamol can have side effects, although not everyone gets them.

Very common: may affect more than 1 in 10 people;

-nausea,

-dizziness, drowsiness.

Common: may affect 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, euphoria –feeling "high" all the time-).

Uncommon: may affect 1 in 100 people;

-increased heart rate or increased blood pressure, heart rhythm and frequency disorders,

-protein in the urine,difficulty or pain urinating,

-skin reactions (e.g. rashes, urticaria),

-tingling, numbness, or pins and needles sensation in the extremities, ear noises, muscle spasms, involuntary muscle contractions,

-depression, nightmares, hallucinations (hearing, seeing, or perceiving something that is not real), memory loss,

-difficulty swallowing, blood in stool,

-chills, hot flashes, chest pain,

-difficulty breathing,

increased liver enzyme values.

Rare: may affect 1 in 1,000 people;

• seizures, difficulty with coordinated movements, transient loss of consciousness (syncope),
• dependence on the medication,
• delirium,
• blurred vision,constricted pupil (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known: cannot be estimated from available data;

• decreased blood sugar levels(hypoglycemia),
• hypotension,
• a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The following recognized side effects have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should tell your doctor:

-dizziness when standing up after lying down or sitting, low 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 tramadol/paracetamol with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

-in rare cases, skin eruptions, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you,interrupt the treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus).

Indeterminate frequency (cannot be estimated from available data)

Serotonin syndrome, which may 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting to take Tramadol/Paracetamol Stada").

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

In exceptional cases, blood tests reveal abnormalities, such as low platelet count, which can cause nasal or gum bleeding.

In very rare cases, severe skin reactions have been reported with paracetamol.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

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

This medication does not require special storage conditions.

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

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofTramadol/Paracetamol Stada

The active principles are tramadol hydrochloride and paracetamol.

One tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.

The other components are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium carboxymethylcellulose (Type A) from potato and pregelatinized cornstarch.

Appearance of the product and contents of the packaging

White, oval, scored tablets.

It is presented in packaging of 20 and 60 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization

Laboratorio STADA S.L.

Frederic Mompou, 5

08960- Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

Sant Cugat del Vallès (Barcelona)

Spain

Last review date of this leaflet:January 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es