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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol/Paracetamol Sandoz 37.5 mg/325 mg film-coated tablets EFG

Tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

3. How to take Tramadol/Paracetamol Sandoz

4. Possible side effects

5. How to store Tramadol/Paracetamol Sandoz

6. Contents of the pack and other information

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

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

Tramadol/Paracetamol is indicated 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 in adults and adolescents over 12 years of age.

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

Do not take Tramadol/Paracetamol Sandoz:

• if you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• in case of acute alcohol intoxication, if you are taking sleeping pills, strong analgesics, or other psychotropic medicines (medicines that may alter mood and emotions),
• if you are taking medicines called 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 before starting to take tramadol/paracetamol if you:

• are taking other medicines containing paracetamol or tramadol,
• have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts,
• have kidney problems,
• have severe breathing difficulties, for example asthma or serious lung disease,
• have epilepsy or have previously experienced seizures or convulsions,
• have recently suffered head trauma, shock, or severe headaches associated with vomiting,
• suffer from unexplained loss of consciousness (if you feel you might faint),
• have dependence on any other medicine used for pain relief, such as morphine,
• are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine,
• are going to be anaesthetised. Inform your doctor or dentist that you are using tramadol/paracetamol,
• suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol Sandoz"). There is a weak risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 "Possible side effects").

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become 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 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 a family member have 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 feel better when you take it again ("withdrawal effect").

If you observe any of these signs, speak with your doctor to determine the best treatment approach for you, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, "If you stop taking Tramadol/Paracetamol Sandoz").

If any of the above situations apply to you or have occurred in the past while taking tramadol/paracetamol, inform your doctor. He or she will decide whether you should continue taking this medicine.

Tramadol is metabolised 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.

Inform your doctor or pharmacist if you experience any of the following symptoms while taking tramadol/paracetamol:

• Sleep-related breathing disorders: tramadol/paracetamol may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, 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.
• 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.

Contact your doctor immediately if, during treatment with tramadol/paracetamol:

You develop serious illnesses, including 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 if you are also taking flucloxacillin (an antibiotic). A serious disorder called metabolic acidosis (an abnormality in blood and 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 difficulties with rapid and deep breathing, drowsiness, feeling unwell (nausea), and malaise (vomiting).

Children and adolescents

The use of tramadol/paracetamol is not recommended in children under 12 years of age, as safety and efficacy have not been established in this age group.

Use in children with breathing problems:

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol/Paracetamol Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Do not take tramadol/paracetamol if you are taking monoamine oxidase inhibitors ("MAOIs") (see section "Do not take Tramadol/Paracetamol Sandoz").

It is not recommended to take tramadol/paracetamol with the following medicines:

• carbamazepine (a medicine usually used to treat epilepsy or certain types of pain such as intense 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 also 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, you should contact your doctor,

• sedative medicines such as benzodiazepines or related medicines (tranquillisers, sleeping medicines). The concomitant use of tramadol/paracetamol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, 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 dose and duration of concomitant treatment should be limited. 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.

  • gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

• other analgesics such as morphine or codeine (also used to treat cough), baclofen (muscle relaxant), medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor,

• medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take tramadol/paracetamol at the same time. Your doctor will advise you whether tramadol/paracetamol is suitable for you,

• certain antidepressant medicines. Tramadol/paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible side effects"),

• warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered and bleeding may occur. You must inform your doctor immediately of any prolonged or unexpected bleeding,

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment.

The effectiveness of tramadol/paracetamol may be altered if you are also taking any of the following medicines:

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine that lowers blood cholesterol).

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

Use of Tramadol/Paracetamol Sandoz with alcohol

Tramadol/Paracetamol Sandoz may make you feel drowsy. Alcohol may also make you feel drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Sandoz.

Pregnancy and breastfeeding

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 this medicine contains tramadol, you should not take this medicine during pregnancy. If you become pregnant while being treated with Tramadol/Paracetamol Sandoz, consult your doctor before taking further tablets.

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

Driving and using machines

Tramadol/Paracetamol Sandoz may make you feel drowsy, which may affect your ability to drive or operate tools and machinery safely.

Tramadol/Paracetamol Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, essentially "sodium-free".

3. How to take Tramadol/Paracetamol Sandoz

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. 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).

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

The dose should be adjusted according to the intensity of pain and individual patient sensitivity. Generally, the lowest effective dose providing analgesia should be selected.

