Cinfatos Antitussive Pediatric 1 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfatós antitussive paediatric 1 mg/ml oral solution

Dextromethorphan hydrobromide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

Leaflet contents

1. What cinfatós antitussive paediatric is and what it is used for
2. What you need to know before taking cinfatós antitussive paediatric
3. How to take cinfatós antitussive paediatric
4. Possible adverse effects
5. How to store cinfatós antitussive paediatric
6. Contents of the pack and other information

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

Dextromethorphan, the active substance of this medicine, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough, irritative cough, nervous cough) in children aged 2 to 11 years.

You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

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

This medicine may cause dependence. Therefore, treatment should be short-term.

Do not take cinfatós antitussive pediatric

• If you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6).
• Children under 2 years of age must not take this medicine.
• If you have a serious lung disease.
• If you have asthmatic cough.
• If you have a cough accompanied by abundant secretions.
• If you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitors (MAOIs) used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine (see section Other medicines and cinfatós antitussive pediatric).

Warnings and precautions

Talk to your doctor or pharmacist before taking cinfatós antitussive pediatric if you are a patient:

• With persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough may be an early sign of asthma.
• With liver disease.
• With atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary predisposition to allergy).
• Who is sedated, weakened, or bedridden.
• If you are taking other medicines such as antidepressants or antipsychotics, cinfatós antitussive pediatric may interact with these medicines 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section If you take more cinfatós antitussive pediatric than you should).

Children and adolescents

This medicine is contraindicated in children under 2 years of age.

Other medicines and cinfatós antitussive pediatric

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

Do not take this medicine during treatment or within 2 weeks after treatment with the following medicines, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitor antidepressants (MAOIs) (moclobemide, tranylcypromine).
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine).
• Bupropion (used to stop smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Before starting this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or interrupt treatment:

• Amiodarone and quinidine (used to treat heart arrhythmias).
• Anti-inflammatory medicines (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 antitussive pediatric with food, drinks, and alcohol

Alcoholic beverages must not be consumed during treatment, as they may cause adverse effects.

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

Other foods and drinks do not affect the effectiveness of the medicine.

Pregnancy and breastfeeding

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

Pregnant women or those who are breastfeeding should not take this medicine without consulting a doctor.

Driving and using machines

Rarely, during treatment, mild drowsiness and dizziness may occur; if you experience these symptoms, you should not drive or operate dangerous machinery.

cinfatós antitussive pediatric contains sorbitol (E-420), Ponceau 4R red (E-124), sodium, sodium benzoate (E-211), and propylene glycol (E-1520).

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

This medicine may cause allergic reactions because it contains Ponceau 4R red (E-124).

This medicine contains less than 1 mmol of sodium (23 mg) per ml; i.e., essentially "sodium-free."

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

This medicine contains 6.839 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 medicines containing propylene glycol or alcohol.

3. How to take cinfatós antitussive pediatric

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Children 6 to 11 years of age: Take 5 ml to 10 ml, depending on the severity of the cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 15 ml may be taken every 6 to 8 hours if needed.

The maximum amount allowed in 24 hours is 60 ml, divided into several doses.

Children 2 to 5 years of age: Under medical supervision, take 2.5 ml to 5 ml, depending on the severity of the cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours. Alternatively, 7.5 ml may be taken every 6 to 8 hours if needed.

The maximum amount allowed in 24 hours is 30 ml, divided into several doses.

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

Children under 2 years of age: This medicine is contraindicated in children under 2 years of age.

For administration to adults and children aged 12 years and older, other more suitable formulations are available.

Always use the lowest effective dose.

How to take:

cinfatós antitussive pediatric is taken orally.

Measure the prescribed amount of medicine using the syringe provided inside the package. Rinse the dosing syringe after each use.

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

May be taken with or without food. Do not take with grapefruit juice, bitter orange juice, or alcoholic beverages. (See section: Taking cinfatós antitussive pediatric with food, drinks, and alcohol.)

If symptoms worsen, 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 pediatric than you should

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

Taking very high amounts of this medicine may cause in children drowsiness, nervousness, nausea, vomiting, or disturbances in gait.

Cases of abuse have been reported with medications containing dextromethorphan, which may lead to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (increased heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrollable eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (loss of coordination of movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

Other symptoms in case of massive overdose may include: coma, severe breathing problems, and seizures.

Contact your doctor or hospital immediately if you experience any of the symptoms listed above.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take cinfatós antitussive pediatric

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

During the period of dextromethorphan use, the following adverse effects have been observed, whose frequency cannot be established with accuracy:

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinfatós antitussive pediatric medicine

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Information for the user

Composition of cinfatós antitussive paediatric

• The active substance 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 liquid sorbitol (E-420), sodium saccharin, sodium cyclamate, strawberry flavour (containing propylene glycol (E-1520)) and purified water.

Appearance of the product and contents of the container

cinfatós antitussive paediatric is a clear, red-pink solution with a strawberry flavour, packaged in bottles made of polyethylene terephthalate with a closure fitted with a high-density polyethylene seal. Each bottle contains 125 ml of oral solution and is supplied in a box containing an oral dosing syringe with a scale ranging 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 leaflet was approved in October 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/