Leaflet: information for the useruser

Tramadol/paracetamol Cinfa 75 mg/650 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.

Tramadol/paracetamolis a combination of two analgesics: tramadol and paracetamol, which act together to relieve pain.

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

Tramadol/paracetamolshould only be used by adults and adolescents over 12 years old.

Do not take tramadol/paracetamolcinfa

• 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 medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medicines that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are also taking MAO inhibitors (certain medications 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 or pharmacist before starting to take tramadol/paracetamol cinfa.

• If you are taking other medications 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 indicative of jaundice or problems with your bile ducts.
• If you have kidney problems.
• If you have severe respiratory 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 medication used for pain relief, for example morphine.
• If you are taking other medications for pain relief 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 are malnourished, chronically alcoholic or 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. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

There is a weak risk that you may experience a serotonin syndrome that can appear after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms linked to this serious syndrome (see section 4 "Possible side effects").

Respiratory disorders related to sleep

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

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, known as tolerance).

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 medication 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 medications or illegal drugs ("addiction").

• You are a smoker.

• You have ever had mood problems (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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 medication for a longer period than advised by your doctor.

• You need to take more of the recommended dose.

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

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

• When you stop taking the medication, you feel unwell, and you feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to determine 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").

Talk to your doctor or pharmacist 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 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.

Tramadol is metabolized 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 achieve sufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of illness or vomiting, constipation, loss of appetite.

If you experience or have experienced any of these problems while taking tramadol/paracetamol, please inform your doctor. He will decide if you should continue taking this medication.

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 may worsen in these children.

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 medication.

Important: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking any other medication 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 anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Youmust not taketramadol/paracetamol with monoamine oxidase inhibitors (MAOIs) (see section ("Do not take tramadol/paracetamolcinfa"))

Do not take tramadol/paracetamol if you are being treated with:

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

The risk of side effectsincreases:

• 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 medications to lower blood pressure, medications 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 medications increases the risk of drowsiness, respiratory 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 medication 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 medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these medications. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• if you are taking antidepressants, tramadol/paracetamol may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• if you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications 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 the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness oftramadol/paracetamolmay be altered if you are also taking:

• Metoclopramide, domperidone or ondansetron (medications for the treatment of nausea and vomiting).
• Colestiramine (a medication that reduces cholesterol in the blood).

Your doctor will know which medications are safe to use withtramadol/paracetamol.

Tramadol/paracetamol cinfa with food and alcohol

Tramadol/paracetamolmay make you feel drowsy. Alcohol may make you feel drowsy, so it is recommended not to drink alcohol while takingtramadol/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 medication.

Pregnancy

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

Fertility

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

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with tramadol/paracetamol. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery 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 administering it concomitantly with other medications.

Tramadol/paracetamol cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 interrupt it (see also section 2).

You should taketramadol/paracetamolfor 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.

Use in children

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

Use in adults

Unless your doctor prescribes something different, the recommended starting dose for adults and adolescents over 12 years old is 1 tablet.

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 4 tablets of tramadol/paracetamol per day.

Do not take tramadol/paracetamolmore frequently than your doctor has indicated.

Older patients

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

Patients with liver or kidney insufficiency/patients on dialysis

If you have a severe 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.

Administration form

Tramadol/paracetamolis 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 oftramadol/paracetamolis 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/paracetamolcinfathan you should

If you have taken moretramadol/paracetamolthan you should, even if you feel well, consult your doctoror pharmacistimmediately, as there is a risk of severe liver damage that will only become apparent later.

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

If you forgot to taketramadol/paracetamol cinfa

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

If you interrupt the treatment withtramadol/paracetamolcinfa

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

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

Like all medicines,this medicinecan 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
• state ofconfusion, sleep disorders, mood changes (anxiety, nervousness, euphoria feeling of being "high" all the time).

Rare(may affect up to 1 in 100 people)

• increased heart rate or increased blood pressure, cardiac 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
• protein in the urine, difficulty or pain urinating
• chills, hot flashes, chest pain.

Very 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 disease who use paracetamol (see section 2).
• decreased blood sugar levels (hypoglycemia)
• hypo
• 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, please tell your doctor:

• Dizziness when getting 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. Please inform your doctor immediately about any prolonged or unexpected bleeding.
• In rare cases, skin rashes, 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, discontinue treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol can make you dependent, 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 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 withtramadol/paracetamol, please consult your doctor.

In exceptional cases, blood tests may reveal certain abnormalities, such as a 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 Medicinal Products for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 individuals who have not been prescribed it.

This medication does not require special conservation conditions.

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

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 pointat 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.

Composition oftramadol/paracetamolcinfa

• The active principles are tramadol hydrochloride and paracetamol. Each coated tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• The other components are:

Tablet core:

Pre-gelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (potato), hydroxypropylcellulose, magnesium stearate of vegetable origin, purified water.

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

Appearance of the product and contents of the package

Coated tablets with a film coating, scored, oblong, biconvex, and yellow in color. It is presented in PVC-white opaque/aluminum and PVC/PVDC-white opaque/aluminum blisters.

Each package contains 20, 60, or 100 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

FARMALIDER, S.A

C/ Aragoneses 2

28108 Alcobendas

Madrid

or

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas

Madrid

or

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last revision date of thisleaflet:February 2025

The detailed and updated information on this medicine 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 medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78174/P_78174.html

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