CINFATOS ANTITUSSIVE INFANTILE 1 mg / ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

cinfatós antitussive infant 1 mg / ml oral solution

Dextromethorphan hydrobromide

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment, especially if you have a high fever, skin rash, or persistent headache.

Package Leaflet Contents

1. What cinfatós antitussive infant is and what it is used for
2. What you need to know before taking cinfatós antitussive infant
3. How to take cinfatós antitussive infant
4. Possible side effects
5. Storage of cinfatós antitussive infant
6. Package Contents and Additional Information

1. What cinfatós antitussive infant is and what it is used for

Dextromethorphan, the active ingredient in 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) in children from 2 to 11 years old.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before taking cinfatós antitussive infant

This medication can cause dependence. Therefore, treatment should be short-term.

Do not take cinfatós antitussive infant

• If you are allergic to dextromethorphan 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 severe 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 last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or bupropion, which is a medication used to quit smoking, or linezolid, which is an antibacterial medication (see section Other Medications and cinfatós antitussive infant).

Warnings and Precautions

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

• With persistent or chronic cough, such as that caused by smoking. 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 scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• Who is sedated, weakened, or bedridden.
• If you are taking other medications such as antidepressants or antipsychotics, cinfatós antitussive infant may interact with these medications, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

There have been cases of abuse with medications containing dextromethorphan by adolescents, so this possibility should be taken into account, as serious side effects can occur (see section If you take more cinfatós antitussive infant than you should).

Children and Adolescents

This medication is contraindicated in children under 2 years old.

Other Medications and cinfatós antitussive infant

Inform your doctor or pharmacist if you are using, have recently used, 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 excitement, high blood pressure, and fever above 40°C (hyperpyrexia) can occur:

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

Before starting to take this medication, you should 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 (used to treat heart arrhythmias).
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib).
• CNS 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 antitussive infant with Food, Drinks, and Alcohol

Alcoholic beverages should not be consumed during treatment, as they can cause side effects.

Do not take with grapefruit or bitter orange juice, as they can increase the side effects of this medication.

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

Pregnancy and Breastfeeding

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

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

Driving and Using Machines

Rarely, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

cinfatós antitussive infant contains sorbitol (E-420),Ponceau 4R Red (E-124), sodium,sodium benzoate (E-211), andpropylene glycol (E-1520).

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

This medication may cause allergic reactions because it contains Ponceau 4R Red (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 sodium benzoate (E-211) per ml. Sodium benzoate can 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 that contain propylene glycol or alcohol.

3. How to Take cinfatós antitussive infant

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

The recommended dose is:

Children from 6 to 11 years old: 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 from 2 to 5 years old: 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 side effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

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

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

Always use the lowest effective dose.

How to take:

cinfatós antitussive infant is taken orally.

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

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

It can be taken with or without food. Do not take with grapefruit or bitter orange juice or alcoholic beverages. (See section: Taking cinfatós antitussive infant with Food, Drinks, and Alcohol).

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

If you take more cinfatós antitussive infant than you should

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

Taking very high doses of this medication can cause children to experience a state of drowsiness, nervousness, nausea, vomiting, or changes in gait.

There have been cases of abuse with medications containing dextromethorphan, which can cause serious side effects such as: anxiety, panic, memory loss, tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal upset, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

If you take more cinfatós antitussive infant than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, changes in consciousness, rapid and involuntary eye movements, cardiac disorders (rapid heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may include: 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take cinfatós antitussive infant

Do not take a double dose to make up for forgotten doses. If you have forgotten a dose, take it as soon as possible and continue with your usual schedule, as indicated in section 3. How to take cinfatós antitussive infant.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency cannot be established with precision:

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal upset, nausea, and vomiting.
• In rarer cases: mental confusion and headache.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System 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. Storage of cinfatós antitussive infant

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 shown on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of cinfatós antitussive infant

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

Appearance of the Product and Package Contents

cinfatós antitussive infantis a clear, red-pink solution with a strawberry flavor, packaged in polyethylene terephthalate bottles with a cap provided 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 from 0.25 ml to 5 ml.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

This package leaflet was approved in October 2019

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