Leaflet: information for the user

cinfatós complex suspensionoral

Paracetamol/ Dextromethorphanhydrobromide/Pseudoephedrinehydrochloride

Read theleaflet carefullybefore you start taking this medicine,becauseit containsimportantinformationforyou.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even ifthey are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen, or if the symptoms persist for more than 5 days (3 days for fever, if present), or if other symptoms appear such as high fever, skin eruptions, or persistent headache.

Contents of theprospecto

1. What cinfatós complex is and for what it is used
2. What you need to know before starting totake cinfatós complex
3. How to take cinfatós complex
4. Possible side effects
5. Storage of cinfatós complex
6. Contents of the package and additional information

cinfatós complex is an association of paracetamol, dextromethorphan and pseudoephedrine.

Paracetamol is effective in reducing pain and fever.

Dextromethorphan has antitussive action (inhibits the cough reflex).

Pseudoephedrine is effective in reducing nasal congestion.

It is indicated for symptomatic relief of gripal processes and common cold that are accompanied by mild or moderate pain, fever, unproductive cough (irritative cough, nervous cough) and nasal congestion in adults and adolescents from 12 years old.

You should consult a doctor if it worsens, or if the symptoms persist for more than 5 days (3 days for fever, if present), or if other symptoms appear such as high fever, skin eruptions or persistent headache.

This medication may cause dependence. Therefore, treatment should be of short duration.

There is a possibility of abuse of one of the active principles that contains cinfatós complex, pseudoephedrine. Large doses of pseudoephedrine can be toxic. Continuous use may cause tolerance and lead to taking more cinfatós complex than the recommended dose to achieve the desired effect, which could lead to an increased risk of overdose. Do not exceed the maximum recommended dose or the duration of treatment (see section 3).

Do not take cinfatós complex

• If you are allergic to paracetamol, dextromethorphan, pseudoephedrine, other nasal decongestants, or any of the other components of this medication (listed in section 6).orif you have any serious lung disease. You have asthma or cough accompanied by abundant secretions.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension by your medication.
• If you have serious heart or blood vessel diseases.
• If you have a serious kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• If you have been diagnosed with hyperthyroidism.
• If you are being treated or have been treated in the past 2 weeks with:

• any monoamine oxidase inhibitor (MAOI) medication used to treat depression, as it may cause a significant increase in blood pressure.
• any medication for Parkinson's disease or other diseases, as well as other serotonin reuptake inhibitors used to treat depression, such as fluoxetine and paroxetine.
• bupropion, which is a medication used to quit smoking.
• linezolid, which is an antibacterial medication (see the section “Other medications and cinfatós complex”).

• If you are pregnant and are in the first trimester of pregnancy.

Warnings and precautions

Do not take more medication than the recommended dose in section 3 “How to take cinfatós complex”.

Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.

Abdominal pain or rectal bleeding may occur with the use of cinfatós complex due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking cinfatós complex and contact your doctor or seek immediate medical attention. See section 4.

Cinfatós complex may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking cinfatós complex and contact your doctor or seek immediate medical attention. See section 4.

There have been reported cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using cinfatós complex immediately and seek medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 for symptoms).

Consult your doctor or pharmacist before starting to take cinfatós complex if you have:

• kidney, liver, heart, or lung diseases, and patients with anemia.
• treatment with any medication to treat epilepsy. You must consult your doctor before taking this medication because, when used together, it reduces the effectiveness and increases the hepatotoxicity of one of the active principles.
• asthma sensitive to acetylsalicylic acid.
• diabetes.
• cardiovascular disease, hypertension.
• high eye pressure (glaucoma).
• difficulty urinating, urinary obstruction.
• chronic cough, such as that caused by smoking. Especially in children, chronic cough may be an early sign of asthma.
• atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• if you are sedated, weakened, or bedridden.
• chronic alcoholics, should be careful not to exceed the recommended amount of this medication in section 3. “How to take cinfatós complex”. If diarrhea occurs during treatment, stop taking this medication immediately and consult your doctor.
• if you are taking other medications such as antidepressants or antipsychotics, cinfatós complex may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• if you have serious diseases, such as severe kidney failure 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, somnolence, feeling unwell (nausea), and vomiting.

Cases of abuse with medications containing dextromethorphan in adolescents have been described, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see the section “If you take more cinfatós complex than you should”).

If you are taking other medications that contain nasal decongestants, do not take this medication.

Stop treatment at least 24 hours before surgery.

The simultaneous use of cocaine with pseudoephedrine may increase cardiovascular effects and the risk of adverse effects.

