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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

tramadol/paracetamol cinfa 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What tramadol/paracetamol cinfa is and what it is used for
2. What you need to know before taking tramadol/paracetamol cinfa
3. How to take tramadol/paracetamol cinfa
4. Possible side effects
5. How to store tramadol/paracetamol cinfa
6. Contents of the pack and other information

1. What tramadol/paracetamol cinfa is and what it is used for

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

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

2. What you need to know before taking tramadol/paracetamol cinfa

Do not take tramadol/paracetamol cinfa

• 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 alter mood and emotions) in case of acute alcohol intoxication.
• if you are currently 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.
• 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 before taking tramadol/paracetamol cinfa

• if you are taking other medicines containing paracetamol or tramadol,
• 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 problems,
• 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 anaesthetised. Inform your doctor or dentist that you are taking tramadol/paracetamol.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and tramadol/paracetamol cinfa”).
• if you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance in blood and body 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 deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

Tramadol/paracetamol cinfa contains an active ingredient belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnoea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). 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 low risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact a doctor immediately if you experience any symptoms associated with 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 make the medicine less effective (you become accustomed to it, known as tolerance).

Repeated use of tramadol/paracetamol cinfa 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 cinfa 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 cinfa, it could indicate 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 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 notice 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 cinfa).

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 experience 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.

If you currently have or have previously had any of these problems while taking tramadol/paracetamol, please inform your doctor.

Children and adolescents

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.

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.

Other medicines and tramadol/paracetamol cinfa

Tell 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 containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Tramadol/paracetamol must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take tramadol/paracetamol cinfa”).

The use of tramadol/paracetamol is not recommended if you are being treated with:

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

The risk of adverse effects increases:

• if you are taking triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhoea, you should contact your doctor.
• if you are taking other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (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, your doctor should 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 mentioned above. Inform your doctor if you experience any of these symptoms.
• if you are taking 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.
• if you are taking medicines for depression. Tramadol/paracetamol may interact with these medicines, and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking warfarin or fenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, posing a risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• if you are taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you also 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.

Taking tramadol/paracetamol cinfa with food and alcohol

Tramadol/paracetamol may make you feel drowsy. Alcohol may increase drowsiness; therefore, it is recommended not to drink alcohol while taking tramadol/paracetamol.

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.

Because tramadol/paracetamol cinfa contains tramadol, it is not recommended to take this medicine 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. Therefore, you should not take tramadol more than once during breastfeeding, or if you take tramadol more than once, you must stop breastfeeding.

Based on human experience, tramadol is not considered to affect 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. Take special care at the beginning of treatment, after a dose increase, after changing formulations, and/or when taking other medicines concomitantly.

tramadol/paracetamol cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, essentially “sodium-free”.

3. How to take tramadol/paracetamol cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. 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 cinfa, when and for how long you should take it, when you should contact your doctor, and when you should discontinue 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 your individual sensitivity. Normally, the lowest possible dose that provides pain relief should be used.

Unless your doctor prescribes otherwise, the recommended 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 your doctor has instructed.

Use in children and adolescents

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

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slowed. 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 cinfa is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

Tramadol/paracetamol is presented in tablet form for oral administration. The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed.

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.

If you take more tramadol/paracetamol cinfa than you should

If you have taken more tramadol/paracetamol than you should, consult 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 number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take tramadol/paracetamol cinfa

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 cinfa

You should not stop taking this medicine suddenly unless your doctor tells you to do so. 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 medicine, 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, diarrhea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling persistently “high-spirited”).

Uncommon: may affect up to 1 in 100 people

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling sensation, numbness, or prickling sensations 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 breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g., rashes, urticarial rash),
• increased liver enzyme levels,
• presence of albumin in urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

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 constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known: cannot be estimated from available data

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
• decrease in blood sugar levels (hypoglycemia).
• hiccups.
• serotonin syndrome, which may present 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 “What you need to know before taking tramadol/paracetamol cinfa”).

The following recognized adverse effects have been reported by individuals taking medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol cinfa, you must inform your doctor:

• Dizziness when standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.

• The use of tramadol/paracetamol 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 rare cases, skin rashes indicating allergic reactions, which may present as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens to you, 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 for you to stop taking it.

Occasionally, people who have taken 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 digestive and intestinal disturbances. Very rarely, individuals may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, or numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping tramadol/paracetamol cinfa, 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.

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 can also report them directly through 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 cinfa

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of tramadol/paracetamol cinfa

• 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: pregelatinized maize starch (gluten-free), povidone, stearic acid, sodium croscarmellose and Opadry II (hypromellose 3 cP, hypromellose 6 cP, titanium dioxide (E-171), polyethylene glycol, yellow iron oxide (E-172), polysorbate 80).

Appearance of the product and contents of the pack

tramadol/paracetamol cinfa is available as pale yellow, round, film-coated tablets.

tramadol/paracetamol cinfa is supplied in PVC/aluminum blisters, available in pack sizes of 20, 60 and 100 (hospital pack) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

KERN PHARMA, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Date of the most recent revision of this summary: February 2025

Detailed and up-to-date information on this medicine 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 about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74647/P_74647.html

QR code link: https://cima.aemps.es/cima/dochtml/p/74647/P_74647.html