Leaflet: information for the user

Tramadol/Paracetamol Stada 37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/Paracetamol

Read this leaflet carefully before you start to take this 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 or pharmacist.
• 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Tramadol/Paracetamol Stada is a combination of two analgesics, tramadol and paracetamol, that 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 old should take tramadol/paracetamol.

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 case of acute overdose.
• with alcohol, with sedatives, painkillers or other psychotropic medicines (medicines that affect mood and emotions).
• if you are also 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 withtramadol/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 skinturn 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 a head injury or severe headaches associated with vomiting.
• if you are dependent on any medicine, including those used to relieve pain, for example, morphine;
• if you are taking other painkillers that contain buprenorphine, nalbuphine or pentazocine;
• if you are to be anaesthetized. 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 hormone 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 experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Respiratory problems related to sleep

Tramadol/Paracetamol may cause respiratory problems 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 awakening due to lack of air, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme and this may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite.

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid. Repeated use of opioids can make the medicine less effective (you become tolerant of it, known as tolerance). Repeated use of tramadol/paracetamol may also cause dependence, abuse and addiction, which may 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 may 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 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 have abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have 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 of the recommended dose
• You use the medicine 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 medicine
• You feel unwell when you stop taking the medicine, and you feel better when you take it again (“withdrawal effect”)

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).

Other medicines and Tramadol/Paracetamol Stada

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Important:This medicine contains paracetamol and tramadol. Inform 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 should not be taken withmonoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol/Paracetamol Stada”).

Do not use tramadol/paracetamol 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 analgesic). The pain relief may be reduced.

The risk of side effects increases

• if you are taking triptans (for migraines) or selective serotonin reuptake inhibitors (SSRIs) (for depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions or diarrhea, you should call your doctor.
• if you are taking other painkillers such as morphine and codeine (also used to treat cough), baclofen (as a muscle relaxant), some medicines to lower blood pressure, allergy medicines. You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of tramadol/paracetamol and sedatives or sleeping pills (e.g., benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medicine with sedatives, your doctor should limit your dose and treatment duration.

Inform your doctor of all sedatives you are taking and follow your doctor's dose recommendation strictly. 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 can cause seizures (such as certain antidepressants and antipsychotics). The risk of having a seizure may increase if you taketramadol/paracetamolat the same time. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• if you are taking certain antidepressants, tramadol/paracetamolmay interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking warfarin or phenprocoumon (to thin the blood). The effectiveness of these medicines may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• if you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and which may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if you are taking the maximum daily doses of paracetamol.
• 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 (medicines to treat nausea and vomiting).
• Colestiramine (medicine to reduce cholesterol in the blood).

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

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, do 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, do not take tramadol/paracetamol more than once during breastfeeding or, alternatively, if you take tramadol/paracetamol more than once, stop breastfeeding.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machines

Tramadol/paracetamol may cause drowsiness, which may 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; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as 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).

You should taketramadol/paracetamolfor the shortest time possible.

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

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

Unless your doctor prescribes something different, the recommended starting dose for adults and adolescents over 12 years old is 2 tablets.

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 8 tablets oftramadol/paracetamolper day.

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

Patients over 65 years old:

In patients over 65 years old, the elimination of tramadol may be slow. If this is your case, your doctor may prolong the dosing intervals.

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

If you have any 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.

Administration form

Take the tablets orally.

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

If you estimate that the effect oftramadol/paracetamolis 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 moretramadol/paracetamolthan you should, although you feel well, consult your doctoror pharmacist immediately. There is a risk of severe liver damage that will only become apparentlater.

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 taken.

If you forgot to take Tramadol/Paracetamol Stada

If you forgot to take a dose oftramadol/paracetamol, it is likely 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 likelihood of unnecessary adverse effects (withdrawal symptoms).

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common: can affect more than 1 in 10 people

• nausea,
• dizziness,drowsiness.

Common:can 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 "on edge").

Uncommon: can affect up to 1 in 100 people

• increased heart rate or increased blood pressure, heart rhythm and frequency disorders,
• tingling, numbness, or pins and needles sensation in the extremities, ear noises, 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. rashes, urticarial hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain urinating),
• chills, hot flashes, chest pain.

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

• seizures, difficulty with coordinated movements, transient loss of consciousness (syncope)
• addiction
• delirium
• blurred vision, pupil constriction (miosis)
• speech disorder
• excessive pupil dilation (mydriasis)

Frequency not known:the frequency cannot be estimated from the available data

• decreased blood sugar levels (hypoglycemia).
• hyp

The following are recognized side effects that have been reported by people taking 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:

• dizziness when getting 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,worseningof existing asthma.

• the use of tramadol/paracetamol with "blood-thinning" medications (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, 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, discontinue treatment and consult a doctor immediately. Do not take the medicine again.

In rare cases, taking a medicine like tramadol can make you dependent on the medication, making it difficult to stop taking it.

In rare instances, people who have been taking tramadol for some time may feel unwell if the treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may experience hyperactivity, difficulty sleeping, and gastrointestinal or intestinal problems. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus).

Frequency not known: 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 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 may lead to nosebleeds or bleeding gums.

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

Cases of rare respiratory depression with tramadol have been reported.

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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach 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.

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.

This medication does not require special storage conditions.

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

Composition of Tramadol/Paracetamol Stada

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

Tablet core coated:

Pregelatinized maize starch (from maize starch)

Maize starch

Sodium carboxymethyl starch (type A) from potato

Microcrystalline cellulose (Avicel PH 102)

Magnesium stearate

Coating with film:

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

Appearance of the product and contents of the package

Yellow clear film-coated, oblong, biconvex tablet.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA S.L Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

MEIJI PHARMA SPAIN S.A.

Avda. de Madrid, 94,

28802Alcalá de Henares,Madrid

Spain

or

Medis International a.s.

factory Bolatice,

Prumyslová 961/16,

74723 Bolatice

Republic of Czech

or

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

or

Martin Dow Pharmaceuticals

Goualle le Puy,

Champs de Lachaud,

Meymac, 19250,

France

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

CZ:Trodon Combo

ES:Tramadol/Paracetamol Stada 37.5 mg/325 mg film-coated tablets

PL:Tramaparastad

PT:Tramadol + Paracetamol Ciclum

Date of the last review of this leaflet:July 2024

The detailed and updated 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/