Children and adolescents

Do not administer to children under 12 years old.

Older adults

Older adults are more sensitive to adverse effects, so it may be necessary to adjust the dose. Consult your doctor.

Other medications and cinfatós complex

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

In particular, if you are using some of the following medications or substances with pharmacological effect listed below, it may be necessary to modify the dose of one of them or interrupt treatment:

• alkalinizing urinary agents (sodium bicarbonate, citrates) as they may make pseudoephedrine eliminate more slowly and increase its effect and toxicity.
• inhalation anesthetics as they may increase the risk of heart problems. Monoamine oxidase inhibitors (MAOIs) used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline) or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidine). If you are being treated with any of them, you should separate their administration from the administration of cinfatós complex by at least 15 days, both before and after. If not, due to the presence of pseudoephedrine, it may cause a significant increase in blood pressure, high fever, and headache.
• medications to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• medications to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, metharbital, primidone, carbamazepine).
• levodopa (used to treat Parkinson's disease) as it may increase heart rate (arrhythmias).
• stimulants of the nervous system (amphetamine, xanthines) as they may cause nervousness, irritability, insomnia, or possibly seizures or altered heart rhythm (arrhythmias), as they may increase the effects of pseudoephedrine, causing a significant increase in blood pressure, high fever, and headache.
• cocaine, which, in addition to stimulating the nervous system, its use together with pseudoephedrine may increase adverse effects on the heart.
• central nervous system depressants (some of which are used to treat: mental illnesses, allergies, Parkinson's disease, etc.).
• some medications to lower blood pressure and treat heart rhythm or urinary elimination (such as beta-blockers, for example, propranolol, ACE inhibitors, diuretics of the loop, such as furosemide, rauwolfia alkaloids, such as reserpine, amiodarone, and quinidine) as it may reduce the effectiveness of these medications.
• digitalis glycosides (used for the heart) as they may cause alterations in heart rhythm.
• nitrates (used to treat angina) as their effects may be reduced.
• oral anticoagulants (acenocoumarol, warfarin).
• medications to lower cholesterol levels in the blood: cholestyramine.
• thyroid hormones (used to treat thyroid diseases) as their effects, as well as those of pseudoephedrine, may be increased.
• medications used to treat tuberculosis: isoniazid, rifampicin.
• medications used to treat gout: probenecid and sulfinpyrazone.
• medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• anti-inflammatory medications: celecoxib, parecoxib, or valdecoxib.
• expectorants and mucolytics (used to eliminate phlegm and mucus).
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that must receive urgent treatment (see section 2).

Do not take this medication during treatment, or in the 2 weeks after treatment with the following medications, as it may cause excitement, high blood pressure, and high fever (hyperpyrexia):

• monoamine oxidase inhibitors (MAOIs) used to treat depression: moclobemide, tranylcypromine.
• serotonin reuptake inhibitors used to treat depression: paroxetine, fluoxetine.
• bupropion (used to quit smoking).
• linezolid (used as an antibacterial).
• procarbazine (used to treat cancer).
• selegiline (used to treat Parkinson's disease).

Interference with diagnostic testsfordiagnostictests

If you are to undergo any analytical test (blood test, urine test, skin tests using allergens, etc.) inform your doctor that you are taking this medication as it may alter the results of these tests.

Taking cinfatós complex with food, beverages, and alcohol

Do not take alcoholic beverages during treatment with this medication as it may cause severe adverse reactions.

Do not take simultaneously with orange or bitter lemon juice. The rest of foods and beverages do not affect the efficacy of the medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Cinfatós complex is contraindicated during the first trimester of pregnancy due to the presence of pseudoephedrine.

Paracetamol and pseudoephedrine pass into breast milk, so women breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

In rare cases, during treatment, mild drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Cinfatós complex contains parahydroxybenzoic acid sodium methylester (E-219) and parahydroxybenzoic acid sodium propylester (E-217), aspartame (E-951), maltitol (E-965), sodium, propylene glycol (E-1520), and ethanol

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid sodium methylester (E-219) and parahydroxybenzoic acid sodium propylester (E-217).

This medication contains 1.8 mg of aspartame (E-951) per ml. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. It may have a mild laxative effect. Caloric value: 2.3 kcal/g maltitol.

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

This medication contains 5.45 mg of propylene glycol (E-1520) per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

This medication contains 1.64 mg of alcohol (ethanol) per ml, which is equivalent to 0.16% (P/V). The amount in 10 ml of this medication is equivalent to less than 1 ml of beer or wine.

