Cinfatos Antitussive 2 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfatós antitussive 2 mg / ml oral solution

Dextromethorphan hydrobromide

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

Follow exactly the administration instructions for this medicine contained in this leaflet or as 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens, or if you also have high fever, skin rashes or persistent headache, or if you do not improve after 7 days of treatment.

Contents of the leaflet

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

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

Dextromethorphan, the active substance in this medicine, is an antitussive that suppresses the cough reflex.

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

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

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

Do not take cinfatós antitussive

• If you are allergic to dextromethorphan or 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 cough with abundant secretions.
• If you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitor (MAOI) medicines 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).

Warnings and precautions

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

• With persistent or chronic cough, such as that caused by smoking. Particularly 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, crusts, and scaling, which begins 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 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 than you should).

Children

Children under 2 years of age must not take this medicine; it is contraindicated.

Children between 2–6 years: This medicine must not be taken due to the dextromethorphan dose. There are other formulations more suitable for this age group.

Other medicines and cinfatós antitussive

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

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 discontinue treatment:

• Amiodarone and quinidine (used to treat heart arrhythmias).

• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib).

• Central nervous system depressants (some used to treat: mental disorders, allergies, Parkinson's disease, etc.).

• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Taking cinfatós antitussive 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 or breastfeeding women must not take this medicine without consulting a doctor.

Driving and using machines

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

cinfatós antitussive contains sorbitol (E-420)

This medicine contains 571.4 mg of sorbitol per ml.

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

cinfatós antitussive contains ethanol

This medicine contains 0.15 mg of alcohol (ethanol) per ml, equivalent to 0.015% (w/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 antitussive contains sodium benzoate (E-211)

This medicine contains 3.5 mg of sodium benzoate per ml.

cinfatós antitussive contains sodium

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

3. How to take cinfatós antitussive

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 years and older: Take 5 ml every 4 hours if needed. If this dose is not sufficient due to the severity of symptoms, 10 ml every 4 hours may be taken if necessary. Do not exceed 6 doses (60 ml) in 24 hours.

Alternatively, 15 ml may be taken 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 lowest effective dose.

Use in children

Children aged 6–11 years: Take 2.5 or 5 ml every 4 hours, depending on the severity of cough, if needed. Do not exceed 6 doses (30 ml) in 24 hours. Alternatively, 7.5 ml may be taken every 6 or 8 hours, as needed.

The maximum amount that can be taken 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 aged 2–6 years: This medicine must not be taken due to the dextromethorphan dose. Other formulations more suitable for this age group are available.

Children under 2 years of age: Contraindicated.

How to take:

This medicine is for oral use. Measure the required amount using the dosing cup provided in the package.

It can be taken directly.

Wash the dosing cup after use.

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

This medicine may be taken with or without food.

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

If your symptoms worsen, if the cough persists beyond 7 days, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more cinfatós antitussive than you should

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

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

Cases of abuse have been reported with medicines 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 rapid eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (loss of coordination), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

If you take more cinfatós antitussive than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, 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 or pharmacist immediately, 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

Do not take a double dose to make up for missed doses. If you forget 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.

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

4. Possible adverse effects

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

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

• In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rarer 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

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of cinfatós antitussive

Each ml contains 2 mg of dextromethorphan hydrobromide as the active substance.

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

Appearance of the product and contents of the container

cinfatós antitussive is a colorless, transparent oral solution with an orange odor.

The medicine is supplied in a topaz glass bottle with a metal cap and Pilfer Proof seal, or in a topaz polyethylene terephthalate (PET) bottle with a polypropylene cap, containing either 125 ml or 200 ml of oral solution.

Only certain package sizes may be marketed.

Each container is supplied with a dosing cup graduated from 2.5 ml to 15 ml.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: June 2022

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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/57623/P_57623.html

QR code to: https://cima.aemps.es/cima/dochtml/p/57623/P_57623.html