Tramadol/paracetamol STADA 75 mg/650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol/paracetamol Stada 75 mg/650 mg tablets

Tramadol hydrochloride, paracetamol

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, inform your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Tramadol/paracetamol should only be used by adults and children 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 any of the active substances 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 medications, strong painkillers (opioids), or other psychotropic medicines (medicines that may alter 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 within the last 14 days before starting treatment with tramadol/paracetamol.

• If you have severe liver disease.

• If you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting tramadol/paracetamol

• If you are taking other medicines containing 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 a sign of jaundice or problems with your bile ducts;

  • If you have kidney problems;

• If you have severe breathing difficulties, for example asthma or serious lung problems;

• If you have epilepsy or have had seizures or convulsions;

• If you have recently suffered a head injury, severe headaches associated with vomiting;

• If you are dependent on any other medicine used for pain relief, for example morphine;

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

• If you are going to be anesthetized. Inform 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 medicines and Tramadol/Paracetamol Stada").

During treatment with Tramadol/Paracetamol Stada, inform your doctor immediately if:

• You have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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

Tolerance, dependence, and addiction

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

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

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

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

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

If you observe any of these signs, speak with your doctor so that he or she can advise you on the best course of treatment, including when it is appropriate to stop taking it and how to do so 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, 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 consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

Sleep-related breathing disorders

Tramadol/Paracetamol may cause sleep-related breathing disorders, 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, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

There is a slight risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Seek immediate medical advice if you develop any symptoms related to this serious syndrome (see section 4, "Possible side effects").

Children and adolescents

The use of this medicine is not recommended in children under 12 years of age. Safety and efficacy have not been established in children.

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.

Other medicines and Tramadol/Paracetamol Stada

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

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

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

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain attacks 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 the treatment of migraine) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

• If you are taking sedatives, sleeping medicines, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• Concomitant use of tramadol/paracetamol with sedative medicines such as benzodiazepines or related medicines increases the risk of sedation, respiratory depression, coma, or even death. Because of this, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes tramadol/paracetamol together with sedatives, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and closely follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

• Medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these treatments. Your doctor will advise whether tramadol/paracetamol is suitable for you.

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

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

• If you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called high anion gap metabolic acidosis) that requires urgent treatment (see section 2).

• If you are taking gabapentin or pregabalin to treat 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 the treatment of nausea and vomiting),
• Cholestyramine (a medicine that lowers blood cholesterol),

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

Taking Tramadol/Paracetamol Stada with food, drinks, and alcohol

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

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

Breastfeeding

Tramadol may pass into breast milk. For this reason, you should not take tramadol/paracetamol more than once during breastfeeding; otherwise, if you take tramadol/paracetamol more than once, you must stop breastfeeding.

Fertility

Based on human experience, there is no indication that tramadol affects fertility in men and women. There are no data available on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor if you can drive or operate machinery during treatment with this medicine. It is important that before driving or operating machinery, you observe how this medicine affects you. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken concomitantly with other medicines.

Tramadol/Paracetamol Stada contains sodium

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

3. How to take Tramadol/Paracetamol Stada

Follow exactly the dosing instructions for 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 stop taking it (see also section 2).

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.

You should take this medicine for the shortest time possible.

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

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

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

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

Do not take this medicine more frequently than prescribed by your doctor.

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

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

Method of administration

The tablets can be swallowed whole or split in half with a glass of liquid, preferably water. The tablet's score line is intended to facilitate splitting the tablet if you have difficulty swallowing it whole or if you need to take a half dose.

If you feel the effect of this medicine is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, you do not get 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 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, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Tramadol/Paracetamol Stada

If you forget to take the tablets, 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 Stada

You should not stop taking this medicine suddenly 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 long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

4. Possible adverse effects

Like all medicines, tramadol/paracetamol can have adverse effects, although not everyone will experience them.

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

• nausea,
• dizziness, drowsiness.

Common: may affect 1 in 10 people:

• vomiting, gastrointestinal problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, agitation,
• confusion, sleep disorders, mood changes (anxiety, restlessness, euphoria – a feeling of continuously being “on a high”).

Uncommon: may affect 1 in 100 people:

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

increased levels of liver enzymes.

Rare: may affect 1 in 1,000 people:

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

Frequency not known: cannot be estimated from available data:

• decrease in blood sugar levels (hypoglycaemia),
• hiccups,
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are taking paracetamol (see section 2).

The following recognised adverse effects have been reported in people who have taken medicines containing either tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking tramadol/paracetamol, you must tell your doctor:

• Dizziness when standing up after lying down or sitting, slow 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 together with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes indicating allergic reactions, which may present 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, taking a medicine such as tramadol may lead to dependence, 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 shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very rarely, people may also experience panic attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and noises in the ears (tinnitus).

Frequency unknown (cannot be estimated from available data):

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 Stada”).

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

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

Very rarely, serious skin reactions have been reported with paracetamol.

Rare cases of respiratory depression have been reported with tramadol.

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 out of the reach and sight 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.

This medicine does not require special storage conditions.

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.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Stada

The active substances are tramadol hydrochloride and paracetamol.

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

Other components are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium carboxymethyl starch (Type A) from potato, and pregelatinized corn starch.

Nature of the product and contents of the pack

White, oblong, scored tablets.

Packaged in packs of 20 and 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and ManufacturerMarketing Authorization Holder

Laboratorio STADA S.L.

Frederic Mompou, 5

08960 - Sant Just Desvern (Barcelona)

Spain

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

Sant Cugat del Vallès (Barcelona)

Spain

Date of the most recent revision of this leaflet: January 2025

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