CINFATOS COUGH SUPPRESSANT 2 mg/ml ORAL SOLUTION

2. What you need to know before taking cinfatós antitussive

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

Do not take cinfatós antitussive

• 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 severe lung disease.
• If you have asthmatic cough.
• If you have 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 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 antitussive).

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfatós antitussiveif 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, debilitated, or bedridden.
• if you are taking other medications such as antidepressants or antipsychotics, cinfatós antitussive 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, hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

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

Children

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

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

Other medications and cinfatós antitussive

Tell your doctor or pharmacist if you are taking, have recently taken, 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 excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur.

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromine).
• Antidepressant serotonin reuptake inhibitors (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, 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 (to treat heart arrhythmias).

• Anti-inflammatory drugs (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 with food, drinks, and alcohol

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

Do not take with grapefruit or bitter orange juice, as they may increase the side 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

cinfatós antitussive 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 you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

cinfatós antitussive contains ethanol

This medicine contains 0.15 mg of alcohol (ethanol) in each ml, which is 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 in this medicine does not produce any noticeable effect.

cinfatós antitussive contains sodium benzoate (E-211)

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

cinfatós antitussive contains sodium

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

3. How to take cinfatós antitussive

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years old: Take 5 ml every 4 hours if necessary. If due to the intensity of the symptoms it is not enough, you can take 10 ml every 4 hours, if necessary. Do not exceed 6 doses of 60 ml in 24 hours.

You can also take 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 lowest effective dose.

Use in children

Children between 6-11 years old: 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. You can also take 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 side effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

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

Children under 2 years old:it is contraindicated.

How to take:

This medicine is taken orally. Measure with the dosing cup included in the box the amount of medicine to take.

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 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 with food, drinks, and alcohol).

If it worsens, if the cough persists after 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 notice: confusion, excitability, restlessness, nervousness, and irritability.

Taking very high amounts of this medicine can cause children to enter a state of stupor, hallucinations, nervousness, nausea, vomiting, or changes in gait.

There have been reports of abuse with medications containing dextromethorphan, which can cause serious side effects, such as anxiety, panic, memory loss, tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil), agitation, vertigo, gastrointestinal upset, slurred speech, nystagmus (involuntary and uncontrolled eye movement), 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 antitussive than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), coordination disorders, 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 Toxicology Information Service, phone 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 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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal upset, nausea, 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 does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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 special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Contents of the pack and additional information

Composition of cinfatós antitussive

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

The other components are: sorbitol solution 70% (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 pack

cinfatós antitussive is a clear, colorless oral solution with an orange flavor.

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

Only some pack sizes may be marketed.

Each pack 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. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this leaflet:June 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet 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