Tramadol/paracetamol Teva-Ratiopharm 37.5 mg/325 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol/Paracetamol Teva-ratiopharm 37.5 mg / 325 mg

film-coated tablets EFG

tramadol hydrochloride / paracetamol

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tramadol/Paracetamol Teva-ratiopharm is and what it is used for
2. What you need to know before taking Tramadol/Paracetamol Teva-ratiopharm
3. How to take Tramadol/Paracetamol Teva-ratiopharm
4. Possible adverse effects
5. Storage of Tramadol/Paracetamol Teva-ratiopharm
6. Package contents and additional information

1. What Tramadol/Paracetamol Teva-ratiopharm is and what it is used for

Tramadol/paracetamol 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, when your doctor considers that a combination of tramadol and paracetamol is necessary.

Tramadol/paracetamol should only be used by adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol/Paracetamol Teva-ratiopharm

Do not take Tramadol/Paracetamol Teva-ratiopharm

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• if you have taken any medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may affect mood and emotions) in case of acute alcohol intoxication;
• 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 Teva-ratiopharm.
• if you have severe liver disease.
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor or pharmacist before starting tramadol/paracetamol if you:

• are taking other medicines containing tramadol or paracetamol;
• 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 problems;
• are epileptic or have had seizures or convulsions;
• suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Taking Tramadol/Paracetamol Teva-ratiopharm with other medicines");
• have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• are dependent on any other medicine used for pain relief, for example morphine;
• are taking other medicines for pain relief containing buprenorphine, nalbuphine, or pentazocine;
• are going to be anaesthetised. Tell your doctor or dentist that you are using Tramadol/Paracetamol Teva-ratiopharm.

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 used to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in a 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 ever 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 so they can advise you on the best course of treatment, 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").

Sleep-related breathing disorders

Tramadol/Paracetamol Teva-ratiopharm may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of experiencing central sleep apnoea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnoea.

There is a slight risk that you may develop a serotonin syndrome after taking tramadol, either in combination with certain antidepressants or with tramadol alone.

Contact a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4, "Possible side effects").

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 contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, general malaise or vomiting, constipation, loss of appetite.

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

Children and adolescents

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

Use in children with breathing problems:

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

Inform 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. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormone supplements.

Taking Tramadol/Paracetamol Teva-ratiopharm with other medicines

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

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

Tramadol/Paracetamol Teva-ratiopharm must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Teva-ratiopharm").

Use of Tramadol/Paracetamol Teva-ratiopharm is not recommended with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal or hepatic impairment, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used, especially if the maximum daily dose of paracetamol is used for a prolonged period. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

The risk of adverse effects increases if you are taking:

• medicines for the treatment of depression, as Tramadol/Paracetamol Teva-ratiopharm may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible side effects").
• triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle contractions, or diarrhoea, contact your doctor immediately.
• other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• 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, they should limit the dose and duration of concomitant treatment. Inform your doctor of 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.
• medicines that may trigger or lower the seizure threshold, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these medicines. Your doctor will advise whether tramadol/paracetamol is suitable for you.
• warfarin or fenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. Report any prolonged or unexpected bleeding to your doctor immediately.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Teva-ratiopharm may be altered if you take:

• metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• cholestyramine (a medicine that lowers blood cholesterol),

Your doctor will know which medicines are safe to use with Tramadol/Paracetamol Teva-ratiopharm.

Taking Tramadol/Paracetamol Teva-ratiopharm with food and alcohol

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

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.

Pregnancy

Because Tramadol/Paracetamol Teva-ratiopharm contains tramadol, use of this medicine during pregnancy is not recommended. If you become pregnant during treatment with Tramadol/Paracetamol Teva-ratiopharm, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take Tramadol/Paracetamol Teva more than once during breastfeeding, or if you take Tramadol/Paracetamol Teva 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 whether you can drive or operate machinery while being treated with tramadol/paracetamol. It is important to observe how this medicine affects you before driving or operating machinery. 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 together with other medicines.

3. How to take Tramadol/Paracetamol Teva-ratiopharm

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist.

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.

Use in children

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

Use in adults

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

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

If necessary, the dose may be increased 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 prescribed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slow. 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 disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration

Tramadol/paracetamol is administered orally.

The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel 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 get adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Teva-ratiopharm than you should

If you have taken more tramadol/paracetamol than you should, consult your doctor 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 the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tramadol/Paracetamol Teva-ratiopharm

If you forget to take a dose of tramadol/paracetamol, 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 Teva-ratiopharm

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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, diarrhoea), stomach ache, dry mouth
• itching, increased sweating (hyperhidrosis)
• headache, restlessness
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling "high-spirited" all the time)

Uncommon: may affect up to 1 in 100 people

• increased pulse, hypertension, 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 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 swallowing, blood in the stools
• chills, hot flushes, chest pain
• increased liver enzyme levels
• difficulty breathing

Rare: may affect 1 in 100 people

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

Frequency not known: cannot be estimated from available data

• decrease in blood sugar levels (hypoglycaemia)
• serotonin syndrome, which may present with 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 ratiopharm")
• 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 adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol ratiopharm, you must 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, changes in perception, worsening of asthma.
• Use of paracetamol alone or in combination with the antibiotic flucloxacillin may induce a blood and fluid disorder (metabolic acidosis with high anion gap) when there is increased acidity in the blood plasma.
• Use of tramadol/paracetamol together with anticoagulants (e.g. fenprocumone, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin rashes indicating allergic reactions may occur, manifesting as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. In very rare cases, serious skin reactions have been reported. 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.

Occasionally, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol ratiopharm, please consult your doctor.

Frequency not known: hiccups

In exceptional cases, blood tests may reveal certain 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Teva-ratiopharm

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 individuals for whom it has not been prescribed.

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your usual pharmacy. 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 Teva-ratiopharm

• The active substances are tramadol hydrochloride and paracetamol.

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

• The other components are:

Tablet core: Kollicoat IR (75% polyvinyl alcohol, 25% polyethylene glycol, 0.3% colloidal silica), pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate from potato, hydroxypropyl cellulose, magnesium stearate.

Coating: Opadry II beige 85F97409 (polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)).

Appearance of the product and contents of the pack

Tramadol/Paracetamol Teva-ratiopharm film-coated tablets are peach-coloured tablets supplied in blister packs.

Tramadol/Paracetamol Teva-ratiopharm is available in packs of 20 and 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor
28108 Alcobendas, Madrid
Spain

Manufacturer:

Teva Operations Poland sp.z.o.o.
Ul. Mogilska 80, 31-546 Krakow
Poland

or

Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

Date of the most recent review of this leaflet: November 2025

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74517/P_74517.html