Use in adults and adolescents (from 12 years of age)

Unless otherwise prescribed by your doctor, the recommended starting dose is 2 tablets.

If necessary, additional doses may be taken 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 Sandoz per day.

Do not take tramadol/paracetamol more frequently than prescribed by your doctor.

If you feel 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.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may recommend a prolonged dosing interval.

Severe liver or kidney disease (insufficiency)/patients on dialysis

Patients with severe hepatic and/or renal insufficiency must not take tramadol/paracetamol. If in your case the insufficiency is mild to moderate, your doctor may recommend prolonging the interval between doses.

Method of administration:

The tablets are for oral use.

Swallow the tablets whole with sufficient liquid. Do not split or chew them.

If you take more Tramadol/Paracetamol Sandoz than you should

Contact your doctor or pharmacist immediately, even if you feel well, as there is a risk of serious 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 telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tramadol/Paracetamol Sandoz

If you forget to take the tablets, 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 Sandoz

You must not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking your 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) (see section 4. "Possible side effects").

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 will experience them.

Some adverse effects may be serious. Contact your doctor immediately if you experience any of the following:

• rarely, skin rash indicating an allergic reaction, which may progress to swelling of the face, tongue or throat, difficulty breathing, or drop in blood pressure and fainting. If this happens, stop treatment immediately. Do not take this medicine again.
• prolonged or unexpected bleeding when tramadol/paracetamol is used with blood-thinning medicines (e.g., warfarin, phenprocoumon).

Additionally, if any of the following adverse effects worsen, contact your doctor or pharmacist:

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, sweating,
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of elevated mood).

Uncommon: may affect up to 1 in 100 people:

• increased pulse or blood pressure, disturbances in heart rate or rhythm,
• difficulty or pain when urinating,
• skin reactions (e.g., rashes, hives),
• tingling, numbness or pins and needles in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or sensing something that is not real), memory loss,
• difficulty swallowing, blood in the stools,
• chills, hot flushes, chest pain,
• difficulty breathing,
• increased liver enzymes (hepatic transaminases), loss of certain proteins in the urine (albumin).

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

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

Frequency not known (cannot be estimated from available data):

• serotonin syndrome, which may present with changes in mental status (e.g., restlessness, hallucinations, coma) and other symptoms 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 Sandoz").
• decreased blood sugar levels,
• 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).

In addition, the following adverse effects have been reported in people who have taken medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should inform your doctor:

• dizziness upon 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 (usually decreased, occasionally increased), changes in perception,
• worsening of existing asthma,
• nosebleeds or bleeding gums, which may result from a low platelet count,
• severe reduction in the number of white blood cells, making infections more likely; possible signs include fever and sore throat (agranulocytosis).

Using a medicine such as tramadol may lead to dependence, making it difficult for you to stop taking it. People who have been taking tramadol for some time may feel unwell when stopping treatment abruptly. They may feel restless, anxious, nervous or shaky. They may become hyperactive, have difficulty sleeping, and experience digestive and intestinal disturbances. A small number of people may also experience panic attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping tramadol/paracetamol, consult your doctor.

The use of tramadol/paracetamol together with anticoagulants (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

Very rare cases of serious skin reactions have been reported.

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 Sandoz

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 people for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton, blister, or container after EXP. The expiry date refers to the last day of the month indicated.

After first opening the container, this medicine may be used for 50 days if stored between 15°C – 30°C.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Sandoz

• The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components are:

Tablet core: polyvinyl alcohol-macrogol copolymer, pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethylstarch (Type A) from potato, hypromellose, magnesium stearate.

Film coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Appearance of the product and contents of the pack

Tramadol/Paracetamol Sandoz film-coated tablets are peach-colored, capsule-shaped, printed with T37.5 on one side and A325 on the other.

Tramadol/Paracetamol Sandoz is available in cardboard packs containing blisters of 2, 10, 15, 20, 30, 40, 60, 80 and 90 tablets, and bottles containing 10 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Teva Pharma, S.L.U.
C/ C, n 4 Polígono Industrial Malpica (Zaragoza) – 50016
Spain

or

Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana
Slovenia

or

Pliva Hrvatska D.O.O.
Prilaz Baruna Filipovica 25 (ZAGREB) – 10000
Croatia

This medicinal product is authorized in Member States under the following names:

Czech Republic: Tutus 37.5 mg/325 mg
Portugal: Tramadol + Paracetamol Sandoz

Date of the latest revision of this leaflet: August 2025

Detailed 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