Introduction

Leaflet: information for the user

tramadol/paracetamol cinfa 37.5 mg/325 mg film-coated tablets

tramadol hydrochloride / paracetamol

Read this leaflet carefully before you start to take this medicine,because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

tramadol/paracetamol cinfa, is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

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

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

Do not take tramadol/paracetamol cinfaifyou are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6).

if you have taken any medicine for the treatment of insomnia, strong analgesics (opioids), or well medicines psychotropic (medicines that can alter mood and emotions) in case of acute alcohol intoxication).
if you are also taking MAO inhibitors (certain medicines used for the treatment of depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with tramadol/paracetamol.
if you have severe liver disease.
if you have uncontrolled epilepsy with your current treatment.

Warnings and precautions

Consult your doctor before starting to take tramadol/paracetamol cinfa

if you are taking other medicines that contain paracetamol or tramadol,
if you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative 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 are dependent on any other pain relief medicine, for example morphine,
if you are taking other pain relief medicines that contain buprenorphine, nalbuphine or pentazocine,
if you are to be anaesthetised. Tell 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 severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Respiratory disorders related to sleep

Tramadol/paracetamol cinfa contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

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 your doctor immediately if you experience any of the 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 can make the medicine less effective (you become tolerant of it, which is known as tolerance).

The repeated use of tramadol/paracetamol cinfa can also cause dependence, abuse and addiction, which can lead to 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 like 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 to tramadol/paracetamol cinfa varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol cinfa 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 cinfa, 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 of the recommended dose

•You use the medicine for reasons other than those prescribed, for example, "to stay calm" or "to sleep"

•You have tried repeatedly and unsuccessfully to stop or control the use of the medicine

•You feel unwell when you stop taking the medicine, and you feel better when you take it again ("withdrawal symptoms")

If you notice any of these signs, talk to your doctor to get advice on the best course of treatment 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 cinfa).

Tramadol is converted in the liver by an enzyme. Some people have a variation of this enzyme and this can affect each person differently. In some people, it may not be possible to get sufficient relief from pain, while others may be more likely to experience serious side effects. If you notice any of the following side effects, stop taking this medicine and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite.

If you experience or have experienced any of these problems while taking tramadol/paracetamol, please inform your doctor.

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity can 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. They may be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Other medicines and tramadol/paracetamol cinfa

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

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

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Tramadol/paracetamolshould not be takentogether with monoamine oxidase inhibitors (MAOIs) (see "Do not take tramadol/paracetamol cinfa").

Tramadol/paracetamol should not be used if you are being treated with:

Carbamazepine (a medicine normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
Buprenorphine, nalbuphine or pentazocine (opioid analgesic). The relief of pain may be reduced.

The risk of side effects increases:

if you are taking triptans (for the treatment of migraine) or selective serotonin reuptake inhibitors, "SSRIs" (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle contractions or diarrhea, you should call your doctor.
if you are taking other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medicines to lower blood pressure, medicines for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of tramadol/paracetamol and sedatives 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 other treatment options are not possible. However, if your doctor prescribes this medicine with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's dose recommendation strictly. 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 facilitate or may cause seizures such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol at the same time as these medicines. Your doctor will tell you if tramadol/paracetamol is suitable for you.
if you are taking medicines for depression treatment. Tramadol/paracetamol may interact with these medicines and you may experience a serotonin syndrome (see section 4 "Possible side effects").
if you are taking warfarin or phenprocoumon (medicine used to prevent blood clots). The effectiveness of these medicines may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
if you are taking gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you are also taking:

metoclopramide, domperidone or ondansetron (medicines for nausea and vomiting treatment).
colestiramine (medicine that reduces cholesterol in the blood).

Your doctor will know which medicines are safe to use with tramadol/paracetamol.

Tramadol/paracetamol cinfa with food and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 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 more than once during breastfeeding, or if you take tramadol more than once, you should stop breastfeeding.

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

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tramadol/paracetamol. It is essential to observe how this medicine affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation and/or when taking it with other medicines.

Tramadol/paracetamol cinfa contains sodium

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

3. How to take tramadol/paracetamol cinfa

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, your doctor will explain what you can 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 stop it (see also section 2).

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

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

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

If necessary, you can increase the dose as recommended by your doctor. The shortest interval between doses should 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 indicated.

Use in children and adolescents

This medication is not recommended for children under 12 years old.

Older patients

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

Patients with liver or kidney disease/patients on dialysis

If you have a severe liver or kidney disease, treatment with tramadol/paracetamol cinfa is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Administration form

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

If you estimate 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 have 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, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of severe liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call theToxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take tramadol/paracetamol cinfa

If you forget to take a dose of tramadol/paracetamol, it is likely that the pain will recur. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with tramadol/paracetamol cinfa

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 it, which can be done by gradually reducing the dose to reduce the risk of unnecessary adverse effects (withdrawal symptoms).

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

4. Possible Adverse Effects

Like all medicines, this medicine may 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 (hyperhidrosis),
headache, agitation,
confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Uncommon: may affect up to 1 in 100 people

increased heart rate or increased blood pressure, heart rhythm and frequency disorders,
tingling, numbness, or pins and needles sensation in the extremities, ear noises, 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 hives),
increased liver enzyme values,
presence of albumin in the urine, difficulty or pain urinating,
chills, hot flashes, chest pain.

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

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

Frequency not known: cannot be estimated from available data

A serious condition that can make the blood more acidic (metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
Decreased blood sugar levels (hypoglycemia).
hyp.
serotonin syndrome, which may manifest as changes in mental state (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 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, you should tell your doctor:

Dizziness when standing up after lying down or sitting, low 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 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 rare cases, skin eruptions, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you,interrupt treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol can make you dependent on it, making it difficult to stop taking it.

In rare instances, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with tramadol/paracetamol, please consult your doctor.

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

In very rare cases, severe skin reactions have been reported with paracetamol.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of side effects

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

5. Conservation of tramadol/paracetamol cinfa

Keep this medication out of the sight and reach of children.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

6. Content of the container and additional information

Composition of tramadol/paracetamol cinfa

The active principles 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 without gluten, povidone, stearic acid, sodium croscarmellose, and opadry light yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide (E-171), polyethylene glycol, yellow iron oxide (E-172), polisorbate 80).

Appearance of the product and content of the container

Tramadol/paracetamol cinfa is presented in the form of yellowish pale film-coated, round tablets.

Tramadol/paracetamol cinfa is presented in PVC/aluminum blisters, available in containers of 20, 60, and 100 (clinical container) film-coated tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

KERN PHARMA, S.L.

Colón II Industrial Estate, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Date of the last review of this leaflet:February 2025

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

You can access detailed and updated information on this medication by scanning with your smartphone the QR code included in the leaflet and 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 to:https://cima.aemps.es/cima/dochtml/p/74647/P_74647.html