Label: information for the user

cinfatós antitusivo infantil 1 mg / ml oral solution

Dextromethorphan hydrobromide

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

• Keep this label, 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 label. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days of treatment and also have high fever, skin eruptions, or persistent headache.

The dextromethorphan, active ingredient of this medication, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of a cough not accompanied by expectoration (irritative cough, nervous cough) in children aged 2 to 11 years.

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

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

Do not take cinfatós antitusivo infantil

• If you are allergic to dextrometorfano or any of the other components of this medication (listed in section 6).
• Children under 2 years old cannot take this medication.
• 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 medications that inhibit serotonin reuptake 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 medications and cinfatós antitusivo infantil).

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfatós antitusivo infantil if you are a patient:

• With persistent or chronic cough, such as that caused by 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, pruritus, 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 antitusivo infantil 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 exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

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

Children and adolescents

This medication is contraindicated in children under 2 years old.

Other medications and cinfatós antitusivo infantil

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• MAOIs (moclobemida, tranilcipromina).
• SSRIs (paroxetina, fluoxetina).
• Bupropión (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procarbazina (used to treat cancer).
• Selegilina (used to treat Parkinson's disease).

Before starting to take this medication, 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:

• Amiodarona and quinidina (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 mucolítics (used to eliminate phlegm and mucus).

Taking cinfatós antitusivo infantil with food, drinks, and alcohol

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

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

The rest of foods and drinks do not affect the efficacy of the medication.

Pregnancy, and lactation

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

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

Driving and operating machinery

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

cinfatósantitusivoinfantil contains sorbitol (E-420),Red 4R (E-124), sodium,benzoate of sodium (E-211) andpropylene glycol (E-1520).

This medication contains 160 mg of sorbitol (E-420) per ml. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication may cause allergic reactions because it contains Red 4R (E-124).

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

This medication contains 3.50 mg of benzoate of sodium (E-211) per ml. Benzoate of sodium may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains 6.839 mg of propylene glycol (E-1520) per ml. If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

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

The recommended dose is:

Children aged 6 to 11 years: take 5 ml to 10 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

It can also be taken 15 ml every 6 or 8 hours if necessary.

The maximum amount that can be taken in 24 hours is 60 ml divided into several doses.

Children aged 2 to 5 years: under medical supervision take 2.5 ml to 5 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. It can also be taken 7.5 ml every 6 or 8 hours if necessary.

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

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

Children under 2 years: this medication is contraindicated in children under 2 years.

For administration to adults and children over 12 years, other presentations are available that are more suitable for this population.

Always use the smallest effective dose.

How to take:

cinfatós antitusivo infantil is taken orally.

Measure the amount of medication to be taken with the syringe provided in the box. Wash the dosing syringe after each use.

It is recommended to drink a glass of water after each dose and abundant liquid throughout 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 antitusivo infantil with food, drinks, and alcohol).

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

If you take more cinfatós antitusivo infantil than you should

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

Taking very high amounts of this medication can cause in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in gait.

Severe adverse effects have been reported in cases of abuse with medications containing dextromethorphan, including: anxiety, panic, memory loss, tachycardia (rapid heartbeat), 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 (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

If you take more cinfatós antitusivo infantil than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (rapid 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 forgot to take cinfatós antitusivo infantil

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 antitusivo infantil.

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

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

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

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, and vomiting.
• In rare instances: 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.

Do not dispose of medications through the drains or trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Cinfatós Antitusivo Infantil

• The active ingredient is dextromethorphan hydrobromide. Each ml contains 1 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: citric acid monohydrate, Red Ponceau 4R (E-124), sodium benzoate (E-211), non-crystallizable liquid sorbitol (E-420), sodium saccharin, sodium cyclamate, strawberry flavor (contains propylene glycol (E-1520)) and purified water.

Appearance of the Product and Contents of the Package

Cinfatós Antitusivo Infantilis a transparent, pink-red solution with a strawberry flavor packaged in polyethylene terephthalate bottles with a polyethylene high-density stopper. Each bottle contains 125 ml of oral solution and is packaged in a box that includes a dosing syringe with a scale of 0.25 ml to 5 ml.

Holder of the Marketing Authorization and Responsible for Manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

This leaflet was approved in October 2019

The 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/