TRAMADOL/PARACETAMOL TEVA-RATIOPHARM 75 mg/650 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tramadol/Paracetamol Teva-ratiopharm75 mg/650 mg film-coated tablets

Tramadol/paracetamol hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Tramadol/Paracetamol Teva-ratiopharm is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Teva-ratiopharm
3. How to take Tramadol/Paracetamol Teva-ratiopharm
4. Possible side effects
5. Storage of Tramadol/Paracetamol Teva-ratiopharm
6. Contents of the pack and other information

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

Tramadol/paracetamol is a combination of two pain relievers: 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 you take Tramadol/Paracetamol Teva-ratiopharm

Do not takeTramadol/Paracetamol Teva-ratiopharm:

• if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6).
• if you have taken any medicine for insomnia, strong pain relievers (opioids), or psychotropic medicines (medicines that can alter 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 in the last 14 days before 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

Consult your doctor or pharmacist before starting to take Tramadol/Paracetamol Teva-ratiopharm:

• if you are taking other medicines that contain tramadol or paracetamol;
• 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 severe lung problems;
• if you are epileptic or have had seizures or convulsions.
• if you have recently had a head injury, shock, or severe headaches associated with vomiting.
• if you have become dependent on any other medicine used for pain relief, for example, morphine;
• if you are taking other pain-relieving medicines that contain buprenorphine, nalbuphine, or pentazocine;
• if you are going to have an anesthetic. Tell your doctor or dentist that you are using Tramadol/Paracetamol Teva-ratiopharm.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol Teva-ratiopharm").
• if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used for a longer period. Metabolic acidosis with high anion gap is a serious disease that requires urgent treatment.

Consult your doctor or pharmacist before starting to take Tramadol/Paracetamol Teva-ratiopharm.

If you experience any of these problems while taking Tramadol/Paracetamol Teva-ratiopharm, please inform your doctor. He will decide if you should continue taking this medicine.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side 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.

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 a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Tell 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 indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

Tolerance, dependence, and addiction

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

Dependence or addiction can make you feel 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 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 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 those prescribed, for example, "to calm down" 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 take it again ("withdrawal effect").

If you observe any of these signs, talk to your doctor, who will indicate the best treatment option 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").

Respiratory disorders related to sleep

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

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

Children and adolescents

It is not recommended to use in children under 12 years of age.

Use in children with respiratory problems:

It is not recommended to use tramadol in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Other medicines and Tramadol/Paracetamol Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as:

• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

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

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

The use of Tramadol/Paracetamol Teva-ratiopharm is contraindicated if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as severe facial pain called trigeminal neuralgia). The harmful effects of paracetamol on the liver may increase.
• Buprenorphine, nalbuphine, or pentazocine (opioid pain reliever). Pain relief may be reduced.

The concomitant use of Tramadol/Paracetamol Teva-ratiopharm and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Tramadol/Paracetamol Teva-ratiopharm with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendation carefully. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Tell your doctor if you experience any of these symptoms.

• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used as an aid to stop smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol Teva-ratiopharm is suitable for you.
• Warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Tramadol/Paracetamol Teva-ratiopharm may be altered if you are also using:

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• Colestyramine (a medicine that reduces cholesterol in the blood),
• Ketoconazole and erythromycin (medicines used against infections).

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

Taking Tramadol/Paracetamol Teva-ratiopharm with food, drinks, and alcohol

Tramadol/Paracetamol Teva-ratiopharm may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Teva-ratiopharm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Because Tramadol/Paracetamol Teva-ratiopharm 75 mg/650 mg tablets contain tramadol, it is not recommended to use this medicine during pregnancy or breastfeeding. If you become pregnant during treatment with tramadol/paracetamol, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol/Paracetamol Teva-ratiopharm more than once during breastfeeding, or if you take Tramadol/Paracetamol Teva-ratiopharm more than once, you should interrupt breastfeeding.

