Package Insert: Information for the User

cinfatós 2 mg / ml oral solution

Dextromethorphan Hydrobromide

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if you worsen, or if you also have high fever, skin eruptions, or persistent headache, or if you do not improve after 7 days of treatment.

The dextromethorphan, active principle of this medication, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) for adults and children aged 6 years and above.

Consult a doctor if it worsens or does not improve after 7 days of treatment.

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

Do not take cinfatós

• If you are allergic to dextromethorphan or any of the other components of this medicine (listed in section 6).
• Children under 2 years old cannot take this medicine.
• If you have a serious lung disease.
• If you have asthma.
• If you have a cough accompanied by abundant secretions.
• If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used for the treatment of depression such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section: Other medicines and cinfatós).

Warnings and precautions

Consult your doctor or pharmacist before starting to takecinfatósif you are a patient:

• with persistent or chronic cough, such as that due to tobacco. Especially in children, chronic cough could be an early symptom of asthma.
• with liver disease,
• with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• who is sedated, weakened, or bedridden.
• if you are taking other medications such as antidepressants or antipsychotics, cinfatós 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, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

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

Children

Children under 2 years old cannot take this medicine, it is contraindicated.

Children between 2-6 years: cannot take this medicine due to the dextromethorphan dose. There are other presentations more suitable for this age group.

Other medicines and cinfatós

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

Do not take this medicine during treatment, or in the 2 weeks following treatment with the following medications, as it may cause excitement, high blood pressure, and fever above 40 ºC (hyperpyrexia).

• MAOIs (moclobemide, tranilcipromine).
• SSRIs (paroxetine, fluoxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Before starting to take this medicine, consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone and quinidine (to treat heart arrhythmias).

• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib).
• Central nervous system depressants (some of which are used to treat: mental illnesses, allergies, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Taking cinfatós with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as they may cause adverse effects.

Do not take with orange or bitter lemon juice, as they may increase the adverse effects of this medicine.

The rest of the food and drinks do not affect the efficacy of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women or breastfeeding women should not take this medicine without consulting their doctor.

Driving and operating machinery

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

cinfatós contains sorbitol (E-420)

This medicine contains 571.4 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

cinfatós contains ethanol

This medicine contains 0.15 mg of alcohol (ethanol) in each ml, equivalent to 0.015% (P/V). The amount in 60 ml of this medicine is equivalent to less than 1 ml of beer or wine.

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

cinfatós contains sodium benzoate (E-211)

This medicine contains 3.5 mg of sodium benzoate in each ml.

cinfatós contains sodium

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

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 12 years and older: Take 5 ml every 4 hours if necessary. If due to the intensity of symptoms it is not enough, it could be taken 10 ml every 4 hours if necessary. Do not exceed 6 doses of 60 ml in 24 hours.

It can also be taken 15 ml every 6 or 8 hours as needed.

The maximum amount that can be taken in 24 hours is 60 ml divided into several doses. Always use the smallest effective dose.

Use in children

Children between 6-11 years: Take 2.5 or 5 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses of 30 ml in 24 hours. It can also be taken 7.5 ml every 6 or 8 hours as needed.

The maximum amount that can be taken in 24 hours is 30 ml divided into several doses.

Severe adverse effects can occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

Children between 2-6 years: cannot take this medication due to the dextromethorphan dose. There are other presentations more suitable for this age group.

Children under 2 years:contraindicated.

How to take:

This medication is taken orally. Measure with the dosing cup included in the box, the amount of medication to be taken.

It can be taken directly.

Wash the dosing cup after use.

It is recommended to drink a glass of water after each dose and abundant liquid during the day.

It can be taken with or without food.

Do not take with orange or bitter lemon juice or with alcoholic beverages (See section: Taking cinfatós with food, drinks, and alcohol).

If it worsens, if the cough persists after 7 days, or if it is accompanied by high fever, skin eruptions, or persistent headache, consult your doctor.

If you take more cinfatós than you should

If you take more cinfatós than recommended, you may notice: confusion, excitability, restlessness, nervousness, and irritability.

The taking of very high doses of this medication can produce in children a state of drowsiness, hallucinations, nervousness, nausea, vomiting, or alterations in the way of walking.

Severe adverse effects have been reported in cases of abuse with medications containing dextromethorphan, including anxiety, panic, memory loss, tachycardia (acceleration of heartbeats), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal disturbances, mumbling speech, nystagmus (uncontrolled and involuntary 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 take more cinfatós than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disturbances, 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.

Contact your doctor or hospital immediately 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 forgot to take cinfatós

Do not take a double dose to compensate for the missed doses. If you have forgotten a dose, take it as soon as possible and continue with your regular schedule, as indicated in section 3. How to take cinfatós.

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

Like all medications,this medicationmay cause adverse effects, although not everyone experiences them.

During the period of use of dextromethorphan, the following adverse effects have been observed, although their frequency has not been established with precision:

• In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rare cases: mental confusion and headache.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

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.

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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Cinfatós Composition

Each milliliter contains 2 mg of dextromethorphan hydrobromide as the active ingredient.

The other components are: 70% sorbitol solution (E-420), sodium benzoate (E-211), sodium saccharin (E-954), citric acid monohydrate, orange flavor, ethanol, and purified water.

Product appearance and packaging contents

Cinfatós is a transparent, colorless oral solution with an orange aroma.

The medication is presented in a amber glass bottle with a metal cap and Pilfer Proof closure or a polyethylene terephthalate bottle with a polypropylene cap, containing 125 ml or 200 ml oral solution.

Only some packaging sizes may be commercially available.

Each package is provided with a dosing cup with a graduation ranging from 2.5 ml to 15 ml.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:June 2022

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