The small amount of alcohol contained in this medication does not produce any perceptible effect.

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years old: 1 dose of 10 ml every 6-8 hours (3-4 times a day). Do not take more than 3 g of paracetamol per 24 hours (see "Warnings and precautions").

Patients with liver or kidney disease:should consult their doctor before taking this medication. If their doctor prescribes this medication, they should wait at least 8 hours between each dose.

Patients over 60 years old:the dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed.

Use in children and adolescents

This medication is only indicated for adolescents from 12 years old. Children under 12 years old should not take it.

How to take:

This medication is takenorally.

Shake the bottlewell before use.

Measure the amount of medication to take with the dosing cup provided with the bottle. After use, wash the dosing cup.

If the medication is taken at night, it should be taken a few hours before going to bed to reduce the possibility of insomnia in patients with difficulty sleeping.

The administration of this medication is subject to the appearance of all symptoms. As these disappear, this medication should be discontinued.

If it worsens, or if the symptoms persist for more than 5 days (3 days for fever if present), or if other symptoms such as high fever, skin eruptions, or persistent headache appear, the patient should consult their doctor.

If you take more cinfatós complex thandebe

If you have taken more cinfatós complex than you should, you may experience symptoms such as dizziness, vomiting, loss of appetite, jaundice (yellow discoloration of the skin) and abdominal pain. You may also experience convulsions, respiratory disturbances, hallucinations, increased blood pressure, irregular heartbeats, excitability, tremors, palpitations, and difficulty urinating.

If you take morecinfatós complexthan indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid eye movements, cardiac disturbances (acceleration of heart rate), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

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 have ingested an overdose, go quickly to a medical center even if you do not have symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

Cases of abuse with medications containing dextromethorphan have been reported, particularly in adolescents, which may lead to severe adverse effects such as: anxiety, panic, memory loss, tachycardia (acceleration of heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus (involuntary and rapid eye movements), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

Like all medicines,this medicinecanproduceside effects, although notall people suffer from them.

Severe side effects (unknown frequency): serious diseases that affect the blood vessels in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using cinfatos complex immediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• Sudden onset of severe headache

• Malaise

• Vomiting

• Confusion

• Seizures

• Changes in vision

Side effectsare rare (may affect up to 1 in 1,000 people):

• Malaise.
• Low blood pressure (hypotension).
• Increased levels of transaminases in the blood.

Very rare side effects (may affect up to 1 in 10,000 people):

• Kidney diseases, cloudy urine.
• Rashes with or without irritation, itching, skin inflammation (dermatitis), jaundice (yellow discoloration of the skin),severe skin reactions.
• Blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Side effects of unknown frequency (cannot be estimated from available data):

• A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).
• Alterations in heart rate (tachycardia, bradycardia, and arrhythmias), palpitations, shortness of breath (dyspnea).
• Excitement symptoms, sleep disorders, restlessness, dizziness, vertigo, headache, seizures, hallucinations, andmental confusion.In the case of seizures or hallucinations, stop taking this medicine immediately.
• Involuntary eyelid closure (blepharospasm), photophobia, and lacrimation.
• Nausea, vomiting,gastrointestinal discomfort,inflammation of the intestine that occurs with frequent diarrhea (ulcerative colitis) andconstipation.
• Ischemic colitis due to inadequate blood supply.
• Urinary retention in men, pain or difficulty urinating.
• Tremor, pallor, weakness, and increased sweating.
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).

Paracetamol can damage the liver when taken in high doses or prolonged treatment.

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 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 medicine.

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

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. Deposit 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.

Cinfa Complex Composition

The active principles are paracetamol, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride. Each milliliter of oral suspension contains :

Paracetamol. 50 mg

Dextromethorphan hydrobromide 2 mg

Pseudoephedrine hydrochloride 6 mg

The other components (excipients) are: maltitol (E-965), glycerol (E-422), sodium citrate, citric acid monohydrate, xanthan gum, methyl parahydroxybenzoate sodium (E-219), aspartame (E-951), ammonium glycyrrhizinate, propyl parahydroxybenzoate sodium (E-217), orange flavor (contains propylene glycol (E-1520) and ethanol), orange juice flavor, masking flavor, and purified water.

Product appearance and packaging content

Cinfa Complex is a homogeneous white ivory or camel-colored suspension with an orange odor.

It is presented in amber glass bottles with a 125 ml oral suspension content, provided with a metal cap with a Pilfer Proof closure. Each package is provided with a dosing cup with markings corresponding to 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: February 2025.

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