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

Driving and using machines

Tramadol/Paracetamol Teva-ratiopharm may cause drowsiness, and this can affect your ability to drive or operate heavy machinery.

Ask your doctor if you can drive or use machines during treatment with Tramadol/Paracetamol Teva-ratiopharm 75 mg/650 mg tablets. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or see double, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when taking it in combination with other medicines.

Tramadol/Paracetamol Teva-ratiopharm 75 mg/650 mg contains sodium

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

3. How to take Tramadol/Paracetamol Teva-ratiopharm

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and on a regular basis during treatment, 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 stop taking it (see also section 2).

The dose must be adjusted to the intensity of the pain and your individual sensitivity.

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

Use in children

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

Use in adults

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

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

Do not take more than 4 Tramadol/Paracetamol tablets per day.

Do not take Tramadol/Paracetamol more frequently than your doctor has indicated.

Elderly patients

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

Patient with hepatic or renal insufficiency/patients on dialysis

If you have a serious 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.

Method of administration

Tramadol/paracetamol is administered orally.

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

If you think 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 have adequate pain relief), tell your doctor.

If you take moreTramadol/Paracetamol Teva-ratiopharmthan you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, consult your doctor immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20.

If you forget to takeTramadol/Paracetamol Teva-ratiopharm

If you forget to take a dose of tramadol/paracetamol, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop takingTramadol/Paracetamol Teva-ratiopharm

Generally, no unwanted effects appear after stopping treatment with tramadol/paracetamol. However, in rare cases, patients who have been taking tramadol/paracetamol for a while and have stopped treatment abruptly may feel unwell (see section 4, "Possible side effects").

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 stop taking it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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, diarrhea), stomach pain, dry mouth.
• Itching, increased sweating.
• Headache, agitation.
• Confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria, feeling "high" all the time).

Uncommon (may affect up to 1 in 100 people)

• Tachycardia, hypertension, cardiac rhythm and frequency disorders.
• Presence of albumin in urine, difficulty or pain when urinating.
• Skin reactions (e.g., rashes, hives).
• Increased liver enzyme values.
• Feeling of tingling, numbness, or pinching 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 stool.
• Chills, hot flashes, chest pain.
• Breathing difficulties.

Rare (may affect up to 1 in 1,000 people)

• Seizures, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope).
• Dependence on the medication.
• 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 (hypoglycemia).
• Hypo.
• Serotonin syndrome, which can manifest 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2, "What you need to know before taking Tramadol/Paracetamol Teva-ratiopharm").

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

• Feeling dizzy when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• Taking paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in blood and fluids (metabolic acidosis with high anion gap) when there is an increase in blood plasma acidity.
• Taking Tramadol/Paracetamol Teva-ratiopharm with anticoagulants (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

• In very rare cases, serious skin reactions have been reported. In rare cases, skin rashes, being indicative of allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medication again. In rare cases, using a medication like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have 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 Teva-ratiopharm, please consult your doctor.

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which can result in nosebleeds or bleeding gums.

Rare cases of respiratory depression with tramadol have been reported.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tramadol/Paracetamol Teva-ratiopharm

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after "EXP" or "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofTramadol/Paracetamol Teva-ratiopharm

• The active ingredients are tramadol hydrochloride and paracetamol.

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

• The other ingredients are:

Core of the tablet:

Pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) of potato, hydroxypropylcellulose, vegetable magnesium stearate, purified water.

Coating: OPADRY yellow 15B82958 (hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), polysorbate 80).

Appearance of the product and package contents

Tramadol/Paracetamol Teva-ratiopharm film-coated tablets are presented in the form of scored, oblong, biconvex, yellow film-coated tablets packaged in white opaque PVC/Al and white opaque PVC/PVDC/Al blisters.

Tramadol/Paracetamol Teva-ratiopharm is presented in packages of 20, 60, and 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B,

1º planta, Alcobendas,

28108 Madrid (Spain)

Manufacturer

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas

Madrid

Date of the last revision of this leaflet:July 2024

"Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)"

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77385/P_77385.html