Tramadol/paracetamol Teva-Ratiopharm 75 mg/650 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol/Paracetamol Teva-ratiopharm 75 mg/650 mg film-coated tablets

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, 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.

Contents of the leaflet

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 side effects
5. How to store 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 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 the 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, paracetamol, or any of the other ingredients of this medicine (listed in section 6);

• if you have taken 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 taking Tramadol/Paracetamol Teva-ratiopharm:

• if you are taking other medicines containing tramadol or paracetamol;
• if you 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;
• if you have kidney problems;
• if you have severe breathing difficulties, for example asthma or serious lung conditions;
• if you have epilepsy or have had seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other medicine used for pain relief, for example morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anaesthetized. Inform 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 disturbances (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if maximum daily doses of paracetamol are used for prolonged periods. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

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

If you develop or have previously experienced any of these problems while taking Tramadol/Paracetamol Teva-ratiopharm, please inform your doctor. He or she will decide whether you should continue taking this medicine.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

There is a weak risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or with tramadol as monotherapy. Contact a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 "Possible side effects").

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 hormonal supplements.

Tolerance, dependence, and addiction

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

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

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

• You or someone in your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• You are a smoker;
• You have 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 you feel better when you take it again ("withdrawal effect").

If you notice any of these signs, talk to your doctor so they can advise you on the best treatment approach, 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 central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

The risk of 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

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

Use in children with respiratory problems:

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

Other medicines and Tramadol/Paracetamol Teva-ratiopharm

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

• Gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain).

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

You must not take Tramadol/Paracetamol Teva-ratiopharm together 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 commonly used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia). The harmful effects of paracetamol on the liver may be increased.
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). 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 may be fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Tramadol/Paracetamol Teva-ratiopharm together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

The risk of adverse effects increases:

• if you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Teva-ratiopharm simultaneously with these medicines. Your doctor will tell you whether Tramadol/Paracetamol Teva-ratiopharm is suitable for you;
• if you are taking medicines for depression, 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 diarrhea, contact your doctor immediately;
• Sedatives, sleeping pills, other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

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 with sedative medicines, they must limit the dose and duration of concomitant treatment.

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 listed above. Inform your doctor if you experience any of these symptoms.

• Antidepressants, anesthetics, neuroleptics (medicines affecting mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will tell you whether Tramadol/Paracetamol Teva-ratiopharm 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. You must inform your doctor immediately of any prolonged or unexpected bleeding.

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

• Metoclopramide, domperidone, or ondansetron (medicines for nausea and vomiting);
• Colestyramine (a medicine that lowers blood cholesterol);
• Ketoconazole and erythromycin (medicines used to treat 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 increase drowsiness; therefore, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Because Tramadol/Paracetamol Teva-ratiopharm 75 mg/650 mg tablets contain tramadol, the use of this medicine is not recommended during pregnancy or breastfeeding. If you become pregnant while being treated 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 must stop breastfeeding.

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

Driving and use of machines

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

Ask your doctor whether you can drive or operate machinery during treatment with Tramadol/Paracetamol Teva-ratiopharm 75 mg/650 mg tablets. 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. Take special care at the beginning of treatment, after a dose increase, after a formulation change, and/or when taken together 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; therefore, it is essentially "sodium-free".

3. How to take Tramadol/Paracetamol Teva-ratiopharm

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 to 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 should be adjusted according to the intensity of pain and your individual sensitivity.

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

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

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

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

Do not take 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 extend the dosing intervals.

Method of administration

Tramadol/paracetamol is administered orally.

The tablets must 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, even if you feel well, contact your doctor immediately, as there is a risk of serious liver damage which may only become apparent later.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

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

Generally, no adverse effects occur after stopping treatment with tramadol/paracetamol. However, in rare cases, patients who have been taking tramadol/paracetamol for some time and stop treatment abruptly may feel unwell (see section 4. "Possible side effects").

You should 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).

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 produce adverse 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, diarrhoea), stomach ache, dry mouth
• itching, increased sweating
• headache, restlessness
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria, feeling persistently "high")

Uncommon (may affect up to 1 in 100 people)

• tachycardia, hypertension, disturbances in heart rhythm and heart rate
• presence of albumin in urine, difficulty or pain when urinating
• skin reactions (e.g. rashes, urticaria)
• increased liver enzyme values
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing or perceiving things that do not exist in reality), memory loss
• difficulty swallowing, blood in the stool
• chills, hot flushes, chest pain
• difficulty breathing

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

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

Frequency not known (cannot be estimated from available data)

• decrease in blood sugar levels (hypoglycaemia)
• hiccups
• 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 Teva-ratiopharm").

The following adverse effects have been reported in individuals taking medicines containing either tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Teva-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.

• The use of paracetamol alone or in combination with the antibiotic flucloxacillin may induce a blood and fluid disorder (metabolic acidosis with high anion gap) due to increased acidity in blood plasma.

• The use of Tramadol/Paracetamol Teva together with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In very rare cases, serious skin reactions have been reported. Rarely, skin rashes may occur, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this occurs, stop treatment and consult your doctor immediately. You must not take this medicine again. In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

Occasionally, individuals 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 sensations 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, for example, low platelet count, which may result in nosebleeds or bleeding gums.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects

If you experience any 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 other people cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

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 pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Tramadol/Paracetamol Teva-ratiopharm

• The active substances are tramadol hydrochloride and paracetamol.

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

• The other components are:

Tablet core:

Pregelatinized maize starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethylstarch (Type A) from potato, hydroxypropylcellulose, vegetable magnesium stearate, purified water.

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

Appearance of the product and contents of the container

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

Tramadol/Paracetamol Teva-ratiopharm is available in pack sizes of 20, 60, and 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B,

1st floor, Alcobendas,

28108 Madrid (Spain)

Manufacturer

FARMALIDER, S.A.

Aragoneses St., 2

28108 Alcobendas

Madrid

Toll Manufacturing Services, S.L.

Aragoneses St., 2

28108 Alcobendas

Madrid

Date of the most recent review of this leaflet: July 2024

“Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)”

You can access detailed and up-to-date information on this medicinal product by scanning the QR code included on the packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77385/P_77385.html